Silhouettes - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate 47.660 mg, corn starch 10.460 mg, hypromellose-2910 0.650 mg, talc 1.600 mg, polacrilin potassium 1,300 mg, magnesium stearate 1,300 mg.

Shell: opedraj II white * 3,000 mg.

The composition of the decadent II white: polyvinyl alcohol 1,200 mg, titanium dioxide 0,750 mg, macrogol-3350 0,606 mg, talc 0,444 mg.

*code: 85F18422

Description:Round biconvex tablets covered with a film shell, white or almost white with engraving "G53" on one side.

Pharmacotherapeutic group:Contraceptive combination (estrogen-gestagen).

ATX: & nbsp

G.03.A.A.16 Dienogest and ethinyl estradiol

Pharmacodynamics:

Siluet® is an oral combination with anti-androgenic effect, contains ethinyl estradiol (EE) as an estrogen and dienogast (DNG) as a progestogen.The contraceptive effect of Siluet® is due to various factors, the most important of which are inhibition of ovulation, increased viscosity of cervical mucus, changes in the peristalsis of the fallopian tubes, and the structure of the endometrium. The antiandrogenic effect of a combination of EE and DNG is based on a decrease in plasma androgen concentration.

In repeated studies, it was shown that the combination of EE with DNG led to a leveling of the symptoms of mild to moderate acne and had a positive result in patients with seborrhea.

DGN is a derivative of norethisterone, which has a 10-30-fold lower affinity for progesterone receptors in vitro compared to other synthetic progesterones. DGN does not have significant androgenic, mineralocorticoid or glucocorticoid effects in vivo.

With an isolated appointment at a dose of 1 mg / day, DMS inhibits ovulation.

Pharmacokinetics:

Ethinylestradiol (30 μg) Suction

EE after ingestion is rapidly and completely absorbed in the small intestine. The maximum plasma concentration (67 pg / ml) is achieved after 1.5-4 hours. At the primary passage through the liver a significant part of the EE is metabolized. Absolute bioavailability is approximately 44%.

Distribution

EE almost completely (about 98%), although non-specific, binds to albumins. EE increases the concentration in the plasma of globulin, which binds sex hormones (SHGG). The apparent volume of distribution is 2.8-8.6 l / kg.

Metabolism

EE undergoes conjugation in the intestinal mucosa and in the liver. The main pathway of EE metabolism is aromatic hydroxylation, but its metabolism also leads to the formation of a large number of hydroxylated and methylated derivatives in free, glucuronated and sulfated form. Clearance is approximately

2.3-7 ml / min / kg.

Excretion

Reduction in the concentration of EE in plasma occurs in two stages: the first stage of elimination half-life - 1 hour, the second - 10-20 hours. EE is not output in unmodified form. Metabolites EE are excreted by the kidneys and liver in a ratio of 4: 6. The half-life of metabolites is about 24 hours.

The equilibrium concentration

The equilibrium concentration is reached during the second half of the treatment cycle, and the EE concentration in the serum increases 2-fold.

DNG

Suction

After oral administration, it is quickly and completely absorbed in the intestine.The maximum concentration in plasma (51 pg / ml) is achieved after 2.5 hours. Absolute bioavailability with simultaneous reception with EE is 96%.

Distribution

DGN binds to blood plasma albumins and does not bind to SHBG and globulin that binds corticosteroid hormones. The fraction of free DNG in plasma is 10%, while 90% is nonspecifically associated with albumin. The apparent volume of distribution is 37-45 liters.

Metabolism

DGN is mainly metabolized by hydroxylation, an alternative route is glucuronization. Its metabolites are inactive and are rapidly eliminated from the plasma, so it is not possible to detect metabolites in plasma in significant amounts, this does not apply to unmodified DNG. The total clearance after a single intake is 3.6 l / h.

