Consequences of long-term use of Diane 35. Geotar medicinal reference book

Diane-35 is not just one of many contraceptives. Gynecologists prescribe it to women with elevated levels of male hormones, as well as for the treatment of infertility. The drug is of German origin and has proven itself well in the European Union. The active substance of this drug inactivates the receptors, making them insensitive to androgens, which are synthesized in the adrenal glands.

Diane-35 instructions for use

Reviews from doctors and patients report that the drug is well tolerated and highly effective . Each tablet Diane-35 coated and contained in blisters of twenty-one pieces each.

Compound

One tablet of the drug contains the following components:

• Cypronetone acetate;
• Ethinyl extradiol.

The drug shell has the following composition:

• Magnesium stearate;
• Talc;
• Corn starch;
• Lactose.

When to use tablets

Reviews from doctors recommend using the drug for hyperandrogenism and to restore hormonal levels. Using Diane-35 as a contraceptive is not effective. It was noticed that if pills to get pregnant quickly. This is due to the fact that the product contains anthrianrogens that suppress male hormones, and this fundamentally distinguishes Diane-35 from other contraceptives. Thus, this drug can be used as a treatment for infertility.

The drug has shown the greatest effectiveness in getting rid of excess hair on the face and body in women. To solve this problem Doctors definitely recommend using Diane-35. Reviews of hairiness can be found on women's forums in quite a large number.

Signs of the disease

With increased levels of male hormones In women, the following symptoms can be observed:

• Baldness or, conversely, increased hairiness;
• Acne on the face;
• General masculinity in appearance.

Instructions for use and dosage

Take one tablet daily from the blister, washed down with water. The time of appointment does not play a special role. You should start using Diane-35 on the first day of the cycle, after which you take a break of seven days and resume taking it.

Side effects of Diane 35

Reviews from women over 35 years old they say that this drug has many undesirable effects:

Contraindications

This drug is contraindicated patients with diabetes mellitus, pregnant women and breastfeeding women. It is not advisable to use the drug for renal failure and liver diseases. The drug is especially dangerous if blood clots are present.

Reviews

At the age of 15, I was diagnosed with PCOS (polycystic ovary syndrome), which means there was practically no menstrual cycle, hirsutism (dark hair above the upper lip), excess weight on the verge of obesity, acne. Hormonal studies showed increased testosterone, cholesterol, T3, free T4, TSH. For hormone therapy, the doctor selected the drug “Diane-35”, which I took for about 9 years with breaks of 2-3 months a year (as prescribed by the doctor). Every year I had an ultrasound of the mammary glands and pelvic organs, donated blood for coagulation and hormones . For me it was perfect.

There were practically no side effects until 2013 (I was prescribed the drug in 2004). No breakthrough bleeding, thrombosis, nausea, weight gain (I lost 20 kg, but this was thanks to proper nutrition and exercise. The pills only supported the cycle - without the pills there is no cycle at all), headaches. I will say right away that PCOS was not cured, but over all these years I had a regular cycle, testosterone dropped to normal, hirsutism almost disappeared, the skin on my face returned to normal and the “tassels” on the ovaries did not increase.

In 2013, severe migraines began (my head hurt like hell for 5 days). Neurologists did not find anything in the head and assumed either it was a side effect of OK, or genetic, or hormonal. After the withdrawal, Diana’s migraines did not go away, but they lasted for 3 days and were not so strong. Doctors are leaning towards genetics (I am an adopted child, I don’t know my biological parents), because hormones and neurology are all fine.

Now I’m 29. I still have the diagnosis of PCOS and the absence of a cycle without hormonal drugs, but hirsutism, excess weight, and increased androgens (male sex hormones) have passed. Girls, before taking this drug, undergo a complete examination of hormones and blood (especially clotting). If a doctor prescribes a similar drug without testing, change the doctor. OK "Diane-35" has a greater therapeutic effect than just contraceptives. Good health to everyone and I wish you never have to deal with my sore!

Anna Russia, Samara

Diana-35 was advised to try by my gynecologist. Before that, I took different birth control pills, some made me gain weight, others disrupted my cycle. I would like to immediately note that these tablets are prescribed to girls with problem skin, here are the indications for use:

Prevention of pregnancy in women with androgenization phenomena (the appearance of male traits in women caused by male sex hormones). Androgenization phenomena (acne /acne/, seborrhea, mild forms of androgenetic alopecia /baldness in women under the influence of male sex hormones/, hirsutism /excessive hair growth in women according to the male pattern/). I did not have any of the listed indications; I took it to prevent pregnancy. After 3 months of use, I noticed that nothing had completely stopped coming out on my face, as happened before before my period, and in general all the unpleasant sensations during menstruation disappeared.

I took Diane for 3 years, during which time I didn’t gain a single extra kg, regular cycles, clear skin. After stopping the pills, I became pregnant 3 months later and gave birth to a healthy child, now I am taking these pills again. Of course, everyone has an individual reaction to the pills, but they work very well for me.

Marina Yarovaya, Krasnoyarsk

This is the second time I have taken Diane-35. The first time I took it was exactly a year. Then I took a break. Here you must strictly adhere to the regimen. It seemed to me that it is better to take it in the evening (I take it at 21.00, as the doctor advised). In the first month of taking it and in the first days, the condition was really not very good (nausea, dizziness, nausea). That’s why it’s better to take it in the evening, so that it’s not all during the day at work, but in the evening. It seemed to me that all these side effects occur in the first hours after taking the pill. Then it returns to normal. But you have to endure it, because then everything becomes normal.

Diana-35 - my review is very positive. Improves the condition of skin and hair. Then menstruation passes painlessly and calmly. If taken for a long time, the amount of hair in unwanted places decreases over time.

But Diana-35, as far as I know, should be taken as prescribed by a doctor, since everyone’s hormonal levels are different and these pills are not suitable for everyone.

Alena Maksakova, Moscow

I did have problems e: irregular cycle (30-60 days), very painful menstruation, even fainting, acne, hair growth on the face and body. My gynecologist is my mother, so, knowing all my problems since I was 12 years old, she prescribed me Diane-35. I've been drinking it for 5 months. Now my cycle begins exactly at the same time, my periods are very small, completely painless, there is no swelling. The acne that plagued my face every month has gone away and my skin has become almost perfect.

My hair became a little less greasy. The “antennae” have become light and invisible, it’s hard to say about the rest of the body, I still remove hair. I did not notice any side effects regarding mood, as well as regarding weight gain - it remained the same as before taking Diane. If you lose weight, you lose weight. The only thing I noticed was a decrease in libido, well, let's say, by half.

Ella Rakitskaya, Kharkov

My friend was diagnosed with a cyst in 2008, she had a hormonal imbalance, sometimes bleeding, her cycle was disrupted, apparently she had a lot of male hormones, she went to the gynecologist, and she advised her to drink Diana-35 first for 3 months, then for another 3 month, everything gradually began to improve for her, her cycle was restored, there was no more bleeding, acne disappeared and she did not gain weight, it was just expensive for her to buy these pills, since they are expensive. And most importantly, she had a peaceful sexual life and did not become pregnant.

I also decided to try these pills as contraceptives, I took them for a month, my cycle was disrupted, and I stopped taking them, maybe they didn’t suit me or I was just afraid of getting fat, in general, I gave up on it. But I’ll say right away that my friend then started drinking Diane-35 for years, but the cyst never got smaller, it just stopped growing, and she couldn’t get pregnant for a long time. She took 1 pill a month, but she also had side effects - headache, nausea, but she endured everything. It is also not recommended to take them on your own; there are many contraindications.

