Yaz film-coated tablets blister pack 28 pcs

One pack contains 28 tablets (24 light pink tablets and 4 white (placebo) tablets).

One light pink tablet contains:

• active ingredients:
  • ethinylestradiol – 0.02 mg (in the form of clathrates from betadex);
  • drospirenone – 3 mg;
• excipients: lactose, corn starch, magnesium stearate, hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172).

One white placebo tablet contains the following excipients: lactose, microcrystalline cellulose, magnesium stearate, hypromellose, talc, titanium dioxide (E 171).

Combined hormonal contraceptives (CHCs) should not be used if any of the following conditions are present. If any of these conditions appear for the first time during CHC use, the drug should be discontinued immediately.

Presence or risk of venous thromboembolism (VTE):

• Current VTE, particularly due to anticoagulant therapy or a history of it (e.g. deep vein thrombosis (DVT) or pulmonary embolism (PE));
• known hereditary or acquired predisposition to VTE, such as resistance to activated protein C (including factor V Leiden mutation), antithrombin-III deficiency, protein C deficiency, protein S deficiency;
• major surgical interventions with prolonged immobilization;
• high risk of VTE due to the presence of multiple risk factors.

Presence or risk of arterial thromboembolism (ATE):

• the presence of ATO now or in history (for example, myocardial infarction) or the presence of prodromal symptoms (for example, angina);
• current or history of cerebrovascular accident, presence of prodromal symptoms (e.g., transient ischemic attack (TIA));
• known hereditary or acquired predisposition to ATO, such as hyperhomocysteinemia and antiphospholipid antibodies (e.g. anticardiolipin antibodies, lupus anticoagulant);
• migraine with focal neurological symptoms in history;
• high risk of ATO due to the presence of multiple risk factors or due to the presence of one serious risk factor, such as:
  • diabetes mellitus with vascular complications;
  • severe arterial hypertension;
  • severe dyslipoproteinemia.

Presence of severe liver disease, current or history, until liver function tests return to normal.

Severe renal failure or acute renal failure.

Presence of liver tumors now or in history (benign or malignant).

Known or suspected malignant tumors (e.g., of the genital organs or mammary glands) that are dependent on sex hormones.

Vaginal bleeding of unknown etiology.

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

The drug “Yaz” is contraindicated when used simultaneously with drugs containing ombitasvir / paritaprevir / ritonavir and dasabuvir.

The tablets should be taken daily in the order indicated on the package, at about the same time, washed down with a small amount of liquid if necessary. The tablets should be taken continuously. The drug is taken one tablet / day for 28 consecutive days. Taking the tablets from each subsequent package should begin the day after the end of the previous package. As a rule, withdrawal bleeding begins on the 2nd-3rd day after starting the placebo tablets (the last row) and may not end before starting the tablets from the next package.

Pregnant women

The drug is contraindicated for use during pregnancy.

COCs are not recommended for use during breastfeeding.

Children

The drug is indicated for use as prescribed by a doctor only after the onset of stable menstruation.

Drivers

No studies have been conducted on the effect of Yaz on the ability to drive or use machines. No effects on the ability to drive or use machines have been observed in women taking COCs.

There are no clinical data on overdose of Yaz tablets. As the general experience of using COCs shows, nausea, vomiting and withdrawal bleeding may occur in case of overdose. Withdrawal bleeding may occur in girls even before menarche in case of unintentional/accidental use of the drug. There is no specific antidote, treatment should be symptomatic.

Mental disorders: emotional lability.

Nervous system: headache.

Gastrointestinal: nausea.

Reproductive system and breast disorders: breast tenderness, metrorrhagia, amenorrhea.

Store at a temperature not exceeding 30 °C, out of the reach of children.

Shelf life – 5 years.