Siluet pills 2 mg + 0.03 mg №63

Film Coated Tablets

Active ingredient

1 tab. contains ethinyl estradiol 30 mcg, dienogest 2 mg

Packaging

63 pieces

Mechanism of action

Siluet - oral combination drug with antiandrogenic effect, contains ethinyl estradiol as an estrogen and dienogest as a progestogen. Contraceptive effect of the drugSiluet due to various factors, the most important among them are - inhibition of ovulation, increased viscosity of cervical mucus, changes in the motility of the fallopian tubes and endometrial structure. The antiandrogenic effect of the combination of ethinyl estradiol and dienogest is based on a decrease in the concentration of androgens in plasma.

Repeated studies have shown that taking a combination of ethinyl estradiol and dienogest resulted in alleviating the symptoms of mild to moderate severity and had a positive result in patients with seborrhea.

Dienogest is a derivative of norethisterone, which has a 10–30 times lower affinity for Progesterone receptors in vitro compared to other synthetic progesterones. Dienogest has no significant androgenic, mineralocorticoid or glucocorticoid effects in vivo.

With an isolated administration of 1 mg / day, dienogest inhibits ovulation.

Indications and usage

• oral contraception;
• treatment of mild to moderate acne (acne) with the ineffectiveness of local treatment in women who need contraception.

Contraindications

PDAs should not be used if one of the following conditions or diseases is present. If any of these conditions or diseases occurs for the first time during the use of PDA, the drug should be stopped immediately.

• Presence or indication of a history of venous thromboembolic diseases (for example, deep vein thrombosis, pulmonary embolism);
• the presence or indication in the history of arterial thromboembolic diseases (myocardial infarction), prodromal symptoms of thrombosis (for example, transient ischemic attack, angina) or cerebrovascular disorder;
• the presence of severe or multiple risk factors for venous or arterial thrombosis: diabetes mellitus with vascular lesions, severe hypertension, severe dyslipoproteinemia;
• hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to argon plasma coagulation (APC), deficiency of antithrombin III, protein C deficiency, protein deficiency S, hyperhomocysteinemia and antiphospholipid antibody (antibodies to cardiolipin, lupus anticoagulant);
• smoking;
• pancreatitis at the moment or in history, if it is associated with severe hypertriglyceridemia;
• the presence or indication in the history of severe liver disease, while the indicators of liver function are not normalized;
• the presence or indication of a history of liver tumors (benign or malignant);
• known or suspected malignant tumors (for example, genitals or mammary glands) that are dependent on sex hormones;
• vaginal bleeding of unknown etiology;
• pregnancy or suspected pregnancy;
• migraine with focal neurological symptoms in history;
• Hypersensitivity to the active substances or any of the components of the drug.

