Expiration date: 07/2025

Structure and Composition

Siluette tablets, film-coated

1 tablet contains 30 mcg ethinyl estradiol, dienogest 2 mg, in the package 21 and 63 pieces.

Pharmachologic effect:

Siluette - oral combination product with anti-androgenic effect, contains ethinyl estradiol as the estrogen and dienogest as a progestogen. The contraceptive effect of the drug Siluette due to various factors, the most important among them are - inhibition of ovulation, increased viscosity of the cervical mucus, changes in motility of the fallopian tubes and endometrium structure. Antiandrogenic effect of a combination of dienogest and ethinylestradiol is based on lowering plasma concentrations of androgens.

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

Dienogest is a derivative of norethisterone, which is 10-30 times lower affinity to the progesterone receptor in vitro in comparison with other synthetic progesterone. Dienogest has no significant androgenic, mineralocorticoid and glucocorticoid effects in vivo.

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

testimony

oral contraception,

treatment of mild to moderate acne (acne) the ineffectiveness of the local treatment of women in need of contraception.

Contraindications:

CPC should not be used if one of the following conditions or diseases. If any of these conditions or diseases arise for the first time during the application of the CPC, the drug should be discontinued immediately.

The presence or indication of a history of venous thromboembolic disease (eg deep vein thrombosis, pulmonary embolism)

the presence or indication of a history of arterial thromboembolic disease (myocardial infarction), prodromal symptoms of thrombosis (eg transient ischemic attack, angina pectoris) or cerebrovascular disorder,

the presence of serious or multiple risk factors with respect to venous or arterial thrombosis: diabetes with vascular disease, severe hypertension, severe dislipoproteinemia,

hereditary or acquired predisposition for venous or arterial thrombosis, such as resistance to argon plasma coagulation (APC), antithrombin III of failure, lack of protein C, protein deficiency the S, hyperhomocysteinemia, and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant)

smoking,

pancreatitis in the moment or in the history if it is associated with severe hypertriglyceridemia,

the presence or indication of a history of severe hepatic disease as long as liver function tests are not normalized,

an indication of the presence or history of liver tumors (benign or malignant)

known or suspected malignant tumors (eg genital or mammary glands) that are dependent on sex hormones

vaginal bleeding of unknown etiology,

pregnancy or suspected pregnancy,

migraine with focal neurological symptoms history,

Hypersensitivity to the active substances or any component of the drug.

Dosing and Administration

Tablets must be taken every day at about the same time, if necessary with a small amount of liquid in the sequence shown on the blister pack. It should take 1 tablet per day for 21 consecutive days. Receiving the first tablet of each next pack should start after a 7-day interval, during which bleeding usually occurs menstrualnopodobnoe which begins 2-3 days after the last tablet and may not end before receiving the next pack of pills.

If hormonal contraceptives in the previous period (last month) were not used. Receiving tablets should begin on the first day of menstrual bleeding.

Switching from another combined hormonal kontratseptiva.Zhelatelno woman to start taking pills Siluette on the next day after taking the last active tablet of the previous combined oral contraceptive (PDA) or the next day after the last active day of the previous handheld.

Go with the method based on the use of progestogen only (minipill, injection, implant). The woman may start taking the drug Siluette on any day after stopping the mini-pill (in the case of the implant or intrauterine system - on the day of the removal, in the case of injection - instead of the next injection).

After an abortion in the I trimester of pregnancy. The drug should be started immediately on the same day after the operation. In this case there is no need to use additional means of contraception.

After delivery or after abortion in the second trimester of pregnancy. Women should be advised to start taking the drug Siluette with 21-28-th day after delivery or abortion in the second trimester of pregnancy. If a woman starts taking the pill later, should be advised to additionally use a barrier method of contraception during the first 7 days of treatment with tablets. However, if intercourse has already taken place, it is necessary to exclude pregnancy or the woman should wait until the first menstrual period before using a PDA.