My friend gained 10 kg and stopped drinking them, now she got married, became pregnant and had her cyst removed by cesarean section, she regained her weight. So, contraceptive pills do not always have a positive effect on the female body; in one case they help, in another they cripple...

Valentina Russia, Yoshkar-Ola

I have many years of experience taking Diane-35. I drank them after the birth of my first child, and now I drink them after my second, for a total of fifteen years. Of course, their main and main purpose is a contraceptive effect, but for me this turned out to be not the main thing, I continued taking it even in those periods when there was no sexual life and was not expected for many months. I continued taking it mainly because Diane-35 saved me from long (up to 7 days), heavy and painful periods. With Diane, I sometimes forget that I have “critical days”, they pass so unnoticed, I don’t even stop going to the gym.

In one of the first years of taking the drug, the doctor advised me to take periodic breaks from taking the drug, but after one time I decided that I would not do this again. After all, only after a few months had the body adapted to the new regime, and then they gave it a new blow. As a result, the cycle began to dance from 20 to 50 days and became even heavier, so from personal experience I will say that you should not take breaks if you are not going to give birth to a child. The antiandrogenic effect of the drug Diane-35 is also very important in my case, because these problems are especially pronounced in me.

It will not be possible to get rid of them completely, the case is too severe, and Diane for me is the most painless and effective option: acne has been reduced to almost zero, the oiliness of the skin and hair has noticeably decreased. In general, this drug suits me, and specifically as a medicine, and the contraceptive effect is an additional bonus, albeit a very significant one. For all the time that I have been taking Diane, I have not noticed a decrease in libido, weight gain, or other side effects that are usually talked about when mentioning hormonal drugs.

Alexandra, Brovary

When my husband and I were planning to plan our first child, I decided to go to the gynecologist to get examined and, as it turned out, it was not in vain. She diagnosed me with a small uterus. Normally, its length in nulliparous women is 7 cm, I had only 3 cm. The doctor told me that with this size I was unlikely to get pregnant, and it was better, in order not to waste time and grow the uterus, to start taking birth control pills. This was 9 years ago, then Diane-35 tablets were very popular, so I was prescribed them for six months.

I had no choice, I had to drink. I’ll say right away that while taking them I didn’t have any side effects, even the skin on my face improved, there were fewer acne spots and the oily sheen decreased, BUT for six months of taking them, or rather, it turned out to be seven months, I gained 12 kg, it was terrible , I couldn’t stop drinking them, and I got better every day.

As a result, I grew my uterus by 1.1 cm during this time, but the visible volumes were larger (((The doctor allowed me to try to get pregnant, although the sizes were still too small, and I decided to stop drinking them and take a risk. I managed to get pregnant immediately, within a During pregnancy, I gained another 16 kg and not a trace remained of my former cane (50 kg with a height of 171 cm). A year after giving birth, I lost these 16 kg, but the ones I gained with Diane-35 remained. I’ve never taken them and I don’t recommend them, besides, there are now many more modern low-dose pills that don’t cause such weight gain.

Polina Krasilova, Chita

The pills worked for me at first, my breasts noticeably enlarged, although I didn’t gain an ounce from them, but, on the contrary, I even lost a little weight. The cycle began to run regularly. I also noticed that the hair on my legs began to grow more slowly. If I had to shave my legs every day, now I could do it less often. Before this I suffered from hair loss problem, but now even that has gone away. My hair became thicker and even grew longer. Also, my nails stopped peeling and constantly breaking, I was able to grow my long and beautiful nails.

But there is still one drawback. Inflammations began to appear on my face, which I had never experienced before. They began to appear in the fourth month of treatment and they became more numerous, but I decided to finish the course and again follow the doctor’s recommendations.

Now this disgusting thing on my face is starting to disappear. It’s a shame that in this respect they didn’t suit me, because in other respects they are simply excellent tablets.

Ksenia T., Voronezh

I took Diane-35 as “self-prescribed” - I was not afraid of pregnancy. In 5 years of living together with a guy and having regular sex with him without protection, there has never been a pregnancy. But after a course of antibiotics, the cycle went wrong, some vague discharge began, the skin deteriorated, and I unwisely (only now I understand that I was lucky by accident, and I shouldn’t have done this) chose Diane-35 based on reviews. In total, I took them for four months.

1 month - I didn’t notice any special changes, but I didn’t identify any side effects either, except for weakness at the end of the day, but it was most likely caused by the wild work schedule. My period started on time, painless, light, and ended in three days (happiness knew no bounds, of course).

2 months - the condition of the skin has improved, I noticed that I have to adjust the “moustaches” less often. My period came on time, quite heavy, but painless. Finished in 4 days.

3 month - stepped on the scales, noted minus 4 kg (extra 4 kg stuck, faithful to me). My skin is completely fine; I have never felt such delight in my life. My period came on the fourth day after it was supposed to, I anointed myself and left. In bewilderment, I decided to continue taking the pills in the hope that this was a temporary glitch and an adaptation of the body.

4th month - period did not come at all. That is, I walked around shamelessly beautiful, thin and happy, but without menstruation. The gynecologist passed off the well-deserved Lyulya for self-prescription, said that there was too much hormone for me and that it was time to stop with Diana and switch to softer contraceptives.

I stopped taking the pills, my skin deteriorated a little, and the weight did not return. 2 weeks after I stopped taking it, my unexpected and best friend, the joy of every day, a big-eared monkey, a beautiful big-butted daughter, settled in and subsequently grew up in me. I still don’t understand what exactly Diana-35 did to my body, which had been resistant to new life for 5 years, but the result exceeded all our expectations))

So I remember taking the pills with tenderness and trepidation, without them now I wouldn’t feel so fussy and wonderful, but it’s a shame that the pills didn’t work for me as a contraceptive and “stopped” my periods. I still remember the condition of the skin and the body as a whole with delight)

P.S. Dear girls, my luck with my skin and weight is an accident. Please get your hormones tested before you start taking hormonal pills. This will keep you out of trouble. Well, if, like us, hormonal contraceptives suddenly bring a new family member - rejoice and dance, and don’t cry and be indignant - this will be the best turn of events in life)))

