Silhouette pills, how long does it take for side effects to start. Price of birth control pills Silhouette - reviews and indications for use. Contraindications to the use of Silhouette

Instructions for use:

Siluet is an oral contraceptive drug that has an antiandrogenic effect.

Pharmacological action of Silhouette

The components included in Siluet tablets stimulate inhibition of ovulation, changes in the structure of the endometrium and peristalsis of the fallopian tubes, as well as an increase in the viscosity of cervical mucus.

Release form

According to the instructions, Siluet is produced in the form of film-coated round, biconvex white or almost white tablets with “G53” engraved on one side, 2 mg in PVC blisters. One tablet contains 30 mcg ethinyl estradiol, 2 mg dienogest, 47.66 mg lactose monohydrate, 1.3 mg potassium polyacrylate, 10.46 mg corn starch, 0.65 mg hypromellose 2910 and 1.3 mg magnesium stearate.

The film shell of Siluet tablets contains 3 mg of Opadry II 85F18422 white (1.2 mg of polyvinyl alcohol, 0.75 mg of titanium dioxide, 0.606 mg of macrogol 3350 and 0.444 mg of talc).

Analogues of Silhouette

Analogues of Siluet tablets in terms of the active substance are the drugs Janine, Zhenetten and Diecyclen. Analogs of Siluet according to the mechanism of action and belonging to the same pharmacological group include:

• Belara;
• Jess;
• Eura;
• Lindinet 30;
• Novinet;
• Regulon;
• Silest;
• Trisiston;
• Femoden;
• Egestrenol;
• Yarina;
• Oralcon.

Indications for use of Silhouette

According to the instructions, Siluet is taken as oral contraception and in the treatment of acne.

How to use Silhouette

According to the instructions, Siluet is taken daily at the same time, one tablet for three weeks. The subsequent intake of Siluet tablets begins a week after the end of the previous package. Usually, within a seven-day gap between pills, withdrawal bleeding begins. If similar drugs have not been used previously, then the first pill intake begins on the first day of menstruation.

When an abortion is carried out in the first trimester of pregnancy, Siluet is prescribed immediately, and when an abortion occurs in the second trimester or after childbirth, taking pills begins after 3-4 weeks.

If you miss taking Siluet for less than 12 hours, the protection is not reduced, but if you miss it for more than 12 hours, the contraceptive protection may be reduced.

Contraindications

According to the instructions, Siluet is contraindicated for use when:

• Arterial and venous thromboembolic diseases currently or in history;
• Porphyria;
• Thrombosis and thromboembolism currently or in history;
• Jaundice and congenital hyperbilirubinemia;
• Sickle cell anemia;
• Smoking over the age of 35;
• Pancreatitis with severe hypertriglyceridemia currently or in history;
• Conditions preceding thrombosis;
• Bleeding from the vagina of unknown origin;
• Angiopathy, retinopathy, uncontrolled arterial hypertension and severe dyslipoproteinemia;
• Lactase deficiency, lactose intolerance and glucose-galactose malabsorption;
• Congenital or acquired predisposition to arterial thrombosis;
• Severe forms of liver disease;
• Liver tumors;
• Hormone-dependent malignant diseases of the genital organs or mammary glands;
• Migraines with local neurological symptoms;
• Epilepsy;
• Pregnancy and lactation;
• Hypersensitivity to the components of the drug.

With caution, Siluet is prescribed for smoking under the age of 35 years, diabetes mellitus, uterine fibroids, multiple sclerosis, endometriosis, controlled arterial hypertension, dyslipoproteinemia, phlebitis of the superficial veins, chronic heart failure, Crohn's disease, impaired renal function, bronchial asthma, liver diseases, tetany.

Side effects of Silhouette

According to reviews, Siluet can cause stroke, venous and arterial thrombosis, pulmonary embolism and myocardial infarction. The risk of these diseases increases with obesity, bleeding disorders, smoking, thrombophlebitis, varicose veins, arterial hypertension and thrombosis.

Also, according to reviews, Siluet causes side effects from various body systems, namely:

• Anemia (blood and lymphatic system);
• Arterial hypertension, tachycardia, varicose veins, hematomas, arterial hypotension, pain along the veins, thrombosis, thrombophlebitis of superficial veins, hot flashes, thrombophlebitis of deep veins, pulmonary embolism, myocardial infarction and cerebrovascular accident (cardiovascular system);
• Migraine, increased excitability, dizziness, headache, cerebrovascular accident (nervous system);
• Visual impairment, dry mucous membranes, conjunctivitis and intolerance to contact lenses (visual organs);
• Hypoacusis, tinnitus, hearing impairment and sudden loss (hearing organs);
• Sinusitis, bronchitis and bronchial asthma (respiratory system);
• Nausea, gastritis, dyspepsia, vomiting, diarrhea, abdominal pain, enteritis, cholecystitis and cholelithiasis (digestive system);
• Infection of the urinary system (kidneys and urinary tract);
• Acne, allergic skin reactions, acneiform dermatitis, chloasma, alopecia, exanthema, erythema multiforme, vascular purpura, hypertrichosis, erythema nodosum, virilism, hyperhidrosis, pruritus, seborrhea, dandruff, eczema, angioedema, telangiectasia and hyperpigmentation (skin and subcutaneous tissues );
• Decrease or increase in body weight, decrease or increase in appetite (metabolism and nutrition);
• Allergic reactions (immune system);
• Bleeding, dyspareunia, pain and tenderness of the mammary glands, ovarian cysts, vaginitis, vulvovaginitis, enlarged mammary glands, increased vaginal discharge, hyperplasia, endometrium, mastitis, salpingitis, acyclic bleeding or painful menstrual-like bleeding, leiomyoma, the appearance of mammary secretions, endometritis , fibrocystic dysplasia of the mammary glands, cervicitis, scanty menstrual-like bleeding, breast lipoma, vulvovaginal itching, cancer and endometrium (genital organs and mammary glands);
• Depression, sleep disorders, decreased mood, anorexia, insomnia, aggression, changes in libido and apathy (mental);
• Back pain, arthralgia, myalgia and cramps in the calf muscles (musculoskeletal system).

Also, according to reviews, Siluet in some women causes liver tumors, venous thromboembolic disorders, vaginitis, arterial hypertension, fungal infections, herpetic lesions of the oral cavity, a feeling of fatigue, arterial thromboembolic disorders, vaginal candidiasis, flu-like symptoms, edema and chloasma.

In case of overdose, Siluet can cause acute toxicity, vomiting, nausea and bloody vaginal discharge.

Silhouette storage conditions

In accordance with the instructions, Siluet must be stored out of the reach of children and protected from light, in a dry place at room temperature up to 25°C. The shelf life if the recommendations are followed is 2 years.