In the case of breast-feeding, see. Use during pregnancy and lactation.

Skipping taking the pill. If the delay in receiving the tablet does not exceed 12 hours, the contraceptive effect of the drug is not reduced. Missed tablet should be taken as soon as it turned out. The next tablet from this package should be taken at the usual time. If the delay in taking the pill more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:

1. tablet-free interval can never be longer than 7 days.

2. Adequate suppression of the hypothalamic-pituitary-ovarian axis is achieved by continuous intake of pills for 7 days.

In accordance with this, consider the following recommendations for daily life:

1st week

The woman should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. She then continues to take tablets at the usual time. Further, over the next 7 days should use a barrier method of contraception, such as a condom. If in the previous 7 days held intercourse, one should consider the possibility of pregnancy. The more tablets receptions missed and the closer pass to 7-day break in taking the drug, the greater the risk of pregnancy.

Week 2

The woman should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. She then continues to take tablets at the usual time. Assuming that the woman taking the correct pills for 7 days prior pass, there is no need to use additional contraceptives. Otherwise or skip> 1 tablet recommended to use additional barrier method of contraception for 7 days.

Week 3

The probability of a significant decrease in contraceptive effect because of the forthcoming tablet-free interval lasting 7 days. However, subject to the regimen of tablets can be avoided by reducing contraceptive protection. If you stick to one of the following options, you will not have the need to use additional contraception when properly taking the pills for 7 days prior to admission. If it is not, it is recommended to adhere to the first of these options and to use additional methods of contraception for the next 7 days.

1. The woman should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. She then continues to take tablets at the usual time. Taking the pills from a new package should start taking immediately after the previous one, then there should not be a tablet-free interval. It is unlikely that a woman will menstrualnopodobnoe bleeding until the end of the pills from the second pack, but there may be spotting or breakthrough bleeding.

2. The woman may also be advised to stop taking tablets from the current package. In the second case, a break in taking the drug must be 7 days, including the days of skipping pills, taking pills to start with the next pack.

If a woman misses pills, and it does not have menstrualnopodobnoe bleeding during the first break in the normal taking the drug, you should consider the likelihood of pregnancy.

Recommendations in case of violations of the gastrointestinal tract. In severe disorders of the gastrointestinal tract (vomiting, diarrhea), possibly incomplete absorption of the drug, in this case, you should use additional means of contraception.

If within 3-4 hours after tablet vomiting occurs, it is necessary as a new tablet can be taken quickly. The new tablet should be taken within 12 hours after the normal time of reception. If it has been> 12 hours, you must abide by the rules of the drug (see. Pass taking the pill). If a woman does not want to change their usual medication regimen, it is necessary to take the extra tablet (s) from a different package.

How to change the time of bleeding "cancel." To delay the first day of menstruation, the woman should continue to take the tablets Siluette of the new packaging and do not break in taking the drug. If desired, the deadline can be extended until the end of the second package. At the same time possible breakthrough bleeding or spotting. The usual method Siluette of the drug is resumed after the 7-day tablet-free interval.

To shift the onset of menstruation to another day of the week, she will need to cut the tablet-free interval for as many days, as much as she wants. It should be noted that the shorter the interval, the more there is a lack menstrualnopodobnoe bleeding and breakthrough bleeding or spotting during the tablet-taking from the second package (as in the case of delay in the onset of menstruation).

Side effects:

the most serious side effects associated with the use of PDAs are described in the section SPECIAL INSTRUCTIONS.

With simultaneous use of dienogest and ethinyl estradiol reported the following adverse reactions (often ?1 / 100 - <1 10 = "" 1 = "" 1000 = "" 100 = "" 000 = "" br = "">, Laboratory indicators: rarely - anemia.

Since the cardiovascular system: rarely - tachycardia, thrombophlebitis, thrombosis / pulmonary embolism, hematoma, cerebral blood flow, seldom - hypertension, hypotension, varicose veins.