Both active ingredients included in the drug Diane-35 have a positive effect on the state of hyperandrogenism. Cyproterone acetate is a competitive antagonist of androgen receptors; it inhibits the synthesis of androgens and determines a decrease in the concentration of these hormones in the blood due to an antigonadotropic effect. This antigonadotropic effect is enhanced by ethinyl estradiol, which also regulates the synthesis of sex steroid binding globulin (SHBG) in the blood plasma. Taking this into account, the level of unbound biologically available androgen in the blood decreases.
When using the drug Diane-35 (usually after 4 months of therapy), acne is eliminated, excessive oily hair and skin disappears even earlier. Hair loss, which often accompanies seborrhea, is also reduced. When using the drug by persons with mild forms of hirsutism (primarily with mild facial hair), the results of therapy should be expected only after several months from its start.
The contraceptive effect of the drug Diane-35 is based on the interaction of various factors, the most important of which are suppression of ovulation and changes in cervical secretion. In addition to preventing pregnancy, the drug has a number of positive properties. The menstrual cycle becomes more regular, menstruation is less painful, and blood loss decreases. The latter helps reduce the incidence of iron deficiency anemia.
The toxicity profile of ethinyl estradiol has been well studied. There are no preclinical data to supplement the information regarding the safety of ethinyl estradiol indicated in the sections of the instructions for medical use of the drug.
Data from standard preclinical toxicity studies following repeated use of cyproterone acetate do not indicate the existence of any specific risk to the human body.
Available clinical experience does not suggest an increased incidence of liver tumors in humans. Carcinogenicity studies of cyproterone acetate in rodents do not indicate the existence of any specific carcinogenic effect. However, it should be taken into account that sex steroids may promote the growth of certain pre-existing hormone-dependent tumors.
Available data provide no basis to oppose the use of Diane-35 in humans when taken in accordance with the instructions provided and at the recommended dose.
Cyproterone acetate
After oral administration, cyproterone acetate is rapidly and completely absorbed. Its peak serum concentration is 15 ng/ml and is achieved approximately 1.6 hours after a single dose. The bioavailability of cyproterone acetate is approximately 88%.
Cyproterone acetate is almost completely bound to albumin in the blood serum. Only 3.5-4% of the total steroid concentration remains in an unbound state. Ethinyl estradiol-induced increase in SHPS levels does not affect protein binding of cyproterone acetate.
Cyproterone acetate is almost completely metabolized. The main metabolite in blood plasma is 15b-OH-CPA. The clearance rate from serum is approximately 3.6 ml/min/kg.
The concentration of cyproterone acetate in the blood serum decreases biphasically, with half-lives of 0.8 hours and 2.3-3.3 days. Some of the steroid is excreted unchanged. Metabolites are excreted in urine and bile in a 1:2 ratio. The half-life of metabolites is 1.8 days.
Taking into account the long half-life of cyproterone acetate from blood serum, its accumulation in the blood serum can be observed during one cycle of therapy with a coefficient of 2-2.5.
Ethinyl estradiol
Adsorption
When taken orally, ethinyl estradiol is rapidly and completely absorbed. Peak serum concentrations of approximately 71 pg/mL are achieved after 1.6 hours.
Distribution
Ethinyl estradiol binds strongly, but not specifically, to serum albumin (approximately 98%) and induces an increase in serum SHBG concentrations.
Ethinyl estradiol is metabolized mainly by aromatic hydroxylation, resulting in a large number of hydroxylated and methylated metabolites, among which there are both free metabolites and conjugates with glucuronides and sulfates. Clearance is 2.3-7 ml/min/kg.
Serum ethinyl estradiol levels decrease in 2 phases with half-lives of approximately 1 and 10-20 hours, respectively. The substance is not excreted from the body unchanged; ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6. The half-life of metabolites is approximately 1 day.
Equilibrium concentration is achieved in the second half of the administration cycle, when the level of the active substance in the blood serum is 60% higher compared to a single dose.

Indications for use of the drug Diane-35

Treatment of androgen-dependent diseases in women, such as acne, especially severe forms and forms accompanied by seborrhea, inflammation or nodule formation (papular-pustular acne, nodular cystic acne), androgenic alopecia and mild forms of hirsutism.

Use of the drug Diane-35

The drug Diane-35 is intended for regular use in order to achieve a therapeutic effect and the necessary contraceptive protection. The use of other hormonal contraceptives should be discontinued. The method of using Diane-35 does not differ from the usual regimen for taking most combined oral contraceptives. Taking this into account, the same instructions regarding the method of use of the drug should be followed. Irregular use of Diane-35 may cause intermenstrual bleeding and impair therapeutic and contraceptive effectiveness.
If hormonal contraceptives were not used in the previous period (last month)
Taking the pills should start on the 1st day of the menstrual cycle. You can start taking it from the 2-5th day, but in this case, during the first cycle, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the drug.
Switching from another combined oral contraceptive (COC)
It is advisable to start taking Diane-35 the day after taking the last active tablet of the previous COC, at least no later than the next day after a break in taking pills or after taking placebo tablets of the previous COC.
Switching from a progestogen-only method (mini-pills, injections, implants) or a progestogen-containing intrauterine system
You can start taking Diane-35 any day after you stop taking the mini-pill (for an implant or intrauterine system - on the day of their removal; in the case of an injection - instead of the next injection). However, in all cases it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pill.
After an abortion in the first trimester of pregnancy
You can start using Diane-35 immediately. In this case, she does not need to use additional contraception.
After childbirth or abortion in the second trimester of pregnancy
If breastfeeding, see subsection " During pregnancy and breastfeeding".
It is recommended to start taking the drug Diane-35 from the 21st to 28th day after childbirth or abortion in the second trimester of pregnancy. If you start taking the pill later, you should additionally use a barrier method of contraception during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting to use the PDA it is necessary to exclude pregnancy or wait until menstruation.
What to do if you miss a pill dose
If the delay in taking the pill does not exceed 12 hours, the contraceptive effect of the drug is not reduced. The missed pill should be taken as soon as possible. The next pill from this package is taken at the usual time.
If the delay in taking the missed pill exceeds 12 hours, contraceptive protection may decrease. In this case, you can be guided by two basic rules:

• a break in taking pills can never exceed 7 days;
• Adequate suppression of the hypothalamus-pituitary-ovarian system is achieved by continuous intake of the pill for 7 days.

Accordingly, the following recommendations should be followed in daily life:

• 1st week
  You should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. In addition, over the next 7 days you must use a barrier method of contraception, such as a condom. If you had sexual intercourse in the previous 7 days, you need to take into account the likelihood of pregnancy. The more pills you miss and the closer the break in taking the drug, the higher the likelihood of pregnancy.
• 2nd week
  You should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. If you take the tablets correctly for 7 days before the first missed period, there is no need to use additional contraceptives. In another case or if more than 1 pill is missed, it is recommended to additionally use a barrier method of contraception for 7 days.
• 3rd week
  The risk of decreased reliability increases as the break in taking the pill approaches. However, if you follow the regimen for taking pills, you can avoid a decrease in contraceptive protection. If you adhere to one of the following options, there will be no need to use additional contraceptives, provided you take the tablets correctly for 7 days before the missed period. If this is not the case, you must adhere to the first of the following options and use additional methods of contraception for the next 7 days.

You should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. Dragees from the next package must be taken immediately after finishing the previous one, that is, there should be no breaks between packages. It is unlikely that menstrual-like bleeding will begin by the end of the second package, although spotting or breakthrough bleeding is possible while taking the pills.
You may also be advised to stop taking the tablets from the current package. In this case, the break in taking the drug should be up to 7 days, including days of missing pills; You must start taking the pills from the next package.
If a pill is missed and the patient does not have menstrual bleeding during the first regular break from taking the pill, the possibility of pregnancy should be excluded.
Recommendations for gastrointestinal disorders
In case of severe gastrointestinal disorders, incomplete absorption of the drug is possible; in this case, additional contraception should be used.
If vomiting occurs within 3-4 hours after taking the pills, it is advisable to use the recommendations regarding skipping pills. If a woman does not want to change her usual regimen of taking the drug, she needs to take additional pill(s) from a different package.
How to change the timing of your period or how to delay your period
To delay the appearance of menstruation, you should continue to take Diane-35 tablets from a new package and not take a break from taking the drug. If desired, the period of administration can be continued until the end of the second package. In this case, breakthrough bleeding or spotting cannot be ruled out. The usual intake of the drug is restored after a 7-day break from taking the pills.
To shift the onset of menstruation to another day of the week, it is recommended to shorten the break in taking pills by the desired number of days. It should be noted that the shorter the break, the more often the absence of menstrual-like bleeding and breakthrough bleeding or spotting while taking the pills from the second package (as in the case of a delay in the onset of menstruation).