Excretion

The half-life of DNG is about 9 hours. A small amount in unchanged form is excreted by the kidneys. After ingestion of 0.1 mg / kg excretion of the intestines and kidneys has a ratio of about 3.2. If ingested, 86% is excreted within 6 days, 42% of which is excreted within the first 24 hours, mostly by the kidneys.

The equilibrium concentration

The concentration of SHBG in plasma does not affect the pharmacokinetics of DNG. The concentration of DNG in plasma increases by 1.5 times, and the equilibrium concentration is reached within 4 days.

Indications:

- Oral contraception;

- Treatment of mild to moderate acne (acne) with ineffective local treatment in women who need contraception.

Contraindications:

Combined oral contraceptives (CPC) should not be used if any of the conditions / diseases listed below are present in the woman. At the first occurrence of any of these conditions during the reception of CPC, the drug should be immediately discontinued:

- Hypersensitivity to Siluet® or any of its components;

- Arterial and venous thromboembolic diseases at present or in the anamnesis (for example, deep vein thrombosis, pulmonary thromboembolism);

- Thrombosis (arterial and venous) and thromboembolism now or in the anamnesis, including thrombosis, deep vein thrombophlebitis; thromboembolism of the pulmonary artery, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders);

- Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris, complicated heart valve disease, atrial fibrillation, subacute bacterial endocarditis, extensive surgery with prolonged immobilization, extensive trauma);

- Pancreatitis with severe hypertriglyceridemia at present or in the anamnesis;

- Porphyria;

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

- Sickle-cell anemia;

- Multiple or expressed risk factors for venous or arterial thrombosis, including a history of risk factors for arterial thrombosis:

- diabetes mellitus with vascular complications (angiopathy, retinopathy);

- uncontrolled arterial hypertension;

- severe dyslipoproteinemia;

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

- Smoking is over the age of 35;

- Severe forms of liver disease (including history) to normalize functional liver samples;

- Liver tumors (benign or malignant), including in the anamnesis;

- Hormonal-dependent malignant diseases of the genital organs or mammary glands, including in the history, or suspicion of them;

- Bleeding from the vagina of unknown origin;

- Migraine with local neurologic symptoms, including in the anamnesis;

- Epilepsy;

- Pregnancy and lactation;

- Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:

The presence of risk factors (such as varicose veins, heart disease, overweight, bleeding disorders) requires a more thorough examination before starting the PDA.

Smoking is less than 35 years. If a woman can not quit smoking, another method of contraception should be used, especially if there are other risk factors.

The potential risk and the expected benefit of using oral contraceptives in each individual case should be carefully weighed in the presence of the following diseases or conditions,or risk factors: dyslipoproteinemia, diabetes mellitus without vascular complications, controlled arterial hypertension, fibrocystic mastopathy, uterine fibroids, endometriosis, multiple sclerosis, severe history of depression, renal dysfunction, with intolerance of contact lenses, Crohn's disease, ulcerative colitis, phlebitis superficial veins, thromboembolism, acute disturbance of cerebral circulation, myocardial infarction at a young age, chronic heart failure, breast cancer in relatives of the 1st st. fine relationship; visual impairment (risk of retinal thrombosis), tetany, hypercalcemia, hypokalemia, bronchial asthma, hereditary angioedema, liver disease, idiopathic jaundice during anterior pregnancy, herpes during pregnancy.

Pregnancy and lactation:

Siluet® is contraindicated during pregnancy.

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

The drug Siluet® is contraindicated for use in breast-feeding women.

Dosing 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. One tablet inside, once a day, is taken daily for 21 days. The taking of tablets from the next package begins 7 days after the last tablet from the previous package, during which the bleeding of "cancellation" usually occurs. It usually starts 2-3 days after taking the last pill and may not end with the beginning of taking the tablets from the next package. In the event that hormonal contraception was not previously applied (for a month), the preparation Siluet® should be started on the 1st day of the menstrual cycle (ie on the first day of menstruation).

In case of transition from combined oral contraceptive:

It is preferable to start taking Siluet® the day after the usual interruption or the next day after the last pill from the current oral contraceptive package.