From the nervous system: often - headache, rare - headache, irritability.

On the part of the organ of vision: rarely - visual impairment, conjunctivitis.

On the part of the organ of hearing: rarely - Gipoakuzija.

With the respiratory system: rarely - sinusitis, asthma, bronchitis.

From the digestive system: often - abdominal pain, rarely - nausea, vomiting, rarely - diarrhea.

From the urinary system: Infrequent - urinary tract infection.

Skin: Infrequent - acne akneformny dermatitis, rash, allergic skin reactions, chloasma, alopecia, rarely - erythema multiforme, pruritus, hypertrichosis, virilism.

On the part of metabolism: rarely - increased appetite, rare - loss of appetite.

Infections: infrequent - vaginitis, vaginal candidiasis.

General disorders: rarely - fatigue / malaise, weight change, rarely - the symptoms arising from the influenza.

Immune system: rare - allergic reactions.

Reproductive system and breast: often - breast tenderness, tension in the breasts, not often - irregular bleeding, dysmenorrhea, breast enlargement, ovarian cysts, dispaureniya, changes in vaginal secretions, rarely - gipomenoreya, mastitis, fibrocystic dysplasia dairy glands, the appearance of secretions from the breast, uterine leiomyoma, endometritis, salpingitis.

On the part of the psyche: Infrequent - mood disorders (including depression), rarely - anorexia, change in libido, aggressiveness, apathy.

The following serious adverse reactions described in the section SPECIAL INSTRUCTIONS, have been reported in women taking contraceptives: venous and arterial thromboembolic disorders, arterial thromboembolic disorders, hypertension, liver tumors, the emergence or worsening of conditions, whose connection with the use of oral contraceptives has not been proven: the disease Crohn's disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uraemic syndrome, cholestatic jaundice, chloasma.

The frequency of diagnosis of cancer of breast among women taking oral contraceptives increased slightly. Because breast cancer in women aged younger than 40 years is rare, increase is small compared to the overall risk of breast cancer. The causal relationship to the use of oral contraceptives has not been proved.

Special instructions:

if any of the following conditions / risk factors should be carefully weigh the potential risks and expected benefits from the use of PDAs in each individual case and discussed with the woman before she decides to start taking the drug. During exacerbation, intensification or first appearance of any of the following conditions or risk factors the woman is recommended to consult a doctor, who can decide whether to cancel the drug.

Violations of the circulatory system

The use of any PDA is associated with an increased risk of venous thromboembolism. Additional risk of VTE is highest during the first year of application of the combined contraceptive.

Described rare cases of thrombosis, other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, vessels of the brain or the retina in women using combined contraceptives. Communication with the CCP is not proven.

Symptoms of venous or arterial thrombotic / thromboembolic or cerebrovascular events may be:

• unilateral pain in the lower extremities, or edema,
  
• sudden severe pain in the chest with / without irradiation to the left arm,
  
• sudden shortness of breath,
  
• suddenly started coughing,
  
• any unusual, severe, prolonged headache
  
• sudden partial or complete loss of vision,
  
• diplopia,
  
• speech impairment, or aphasia,
  
• dizziness,
  
• loss of consciousness, with or without partial epileptic attack him,
  
• weak or strong expression sudden numbness on one side or one part of the body,
  
• dysmotility,
  
• acute abdomen.
  

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 relatives at a relatively early age). If you intend to hereditary predisposition, the woman should consult a specialist before assigning the CPC,

prolonged immobilization, radical surgery, any surgery to the lower limbs, extensive trauma. In these cases it is recommended to stop using the product (for planned operations is not less than 4 weeks prior) and not to resume taking it earlier than 2 weeks after the end of remobilization. Additionally, you can assign antithrombotic therapy, if the pills had not been terminated at the recommended time frame,

obesity (body mass index> 30 kg / m2)

there is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism,

smoking (in combination with an intensive smoking and increasing age the risk increases, especially in women over 35 years old)

dislipoproteinemia,

AG

valvular heart disease,

atrial fibrillation.