Contraindications to the use of the drug Diane-35

COCs should not be used if you have at least one of the following conditions or diseases. If any of these conditions or diseases occur for the first time while using a COC, the drug should be stopped immediately.
Venous or arterial thrombotic/thromboembolic events (eg deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorders, current or in history.
The presence or history of prodromal symptoms of thrombosis (transient cerebrovascular accident, angina pectoris).
History of migraine with focal neurological symptoms.
Diabetes mellitus with vascular damage.
The presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see).
Current or history of pancreatitis if associated with severe hypertriglyceridemia.
Current or history of severe liver disease until liver function tests return to normal.
Liver tumors (benign or malignant) - diagnosed or present in history.
Diagnosed or suspected malignant tumors (for example, genitals or mammary glands) that are dependent on sex hormones.
Vaginal bleeding of unknown etiology.
Diagnosed or suspected pregnancy.
Hypersensitivity to the active substances or to any of the components of the drug.
The drug Diane-35 is not prescribed to men.

Side effects of the drug Diane-35

Side effects have been reported when using Diane-35, but their connection with the use of the drug has been neither confirmed nor refuted:

Organs and systems	Frequent (≥1/100)	Uncommon (≥1/1000 and ≤/100)	Single (≤1/1000)
			Contact lens intolerance
	Nausea, abdominal pain	Vomiting, diarrhea
The immune system			Hypersensitivity
Study	Weight gain		Reducing body weight
Metabolism and nutritional disorders		Fluid retention
Mental disorders	Depressed state, mood disturbance	Decreased libido	Increase libido
Reproductive system and mammary glands			Changes in vaginal secretion, the appearance of secretion from the mammary glands
Skin and subcutaneous tissues		Skin rashes, urticaria	Erythema nodosum, exudative erythema multiforme

Special instructions for the use of the drug Diane-35

Clinical data regarding estrogen/progestogen combinations, such as Diane-35, are based on experience with the use of COCs. With this in mind, the following warnings regarding taking COCs also apply to this drug.
If any of the following conditions/risk factors are present, it is necessary to evaluate the benefits of using Diane-35 and the possible risks, taking into account the individual characteristics of each patient and discuss this with her before she decides to take the drug. If any of the following conditions or risk factors become worse, worse, or occur for the first time, it is recommended that you consult your doctor. The doctor must decide whether to stop using Diane-35.
Circulatory disorders
Based on the results of epidemiological studies, there is an association between the use of COCs and an increased risk of venous and arterial thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These conditions occur rarely.
Venous thromboembolism (VTE), manifested as venous thrombosis and/or pulmonary embolism, can occur with the use of any COC. The risk of venous thromboembolism is highest during the 1st year of COC use. The incidence of VTE in patients taking oral contraceptives with a low dose of estrogens (≤0.05 mg ethinyl estradiol) is up to 4 cases per 10,000 women/year compared with 0.5-3 cases per 10,000 women/year in women not using oral contraceptives. The incidence of VTE associated with pregnancy is 6 cases per 10,000 women/year.
Thrombosis of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, cerebral vessels or retina, has been extremely rarely reported in women using COCs. There is no consensus regarding the connection between these complications and the use of PDAs.
Symptoms of venous or arterial thrombotic/thromboembolic events or stroke may include: unilateral lower extremity pain or swelling; sudden severe chest pain radiating to the left arm; sudden shortness of breath; sudden onset of cough; any unusual, severe, prolonged headache; sudden decrease or complete loss of vision; diplopia; speech impairment or aphasia; vertigo; collapse with or without partial epileptic seizure; weakness or very severe sudden numbness of one side or one part of the body; motor impairment; symptoms of acute abdomen.
Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or stroke:

• age;
• tobacco smoking (in combination with heavy smoking and with age, the risk increases, especially in women over 35 years of age);
• family history (for example, cases of venous or arterial thromboembolism in siblings or parents at a relatively early age). If a hereditary predisposition is suspected, before a decision is made on the use of any COC, the patient should be referred for consultation to an appropriate specialist;
• obesity (body mass index - more than 30 kg/m2);
• dyslipoproteinemia;
• AH (arterial hypertension);
• heart valve pathology;
• atrial fibrillation;
• prolonged immobilization, radical surgical interventions, any surgical operations on the lower extremities, significant injuries. In these cases, it is recommended to stop using the COC (for planned operations at least 4 weeks before they are performed) and not restore it earlier than 2 weeks after complete remobilization.

There is no consensus regarding the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other diseases that may be associated with serious circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increased incidence of migraine or its exacerbation during the period of use of COCs (which may be a harbinger of cerebrovascular accident) requires urgent cessation of COC use.
Biochemical indicators characteristic of hereditary or acquired susceptibility to venous or arterial thrombosis include: activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies).
When analyzing the risk/benefit ratio, the doctor must take into account that adequate treatment for the conditions mentioned above can reduce the associated risk of thrombosis, and also that the risk of thrombosis associated with pregnancy is higher than with the use of COCs in low doses (≤0.05 mg ethinyl estradiol).
Tumors
The most important risk factor for the development of cervical cancer is the persistence of papillomavirus. Some epidemiological studies suggest an additional increase in this risk with long-term use of COCs, however, this statement is controversial because the extent to which the study results take into account concomitant risk factors, such as cervical smears and sexual behavior, including the use of barrier methods of contraception, is unclear. .
The results of a meta-analysis based on data obtained from 54 epidemiological studies indicate a slight increase in the relative risk (RR = 1.24) of developing breast cancer in women using COCs. This increased risk gradually disappears within 10 years of stopping taking COCs. Because breast cancer is rarely diagnosed in women under 40 years of age, the increase in breast cancer diagnosis among current or recent COC users is small relative to the overall risk of breast cancer. The results of these studies do not provide evidence of a causal relationship. The increased risk may be due to both earlier diagnosis of breast cancer in women using COCs, the biological effects of COCs, or a combination of both factors. There has been a tendency that breast cancer detected in women who have ever taken COCs is clinically less severe than in those who have never taken COCs.
In isolated cases, benign, and even less often, malignant liver tumors were noted in women using COCs, which sometimes led to life-threatening intra-abdominal bleeding. If there are complaints of severe pain in the epigastric region, liver enlargement or signs of intra-abdominal bleeding, the differential diagnosis should take into account the possibility of a liver tumor in women taking COCs.
Other conditions
Women with hypertriglyceridemia or a family history of this disorder are at risk of developing pancreatitis when using COCs.
Although slight increases in blood pressure have been reported in many women taking COCs, clinically significant increases in blood pressure are rare. However, if prolonged clinically significant hypertension (arterial hypertension) occurs while taking a COC, then it is sometimes advisable to discontinue the COC and direct treatment to the hypertension (arterial hypertension).
The occurrence or exacerbation of the following diseases has been reported during pregnancy and with the use of COCs, but their relationship with the use of COCs has not been conclusively established: jaundice and/or pruritus associated with cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis.
In acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function tests return to normal. If cholestatic jaundice relapses, which first occurred during pregnancy or previous use of sex hormones, taking COCs should be discontinued.
Although COCs may affect peripheral insulin resistance and glucose tolerance, there are no data regarding the need to change the therapeutic regimen in women with diabetes mellitus taking low-dose COCs (containing ≤0.05 mg ethinyl estradiol). However, women with diabetes should be closely monitored while taking COCs.
Crohn's disease and ulcerative colitis may be associated with COC use.
Chloasma can sometimes occur, especially in women with a history of chloasma during pregnancy. Women prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking COCs.
Medical examination
Before starting or resuming taking Diane-35, you should conduct a full medical examination and study the patient’s medical history in detail, taking into account contraindications (see) and warnings (see). When using COCs, periodic examinations are recommended, which is very important, since contraindications (for example, transient circulatory disorders, etc.) or risk factors (for example, a family history of venous or arterial thrombosis) may arise for the first time while taking the drug.
The frequency and nature of these examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each woman, however, special attention is paid to examination of the pelvic organs, including standard analysis of cytology of the cervix, abdominal organs, mammary glands, determination of blood pressure.
It is necessary to warn the woman that Diane-35, like other oral contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of Diane-35 may be reduced if a pill is missed, gastrointestinal dysfunction or other medications are used.
Cycle control
When taking oral contraceptives, intermenstrual bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months of treatment. Taking this into account, examination in the event of any intermenstrual bleeding should be carried out only after a period of adaptation of the body to the drug, which is approximately 3 cycles.
If cycle irregularities continue or recur after several normal cycles, non-hormonal causes of bleeding should be considered and appropriate investigations should be carried out to exclude the presence of a tumor or pregnancy. Diagnostic measures can include curettage.
Some women may not experience menstrual bleeding during a break from taking the drug. Pregnancy is unlikely when you take COCs as directed. However, if the contraceptive is taken irregularly or if menstrual-like bleeding is absent for 2 cycles, pregnancy must be excluded before continuing to take the COC.
During pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. If pregnancy occurs while using the drug Diane-35, the drug should be discontinued. However, according to the results of embryotoxicity studies when using a combination of two active components of the drug, there was no confirmation of the teratogenic effect of the drug during organogenesis. Although taking cyproterone acetate in high doses during the hormone-sensitive phase of genital differentiation causes the appearance of female sexual characteristics in male fetuses, during the observation of newborn boys whose mothers took cyproterone acetate during pregnancy, no female sexual characteristics were detected.
The use of Diane-35 is contraindicated during breastfeeding. Cyproterone acetate passes into breast milk. About 0.25% of the dose of cyproterone acetate taken by the mother enters the child's body with milk, which corresponds to 1 mcg/kg body weight and 0.2% of the daily dose of ethinyl estradiol.
Impact on the ability to drive vehicles and operate machinery
No effect noted.

