HARMONET 0.075mg / 0.020mg dragees medication leaflet

G03AA10 gestoden + ethinylestradiol • Genito urinary system and sex hormones | Hormonal contraceptives for systemic use | Progestogens and estrogens, fixed combinations

The combination of gestodene and ethinylestradiol is used as a combined oral contraceptive to prevent pregnancy. It is one of the most commonly used methods of hormonal contraception, providing effective protection when taken correctly.

- Gestodene is a third-generation progestin that mimics the action of natural progesterone. It prevents ovulation, thickens cervical mucus (blocking sperm entry), and alters the uterine lining, making it less favorable for implantation of a fertilized egg.
- Ethinylestradiol is a synthetic estrogen that regulates the menstrual cycle and contributes to ovulation prevention by inhibiting the secretion of gonadotropins (FSH and LH).

This combination is taken in tablet form, usually in a 21-day cycle of daily administration, followed by a 7-day break (or placebo tablets), during which withdrawal bleeding occurs.

Common side effects include nausea, headaches, breast tenderness, mood changes, weight gain, or breakthrough bleeding. In rare cases, more serious reactions such as venous thromboembolism, high blood pressure, or allergic reactions may occur.

It is important for patients to strictly follow their doctor’s instructions and not miss doses. Combined oral contraceptives are not recommended for women with a history of thrombosis, cardiovascular diseases, severe migraines with aura, or smokers over the age of 35. If unusual symptoms occur (such as severe headaches, chest pain, or leg swelling), a doctor should be consulted immediately.

General data about HARMONET 0.075mg / 0.020mg

Substance: gestoden + ethinylestradiol

Date of last drug list: 01-06-2025

Commercial code: W65040001

Concentration: 0.075mg / 0.020mg

Pharmaceutical form: dragees

Quantity: 21

Product type: original

Price: 28.07 RON

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: PFIZER IRELAND PHARMACEUTICALS - IRLANDA

Holder: PFIZER EUROPE MA EEIG - BELGIA

Number: 3697/2011/01

Shelf life: 3 years

Pharmaceutical forms available for gestoden + ethinylestradiol

Concentrations available for gestoden + ethinylestradiol

0.075mg/0.020mg, 0.075mg/0.02mg, 15mcg/60mcg, 60mcg/13mcg/24h, 60mcg/15mcg, 60mcg/15micorgrame, 75mcg/20mcg, 75mcg/30mcg