Women over the age of 35 years is recommended to quit smoking, if they decide to take the CCP. If a woman can not give up smoking, you should use another method of contraception, especially in the presence of other risk factors.

The presence of one serious risk factor or multiple risk factors for venous or arterial disease may be contraindicated. Women applying the CPC should immediately consult your doctor in case of possible symptoms of thrombosis occurs. In cases of suspected or confirmed thrombosis thrombosis receiving CCP must stop. Required to choose an adequate method of contraception due to the teratogenicity of anticoagulant therapy (coumarins).

It is necessary to take into account the increased risk of thromboembolism during the postpartum period.

Other diseases that may be associated with serious circulatory disorders include diabetes mellitus, systemic lupus erythematosis, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Increased frequency and severity of migraine or its aggravation during the application of the CPC (which may be prodromal symptoms of cerebral blood flow) may require an urgent cessation of the use of PDAs.

Tumors

The results of some epidemiological studies suggest an additional increase in the risk of cervical cancer in long-term use of PDAs (> 5 years), but this statement is still controversial, because finally found how research results include sexual behavior and associated risk factors, such as papilloma virus human.

Studies indicate a slight increase in the risk of developing breast cancer in women who use PDAs. This increased risk disappears gradually within 10 years after discontinuation of the CPC.

In rare cases, women using the CCP observed benign, and even more rarely - malignant tumors of the liver. In some cases, these tumors cause life-threatening intra-abdominal bleeding. In case of complaints of severe pain in the epigastric region, enlarged liver or signs of intra-abdominal bleeding in the differential diagnosis should take into account the possibility of a liver tumor in women taking the CPC.

other conditions

Women with hypertriglyceridemia, or a violation having a family history, are at risk of pancreatitis when using PDAs.

Although a slight increase in blood pressure is described in many women taking the CPC, a clinically significant increase in blood pressure is an isolated phenomenon. Only in rare cases require immediate discontinuation of the CPC. If, during the application of the CPC in cases of pre-existing hypertension or elevated blood pressure constantly antihypertensive therapy does not provide adequate effect, taking the PDA should be stopped. If you want to receive the CCP can be extended, if due to antihypertensive treatment achieved normal blood pressure values.

It reported the occurrence or aggravation of the following diseases during pregnancy and in the application of the CPC, but their relationship with the CPC is not a final clarification: jaundice and / or pruritus associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic -uremichesky syndrome, Sydenham's chorea, herpes gestationis, hearing loss associated with otosclerosis.

When acute or chronic disturbances of liver function may need to cease the use of the PDA as long as liver function tests are not normalized. When relapse cholestatic jaundice which occurred first during pregnancy or previous use of sex hormones, intake of CPC should be discontinued.

Although PDA may affect peripheral insulin resistance and glucose tolerance, there is no data on the need to alter the therapeutic regimen in women with diabetes, taking low-dose PDAs (containing ?0,05 mg of ethinyl estradiol). However, women with diabetes should be monitored carefully for the reception of the CCP.

Crohn's disease and ulcerative colitis may be associated with the use of PDAs.

Sometimes chloasma may occur, especially in women with a history of chloasma pregnant. Women prone to the emergence of chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking handheld.

Medical examination

Before you start applying the CPC should be carefully examine the patient's medical history, including a family and a medical examination to exclude pregnancy. It is necessary to measure blood pressure and to carry out a general inspection, taking into account the contraindications (see Contraindications.) And side effects (see. SIDE EFFECTS). It is necessary that the patient carefully read the instructions for medical use and said it followed the recommendations. The frequency and nature of examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each woman.