0.03 mg.

Lactose, corn starch, hypromellose, talc, magnesium stearate, potassium polacriline, as excipients.

Release form

Coated tablets No. 21.

pharmachologic effect

Inhibition of ovulation, changes in the structure of the endometrium and increased viscosity of cervical secretions under the influence of active substances provide reliable contraception. Dienogest - derivative norethisterone at a dose of 1 mg inhibits ovulation. Does not have significant mineralocorticoid and glucocorticoid effects.

Pharmacokinetics

Ethinyl estradiol is quickly absorbed in the intestine, and the maximum concentration is determined after 1.5–4 hours. Bioavailability is 44%. Almost completely associated with albumins . Equilibrium concentration is achieved in the 2nd half of the cycle. A significant part is metabolized in the liver.

The elimination of metabolites occurs in 2 stages: their concentration decreases after 1 hour and finally after 10–20 hours. Metabolites are excreted by the liver and kidneys.

Dienoges t is also quickly absorbed in the intestines and after 2.5 hours the maximum concentration is determined in the blood. Bioavailability reaches 96%. Equilibrium concentration is achieved in 4 days.

Contacts albumins blood. Metabolized by hydroxylation, the metabolites are inactive and are very quickly eliminated from the plasma. The half-life is 9 hours. Most of it is excreted by the kidneys.

Indications for use

Siluet is used for treatment and for contraception.

Contraindications

The drug Siluet is contraindicated in:

• increased sensitivity;
• and deep veins;
• liver diseases and jaundice;
• severe arterial hypertension ;
• severe dyslipoproteinemia ;
• with vascular complications;
• uterine bleeding of unknown origin;
• breastfeeding.

Side effects

Frequently encountered adverse reactions that can be caused by the drug Siluet:

• nausea, vomiting;
• pain in the mammary glands, their enlargement;
• backache;
• cramps of the calf muscles;
• increased appetite;
• menstrual-like bleeding;
• weight gain;
• decreased mood;
• venous thromboembolism .

Rarely encountered reactions:

• abdominal pain;
• anemia ;
• increased excitability;
• blurred vision, dry eye mucosa;
• tinnitus, hearing impairment;
• and fungal infections;
• phlebeurysm;
• weakness;
• flu-like symptoms;
• arthralgia , muscle pain.

Siluet, instructions for use (Method and dosage)

The tablets are taken orally, one daily, in the prescribed order for 21 days. Tablets from the new package are taken after a week's break. At this time, withdrawal bleeding appears.

If the drug is being taken for the first time, you should start taking it on the 1st day of menstruation.

When switching from other combined drugs, start taking it after the usual break.

After the first trimester they begin to take it immediately. After birth - on the 21st day.

If a pill is missed and the missed time is less than 12 hours, there is no need to worry about a decrease in contraceptive protection. However, you need to take the pill quickly. Reception cannot be interrupted for more than 7 days.

The instructions contain complete information on how to take the drug in other situations, how to delay withdrawal bleeding and in which cases additional contraceptive measures are necessary.

Overdose

If the instructions are strictly followed, Siluet does not cause an overdose.

Interaction

Breakthrough bleeding may occur when taken concomitantly with hydantoin ,

Endometriosis is a common gynecological disease that progresses due to the growth of the inner uterine layer (endometrium) in the tissues of the uterus and beyond. If treated incorrectly, over time, pathological lesions affect all pelvic organs, which naturally negatively affects the health and quality of life of a woman. But the main complication of the pathology is infertility, and yet almost every woman dreams of giving birth and raising a child.

If you have been diagnosed with endometriosis, you must begin treatment immediately. In advanced stages, the disease is incurable; in some cases, a woman is prescribed surgery to remove the uterus and other affected reproductive organs. But it is worth remembering that only a doctor can choose the most suitable medicine for treatment.

The main reason for the development of pathology is considered to be hormonal imbalance, that is, the ovaries cease to produce sufficient amounts of sex hormones. But it is possible to determine which hormones are lacking and which, on the contrary, are produced in excess, only after a thorough laboratory and instrumental diagnosis. Therefore, self-medication is unacceptable; you can greatly harm your health.

Only after diagnosis, the gynecologist selects individual treatment for each patient. The main drugs for the treatment of endometriosis are combined oral contraceptives (COCs). One of the new drugs is “Silhouette”; its effectiveness in the treatment of endometriosis is confirmed by both doctors and patients.

The combined drug "Silhouette" is a new generation of contraceptive pills produced by the Hungarian pharmaceutical company Gedeon Richter. The drug has an affordable price compared to its analogues, for example the well-known ones, which cost 3 times more. But in terms of properties and effect, “Silhouette” is in no way inferior to expensive analogues, which is why it is in demand. Reviews of Silhouette for endometriosis from both doctors and patients are positive.

The medicine has an antiandrogenic effect, its action is aimed at inhibiting ovulation and changing the structure of the endometrium. The active ingredients are quickly absorbed into the blood, reaching maximum concentration after 2 hours. Within 24 hours, it is completely absorbed and excreted in the urine. The drug "Silhouette" is available in the form of tablets, which can be purchased at any pharmacy.

The composition of the drug is characterized by low doses of its constituent hormones:

• Dienogest – 2 mg.
• Ethinyl estradiol – 0.03 mg.

The main active ingredient is dienogest, which, when entering the body, reduces the production of estrogen in the ovaries, this provides a high progestogenic effect. At the same time, dienogest does not have mineralocorticoid and glucocorticoid effects on the body, in other words, it does not suppress the woman’s immune system. This synthetic hormone does not disrupt metabolic processes in the body, so Silhouette can be taken for a long time.

The second component, ethinyl estradiol, replenishes estradiol deficiency in the body and normalizes metabolic processes, has an anti-atherogenic effect, reduces cholesterol, and increases calcium absorption.

The use of the drug "Silhouette" contributes to a significant improvement in women's health. The tablets normalize the ovulation process, block the growth of pathological endometrial cells, prevent inflammatory processes and reduce pain by blocking prostaglandins.

Instructions for use for endometriosis

For the treatment of the disease, the drug is prescribed in the following cases:

• Early stage of endometriosis;
• Preparation for surgical removal of endometroid lesions;
• Prophylactic therapy after surgery to prevent the appearance of new endometrial growths.

The dosage for the treatment of endometriosis is selected by the attending physician, taking into account the woman’s desire to become pregnant in the near future. This factor affects the duration of treatment.