Dosage and administration

Tablets should be taken daily at about the same time, if necessary, with a small amount of liquid, in the order indicated on the blister pack. You should take 1 pill per day for 21 days in a row. Taking the first pill from each subsequent package should begin after a 7-day interval, during which menstrual-like bleeding usually begins, which starts 2-3 days after taking the last pill and may not end before taking the pills from the next package.
If hormonal contraceptives in the previous period (last month) were not used. Taking the pills should begin on the first day of the menstrual bleeding.
The transition from another combined hormonal contraceptive.It is advisable that a woman start taking Siluet pills on the next day after taking the last active pill of the previous combined oral contraceptive pill (CPC) or the day after the last active day of the previous CPC.
Transition from a progestogen-only method (mini-pili, injections, implants). A woman can start taking Siluet on any day after stopping a mini-drink (in the case of an implant or intrauterine system, on the day of their removal, in the case of an injection, instead of the next injection).
After abortion in the first trimester of pregnancy. The drug should be started immediately on the same day after surgery. In this case, there is no need to use additional contraceptives.
After childbirth or after abortion during the second trimester of pregnancy. Women should be advised to start taking Siluet with the 21–28 day after birth or abortion during the second trimester of pregnancy. If a woman starts taking the pills later, it is recommended to additionally use a barrier method of contraception during the first 7 days of using the pills. However, if sexual intercourse has already taken place, then before starting to use the CCP, pregnancy should be excluded or the woman should wait for the first menstruation.
In case of breastfeeding see Use during pregnancy and lactation.
Skip taking pills. 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 it became clear. The next pill from this package should be taken at the usual time. If the delay in taking the pill exceeds 12 hours, contraceptive protection may be reduced. In this case, you can follow the two main rules:
1. A break in taking pills can never be more than 7 days.
2. Adequate suppression of the hypothalamus-pituitary-ovaries system is achieved by continuous administration of pills for 7 days.
In accordance with this, in everyday life the following recommendations should be guided:
1st week 
A woman should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After that, she continues to take pills at the usual time. In addition, over the next 7 days, you should use a barrier method of contraception, such as a condom. If sexual intercourse took place in the previous 7 days, you should consider the possibility of pregnancy. The more pills are missed and the closer the pass to the 7-day break in taking the drug, the higher the risk of pregnancy.
2nd week 
A woman should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After that, she continues to take pills at the usual time.Provided that the woman took the pills correctly for 7 days before skipping, there is no need to use additional contraceptives. Otherwise, or when skipping> 1 pill, it is recommended to additionally use a barrier method of contraception for 7 days.
3rd week 
The probability of reducing the contraceptive effect is significant due to the upcoming break in the pill for 7 days. However, if you follow the pill regimen, you can avoid a reduction in contraceptive protection. If you stick to one of the following options, you will not need to use additional contraceptives if you take the pills correctly for 7 days before the release. If this is not the case, it is recommended that you stick to the first of the following options and use additional methods of contraception over the next 7 days.
1. A woman should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After that, she continues to take pills at the usual time. Taking the pills from the new package should be started immediately after the end of the previous one, that is, there should not be a break in taking the pills. It is unlikely that a woman will start menstrual-like bleeding before the end of taking the pills from the second pack, although there may be spotting or a breakthrough bleeding.
2The woman may also be advised to stop taking the pills from the current package. In the second case, a break in taking the drug should be 7 days, including the days of skipping pills; taking pills should start with the next pack.
If a woman misses taking the pill and has no menstrual bleeding during the first normal break in taking the drug, the probability of pregnancy should be considered.
Recommendations in case of violations by the gastrointestinal tract. In severe disorders of the gastrointestinal tract (vomiting, diarrhea) may be incomplete absorption of the drug; in this case, additional contraceptives should be used.
If vomiting occurs within 3-4 hours after taking the pill, take a new pill as soon as possible. A new pill should be taken within 12 h after the usual time of admission. If it has been> 12 hours, you must follow the rules for taking the drug (see Skip the pill). If a woman does not want to change her usual regimen, she needs to take an extra pill (s) from another package.
How to change the time of occurrence of bleeding "cancel". To delay the day of the onset of menstruation, a woman should continue to take Hiloil’s pills from a new package and not take a break from taking the drug. If desired, the period of admission can be extended until the end of the second package. If this is possible breakthrough bleeding or spotting bleeding.Routine administration of the drug Silayet resumes after a 7-day break in taking pills.
To shift the time of menstruation on another day of the week, a woman is recommended to reduce the break in taking pills for as many days as she wants. It should be noted that the shorter the break is, the more often there is a lack of menstrual-like bleeding and breakthrough bleeding or bloody discharge during taking the pills from the second package (as in the case of delayed onset of menstruation).