It is necessary to warn the patient that oral contraceptives do not protect against HIV infection (AIDS) and other diseases, sexually transmitted diseases.

decline in efficiency

The effectiveness of the CCP can be reduced in the case of missing tablets, violations of the gastrointestinal tract, or while taking other medicines.

cycle Control

Upon receipt of the CCP may experience intermenstrual bleeding (spotting or breakthrough bleeding), especially during the first months of the drug. With this in mind, the survey with the appearance of any irregular bleeding should be performed only after a period of adaptation to the drug of approximately 3 cycles.

If irregular bleeding continues or there are normal after a few regular cycles, it is necessary to consider the non-hormonal causes and conduct appropriate diagnostic measures to exclude malignancy or pregnancy. These may include curettage. Some women may not come menstruation during a break in the reception of the CCP. If the CCP took according to the directions described in the section Application, then pregnancy is unlikely. However, if the use of contraceptives was carried out irregularly, or if menstruation is absent for 2 cycles, pregnancy must be excluded before continuing the use of PDAs.

Medicines based on herbs containing St. John's wort (Hypericum perforatum), should not be used simultaneously with the silhouette, as they can reduce the level of drug in plasma and reduce the effectiveness of the combination of dienogest with ethinylestradiol.

Medicament containing 47.66 mg of lactose in one tablet. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose, which are on a diet with the exception of lactose, should take this into account.

Use during pregnancy and lactation. The drug is contraindicated during pregnancy. In case of pregnancy during use of the Siluette of the drug should be discontinued. However, epidemiological studies do not indicate an increase in the risk of birth defects in children born to women who took oral contraceptives prior to pregnancy, as well as the existence of teratogenicity Accidental use of oral contraceptives in early pregnancy. Such studies have not been conducted drug silhouette.

Hormonal contraceptives can reduce milk production and to change its composition, as well as in small quantities into breast milk, so taking these drugs during lactation is contraindicated.

Children. The drug is not intended for use in children.

Ability to influence the reaction rate when driving or operating other machines. Tablets Siluette does not affect the ability to drive vehicles or operate machinery with an increased risk of injury.

Drug interactions

interactions that are associated with the activation of microsomal enzymes (eg hydantoin, phenobarbital, primidone, carbamazepine, rifampicin, and possibly also rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate, felbamata, ritonavir, griseofulvin and drugs containing St. John's wort), between oral contraceptives and other drugs may lead to breakthrough bleeding and / or to reduce effectiveness. The mechanism of these interactions is based on the ability to activate the above preparations of liver microsomal enzymes.

Some studies suggest the possibility that the enterohepatic circulation of estrogen can be reduced when receiving certain antibiotics, which can reduce the concentration of ethinyl estradiol (e.g. antibiotics penicillin and tetracycline).

In the treatment of any of the drugs listed above woman should temporarily use a barrier method of contraception in addition to the receiving CCP or choose another method of contraception.

In the treatment of rifampicin a barrier method of contraception should be used during the entire treatment period, the relevant drug and another for 28 days after the termination of his admission. If the CCP pills in the package have been completed and it is necessary to take concomitant medications, the use of tablets from the next pack should be started without the usual break.

With prolonged use of concomitant drug having the ability to activate liver enzymes, your doctor may consider the need to increase the dose of contraceptive steroids. If this method leads to adverse events (eg irregular bleeding) or a decrease in efficiency, it is necessary to use another method of contraception.

Dienogest when used in usual concentrations does not inhibit cytochrome P450 interactions therefore this nature were observed.

Laboratory research. Oral contraceptives can affect the results of the individual laboratory tests, including biochemical liver function tests, thyroid, adrenals and kidneys, as well as on plasma transport proteins levels of blood such as kortikosteroidsvyazyvayuschy globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis. Changes usually occur within laboratory standards.

Overdose:

Acute overdosage with the combination of dienogest and ethinyl estradiol is very low. The probability of occurrence of intoxication symptoms is low, even in children who accidentally took some pills.

In case of overdose may be nausea, vomiting, slight vaginal bleeding. Antidote not, treatment should be symptomatic.