Treatment regimens:

1. When treating endometriosis followed by pregnancy, Silhouette should be taken according to the standard regimen: one tablet per day, at approximately the same time, with water. The course is 21 days, after which they take a 7-day break and start taking tablets from the next package. Duration of therapy is three months, treatment can be extended if necessary. When treating endometriosis, it is better to start taking birth control pills on the first day of your cycle.
2. If pregnancy is not planned, it is recommended to take pills according to the following regimens:

• Continuously for 42 days (6 weeks), then 7 days break;
• Continuously 63 days (9 weeks), then 7 days break;
• Continuously for 84 days (12 weeks), then a 7-day break.

According to these regimens, treatment can last for several years, the doctor decides how to take the drug after a monthly additional examination. Strictly follow the dosage prescribed by your doctor.

If you miss your next pill dose, you need to take the medicine as quickly as possible. If you frequently skip pills, the effectiveness of treatment decreases and uterine bleeding may suddenly occur. Therefore, you need to take hormonal medications responsibly.

Contraindications to the drug

Like all hormonal drugs, Silhouette tablets can have a negative effect on the body. The medicine should not be taken if you have a history of the following pathologies:

• diabetes mellitus (or hereditary predisposition to the disease);
• arterial hypertension;
• pathologies of the gallbladder, kidneys or liver;
• various heart diseases (stroke, ischemia, heart attack);
• thrombophlebitis and venous diseases;
• constant headaches;
• epilepsy and schizophrenia;
• bacterial endocarditis;
• haemorrhoids;
• pulmonary embolism;
• congenital hyperbilirubenia;
• bleeding of unknown nature;
• allergy to lactose;
• individual intolerance to the components of the drug.

Smoking patients over 35 years of age should take the drug with caution; serious complications are possible - blood clots, stroke, heart attack. You need to completely give up cigarettes, at least for the duration of treatment.

In special cases, the doctor may prescribe the drug "Silhouette", but only if the risks correlate with the expected result of treatment. In other words, if hormonal therapy is unavoidable, the patient can take the pills under the constant supervision of the attending physician.

Side effects

Side effects mainly appear at the initial stage of the treatment course. When using tablets, you may feel tension and pain in the mammary glands, and sometimes bleeding occurs. But with further use, these symptoms should disappear. The following side effects are also possible:

• weight gain;
• enlargement of the mammary glands;
• dryness in the nasopharynx;
• general weakness;
• dizziness;
• lower abdominal pain;
• deterioration of vision and hearing;
• lower back pain;
• headache and migraine;
• insomnia;
• decreased sex drive;
• leg cramps;
• dermatitis;
• depression, anxiety;
• nausea and vomiting, flatulence and bloating;
• digestive disorders, diarrhea.

In case of pronounced side effects, you should stop taking the pills and consult a doctor. He will determine the exact cause of the deterioration in health and determine whether it is worth continuing such treatment. Sometimes it is not the drug itself that has a negative effect, but its combined use with other drugs.

"Silhouette" and other medications

Hormonal medications should be combined with other medications with caution; if you are taking any medications for a long time for health reasons, be sure to warn your doctor about this. It is not recommended to take Silhouette together with certain antifungal, antiviral and antibiotic medications. Joint use can lead to the above side effects, or to a completely unpredictable result. It is advisable not to drink alcohol during the course of treatment.

"Silhouette" and pregnancy

Birth control pills "Silhouette" primarily protect against unwanted pregnancy, so it is almost impossible to conceive a child while taking the medicine.

No special studies have been conducted to study the effect of the drug on pregnant women. But doctors confirm that if the drug is accidentally taken in the early stages (when the woman is not yet aware of the pregnancy), the drug does not have a negative effect on the intrauterine development of the fetus. But the drug is excreted from the body along with breast milk, so you cannot drink the medicine during lactation.

"Silhouette" is a relatively inexpensive and effective medicine for endometriosis. According to gynecologists, the drug is one of the effective and safe means for preventing pregnancy and for the treatment of gynecological diseases. Many women who completed the course of treatment were able to quickly become pregnant and safely give birth to a child.

Patients with endometriosis show steady positive dynamics after treatment. In addition, according to reviews from women, taking the drug reduces pain during menstruation, improves mood and overall well-being. Reviews of Silhouette tablets for endometriosis are mostly positive.

But it is worth remembering that hormonal medications cannot be used without a doctor’s permission. Before taking Silhouette, consult your gynecologist, even if you want to take pills for contraception.

Endometriosis is a gynecological pathology that affects more and more women every day. The disease causes the growth of the endometrium, which covers the uterus from the inside, as a result of which cells leave the uterus and settle on neighboring organs, leading to their dysfunction.

Medications may be prescribed as treatment, as well as surgical methods, if there are direct indications for them. Despite the treatment tactics, even after the operation the woman is prescribed a course of medications that help avoid exacerbations and complications.

As a rule, women are prescribed combined oral contraceptives as treatment. Reviews and instructions for use of Silhouette tablets indicate that this is the safest and most effective treatment for endometriosis known today. The drug is capable of destroying foci of endometriosis, as well as accelerating tissue regeneration and restoration of the female body.

Endometriosis is a hormone-dependent disease in which the endometrium grows outside the uterus. Most often, foci of the disease occur in the ovaries, fallopian tubes, rectum, and abdominal organs.

The classification of endometriosis distinguishes 2 types of pathology:

• internal endometriosis (damage occurs in the uterus itself);
• external (the disease affects organs outside the uterus).

Often the symptoms of endometriosis are associated with emotional stress and physical stress. But a doctor can make such a diagnosis only after a comprehensive examination. With timely diagnosis and treatment, therapy can achieve a positive result and also avoid problems with reproductive function. Unfortunately, it is impossible to completely recover from the disease, but you can minimize its manifestations, which will not interfere with natural pregnancy and childbirth.

What is the drug Silhouette?

Silhouette is the most effective and safe drug used in the treatment of endometriosis. This is a monophasic low-dose contraceptive, produced by a Romanian pharmaceutical company.

The silhouette is considered a structural analogue of Janine, similar in its medicinal properties. But, Silhouette is more accessible than Janine, thanks to its budget price.

Silhouette is a drug that combines 2 active ingredients with a constant concentration, regardless of the cyclicity of menstruation. Moreover, the amount of the main active ingredient exceeds its amount in similar preparations.

Compound

Silhouette tablets contain 2 main components: dienogest and ethinyl estradione. The amount of the first is 2 mg, the second is 0.3 mg.

The combination of these two components gives the drug an antiandrogenic effect and is also a contraceptive. In addition, the composition contains a number of other components that are indispensable for contraceptive and therapeutic effects.

The main component of Silhouette is artificial analogues of progesterone and estrogen, which are produced by the female body. The concentration of active components affects the structure of endometrial tissue and also affects the condition of the breast.

