SIBILLA 2mg / 0.03mg film-coated tablets medication leaflet

G03AA16 dienogest + ethinylestradiol • Genito urinary system and sex hormones | Hormonal contraceptives for systemic use | Progestogens and estrogens, fixed combinations

The combination of dienogest and ethinylestradiol is used as an oral contraceptive to prevent pregnancy. Dienogest is a progestin, and ethinylestradiol is an estrogen, both working to inhibit ovulation and alter the uterine lining.

The medication is taken orally, usually once daily at the same time, following a 21- or 28-day cycle. It is important to adhere to the administration schedule to ensure contraceptive effectiveness.

Side effects may include nausea, headaches, breast tenderness, or mood changes. In rare cases, severe reactions such as venous thromboembolism may occur.

This combination is not recommended for pregnant women, breastfeeding mothers, or patients with a history of thrombosis, severe liver disease, or hypersensitivity to any of the components.

General data about SIBILLA 2mg / 0.03mg

Substance: dienogest + ethinylestradiol

Commercial code: W58771001

Concentration: 2mg / 0.03mg

Pharmaceutical form: film-coated tablets

Quantity: 21

Product type: generic

Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

Manufacturer: GEDEON RICHTER PLC. - UNGARIA

Holder: GEDEON RICHTER ROMANIA S.A. - ROMANIA

Number: 10067/2017/01

Shelf life: 3 years