Injectable form, implants:

Switching from the reception of tablets containing only progesterone, you can spend any day;

transition from the use of implants is carried out on the day of implant removal; at the transition from the injection form - from the day when the next injection should have been made. After abortion in the first trimester of pregnancy:

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

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 taken later, the woman should be warned about the need to use additional barrier methods (condoms) within the first 7 days. However, if a sexual contact has already occurred,Before starting combined oral contraceptives, you must exclude pregnancy or wait for the first menstrual period.

Acceptance of missed tablets:

If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. A woman should take the drug as soon as possible, taking the next pill - at the usual time.

If the delay in taking the tablet is more than 12 hours, the contraceptive protection can be reduced. In this case, you can follow the following two basic rules:

- the drug should never be interrupted for more than 7 days;

- 7 days of continuous intake of the pill are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given if the delay in taking the tablets was more than 12 hours:

The first week of taking the drug

The woman should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. In addition, a barrier method of contraception (for example, a condom) should be used for the next 7 days.If there was a sexual intercourse within a week before passing the pill, it is necessary to take into account the probability of pregnancy. The more pills are missed, and the closer this pass to the 7-day break in taking the pill, the higher the risk of pregnancy.

The second week

The woman should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. In the event that within 7 days before the admission the woman correctly took the pill, there is no need for additional contraceptive means. However, if she missed taking more than one pill, she should use additional contraceptive methods (condoms) for 7 days.

The third week

The risk of a decrease in reliability is inevitable due to the upcoming 7-day break in admission. However, when adjusting the schedule of taking tablets, it is possible to prevent the weakening of contraceptive protection.

If one of the two proposed methods is followed, there is no need to use additional methods of contraception, if within 7 days before admission the woman correctly took the pill.Otherwise, it should follow the first of these two methods, and also use additional methods of contraception during the next 7 days.

The woman should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. Reception of tablets from the next blister pack should be started immediately after the reception of the previous one is completed, i.e. There should not be an ordinary break between receptions. Most likely, the woman will not have a bleeding "cancellation" to the end of the second package, but she may have spotting spotting or breakthrough uterine bleeding on the days of taking the tablets.

In addition, it is possible to stop taking the tablets from the current blister pack. Then there should be a 7-day break in taking the tablets, including the days of the missed tablets, and then you need to start taking the tablets from the new package.

If a woman missed taking the pill, and then at the first normal interval between the doses of the drug, she does not have a bleeding "withdrawal", it is necessary to exclude pregnancy.If a woman has vomiting within 4 hours after taking the pill, the absorption may be incomplete, and additional contraceptive measures should be taken. In these cases, a new (replacement) tablet should be taken as soon as possible. A new tablet should be taken as soon as possible within 12 hours after the usual intake time. If more than 12 hours have passed, the recommendations should be followed when skipping tablets in the "Taking Missed Tablets" section. If a woman does not want to change the normal mode of taking tablets, she should use an additional tablet from another blister pack.

How to delay the bleeding of "cancellation"

In order to delay the onset of menstrual bleeding, a woman should continue taking Silute® from the new package immediately after taking all the pills from the previous one, without interruption in admission. Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. Resume the use of Siluet®, film-coated tablets from a new pack should be taken after an ordinary 7-day break.In order to transfer the day of the onset of menstrual bleeding to another day of the week, a woman can be recommended to shorten the nearest break in taking the pill for as many days as she wants. The shorter the interval, the higher the risk that there will be no bleeding of the "cancellation" and later, during the next package, there will be spotting and breakthrough bleeding (as well as in the case when she would like to delay the onset of menstrual bleeding).

Side effects:

The use of any combination oral contraceptives is associated with an increased risk of arterial and venous thrombosis and thromboembolism (eg, venous thrombosis, pulmonary embolism, stroke, myocardial infarction). The risk increases with smoking, the presence of hypertension, impaired coagulability, obesity, varicose veins, thrombophlebitis and thrombosis.