Analogs of Siluet in the treatment of endometriosis

Today, Silhouette is popular among specialists, because its effectiveness, safety and accessibility are obvious. Most gynecologists give preference to it when prescribing it to patients with endometriosis.

But this does not mean that analogue drugs are less effective. For example, the following drugs are also in demand:

• Janine;
• Yarina;
• Utrozhestan;
• Duphaston;
• Danazol.

A more detailed comparative table of Silhouette analogues is given below.

Despite the fact that each of the above Silhouette analogues has a different principle of action and composition, they all fight the disease perfectly. The duration of treatment with Silhouette, as well as its analogues, is determined by the attending physician. But, basically, therapy takes at least six months. This is exactly how much the female body needs to restore and start all processes.

Price

The cost of the drug Silhouette may vary depending on the region, as well as the pharmacy network. Despite this, it is absolutely available for purchase.

The average price of 1 blister with 21 tablets is 640 rubles. A package of the drug, which contains 3 blisters, costs on average about 1,450 rubles.

Reviews about the drug

Despite its affordability, the drug Silhouette is considered an effective remedy for the fight against endometriosis. The tablets are also used as a contraceptive and for the treatment of other gynecological pathologies.

Despite many positive reviews about the drug, you should not self-medicate. You should start treatment with Silhouette tablets only after a doctor’s prescription.

Female patients

Girls who have undergone course therapy with Silhouette speak very positively about the drug. Many claim that this treatment allowed them to get pregnant and give birth to a healthy baby.

Patients who treated endometriosis with pills notice positive changes. In addition, after taking Silhouette, periods become less painful, and overall well-being and mood improve.

Also, many women note the plus that, despite the fact that Silhouette is a hormonal drug, their weight has remained the same, for which many representatives of beautiful bodies are very afraid.

Doctors

Reviews from doctors about the drug are also positive. In their practice, many people prescribe Silhouette not only for the treatment of endometriosis, but also a number of other gynecological diseases, which gives good results.

They also note the fact that the tablets have no side effects, and the cost is affordable for women of different incomes.

Simultaneous use with other drugs

It’s not news to anyone that hormone-based drugs need to be combined with other medications with extreme caution. If a woman constantly takes any medications to maintain her health, she must inform the gynecologist prescribing Silhouette about this.

According to the instructions for the tablets, Silhouette is not recommended to be taken simultaneously with certain antifungal and antiviral drugs, as well as antibiotics. Otherwise, unexpected reactions of the body are possible.

• medications containing St. John's wort;
• antidepressants.

Action of Silhouette tablets

Since Silhouette is considered a combined contraceptive drug, it works comprehensively, actively preventing pregnancy. As a treatment for endometriosis, tablets have a positive therapeutic effect.

The use of the drug prevents the growth of the endometrium and promotes the destruction of lesions, regardless of their location. The pills also interfere with the production of estrogen and suppress ovulation.

It is equally important that Silhouette does an excellent job of eliminating inflammatory processes. Also, some women manage to get rid of pain during menstrual periods, or make the pain less pronounced.

The work of the active components of the drug minimizes the likelihood of endometrial tissue implantation outside the uterus; already formed lesions stop growing, which helps to avoid iron deficiency anemia.

Scientists have also proven that the Silhouette components prevent the malignancy of lesions, protecting the female body from the development of cancer.

Indications for use

Silhouette is prescribed as a medicine in the following cases:

• for the treatment of early stage endometriosis;
• in preparation for surgery to remove endometroid lesions;
• as a prophylaxis in the postoperative period;
• to prevent the proliferation of endometrial tissue.

The dosage and treatment features are regulated by the attending physician. At the same time, the gynecologist must take into account whether the girl is planning a pregnancy in the near future, because the duration of the therapeutic course depends on this.

How to take Silhouette

The specific features of taking the drug are regulated by the attending physician. It all depends on whether the girl plans to become a mother soon, what is the general condition of the body and at what stage the disease is diagnosed.

For women who do not want to get pregnant, to prevent relapses, a prolonged treatment regimen is selected. Similar regimens for taking Silhouette have been followed for years; it is important not to disturb or interrupt them in order to avoid complications.

When treating endometriosis, the first tablet should be taken on the 1st day of menstruation, sometimes it is prescribed from 2 to 5 days after the start of the cycle.

Note. When treated with Silhouette, barrier contraception is needed in the first week of taking the pills.

Application diagram

The dosage and duration of taking Silhouette may vary, depending on the regimen used for the patient, which are as follows:

1. For the treatment of endometriosis, patients planning pregnancy are prescribed a standard regimen: 1 tablet per day for 21 days. After this, a break is taken for 7 days, after which therapy continues. The duration of treatment is 3 months. According to indications, the course can be re-prescribed. With this treatment, it is recommended to take additional contraceptive medications from the first day of your period.
2. For patients not planning pregnancy, the following regimens are recommended:
   1. 42/7 – 42 days take Silhouette, 7 days break;
   2. 63/7 – 63 days of treatment, 7 days break;
   3. 84/7 – continuous use for 84 days, 7 days break.

Depending on the prescribed tactics for taking Silhouette tablets, a woman should strictly adhere to the dosage prescribed by the doctor. After each course, you need to be examined by a doctor and consult about repeating the course.

Skipping a pill

If the patient misses taking the pill by less than 12 hours, the contraceptive properties of the drug do not change. The missed dose should be taken as quickly as possible as soon as a medication error is discovered. The next tablet can be taken at the scheduled time without any shifts or delays.

If a dose is missed for more than 12 hours, the likelihood of an unwanted pregnancy increases. At the same time, it is important not to take a break between courses for more than a week, because complete blunting of the hypothalamic-pituitary-ovarian system is observed only when taking the pills continuously for 7 days.

Can children take Silhouette?

Since the drug is used not only for the treatment of gynecological pathologies, but also to normalize the cyclicity of menstruation, and also as a contraceptive, given the insufficient amount of verified data regarding the effect of the drug on the children's body, children are prohibited from taking the pills. The drug is prescribed only after the onset of the menstrual cycle.

Use during pregnancy and breastfeeding

The silhouette is contraindicated for pregnant girls.

In case of pregnancy, the pills should be discontinued as soon as possible. Practice shows that the use of Silhouette in the early stages of pregnancy does not in any way affect the embryo and its subsequent development, as well as in cases where the girl was treated with Silhouette before pregnancy.

Animal tests have shown that taking Silhouette during pregnancy has negative effects. But it cannot be said with certainty that the risk of all kinds of complications and pathologies observed in animals is also possible in humans.

The drug Silhouette and its taxes have an impact on lactation, because while taking such drugs, the production of breast milk and its composition decreases. Although in small quantities, the components of the tablets still penetrate into breast milk. Even small doses of the drug are enough to have a detrimental effect on the child.