The most serious side effects associated with the use of PDAs are described in the SPECIAL INSTRUCTIONS section.
With simultaneous use of dienogest and ethinyl estradiol, the following adverse reactions were reported (often ≥1 / 100 - <1/10; infrequently (≥1 / 1000 - <1/100); rarely (≥1 / 10 000 - <1/1000).
Laboratory values: rarely - anemia.
Since the cardiovascular system: rarely - tachycardia, thrombophlebitis, thrombosis / pulmonary embolism, hematoma, impaired cerebral circulation; infrequently - AH, arterial hypotension, varicose veins.
From the nervous system: often - headache; infrequently - migraine, irritability.
On the part of the organ of vision: rarely - visual disturbances, conjunctivitis.
From the organ of hearing: rarely hypoacusia.
On the part of the respiratory system: rarely - sinusitis, BA, bronchitis.
From the digestive system: often - pain in the abdomen; infrequently - nausea, vomiting; rarely diarrhea.
From the urinary system: infrequently, urinary tract infections.
From the skin: infrequently - acne, acneform dermatitis, exanthema, skin allergic reactions, chloasma, alopecia; rarely, erythema multiforme, pruritus, hypertrichosis, virilism.
Metabolism: infrequently - increased appetite; rarely - loss of appetite.
Infections: infrequently - vaginitis, vaginal candidiasis .
General violations: infrequently - fatigue / malaise, change in body weight; rarely, flu-like symptoms.
On the part of the immune system: rarely - allergic reactions.
From the reproductive system and mammary glands: often - breast tenderness, tension in the mammary glands; infrequently - irregular bleeding, dysmenorrhea, enlargement of the mammary glands, ovarian cyst, dysporenia, changes in vaginal secretions; rarely - hypomenorrhea, mastitis, fibrocystic dysplasia of the mammary glands, the appearance of secretions from the mammary glands, leiomyoma, endometritis, salpingitis.
From the psyche: infrequently - mood disorders (including depression); rarely - anorexia, change of libido, aggressiveness, apathy.
The following serious adverse reactions, described in the SPECIAL INDICATIONS section, have been reported in women taking contraceptives: venous and arterial thromboembolic disorders; arterial thromboembolic disorders; AH; liver tumors; appearance or worsening of conditions whose connection with oral contraceptive use has not been proven: Crohn's disease, ulcerative colitis, porphyria, systemic lupus erythematosus, pregnant herpes, Sydengham's chorea, hemolytic uremic syndrome, cholestatic jaundice; chloasma.
The frequency of diagnosis of breast cancer among women taking oral contraceptives is slightly increased. Since breast cancer is rare in women younger than 40 years, the increase is small compared with the overall risk of developing breast cancer. A causal relationship with oral contraceptive use has not been proven.

If you have any of the following conditions / risk factors, you should carefully weigh the potential risk and the expected benefits of using a PDA in each individual case and discuss this with the woman before she decides to start taking the drug. When exacerbation, aggravation, or first occurrence of any of the following conditions or risk factors, a woman is recommended to consult a doctor who may decide to discontinue the drug.
Disturbances from the circulatory system 
The use of any PDA is associated with an increased risk of venous thromboembolism. The additional risk of venous thromboembolism is maximum during the first year of use of the combined contraceptive.
Rare cases of thrombosis of other blood vessels, such as the arteries and veins of the liver, kidneys, mesenteric vessels, brain vessels, or retina in women using combined contraceptives, have been described. Communication with the use of PDAs is not proven.
Symptoms of venous or arterial thrombotic / thromboembolic or cerebrovascular events can be:

• unilateral pain in the lower limbs or their swelling;
• sudden severe chest pain with / without irradiation to the left arm;
• sudden shortness of breath;
• sudden cough;
• any unusual, severe, prolonged headache;
• sudden partial or complete loss of vision;
• diplopia;
• speech impairment or aphasia;
• dizziness;
• loss of consciousness with or without a partial epileptic seizure;
• weakness or a pronounced sudden numbness of one side or one part of the body;
• motility disorders;
• sharp belly.

Factors that increase the risk of venous or arterial thrombotic / thromboembolic events or the risk of stroke in women:

• age;
• family history (venous or arterial thromboembolism in close relatives at a relatively early age). If a hereditary predisposition is assumed, a woman should consult a specialist before prescribing a PDA;
• prolonged immobilization, radical surgery, any surgery on the lower limbs, extensive injuries. In these cases, it is recommended to discontinue the use of the drug (for planned operations no less than 4 weeks before) and not to resume its administration earlier than 2 weeks after the end of the remobilization. Additionally, it is possible to prescribe antithrombotic therapy if the pill is not discontinued at the recommended time;
• obesity (body mass index> 30 kg / m²);
• there is no consensus regarding the possible role of varicose veins and surface thrombophlebitis in the development of venous thromboembolism;
• smoking (in combination with intensive smoking and increasing age increases the risk, especially among women over 35);
• dyslipoproteinemia;
• AH;
• valvular disease;
• atrial fibrillation.