The side effects listed below are presented according to the system-organ classes according to the classification MedDRA and with the following frequency: very frequent (> 1/10); frequent (from > 1/100 to <1/10); infrequent > 1/1 000 to <1/100); rare (from > 1/10000 to <1/1000); very rare (<1/10000).

Class of organ system	Frequent> 1 / 100- <1/10	Infrequent> 1 / 1000- <1/100	Rare> 1 / 10000- <1/1000	Very rare <1/10000
Violations from the blood and lymphatic system			anemia
Class of organ system	Frequent> 1 / 100- <1/10	Infrequent> 1 / 1000- <1/100	Rare> 1 / 10000- <1/1000	Very rare <1/10000
Heart Disease			tachycardia	myocardial infarction
Disturbances from the nervous system	headache	Migraine, increased excitability, dizziness	cerebrovascular accident
Disturbances on the part of the organ of sight			impaired vision, conjunctivitis, dry mucous membrane, intolerance contact lenses
Violations from the organ of hearing and labyrinth			hypoacusia, tinnitus, sudden hearing loss, hearing impairment
Disturbances from the respiratory, thoracic and mediastinal organs			sinusitis, bronchial asthma, bronchitis
Disorders from the gastrointestinal tract tract	nausea, vomiting	abdominal pain	diarrhea, dyspepsia, gastritis, enteritis	cholecystitis, cholelithiasis
Infringements from kidney and urinary tract		infection urinary individual systems
infection urineindividual systems		acne, acneiform dermatitis, exanthema, dermal allergic reaction, Chloasma, alopecia, multiform erythema, itching, including generalized itching, knotty erythema, vascular purpura	hypertrichosis, virilism, hyperhidrosis, seborrhea, hyperpigmentation- eczema, dandruff, angioneuros- hypodermic edema, telangiectasiath asterisks)
Infringements from metabolism and supply	rise body weight	rise appetite, weight loss	decline appetite
Infectious and parasitic diseases		vaginitis, vaginal candidiasis	fungal infection, herpetic defeat oral cavity
Infringements from cardiovascular system		arterial hypertension, arterial hypotension, varicose expansion of veins, thrombophlebitis superficial veins	thrombophlebitis deep veins, thromboses, thromboembo- pulmonary arteries, hematoma, violation of cerebral circulatory tion, "hot flashes", pain along the way veins
General disorders and violations in place introduction of		feeling fatigue / malaise, edema	influenza-like symptoms
Infringements from immune system			allergic reactions
Infringements from genital organs and mammary gland	pain and morbidity of dairy glands, enlargement dairy glands	acyclic spotting or bleeding, painful menstrual- similar bleeding, ovarian cysts, dyspareunia, gain of vagina, hyperplasia endometrium, vaginitis / vulvovaginitis, salpingitis, endometritis	scanty menstrual-like bleeding, mastitis, fibrotic- cystic dysplasia dairy glands, emergence secret dairy glands, leiomyoma, endometritis, salpingitis, cervicitis, vulvovagi- itching, lipoma dairy glands	cancer endometrium
Infringements from psyche	decline moods		insomnia, violations sleep, depression, anorexia, change libido, aggressiveness, apathy
Disorders from the musculoskeletal tissue and connective tissue	back pain, cramps in the calf muscles		arthralgia, myalgia

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

- Venous thromboembolic disorders;

- Arterial thromboembolic disorders;

- Arterial hypertension;

- Liver tumors;

- Appearance or aggravation of conditions for which communication with the administration of CPC is not proved: Crohn's disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes of pregnant women, Sydenham's chorea, haemolytic-uremic syndrome, cholestatic jaundice;

- Chloasma.

The incidence of breast cancer in women taking CPC, increases very slightly. Since breast cancer rarely occurs in women younger than 40 years, 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 (later than 52 years), lack of birth, the presence of anovulatory cycles, etc., indicate the role of hormones in the development of this disease. Receptors to hormones play a key role in the cellular biology of breast cancer, estrogens are able to enhance the effects of growth factors (eg, TGF-alpha).