Use for renal impairment

Since the necessary studies have not been conducted to monitor the effects of the Silhouette drug on patients with kidney dysfunction, there is no reason to categorically prohibit tablets if the organ is not functioning properly. All a doctor needs to do is compare the benefits/harms of treatment with Silhouette and keep “problem” patients under control.

Side effects

Sometimes, when treating endometriosis with modern medications, negative reactions from the female body can develop. With constant use, the level of blood coagulation increases, as well as the likelihood of blood clots forming in the vessels. This picture is especially pronounced among women who abuse cigarettes. Therefore, when prescribing long-term treatment with Silhouette, it is recommended to get rid of the addiction as quickly as possible.

Patients with bleeding disorders, varicose veins, obesity, and arterial hypertension should be especially careful. If the characteristics of the body and chronic diseases are not taken into account, irreversible consequences, such as thromboembolic complications, are possible.

Having an effect on the central nervous system, Silhouette can provoke the following side effects:

• migraine;
• excessive excitement;
• dizziness;
• distortion of auditory perception, deafness.

Girls wearing contact lenses also need to take tablets with caution, because the drug does not tolerate such materials. In this case, blurred vision, dryness, and inflammation are possible.

The following adverse reactions are possible from the gastrointestinal tract:

• nausea and vomiting;
• problems with stool;
• gas formation;
• gastritis, cholecystitis, enteritis.

Since the main effect of the drug is on reproductive function, the following negative reactions are possible on its part:

• acyclic bleeding and vaginal spotting;
• chest pain, nipple discharge, changes in the structure of the mammary glands.

Overdose

If the dosage or regimen for taking Silhouette tablets is not followed, intoxication is unlikely. But, despite the safety of the drug, the following manifestations of overdose are possible:

• nausea, vomiting;
• in adolescence, vaginal bleeding.

In case of overdose symptoms, specialized treatment is not required. In some cases, symptomatic therapy may be used.

Storage conditions

As stated in the instructions, Silhouette tablets should be stored at a temperature of no more than 25 o C in a place protected from light and sunlight.

The drug should be stored in a place inaccessible to children.

Dispensing conditions in pharmacies

Despite the widespread use of tablets for the treatment of female gynecological pathologies, as well as as contraceptives, Silhouette tablets are sold in pharmacies only with a prescription from the attending physician.

Which drug is more effective?

Despite the fact that all drugs for the treatment of endometriosis affect the level of hormones in a woman’s body, the following are most often used as therapy:

• contraceptives (Zhanin, Yarina);
• progesterone-containing drugs and its analogues (Duphaston, Utrozhestan);
• analogues of gonadotropins (Buserelin, Zoladex).

Regardless of the cost and composition, it is difficult to specifically identify the most effective drug, because the effect of each drug on the female body is different. This is caused not only by different active substances, but also by the individual characteristics of the body.

In order not to select the most suitable drug for treatment, it is important to take care of the body in a timely manner, prevent diseases, and undergo regular examinations. This will allow every woman to remain attractive and confident, regardless of age!

Compound

Description of the dosage form

Pills: round, biconvex, film-coated, white or almost white, with “G53” engraved on one side.

pharmachologic effect

pharmachologic effect- antiandrogenic, contraceptive.

Pharmacodynamics

Siluet ® is an oral combination drug with an antiandrogenic effect, containing ethinyl estradiol (EE) as an estrogen and dienogest (DNG) as a progestogen. The contraceptive effect of the drug Siluet ® is due to various factors, the most important among them are inhibition of ovulation, increased viscosity of cervical mucus, changes in peristalsis of the fallopian tubes and endometrial structure.

The antiandrogenic effect of the combination of EE and DNG is based on a decrease in the concentration of androgens in plasma.

Repeated studies have shown that taking a combination of EE with DNG led to the elimination of symptoms of mild to moderate acne and had a positive result in patients with seborrhea.

DNG is a derivative of norethisterone, which has a 10-30 times lower affinity for progesterone receptors in vitro in comparison with other synthetic progesterones. DNG has no significant androgenic, mineralocorticoid, or glucocorticoid effects in vivo.

When administered alone at a dose of 1 mg/day, DNG inhibits ovulation.

Pharmacokinetics

Suction. EE after oral administration is quickly and completely absorbed in the small intestine. Cmax in plasma - 67 pg/ml, Tmax - 1.5-4 hours. During the initial passage through the liver, a significant part of the EE is metabolized. Absolute bioavailability is approximately 44%.

Distribution. EE almost completely (about 98%), although nonspecifically, binds to albumin. EE increases plasma concentrations of sex hormone binding globulin (SHBG). The apparent Vd is 2.8-8.6 l/kg.

Metabolism. EE undergoes conjugation in the intestinal mucosa and in the liver. The main route of metabolism of EE is aromatic hydroxylation, but its metabolism also leads to the formation of a large number of hydroxylated and methylated derivatives in free, glucuronidated and sulfated forms. Clearance is approximately 2.3-7 ml/min/kg.

Excretion. The decrease in the concentration of EE in plasma occurs in 2 stages: 1st stage - T1/2 is 1 hour, 2nd - 10-20 hours. EE is not excreted in unchanged form. EE metabolites are excreted by the kidneys and liver in a ratio of 4:6. T1/2 metabolites - about 24 hours.

Equilibrium concentration. C ss is achieved during the 2nd half of the treatment cycle, and the concentration of EE in the serum increases by 2 times.

Suction. After oral administration, it is quickly and completely absorbed from the intestines. Cmax in plasma - 51 pg/ml, Tmax - 2.5 hours. Absolute bioavailability when taken simultaneously with EE is 96%.

Distribution. DNG binds to plasma albumin and does not bind to SHBG and corticosteroid hormone-binding globulin. The fraction of free DNG in plasma is 10%, while 90% is nonspecifically bound to albumin. The apparent V d is 37-45 l.

Metabolism. DNG is primarily metabolized by hydroxylation, with an alternative pathway being glucuronidation. Its metabolites are inactive and are quickly eliminated from plasma, so it is not possible to detect metabolites in significant quantities in blood plasma, this does not apply to unchanged DNG. The total clearance after a single dose is 3.6 l/h.

Excretion. T1/2 of DNG is about 9 hours. A small amount is excreted unchanged by the kidneys. When taken orally, 86% is excreted within 6 days, of which 42% is excreted within the first 24 hours, mainly by the kidneys.

Equilibrium concentration. C ss is achieved within 4 days.

Indications of the drug Siluet ®

contraception;

treatment of mild to moderate acne when local treatment is ineffective in women requiring contraception.