Interactions of the drug Diane-35

Interactions between drugs containing a combination of estrogen/progestagen (such as Diane-35) and other drugs may lead to breakthrough bleeding and/or loss of contraceptive effectiveness. The following interactions have been reported in the literature.
Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, which can cause an increase in the clearance of sex hormones (for example, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs containing St. John's wort) .
Interaction with the enterohepatic circulation: The results of some clinical studies suggest that the enterohepatic circulation of estrogens may be reduced when taking certain antibiotics that reduce ethinyl estradiol concentrations (for example, penicillin and tetracycline antibiotics).
When treating any of the above drugs, a woman should temporarily use a barrier method in addition to taking Diane-35 or choose another method of contraception. When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When treating with antibiotics (excluding rifampicin and griseofulvin), the barrier method should be used for another 7 days after discontinuation of the antibiotic. If the barrier method is still being used, and the tablets in the Diane-35 package have already run out, taking the tablets from the next package should be started without the usual break.
Oral contraceptives containing estrogen/progestogen (such as Diane-35) may affect the metabolism of other drugs. Therefore, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change.
Note. To establish the potential for interaction with drugs that are prescribed concomitantly with Diane-35, it is recommended that you read the instructions for the medical use of these drugs.
Impact on laboratory results
Taking contraceptives such as Diane-35 may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, and plasma levels of proteins (carriers) such as sex-binding globulin hormones and lipid/lipoprotein fractions, carbohydrate metabolism parameters, as well as coagulation and fibrinolysis parameters.

Overdose of the drug Diane-35, symptoms and treatment

No serious adverse effects due to overdose have been reported. The following symptoms of overdose are possible: nausea, vomiting, and in young girls - slight bleeding from the vagina. There are no specific antidotes treatment must be symptomatic.

Storage conditions for the drug Diane-35

At a temperature not exceeding 30 °C.

List of pharmacies where you can buy Diane-35:

• Saint Petersburg

Monophasic low-dose oral contraceptive containing cyproterone acetate, a progestogen with a pronounced antiandrogenic effect.

DIANA 35 - “Gold standard” in the treatment of androgen-dependent diseases in women:

• Relieves acne, especially common forms and forms accompanied by seborrhea, inflammation or nodule formation (papular-pustular acne, nodular cystic acne), androgenetic alopecia and mild forms of hirsutism. reduces skin greasiness.
• Well tolerated

INSTRUCTIONS FOR USE

Composition and release form
coated pellets:
1 tablet contains ethinyl estradiol 35 mcg and cyproterone acetate 2 mg; 21 pcs. packaged.

pharmachologic effect
Diane-35 is a combined low-dose monophasic oral contraceptive with an antiandrogenic effect, containing estrogen - ethinyl estradiol and an antiandrogen with gestagenic activity - cyproterone acetate.

Cyproterone acetate contained in Diana-35 inhibits the influence of androgens, which are also produced in the female body. Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.

While taking it, the increased activity of the sebaceous glands, which plays an important role in the occurrence of acne and seborrhea, decreases. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness in hair and skin disappears even earlier. Hair loss, which often accompanies seborrhea, is also reduced. Therapy for women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of treatment should be expected only after several months of use.

Cyproterone acetate also has a pronounced gestagenic effect.

The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation and changes in the secretion of cervical mucus. The cycle becomes more regular, painful menstruation is less frequent, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia.

Indications
Contraception in women with androgenization phenomena;
Androgen-dependent diseases in women: acne (especially its severe forms, accompanied by seborrhea, inflammation with the formation of nodes), androgenic alopecia and mild forms of hirsutism.

Contraceptive effect
Can be used for long-term contraception as a first-choice drug, especially in women with acne, seborrhea, oily skin and excess hair growth (hirsutism). If it is necessary to enhance the antiandrogenic effect, it can be combined with Androcur 10®. Before prescribing Diane-35® for contraception, there is no need for a special examination that differs from the usual examination before prescribing combined oral contraceptives. Medical examination of women taking Diana-35® is also carried out according to the usual scheme.


Therapeutic effect
Due to the antiandrogenic properties of Diana-35®. Clinically, the antiandrogenic effect is manifested in eliminating acne, reducing the secretion of sebaceous glands, improving hair growth on the head, and reducing hair growth in androgen-dependent areas.

Directions for use and doses
Diane-35 is taken orally, 1 tablet per day. The pills are taken without chewing and washed down with a small amount of liquid at the same time, preferably after breakfast or dinner.

Reception begins on the 1st day of the cycle, using tablets of the corresponding day of the week from the calendar package. After finishing taking all 21 tablets from the calendar pack, a break of 7 days is taken, during which menstrual-like bleeding occurs. After 28 days from the start of taking the drug (21 days on and 7 days off), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.

After abortion in the first trimester of pregnancy the woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the second trimester of pregnancy Taking Diane-35 should start on days 21-28. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill.

Missed jelly bean the woman should take it as soon as possible, the next tablet is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pill is more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that the administration of the tablet should never be interrupted for more than 7 days, and that 7 days of continuous administration of the tablet are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

If the delay in taking Diane 35 tablets was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed tablet as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days.

If the delay in taking the pill is more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time ). The next pill is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is finished, i.e. nonstop. Most likely, the woman will not experience withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough uterine bleeding on the days she takes the pill.

If a woman has vomited within 3 to 4 hours after taking Diana-35, absorption of the active substances may be incomplete. In this case, you need to follow the recommendations when skipping pills.

In order to delay the onset of menstruation, a woman should continue taking pills from a new package immediately after all pills from the previous one have been taken, without interruption. The pills from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Diane-35 from a new package after the usual 7-day break.

In order to postpone the start of menstruation to another day of the week, a woman should shorten the next break from taking Diane-35 tablets by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).