Women over the age of 35 are advised to stop smoking if they decide to take the CCP. If a woman cannot stop smoking, another method of contraception should be used, especially if there are other risk factors.
Having one of the serious risk factors or multiple risk factors for arterial or venous disease may be a contraindication. Women who use PDA should immediately see a doctor if symptoms of a possible thrombosis occur. In cases of suspected thrombosis or confirmed thrombosis, the use of CPC should be stopped. It is required to select an adequate method of contraception due to the teratogenicity of anticoagulant therapy (coumarins).
It is necessary to consider 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).
An increase in the frequency and severity of migraine or its exacerbation during the use of PDA (which may be a prodromal symptom of cerebral circulation disorder) may require an immediate discontinuation of PDA.
Tumors 
The results of some epidemiological studies indicate an additional increase in the risk of developing cervical cancer with prolonged use of CCP (> 5 years), but this statement is still controversial, because it is not fully determined how much research results take into account sexual behavior and associated risk factors, such as human papilloma .
Studies indicate a slight increase in the risk of developing breast cancer in women using PDA. This increased risk gradually disappears within 10 years after the end of taking the PDA.
In rare cases, women using CPC have had benign, and even more rarely, malignant liver tumors. In some cases, these tumors caused life-threatening intra-abdominal bleeding. In the event of complaints of severe pain in the epigastric region, an increase in the liver or signs of intra-abdominal bleeding during differential diagnosis, the possibility of a liver tumor in women taking CPC should be considered.
Other states 
Women with hypertriglyceridemia or having a family history of this disorder are at risk of developing pancreatitis with the use of PDA.
Although a slight increase in blood pressure has been described in many women taking CPC, a clinically significant increase in blood pressure is a single event. Only in rare cases is the immediate cessation of the use of PDAs necessary.If during the use of PDA in cases of previously existing hypertension, blood pressure is constantly increased or antihypertensive therapy does not give an adequate effect, the use of PDA should be stopped. If necessary, the use of PDA can be continued if, thanks to antihypertensive therapy, normal blood pressure values ​​are achieved.
It was reported about the occurrence or exacerbation of the following diseases during pregnancy and with the use of PDA, but their relationship with the use of PDA is not finally clarified: jaundice and / or itching associated with cholestasis ; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis.
In acute or chronic liver dysfunction, it may be necessary to discontinue the use of PDA, as long as the indicators of liver function do not normalize. When recurrent cholestatic jaundice, which first appeared during pregnancy or prior to the use of sex hormones, the use of CPC should be stopped.
Although KPC may affect peripheral insulin resistance and glucose tolerance, there is no evidence that changing the therapeutic regimen in diabetic women who take low-dose KPC (containing ≤0.05 mg of ethinyl estradiol). However, women with diabetes should be closely monitored while taking PDA.
Crohn's disease and ulcerative colitis may be associated with the use of PDAs.
Chloasma can sometimes occur, especially in women with a history of chloasma in pregnant women. Women prone to chloasma should avoid exposure to direct sunlight and ultraviolet radiation while taking PDA.
Medical examination 
Before you start using the PDA, you must carefully examine the patient’s history, including family history, and conduct a medical examination to rule out pregnancy. It is necessary to measure blood pressure and conduct a general examination, taking into account contraindications (see CONTRAINDICATIONS) and adverse reactions (see ADVERSE EFFECTS). It is necessary that the patient carefully read the instructions for medical use and follow the recommendations indicated in it. The frequency and nature of examinations should be based on existing norms of medical practice, taking into account the individual characteristics of each woman.
The patient should be warned that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency 
The effectiveness of PDA may be reduced in the case of missing tablets, disorders of the gastrointestinal tract, or while taking other medicines.
Cycle control 
When taking CPC, intermenstrual bleeding may occur (spotting or breakthrough bleeding), especially during the first months of the drug use.Given this, the examination for the appearance of any irregular bleeding should be carried out only after a period of adaptation of the body to the drug, which is approximately 3 cycles.
If irregular bleeding continues or occurs after several normal regular cycles, it is necessary to consider non-hormonal causes and to take appropriate diagnostic measures to exclude malignant neoplasms or pregnancy. They may include curettage. In some women, menstrual bleeding may not occur during a break in the intake of CPC. If the PDA was taken according to the instructions described in the APPLICATION section, then pregnancy is unlikely. However, if the use of a contraceptive was carried out irregularly or if there is no menstrual bleeding for 2 cycles, pregnancy should be excluded before continuing with the use of PDA.
Drugs based on herbs containing St. John's wort (Hypericum perforatum) should not be used concurrently with Siluet, because they can reduce the plasma levels of the drug and reduce the effectiveness of the combination of dienogest with ethinyl estradiol.
The drug contains 47.66 mg of lactose per 1 tablet. Patients with rare hereditary intolerance to galactose, Lapp's lactase deficiency, or glucose-galactose dysfunction, who are on a diet with lactose, should take this into account.
Use during pregnancy and lactation. The drug is contraindicated during pregnancy. In the event of pregnancy during the administration of Siluet, the drug should be stopped. However, the results of epidemiological studies do not indicate an increased risk of congenital malformations in children born to women who took oral contraceptives before pregnancy, as well as the existence of a teratogenic effect in case of unintentional administration of oral contraceptives in early pregnancy. Such studies with the drug Siluet not conducted.
Hormonal contraceptives can reduce the production of milk and change its composition, as well as in a small amount penetrate into breast milk, so taking these drugs during breastfeeding is contraindicated.
Children. The drug is not intended for use in children.
The ability to influence the reaction rate when driving or working with other mechanisms. Siluet pills do not affect the ability to drive vehicles or work with mechanisms with an increased risk of injury.