Contraindications

Combined oral contraceptives (COCs) should not be used if a woman currently has any of the conditions/diseases listed below. At the first appearance of any of these conditions while taking COCs, the drug should be stopped immediately:

hypersensitivity to the drug Siluet ® or any of its components;

arterial and venous thromboembolic diseases currently or in history (for example, deep vein thrombosis, pulmonary embolism);

thrombosis (arterial and venous) and thromboembolism currently or in history, incl. thrombosis, deep vein thrombophlebitis; pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders;

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris, complicated lesions of the heart valve apparatus, atrial fibrillation, subacute bacterial endocarditis, extended surgery with prolonged immobilization, extensive trauma);

pancreatitis with severe hypertriglyceridemia currently or in history;

porphyria;

jaundice, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome);

sickle cell anemia;

multiple or severe risk factors for venous or arterial thrombosis; history of risk factors for arterial thrombosis:

Diabetes mellitus with vascular complications (angiopathy, retinopathy);

Uncontrolled arterial hypertension (AH);

Severe dyslipoproteinemia.

congenital or acquired predisposition to arterial thrombosis, for example resistance to activated protein C, antithrombin III deficiency, protein C, S deficiency, hyperhomocysteinemia and the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

smoking over the age of 35;

severe forms of liver disease (including history) until liver function tests normalize;

liver tumors (benign or malignant), incl. in the anamnesis;

hormone-dependent malignant diseases of the genital organs or mammary glands, incl. history or suspicion of them;

bleeding from the vagina of unknown origin;

migraine with local neurological symptoms, incl. in the anamnesis;

epilepsy;

lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

pregnancy;

lactation period.

Carefully: the presence of risk factors (varicose veins, heart disease, excess body weight, bleeding disorders) requires a more thorough study before starting to take COCs; smoking under the age of 35 (if a woman cannot quit smoking, another method of contraception should be used, especially if there are other risk factors); the potential risk and expected benefit of using oral contraceptives should be carefully weighed in each individual case if the following diseases, conditions or risk factors exist: dyslipoproteinemia, diabetes mellitus without vascular complications, controlled arterial hypertension, fibrocystic mastopathy, uterine fibroids, endometriosis, multiple sclerosis, history of severe depression, renal dysfunction, contact lens intolerance, Crohn's disease, ulcerative colitis, superficial vein phlebitis, thromboembolism, acute cerebrovascular accident, myocardial infarction at a young age, chronic heart failure, breast cancer in 1st degree relatives ; visual impairment (risk of retinal thrombosis), tetany, hypercalcemia, hypokalemia, bronchial asthma, hereditary angioedema, liver disease, idiopathic jaundice during a previous pregnancy, herpes during pregnancy.

Use during pregnancy and breastfeeding

Siluet ® is contraindicated during pregnancy.

If pregnancy occurs while taking Siluet ®, the use of the drug should be stopped immediately. The available information regarding the use of Siluet ® during pregnancy is too limited to draw conclusions about the negative effects of Siluet ® on pregnancy, fetal and newborn health. Extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took sex hormones for contraception before pregnancy or, through negligence, in early pregnancy.

The drug Siluet ® is contraindicated for use in breastfeeding women.

Side effects

The use of any COC is associated with an increased risk of arterial and venous thrombosis and thromboembolism (for example, venous thrombosis, pulmonary embolism, stroke, myocardial infarction). The risk increases with smoking, hypertension, bleeding disorders, obesity, varicose veins, thrombophlebitis and thrombosis.

The side effects listed below are presented by organ system class according to the MedDRA classification with the following frequency: very often - ≥1/10; often - ≥1/100 and<1/10; нечасто — ≥1/1000 и <1/100; редко — ≥1/10000 и <1/1000; очень редко — <1/10000.

From the blood and lymphatic system: rarely - anemia.

From the heart: rarely - tachycardia; very rarely - myocardial infarction.

From the nervous system: often - headache; infrequently - migraine, increased excitability, dizziness; rarely - cerebrovascular accident.

From the side of the organ of vision: rarely - blurred vision, conjunctivitis, dry mucous membrane, intolerance to contact lenses.

From the organ of hearing and labyrinth: rarely - hypoacusia, tinnitus, sudden hearing loss, hearing impairment.

From the respiratory system, chest and mediastinum: rarely - sinusitis, bronchial asthma, bronchitis.

From the gastrointestinal tract: often - nausea, vomiting; infrequently - abdominal pain; rarely - diarrhea, dyspepsia, gastritis, enteritis; very rarely - cholecystitis, cholelithiasis.

From the kidneys and urinary tract: infrequently - urinary tract infection.

For the skin and subcutaneous tissues: uncommon - acne, acneiform dermatitis, exanthema, allergic skin reactions, chloasma, alopecia, erythema multiforme, pruritus, including generalized pruritus, erythema nodosum, vascular purpura; rarely - hypertrichosis, virilism, hyperhidrosis, seborrhea, hyperpigmentation, eczema, dandruff, angioedema, telangiectasia (spider veins).

Metabolism and nutrition: often - weight gain; infrequently - increased appetite, weight loss; rarely - loss of appetite.

From the vascular system: infrequently - hypertension, arterial hypotension, varicose veins, thrombophlebitis of superficial veins; rarely - deep vein thrombophlebitis, thrombosis, pulmonary embolism, hematoma, cerebrovascular accident, hot flashes, pain along the veins.

General disorders and disorders at the injection site: infrequently - feeling of fatigue/malaise, swelling; rarely - flu-like symptoms.

From the immune system: rarely - allergic reactions.

From the genital organs: often - pain and tenderness of the mammary glands, enlargement of the mammary glands; uncommon - acyclic spotting or bleeding, painful menstrual-like bleeding, ovarian cysts, dyspareunia, increased vaginal discharge, endometrial hyperplasia, vaginitis/vulvovaginitis, salpingitis, endometritis; rarely - scanty menstrual-like bleeding, mastitis, fibrocystic dysplasia of the mammary glands, the appearance of mammary gland secretions, leiomyoma, endometritis, salpingitis, cervicitis, vulvovaginal itching, mammary gland lipoma; very rarely - endometrial cancer.

From the mental side: often - decreased mood; rarely - insomnia, sleep disturbances, depression, anorexia, changes in libido, aggression, apathy.

From the musculoskeletal and connective tissue side: often - back pain, cramps in the calf muscles; rarely - arthralgia, myalgia.

The following serious adverse events were observed in women using the drug Siluet ®:

Venous thromboembolic disorders;

Arterial thromboembolic disorders;

Liver tumors;

The appearance or aggravation of conditions for which the connection with the use of COCs has not been proven - Crohn's disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes pregnant, Sydenham's chorea, hemolytic-uremic syndrome, cholestatic jaundice;

Chloasma.