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

Overdose:Acute toxicity with oral intake of a combined preparation of EE and DNG in an overdose is low. In these cases, nausea, vomiting and bloody discharge / bleeding from the vagina may occur. There is no need for special therapy. If necessary, treatment should be symptomatic.

Interaction:

Interactions associated with the activation of microsomal enzymes between oral contraceptives and other medications can lead to breakthrough bleeding and / or a decrease in contraceptive effectiveness. These effects have been shown for hydantoin, phenobarbital, primidon, carbamazepine and rifampicin. Such effects are also possible for rifabutin, efavirenz, nevirapine, oksikarbazepina, topiramate, felbamate, ritonavir, griseofulvin and herbal medicine 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, concurrent administration with certain antibiotics (such as ampicillin and tetracycline) can lead to a decrease in the effectiveness of contraception, the cause of this phenomenon is unknown.

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

Women taking rifampicin, should use barrier methods during the time of rifampicin intake and 28 days after graduation. If the concomitant drug is taken at the end of taking the tablets from the package, the next package should be taken immediately, without the usual interval.

With the long-term administration of concomitant drug, which has the ability to activate liver enzymes, the doctor may consider the need to increase the doses of hormonal contraceptives. If this approach leads to the occurrence of undesirable phenomena (eg, irregular bleeding) or a decrease in effectiveness, another method of contraception should be used.

On the basis of in vitro studies, it has been shown that using conventional concentrations of DNG does not inhibit cytochrome P450, so interactions of this nature are not expected to be detected.

Interactions of drugs that enhance the clearance of sex hormones can lead to breakthrough uterine bleeding and a decrease in the effectiveness of contraception.

Special instructions:

Before starting or resuming the use of Siluet®, film-coated tablets, it is necessary to collect an anamnesis (including a family history), and pregnancy should be excluded. It is necessary to measure blood pressure and conduct a general examination taking into account contraindications and warnings. It is necessary to explain to the woman the need to carefully read the instructions for the use of Siluet® and follow the recommendations set forth therein. The nature of medical examinations involving at a general medical and gynecological examination, is determined by the treating physician-gynecologist individually for each woman and is conducted at a different frequency, 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

Reduction of the effectiveness of the combination of EE and DG occurs in the case, for example, of missed admission, with gastrointestinal disorders or with the concomitant therapy.

Changing the nature of bleeding

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

If irregular bleeding is present continuously or appear after previous normal regular cycles, nonhormonal causes of these phenomena should be considered and the malignant neoplasms and pregnancy should be excluded. In this case, you need to see a gynecologist.

In some women, bleeding "cancellation" may not occur during a break between doses of the drug. If a woman took Siluet® as directed, pregnancy is unlikely. However, if a woman has been admitted to receive a drug before the first "bleeding" bleed, or if there are two passes, pregnancy should be excluded before continuing with Silute®.Herbal medicines containing St. John's wort (Hypericum perforatum), should not be used in parallel with Siluet® because of their ability to reduce the plasma level of the drug and reduce the effectiveness of the combination of DNG and EE.

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

Symptoms of arterial or venous thrombotic or thromboembolic complications may include:

- Unusual unilateral leg pain and / or swelling;

- Sudden severe pain in the chest with possible irradiation in the left arm;

- Sudden shortness of breath;

- A sudden fit of coughing;

- Any unusual, severe prolonged headache;

- Sudden partial or complete loss of vision;

- Diplopia;

- Slurred speech or aphasia;

- Dizziness;

- Fainting condition, accompanied by a partial epileptic fit or without it;

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

- Movement disorders;

- "Acute abdomen."

The risk of venous thromboembolic complications increases:

- With age;

- In the presence of a family history (venous thromboembolism, 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 decide whether to prescribe Siluet®;

- For prolonged immobilization, after serious surgical intervention, any surgical intervention on the legs or after a serious injury. In these cases, it is preferable to stop taking the tablets (with scheduled operations for at least four weeks) and not resume until two full weeks after remobilization. If the drug has not been canceled in advance, antithrombotic therapy should be prescribed;

- With 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 onset and development of venous thrombosis.