At treatment of hyperandrogenic conditions The duration of treatment is determined by the severity of the disease. After the symptoms disappear, it is recommended to take Diana-35 for at least another 3-4 months. If a relapse occurs several weeks or months after completion of the course, repeated therapy can be performed.

Side effect
From the endocrine system: in rare cases - engorgement, soreness, enlargement of the mammary glands and discharge from them, change in body weight.
From the reproductive system: in rare cases - intermenstrual bleeding, changes in vaginal secretion, changes in libido.
From the side of the central nervous system: in rare cases - headache, migraine, decreased mood.
From the digestive system: in rare cases - nausea, vomiting.
Other: in very rare cases - poor tolerance to contact lenses, allergic reactions, the appearance of age spots on the face (chloasma).

These side effects may develop in the first few months of use and usually decrease over time.

Contraindications
- thrombosis and thromboembolism, incl. history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
- diabetes mellitus complicated by microangiopathies;
- the presence of severe or multiple risk factors for venous or arterial thrombosis;
- diseases or severe liver dysfunction;
- liver tumors (including in history);
- hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including in history);
- uterine bleeding of unknown etiology;
- pancreatitis (including a history), if it was accompanied by severe hypertriglyceridemia;
- a history of migraine, which was accompanied by focal neurological symptoms;
- lactation (breastfeeding);
- pregnancy or suspicion of it;
- hypersensitivity to the components of the drug.

special instructions
Before starting to use Diana 35, it is necessary to conduct a general medical examination (including mammary glands and cytological examination of cervical mucus), exclude pregnancy and disorders of the blood coagulation system. With long-term use, preventive control examinations must be carried out every 6 months.

If there are risk factors, the potential risk and expected benefit of therapy should be carefully assessed and discussed with the woman before she decides to start taking Diana 35. If any of these conditions or risk factors worsen, worsen, or appear for the first time, discontinuation of the drug may be necessary .

The patient should be warned that if symptoms of venous or arterial thrombosis develop, she should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain radiating to the left arm or without radiating; sudden shortness of breath; sudden attack of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraines; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with/without partial seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.

The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diana-35 should be discontinued and appropriate antihypertensive therapy prescribed. Taking the contraceptive can be continued if blood pressure normalizes.

If liver dysfunction occurs, temporary discontinuation may be required until laboratory parameters normalize. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking combined oral contraceptives. If symptoms have recently developed or become significantly worse in women with hirsutism, other causes, such as androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.

While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) may sometimes occur, especially during the first months of therapy. Therefore, any irregular bleeding should only be assessed after an adaptation period to Diana 35 of approximately 3 cycles. If irregular bleeding recurs or develops after previous regular cycles, non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignancy or pregnancy. These may include diagnostic curettage.

In some cases, withdrawal bleeding may not develop during a break in taking the pill. If you do not take the pill regularly or if there are no two menstrual-like bleedings in a row, pregnancy should be excluded before continuing to take the drug.

Drug interactions
When used simultaneously with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and also possibly with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinyl estradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or reduced contraceptive reliability . When used simultaneously with ampicillins and tetracyclines, the contraceptive reliability of Diane-35 is reduced.

Diane 35 is a low-hormone contraceptive pill that can be used as a method of contraception, or as a treatment for acne, seborrhea, and other diseases accompanied by an increase in the level of androgens (male sex hormones) in the blood.

ATTENTION: The drug has contraindications. Do not start using this drug without first consulting your doctor.

Composition of tablets and packaging

Diane 35 belongs to the group of monophasic drugs. This means that all tablets (dragées) in the package contain the same dose of hormones. One tablet of Diane 35 contains 35 mcg of ethinyl estradiol and 2 mg of cyproterone acetate. Cyproterone acetate, which is part of Diane 35, provides an antiandrogenic effect (fights increased testosterone in the blood).

One blister contains 21 tablets. One package of Diane 35 contains 3 or 6 blisters.

Advantages of Diana 35

Diane 35 has a reliable contraceptive effect, which is achieved mainly by suppressing ovulation in the ovaries. The effect of the drug is reversible, so immediately after discontinuation of Diana 35, pregnancy becomes possible again.

The oral contraceptive Diane 35 has a powerful antiandrogenic effect, so it can be prescribed for acne, seborrhea, hirsutism (excessive body hair growth), hair loss (androgenetic alopecia).

This drug can be prescribed in the treatment of infertility due to polycystic ovary syndrome. To achieve the effect, Diane 35 must be taken for 3-6 months. After stopping the pills, the chances of natural ovulation increase significantly.

While taking these pills, the menstrual cycle is restored, menstruation becomes less painful, and the amount of blood loss during menstruation decreases.

Rules for admission to Diana 35

Diana 35 should be taken one tablet per day, regardless of meals (before or after meals), at any convenient time of the day. The incidence of side effects is significantly reduced if you take the tablets in the evening, before bed.

It is advisable to take the tablets at the same time every day.

If you have not used any hormonal contraceptives in the past month

You need to start taking Diana 35 on the first day of the menstrual cycle. The first day of the menstrual cycle is considered the day when the first spotting appears, even if it is not heavy. After you start taking Diane 35, your periods may stop: this is normal and is associated with the start of taking hormones. It is also possible that your periods will not stop, but on the contrary, will drag on for 7-10 days or more. This is also normal.

Take one Diane 35 tablet once a day for 21 days in a row. After the pack is finished, take a break for 7 days and start a new pack on the eighth day. During a week-long break, menstrual-like bleeding (menstruation) may occur. Your periods may not be as heavy as usual. This is fine.

When will the contraceptive effect occur?

If you start taking the pills on the first day of your period, the contraceptive effect occurs immediately. You may no longer use other methods of protection against pregnancy.

If you take the first pill from the 2nd to the 5th day of your period, the contraceptive effect will occur after 7 days. In this case, Diana 35 needs to use condoms for another 7 days after starting to take it.

Will the contraceptive effect continue after a week's break?

Provided that the pills are taken correctly (without omissions and without factors that reduce the effect of OK), the contraceptive effect of Diane 35 is maintained even during the 7-day break between packs.

How to switch to Diana 35 from other birth control pills?

If your previous birth control pills contained 21 tablets in a blister pack:

You can start taking Diane 35 the next day after the last tablet taken of the previous OC, or

on the eighth day after the end of the previous OK

If your previous birth control pills contained 28 tablets per blister:

You can start taking Diane 35 the day after the last active tablet you took, or

the next day after drinking 28 tablets of the previous OK

If you did not manage to start taking Diane 35 within the specified time frame, then you should wait until your next menstruation and take the first tablet on the first day of your period. To avoid unwanted pregnancy, you should use or before starting to take the pills.

How to switch to Diana 35 from a vaginal ring or from a hormonal patch?

You can take the first Diane 35 tablet on the day of removal of the vaginal ring or on the day when you needed to install a new vaginal ring or attach a new patch.

How to switch to Diana 35 from an intrauterine device (IUD)?

You need to start taking Diana 35 on the day of removal. To avoid unwanted pregnancy, use condoms for the first 7 days after starting birth control pills.

How to start taking Diana 35 after an abortion?

After an abortion in the early stages of pregnancy (up to 12 weeks), you need to start taking Diane 35 on the day of the abortion. In this case, the contraceptive effect occurs immediately and additional contraceptives are not needed.

After an abortion during a pregnancy of 12 weeks or more, you need to start taking Diane 35 on days 21-28 after the abortion (use condoms before starting Diane 35). In this case, the contraceptive effect occurs immediately and additional contraceptives are not needed. If taking the pills was started later, it is recommended to use additional contraception (condoms) for another 7 days after starting to take Diane 35.

How to start taking Diana 35 after giving birth?

