Siluet (dienogest, ethinylestradiol) coated tablets 2 mg/0.03 mg. №63


Manufacturer: Hungary

Oral contraception. Before prescribing Silhouette , one should assess the individual’s risk factors, especially for venous thromboembolism (VTE), and compare the risk of venous thromboembolism when taking Siluet with the risk of taking other combined hormonal contraceptives.


Siluet (dienogest, ethinylestradiol) coated tablets 2 mg/0.03 mg. №63


active substances: dienogest, ethinylestradiol;

1 film-coated tablet contains dienogest 2 mg and ethinylestradiol 0.03 mg;

excipients: lactose monohydrate, corn starch, hypromellose (type 2910), talc, potassium polacrilin, magnesium stearate;

shell: Opadry II 85F18422 white (polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc).

Medicinal form

Film-coated tablets.

The main physical and chemical properties: white or almost white round, biconvex, film-coated tablets, engraved with “G53” on one side, the other side without engraving. The diameter is about 5.5 mm.

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system. Progestogens and estrogens, fixed combinations.
ATX code G0ЗАА16.

Pharmacological properties

This drug belongs to the group of hormonal contraceptives, the nature of its use is systemic. This drug is combined, based on ethinylestradiol and dienogest.
The contraceptive effect of the drug is due to the interaction of various factors, the most important of which is the suppression of ovulation and the change in cervical secretion.
Dienogest, which is part of the drug, is a derivative of nortestosterone with antiandrogenic activity. In general, it accounts for a third of the activity of cyproterone acetate.
This substance also has the ability to reduce the endogenous production of estradiol.


Possesses highly effective contraceptive properties when used systemically.
If the use of hormonal methods of contraception occurs in accordance with the instructions, then contraceptive failures are practically excluded (less than 1%). The failure rate rises if a drug is missed.
The contraceptive effect from the use of this drug is based on the mutual influence of various factors, the most important of which is the suppression of ovulation and changes in the quality and viscosity of cervical secretions.
Siluet tablets has the ability to bind to progesterone receptors located in the uterus, however, with only 10% relative affinity. Despite the fact that the active substance of the drug has a low affinity for the progesterone receptor, dienogest produces a strong progestogenic effect in vivo.
Siluet tablets does not have significant androgenic, mineralocorticoid or GCS activity in vivo. Other properties, in particular, immunological and antiangiogenic, contribute to the inhibition of dienogest on cell proliferation.


Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Contraindicated if the patient has symptoms of diseases such as:

  • venous thromboembolism;
  • arterial or cardiovascular pathology, in particular, myocardial infarction, heart ischemia, cerebrovascular diseases, angina pectoris, strokes;
  • diabetes mellitus, accompanied by vascular pathologies;
  • severe forms of liver disease, including tumors of any genesis;
  • uncontrolled arterial hypertension;
  • tumors that depend on sex hormones;
  • vaginal bleeding of unknown origin;
  • lactase deficiency;
  • pancreatitis;
  • migraine;
  • smoking;
  • hereditary predisposition to venous or arterial thrombosis.

Taking the drug increases the risks of thromboembolism, therefore, before prescribing it, you should carefully study the state of the patient’s body and prescribe this drug only after factors that increase the likelihood of thromboembolism have been excluded – smoking, obesity, arterial hypertension, thrombosis in close relatives.
At the first signs of thrombosis, you should stop taking hormonal contraceptives and treat them.
The drug is not prescribed for girls before the onset of the first menstruation.
During the period of treatment with this drug, barrier methods of contraception should be used, since the use of hormonal contraceptives during this period is excluded.

Application during pregnancy and lactation

This drug is not prescribed during pregnancy.
At the same time, it is recommended to exclude pregnancy before starting treatment with this drug.
If there is a need to use this drug during lactation, then breastfeeding should be suspended.

Method of administration and dosage

The drug Siluet tablets is taken 1 tablet a day, at the same time of the day.
The drug Siluet tablets is taken on the first day of the menstrual cycle. Reception lasts 21 days, according to the directions on the back of the blister. Reception time is approximately at the same time of the day.
Then, within 7 days, a break in admission is made. At this time, the woman experiences bleeding from the vagina, similar to menstrual bleeding (withdrawal bleeding).
Discharge begins on the 2nd – 3rd day after cancellation and may not end with the start of a new package of the drug. This should not be alarming.
Features of taking the drug when switching from one oral contraceptive to another, during abortion, after childbirth, etc. are detailed in the instructions attached to the drug.
If the appointment was missed for more than 12 hours, or the patient experienced vomiting or diarrhea (diarrhea), the effect of taking the drug may be reduced. In this case, by the end of the month, it is necessary to use barrier methods of contraception.
If the drug intake was missed, then the next pill should be taken as soon as possible (3-4 hours), and the next one should be taken at the usual time. In this case, the dosage is not increased, leaving the same.
Do the same when skipping an appointment due to vomiting or diarrhea.
There is no need for dosage adjustment for those suffering from renal insufficiency.
The drug is not prescribed for patients who have had menopause.


Overdose with this drug has not been observed at the moment. The drug is not highly toxic. Taking several daily doses did not cause poisoning.
Overdose can cause nausea, vomiting, minor bleeding from the vagina.
Symptomatic therapy is recommended.
There is no specific antidote.

Side effects

The use of this drug can cause side effects, especially in the first months of taking it. These effects disappear during treatment.
Reactions have been reported such as:

  • vaginitis, vulvovaginitis;
  • anemia;
  • varicose veins, thrombophlebitis, thrombosis;
  • increased appetite (up to gaining excess weight) or decreased appetite (up to the development of anorexia);
  • depressive, depressed state;
  • headache, stroke, ischemia, dystonia;
  • discomfort in the area of ​​the mammary glands;
  • dryness of the mucous membrane of the eye, intolerance to contact lenses;
  • hypertension, hypotension;
  • a state of depression;
  • acne (acne), alopecia, itching.

If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.