The risk of arterial thromboembolic complications or the risk of stroke in women using a combination of DNG and EE is increased:

- With age;

- In the presence of dyslipoproteinemia;

- In the presence of arterial hypertension;

- In diseases of the heart valves;

- With atrial fibrillation;

- When smoking: smoking increases the risk of severe cardiovascular complications (such as myocardial infarction, stroke); the risk rises 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. To consider also it is necessary to accept the possibility of using anticoagulant therapy. It should be noted that women who receive Siluet® receive the need to contact a doctor if they suspect a history of thrombosis. In the 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).

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

Other conditions associated with adverse adverse vascular reactions include diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, and chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis).

An increase in the frequency and severity of migraine when taking a combination of DGT and EE (which may be a harbinger of cerebral circulatory disorders) may be an indication for immediate withdrawal of the drug. Tumors

Some epidemiological studies have reported an increased risk of developing cervical cancer with prolonged use of a combination of DGN and EE (more than 5 years). However, there are still contradictions as to the extent to which these cases are related to the characteristics of sexual behavior and other factors, for example, the human papillomavirus (HPV).

The studies show a slight increase in relative risk (RR = 1.24) of breast cancer in women who used combined oral contraceptives.The increased risk gradually decreases within 10 years after the withdrawal of these drugs.

In rare cases, against the background of the combination of DNG and EE, the development of benign liver tumors, in even more rare cases, malignant tumors. In some cases, these tumors led to life-threatening intra-abdominal bleeding. When severe pain occurs in the upper abdominal region, liver enlargement and signs of intraperitoneal bleeding in women taking combinations of DG and EE, liver tumors should be excluded.

Other states

Women with hypertriglyceridemia, at the present time or in the anamnesis, have an increased risk of developing pancreatitis when using a combination of DGN and EE. Although a small increase in blood pressure (BP) has been reported in many women taking combinations of DMS and EE, clinically significant increases have been rare. Nevertheless, if during the administration of CPC by women with arterial hypertension (AH) there is a stable increase in blood pressure, or sudden increases in blood pressure do not respond to antihypertensive therapy, the drug should be withdrawn. If possible, admission can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

Acute or chronic liver disease may require discontinuation of Siluet® until the liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous reception of sex hormones, requires discontinuation of the combination of DNG and EE.

Although a combination of DNG and EE can affect insulin resistance and glucose tolerance, there is usually no need to adjust the treatment regimen in diabetic patients. However, women with diabetes should be carefully monitored by the doctor while taking Siluet®.

Against the background of the combination of DNG and EE, the course of Crohn's disease and ulcerative colitis may worsen.

Periodically, chloasma may appear, especially in women with a history of chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation during the administration of Siluet®.

Laboratory research

The use of contraceptive steroids can affect the results of some laboratory studies, including biochemical indicators of liver function,thyroid gland, adrenal gland and kidneys, as well as the plasma levels of transport proteins, for example, corticosteroid-binding globulin and lipid / lipoprotein fractions, the parameters of carbohydrate metabolism, as well as coagulation and fibrinolysis. Changes usually remain within the normal range.

Effect on the ability to drive transp. cf. and fur:The drug Siluet® does not affect the ability to drive and use sophisticated technology. When using the drug should take into account the possibility of a visual impairment or dizziness.

Form release / dosage:

Film-coated tablets, 2 mg + 0.03 mg.

Packaging:For 21 tablets in a blister of PVC / PE / PVDC - aluminum foil. For 1 or 3 blisters in a cardboard box together with instructions for use. In the cardboard box is enclosed a cardboard flat case for storing the blister.

Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children!

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001145

Date of registration:11.11.2011

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp30.01.2016

Illustrated instructions

Instructions

Siluet® (Siluette®)