interactions associated with the activation of microsomal enzymes (for example, hydantoin, phenobarbital, primidone, Carbamazepine , rifampicin, and possibly also rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate , felbamate, ritonavir,griseofulvin and medicines containing St. John's wort) between oral contraceptives and other medicines can lead to breakthrough bleeding and / or to a decrease in the contraceptive effect. The mechanism of these interactions is based on the ability of the above drugs to activate microsomal liver enzymes.
Some studies suggest that the enterohepatic circulation of estrogen may be reduced by taking certain antibiotics that may decrease the concentration of ethinyl estradiol (for example, penicillin and Tetracycline antibiotics).
When treating any of the above drugs, a woman should temporarily use a barrier method of contraception in addition to taking CPC or choose another method of contraception.
In the treatment of rifampicin, a barrier method of contraception should be used during the entire period of treatment with the appropriate drug and for another 28 days after stopping its use. If the packaged PDA pills have already run out and you need to take a concomitant medication, the use of pills from the next package should be started without the usual break.
With prolonged use of a concomitant drug that has the ability to activate liver enzymes, the doctor may consider the need to increase the doses of contraceptive steroids.If this method leads to undesirable effects (for example, irregular bleeding) or reduced efficacy, another method of contraception should be used.
Dienogest, when used in normal concentrations, does not inhibit cytochrome P450; therefore, no interactions of this nature are noted.
Laboratory research. Contraceptive use may affect the results of individual laboratory tests, including biochemical indicators of liver function, thyroid gland, adrenal glands and kidneys, as well as levels of transport proteins of blood plasma, such as corticosteroid binding globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis. Changes usually occur within laboratory norms.

acute toxicity with a combined overdose of dienogest and ethinyl estradiol is very low. The likelihood of symptoms of intoxication is low even in children who have accidentally taken a few pills.
Overdose can cause nausea, vomiting, slight bleeding from the vagina. There is no antidote, treatment should be symptomatic.