You can start taking pills on days 21-28 after birth. In this case, the contraceptive effect occurs immediately and additional contraceptives are not needed. If you started taking Diane 35 later, you need to use condoms for another 7 days.

If after giving birth and before starting to take Diane 35 you had unprotected sexual intercourse, then you first need to rule out pregnancy and only then start taking birth control pills.

Can Diane be taken by 35 nursing mothers?

If you are breastfeeding, then taking Diane 35 is contraindicated for you.

What should I do if I mixed up the order of taking Diana 35?

All Diane 35 tablets contain the same dose of hormones. If you mixed up the order of taking the pills, but still took one pill a day, then the contraceptive effect remains at the same level. Continue drinking Diane 35 as usual.

What to do if you miss a Diane 35 tablet?

A delay of less than 12 hours in taking the next pill is not considered a miss and does not reduce the contraceptive effect. In this case, take the missed tablet as soon as possible and continue taking subsequent tablets at your usual time.

If you are 12 hours or more late in taking your next pill, the contraceptive effect may be reduced in the next 7 days. To understand what to do in this case, look at which pill you missed:

From 1 to 14 tablets (first and second weeks of use) : Take the missed tablet as soon as possible, even if you have to take 2 tablets at the same time. Then take the tablets as usual. For another 7 days after skipping, use additional means of protection against pregnancy (for example, condoms).

From 15 to 21 tablets (third week of use) : There are two possible actions.

1. Take the missed pill as soon as possible, even if you have to take two pills at the same time. Then take the tablets as usual. If you have not missed a dose in the previous 7 days, you do not need to use additional contraception. If you choose this option, then you need to skip the break: that is, immediately after finishing the current pack, start a new one the next day. Drink the second package to the end and only then take a break.

2. Throw away the current package of Diana 35 and after 7 days start a new one. This way you will go on break a few days earlier. Be sure to ensure that the break lasts no more than 7 days. Otherwise, the contraceptive effect may be reduced and pregnancy may occur. If you have not had any other absences in the last week, you do not need to use additional contraception.

What should I do if I missed several Diane 35 tablets?

If you missed 2 Diana 35 tablets in a row, then the contraceptive effect of the drug may be reduced. Pay attention to the numbers of missed tablets:

From 1 to 14 (first and second week of admission) : Take two tablets one day and two tablets the next day. Then continue taking the tablets as usual, one per day. Use additional contraception (for example, condoms) for another 7 days after skipping.

From 15 to 21 (third week of admission) : Throw away the current package of Diana 35 and start a new package. You should drink the new package to the end and only then take a 7-day break. If you have not had any other absences in the week before your pass, you do not need to use additional contraception. If you have had other absences in the previous 7 days, then use condoms for another week after the absence.

If you missed 3 Diana 35 tablets in a row, then throw away the current pack of tablets and start a new one. The new package should be drunk to the end. Use additional contraception for 7 days after missing a dose.

If you had unprotected sexual intercourse in the previous 7 days before skipping, then there is a risk of pregnancy. To exclude a possible pregnancy, you can take a pregnancy test 3.5 weeks after your last unprotected intercourse, or take a blood test for hCG 11 days after your last unprotected intercourse.

If you know what to do in your situation, use additional contraception until you consult with your doctor.

How to delay your periods with Diane 35?

If for some reason the arrival of menstruation this month is undesirable for you, you can delay your period by one month. To do this, do not take a 7-day break between packs: immediately after finishing one pack, start a new one the next day.

In this case, your period will most likely not come. However, you may experience some spotting halfway through the second pack. This is a normal reaction. In this case, continue to take the tablets as usual until the end of the pack.

What to do if during the break Diana 35 did not get her period?

If you had any omissions in the last month or had other factors that reduced the effectiveness of Diane 35, then it is better for you not to start a new package of Diane 35 until pregnancy has been ruled out.

Pregnancy can be excluded by taking the test 3.5 weeks after the last unprotected intercourse, or by taking the test 11 days after the last unprotected intercourse.

If in the past month you took the pills without skipping, or if you were not sexually active and pregnancy is excluded, then you can continue taking Diane 35, despite the absence of menstruation. If menstruation does not occur after a month, consult a gynecologist. You can read about other reasons for the delay in the article.

In what cases can the effect of Diane 35 decrease?

The contraceptive effect of Diane 35 may be reduced if:

• Missing one or more tablets.
• Digestive disorders accompanied by vomiting or diarrhea. You can read about what to do in this case in the article.
• Reception.
• Reception.

What if the effect of Diane 35 could be reduced?

If you suspect that the effect of Diane 35 could be reduced due to certain circumstances, then use additional contraception for another 7 days after exposure to the adverse factor. If this happens in the last week of taking the pills, skip the week-long break and start a new pack immediately after finishing the previous one.

If you don't know what to do in your situation, use condoms during sex until you consult your gynecologist.

What should you do if you experience spotting or menstruation while taking Diane 35?

While taking any contraceptive pills, including Diana 35, you may experience spotting in the middle of the cycle (in the middle of the package). This phenomenon is especially common in the first months of taking the pills.

This discharge is not dangerous and does not threaten your health. Continue to take the pills as usual, despite the discharge.

Usually, spotting goes away by the end of the first pack or the beginning of the second pack of tablets. Some women may normally experience discharge during the first 3 months of taking Diane 35.

How to properly stop taking Diane 35?

If you decide to stop taking Diane 35 birth control pills, then use the following advice from gynecologists:

Never stop taking pills halfway through the pack. This can lead to menstrual irregularities or uterine bleeding.

To properly stop taking Diana 35, finish the current package to the end and after a break, simply do not start a new one.

Keep in mind that the contraceptive effect of Diane 35 lasts only for the duration of taking this drug. You can get pregnant in the first month after stopping OK. If pregnancy is not desirable for you, start using additional contraception as soon as you stop taking birth control pills.

If you are planning a pregnancy, start taking it at least 1 month before the expected conception.

Name:

Diane-35

Pharmacological
action:

Combined low-dose monophasic oral contraceptive with an antiandrogenic effect, containing estrogen - ethinyl estradiol and antiandrogen with gestagenic activity - cyproterone acetate.
Cyproterone acetate contained in Diana-35 inhibits the influence of androgens, which are also produced in the female body.
Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.
While taking Diane-35 increased activity of the sebaceous glands decreases, which plays an important role in the occurrence of acne and seborrhea.
After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness in hair and skin disappears even earlier.
Hair loss, which often accompanies seborrhea, is also reduced.

Therapy for Diane-35 in women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of treatment should be expected only after several months of use.
Along with the above-described antiandrogenic effect of cyproterone acetate, it also has a pronounced gestagenic effect.
The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are inhibition of ovulation and changes in the secretion of cervical mucus.
The cycle becomes more regular, painful menstruation is less frequent, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia.

Pharmacokinetics

Cyproterone acetate
Suction
After taking Diane-35 cyproterone acetate, it is completely absorbed from the gastrointestinal tract. Bioavailability - 88%. After oral administration of 1 tablet Diane-35, Cmax is reached after 1.6 hours and is 15 ng/ml.
Distribution
Cyproterone acetate is almost completely bound to plasma albumin, approximately 3.5-4.0% is in the free state. Because protein binding is nonspecific, changes in sex steroid binding globulin (SGBS) levels do not affect the pharmacokinetics of cyproterone acetate. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk.
Metabolism and excretion
The pharmacokinetics of cyproterone acetate is biphasic, T1/2 is 0.8 hours and 2.3 days, respectively, for the first and second phases. Total plasma clearance is 3.6 ml/min/kg. Biotransformed by hydroxylation and conjugation, the main metabolite is the 15β-hydroxyl derivative. It is excreted mainly in the form of metabolites in urine and bile in a ratio of 1:2, a small part is excreted unchanged in bile. T1/2 for cyproterone acetate metabolites is 1.8 days.