The incidence of breast cancer in women taking COCs increases very little. Because breast cancer rarely occurs in women under 40 years of age, this excess is very small in relation to the overall risk of developing breast cancer. Breast cancer is a hormone-dependent tumor. Known risk factors for breast cancer, such as early menarche, late menopause (after 52 years), nulliparity, anovulatory cycles, etc., indicate the role of hormones in the development of this disease. Hormone receptors play a key role in the cell biology of breast cancer, and estrogens can enhance the effects of growth factors (eg TGF-alpha).

Epidemiological studies have shown a possible causal relationship between long-term use of COCs started at a young age and the development of breast cancer in middle age. However, the use of COCs is only one of many risk factors.

Interaction

Interactions due to activation of microsomal enzymes between oral contraceptives and other drugs may lead to breakthrough bleeding and/or decreased contraceptive effectiveness. These effects have been shown for hydantoin, phenobarbital, primidone, carbamazepine and rifampicin. Such effects are also possible for rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and herbal drugs - preparations of St. John's wort (St. John's wort) Hypericum perforatum). The mechanism of these interactions is based on the ability of these drugs to activate microsomal liver enzymes.

According to clinical observations, simultaneous administration with certain antibiotics (such as ampicillin and tetracycline) can lead to a decrease in the effectiveness of contraception; the reason for this phenomenon is unknown.

Women taking the above drugs for a short period of time (up to a week) should, in addition to COCs, temporarily use barrier methods of contraception, for example, during the period of taking one of the drugs listed and 7 days after.

Women taking rifampicin should use barrier methods while taking rifampicin and for 28 days thereafter. If taking a concomitant drug occurs at the end of taking the tablets from the package, taking the next package should be started immediately, without the usual interval.

With long-term use of a concomitant drug that has the ability to activate liver enzymes, the doctor may consider the need to increase the dose of hormonal contraceptives. If this approach results in adverse events (such as irregular bleeding) or reduced effectiveness, another method of contraception must be used.

Based on research in vitro DNG has not been shown to inhibit cytochrome P450 at normal concentrations, so an interaction of this nature is not expected.

Drug interactions that increase the clearance of sex hormones can lead to breakthrough uterine bleeding and a decrease in the contraceptive effectiveness of the drug.

Directions for use and doses

Inside, 1 tablet/day, daily, at approximately the same time, if necessary, with a small amount of liquid, in the order indicated on the blister pack, for 21 days. Taking tablets from the next package begins 7 days after taking the last tablet from the previous package, during which withdrawal bleeding usually occurs. It usually begins on the 2-3rd day after taking the last tablet and may not end by the time you start taking the tablets from the next package.

You can switch from taking progesterone-only pills any day.

If hormonal contraception has not been used previously (for a month)

Taking Siluet ® should be started on the 1st day of the menstrual cycle (i.e. on the 1st day of menstruation).

In case of switching from a PDA

It is preferable to start taking Siluet ® the day after the usual break in use or the day after the last dose of the last tablet from the current package of oral contraceptives.

Injection form, implants

The transition from the use of implants is carried out on the day of implant removal; when switching from the injection form - the day after the last injection.

After an abortion in the first trimester of pregnancy

You can start taking it immediately; in this case there is no need to use additional contraception.

After childbirth or abortion in the second trimester

It is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If the drug is started later, the woman should be warned about the need to use additional barrier methods (condom) during the first 7 days. However, if sexual intercourse has already occurred, before starting to take COCs, it is necessary to exclude pregnancy or wait until the 1st menstruation.

Taking missed pills

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. The woman should take the drug as soon as possible, taking the next tablet at the usual time. If the delay in taking the pill is more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

The drug should never be interrupted for more than 7 days;

It takes 7 days of continuous tablet use to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given if the delay in taking pills is more than 12 hours.

1st week A woman should take the last missed tablet as soon as possible, even if this means taking 2 tablets. simultaneously. The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) should be used for the next 7 days. If you had sexual intercourse during the week before missing the pill, you need to consider the possibility of pregnancy. The more pills you skip and the closer this skip is to the 7-day break in taking pills, the higher the risk of pregnancy.

2nd week A woman should take the last missed tablet as soon as possible, even if this means taking 2 tablets. simultaneously. The next tablet is taken at the usual time. If the woman took the pills correctly within 7 days before the missed period, there is no need for additional contraception. However, if she misses more than 1 tablet, she should use additional methods of contraception (condom) for 7 days.

3rd week The risk of reduced reliability is imminent due to the upcoming 7-day interruption in reception. However, by adjusting the pill-taking schedule, the weakening of contraceptive protection can be prevented. If you follow one of the 2 proposed methods, there is no need to use additional methods of contraception if the woman took the pills correctly within 7 days before the missed period. Otherwise, she must follow 1 of these 2 methods and also use additional methods of contraception for the next 7 days.

1. A woman should take the last missed tablet as soon as possible, even if this means taking 2 tablets. simultaneously. The next tablet is taken at the usual time. Taking tablets from the next blister pack should be started immediately after taking the previous one, i.e. There should be no usual break between doses. Most likely, the woman will not have withdrawal bleeding until the end of the 2nd pack, but she may experience spotting or breakthrough uterine bleeding on the days she takes the pills.

2. It is possible to stop taking tablets from the current blister pack. There should then be a 7-day break from taking the pills, including days of missed pills, and then you should start taking the pills from a new pack. If a woman misses taking a pill and then does not have withdrawal bleeding during the first normal interval between doses of the drug, pregnancy must be ruled out.

If the woman has vomited within 4 hours after taking the pill

Absorption may be incomplete and additional contraceptive measures should be taken. In these cases, you should take a new (replacement) tablet as soon as possible. If possible, the new tablet should be taken within 12 hours of the usual dosing time. If more than 12 hours have passed, you should follow the recommendations when skipping tablets in the section Taking missed pills.

If a woman does not want to change her normal pill regimen, she should use an additional pill from a different blister pack.

How to Delay Withdrawal Bleeding

In order to delay the onset of menstrual bleeding, a woman should continue taking Siluet ® from a new package immediately after taking all the tablets from the previous one, without interruption. While taking the drug from the 2nd package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Siluet ® from a new pack after the usual 7-day break.

In order to move the day of the onset of menstrual-like bleeding to another day of the week, a woman can be advised to shorten the next break in taking the pill by as many days as she wants. The shorter the interval, the higher the risk that there will be no withdrawal bleeding and in the future, while taking the next package, spotting and breakthrough bleeding will appear (the same as in the case when she would like to delay the onset of menstrual-like bleeding).

Overdose

Acute toxicity following oral administration of a combination drug of EE and DNG in overdose is low.

Symptoms: Nausea, vomiting and spotting/bleeding from the vagina may occur.

Treatment: symptomatic, there is no need for special therapy.

special instructions

Before starting or resuming taking the drug Siluet ®, it is necessary to collect an anamnesis (including family history), and also exclude pregnancy. It is necessary to measure blood pressure and conduct a general examination, taking into account contraindications and precautions. It is necessary to explain to the woman the need to carefully read the instructions for use of the drug Siluet ® and follow the recommendations contained therein. The nature of medical examinations, including general medical and gynecological examinations, is determined by the attending gynecologist individually for each woman and is carried out at varying frequencies, but at least once every 6 months. A woman should be warned that oral contraceptives do not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Reduced efficiency

A decrease in the effectiveness of the combination of EE and DNG occurs in the case of, for example, a missed dose, gastrointestinal disorders or when taking concomitant therapy.

Change in bleeding pattern

The use of the drug Siluet ®, especially in the first 3 cycles, may be accompanied by the appearance of acyclic spotting/bleeding from the vagina, which can be considered as an adaptation period.

If irregular bleeding is persistent or appears after previous normal regular cycles, non-hormonal causes should be considered and malignancy and pregnancy excluded. In this case, you need to consult a gynecologist.

In some women, withdrawal bleeding may not occur between doses of the drug. If a woman takes Siluet ® as directed, pregnancy is unlikely. However, if a woman had violations of taking the drug before the 1st missed withdrawal bleeding or if there were 2 missed withdrawal bleedings, pregnancy should be excluded before continuing to take the drug Siluet ®. Herbal medicines containing St. John's wort ( Hypericum perforatum), should not be used in parallel with the drug Siluet ® (due to their ability to reduce the level of the drug in plasma and reduce the effectiveness of the combination of DNG with EE).

The use of combined oral contraceptives leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is highest in the 1st year of COC use. The risk of VTE associated with taking the combination of DNG with EE is less than the risk associated with pregnancy, it is 60 cases per 100,000 pregnancies. VTE is fatal in 1-2% of cases.

Symptoms of arterial or venous thrombotic or thromboembolic complications may include the following conditions:

Unusual unilateral leg pain and/or swelling;

Sudden severe chest pain with possible radiation to the left arm;

Sudden shortness of breath;

Sudden attack of coughing;

any unusual, severe, long-lasting headache;

Sudden partial or complete loss of vision;

Diplopia;

slurred speech or aphasia;

Dizziness;

Fainting, accompanied by a partial epileptic seizure or without it;

sudden weakness or significant numbness on one side or in one part of the body;

Movement disorders;

Acute abdomen syndrome.

The risk of venous thromboembolic complications increases:

With age;

If you have a family history (VTE, which has ever occurred in close relatives and parents at a relatively young age); if a congenital predisposition is possible, the woman should be referred to a specialized specialist to make a decision on prescribing the drug Siluet ®;

During prolonged immobilization, after major surgery, any surgery on the legs, or after serious injury. In these cases, it is preferable to stop taking the tablets (for elective operations at least 4 weeks in advance) and not resume until 2 full weeks have passed after remobilization. If the drug has not been discontinued in advance, antithrombotic therapy should be prescribed;

For obesity (body mass index more than 30 kg/m2). There is no consensus on the role of varicose veins or thrombophlebitis of superficial veins in the occurrence and development of venous thrombosis.

The risk of arterial thromboembolic complications or the risk of stroke in women using the combination of DNG with EE increases:

With age;

In the presence of dyslipoproteinemia;

Presence of hypertension;

Heart valve diseases;

Atrial fibrillation;

Smoking - smokers increase the risk of severe cardiovascular complications (such as myocardial infarction, stroke); The risk increases with age and the number of cigarettes smoked.

The presence of one severe or several risk factors for the development of venous or arterial diseases, respectively, may also be a contraindication. The possibility of using anticoagulant therapy should also be considered. Women receiving Siluet ® should be reminded of the need to contact their doctor if they suspect symptoms of thrombosis. In case of suspected or proven thrombosis, the drug should be discontinued. In this case, women need to use other suitable methods of contraception due to the teratogenic effect of anticoagulant drugs (coumarins).

The increased risk of thromboembolism during the postpartum period must be taken into account.

Diseases such as diabetes mellitus, SLE, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.

An increase in the frequency and severity of migraine when taking a combination of DNG and EE (which may be a harbinger of cerebrovascular accident) may be an indication for immediate discontinuation of the drug.

Tumors

Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of the combination of DNG and EE (more than 5 years). However, controversy remains about the extent to which these cases are related to sexual behavior and other factors such as human papillomavirus.

Studies have shown a slight increase in relative risk (RR - relative risk- 1.24) development of breast cancer in women who used COCs. The increased risk gradually decreases over 10 years after stopping these drugs.

In rare cases, during the use of a combination of DNG and EE, the development of benign liver tumors was observed, and in even more rare cases, malignant ones. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. If severe pain appears in the upper abdominal region, liver enlargement and signs of intraperitoneal bleeding in women taking combinations of DNG and EE, liver tumors should be excluded.

Other states

Women with a current or history of hypertriglyceridemia are at increased risk of developing pancreatitis when using the combination of DNG and EE. Although slight increases in blood pressure have been described in many women taking combinations of DNG and EE, clinically significant increases have been reported rarely.

However, if women with hypertension experience a stable increase in blood pressure while taking COCs, or if sudden increases in blood pressure do not respond to antihypertensive therapy, the drug should be discontinued. If possible, treatment can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

Acute or chronic liver disease may require discontinuation of Siluet ® until liver function tests return to normal.

Recurrent cholestatic jaundice, which developed for the first time during pregnancy or previous use of sex hormones, requires discontinuation of the combination of DNG and EE.

Although the combination of DNG and EE may have an effect on tissue insulin resistance and glucose tolerance, there is usually no need to adjust the treatment regimen in patients with diabetes. However, women with diabetes should be under close medical supervision while taking Siluet ®.

The use of a combination of DNG and EE may worsen the course of Crohn's disease and ulcerative colitis.

Chloasma may appear periodically, especially in women with a history of chloasma during pregnancy. Women prone to chloasma should avoid prolonged sun exposure and exposure to UV radiation while taking Siluet ®.

Laboratory research

The use of contraceptive steroids may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, as well as plasma levels of transport proteins, such as corticosteroid hormone-binding globulin and lipid/lipoprotein fractions, and parameters of carbohydrate metabolism , coagulation and fibrinolysis. Changes usually remain within normal limits.