Ethinyl estradiol
Suction
After taking Diane-35, ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. During the process of absorption and “first pass” through the liver, ethinyl estradiol undergoes intensive metabolism, which causes a bioavailability of approximately 45% and its significant individual variability. After oral administration of 1 tablet Diane-35, Cmax is approximately 80 pg/ml and is achieved after 1.7 hours.
Distribution
Binding to proteins (albumin) in blood plasma is high (2% is found in free form in plasma). Vd is approximately 5 l/kg. Up to 0.02% of the dose of ethinyl estradiol is excreted in breast milk. Ethinyl estradiol increases the hepatic synthesis of SHBG and CSG (corticosteroid binding globulin) during continuous use. During treatment with Diane-35, the serum SHG concentration increases from approximately 100 nmol/l to 300 nmol/l and the serum concentration of DSG increases from approximately 50 μg/ml to 95 μg/ml.
Metabolism and excretion
The pharmacokinetics of ethinyl estradiol is biphasic, with T1/2 1-2 hours (α-phase) and approximately 20 hours (β-phase), respectively. Plasma clearance is about 5 ml/min/kg. Ethinyl estradiol is excreted from the body in the form of metabolites; about 40% - with urine, 60% - with bile.

Indications for
application:

Contraception in women with androgenization phenomena;
- androgen-dependent diseases in women: acne (especially its severe forms, accompanied by seborrhea, inflammatory phenomena with the formation of nodes / papular-pustular acne, nodular cystic acne /), androgenic alopecia and mild forms of hirsutism.

Mode of application:

Diana-35 taken orally 1 tablet/day. The pills are taken without chewing and washed down with a small amount of liquid.
The time of taking the drug does not matter, however, subsequent doses should be taken at the same selected hour, preferably after breakfast or dinner.
Reception of Diane-35 begins on the 1st day of the cycle, using tablets of the corresponding day of the week from the calendar package.
Daily administration of the drug is carried out using tablets from the calendar package sequentially in the direction of the arrow marked on the foil until all tablets have been taken. After finishing taking all 21 tablets from the calendar pack, there is a break in taking the drug for 7 days, during which menstrual-like bleeding occurs.

After 28 days from the start of taking the drug (21 days on and 7 days off), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.
When switching from combined oral contraceptives Diane-35 should be taken the next day after taking the last tablet with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 tablets). Continue according to the scheme described above. If the patient took the previous contraceptive daily for 28 days, Diane-35 should be started after taking the last inactive pill.
When switching from contraceptives containing only gestagens ("mini-pills"), Diane-35 can be started without interruption.
When using injectable forms of contraceptives, Diane-35 begins to be taken from the day when the next injection is due. When switching from an implant - on the day of its removal. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill.

After an abortion in the first trimester of pregnancy and the woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.
After childbirth or abortion in the second trimester of pregnancy The drug should be taken on days 21-28.
If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill.
If a woman was sexually active in the period between childbirth or abortion and the start of taking Diane-35, then pregnancy should first be excluded or you must wait until the first menstruation.
Missed jelly bean the woman should take it as soon as possible, the next tablet is taken at the usual time.
If the delay is less than 12 hours, the reliability of contraception does not decrease.
If the delay in taking the pill is more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that the administration of the tablet should never be interrupted for more than 7 days, and that 7 days of continuous administration of the tablet are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days.
If the delay in taking the pill is more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time ). The next pill is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is finished, i.e. nonstop. Most likely, the woman will not experience withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough uterine bleeding on the days she takes the pill.
If a woman has vomited within 3 to 4 hours after taking Diane-35, absorption of the active substances may be incomplete. In this case, you need to follow the recommendations when skipping pills.

To delay the onset of menstruation, a woman should continue taking pills from the new Diane-35 package immediately after taking all the pills from the previous one, without interruption.
The pills from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding.
You should resume taking Diane-35 from a new package after the usual 7-day break.
For that, to move the start of your period to another day of the week, a woman should shorten the next break from taking the pills by as many days as she wants.
The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).
In the treatment of hyperandrogenic conditions The duration of treatment is determined by the severity of the disease. After the symptoms disappear, it is recommended to take Diane-35 for at least another 3-4 months. If a relapse occurs several weeks or months after completion of the course, Diane-35 can be re-treated.

Side effects:

From the endocrine system: in rare cases - engorgement, soreness, enlargement of the mammary glands and discharge from them, change in body weight.
From the reproductive system: in rare cases - intermenstrual bleeding, changes in vaginal secretion, changes in libido.
From the side of the central nervous system: in rare cases - headache, migraine, decreased mood.
From the digestive system: in rare cases - nausea, vomiting.
Others: in very rare cases - poor tolerance to contact lenses, allergic reactions, the appearance of age spots on the face (chloasma).
The listed side effects may develop in the first few months of taking Diane-35 and usually decrease over time.

Contraindications:

Thrombosis and thromboembolism, incl. history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
- diabetes mellitus complicated by microangiopathies;
- the presence of severe or multiple risk factors for venous or arterial thrombosis;
- diseases or severe liver dysfunction;
- liver tumors (including in history);
- hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including in history);
- uterine bleeding of unknown etiology;
- pancreatitis (including a history), if it was accompanied by severe hypertriglyceridemia;
- a history of migraine, which was accompanied by focal neurological symptoms;
- lactation (breastfeeding);
- pregnancy or suspicion of it;
- hypersensitivity to the components of the drug.
If any of these conditions develop for the first time while taking Diane-35, the drug should be discontinued immediately.

Before using Diane-35 it is necessary to conduct a general medical examination (including mammary glands and cytological examination of cervical mucus), exclude pregnancy, and disorders of the blood coagulation system. With long-term use of the drug, preventive control examinations must be carried out every 6 months.
If there are risk factors, the potential risks and expected benefits of therapy should be carefully assessed and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, worsen, or appear for the first time, discontinuation of the drug may be necessary.
Estimated incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogens (less than 50 mcg ethinyl estradiol) is up to 4 per 10,000 women per year compared to 0.5-3 per 10,000 women not taking oral contraceptives. However, the incidence of VTE when taking combined oral contraceptives is lower than the incidence of VTE associated with pregnancy (6 per 10,000 pregnant women per year).

The patient should be warned that if symptoms of venous or arterial thrombosis develop, you should immediately consult a doctor.
These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain radiating to the left arm or without radiating; sudden shortness of breath; sudden attack of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraines; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with/without partial seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.
The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs Diana-35 should be discontinued and appropriate antihypertensive therapy prescribed. Taking the contraceptive can be continued if blood pressure normalizes.

If liver dysfunction occurs Temporary withdrawal of Diane-35 may be required until laboratory parameters normalize. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.
Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, they usually there is no need to adjust the dose of glucose-lowering drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under close medical supervision.
Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking combined oral contraceptives.
If symptoms have recently developed or become significantly worse in women with hirsutism, other causes, such as androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.

While taking Diane-35, sometimes Irregular bleeding may occur(spotting or breakthrough bleeding), especially during the first months of therapy. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.
If irregular bleeding recurs or develop after previous regular cycles, non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignancy or pregnancy. These may include diagnostic curettage.
In some cases, withdrawal bleeding may not develop during a break in taking the pill. If you do not take the pill regularly or if there are no two menstrual-like bleedings in a row, pregnancy should be excluded before continuing to take the drug.