BELARA 2mg / 0.03mg tablets medication leaflet

G03AA15 chlormadinone + ethinyl estradiol • Genito urinary system and sex hormones | Hormonal contraceptives for systemic use | Progestogens and estrogens, fixed combinations

Chlormadinone and ethinylestradiol are used together in combined oral contraceptives to prevent pregnancy. This combination contains a progestin (chlormadinone) and a synthetic estrogen (ethinylestradiol), which work together to inhibit ovulation, alter cervical mucus, and affect the endometrium, thereby preventing the implantation of a fertilized egg.

Chlormadinone is a progestin with antiandrogenic properties, meaning it can reduce the effects of androgens, such as acne or seborrhea. Ethinylestradiol is a synthetic estrogen that stabilizes the menstrual cycle and contributes to contraceptive efficacy. Together, these substances provide a safe and effective contraceptive method with a high success rate when used correctly.

While this combination is effective, its use may cause side effects. The most common include nausea, headaches, breast tenderness, weight changes, and mood swings. In rare cases, more serious reactions may occur, such as venous thromboembolism, high blood pressure, or liver disorders. Women who smoke, especially those over 35 years old, are at an increased risk of cardiovascular complications.

This combination should be used as directed by a doctor, and the patient should adhere to the dosing schedule to ensure contraceptive efficacy. Regular medical check-ups are important, and the doctor should be informed of any pre-existing conditions or concurrent medications. If severe side effects occur, such as chest pain, difficulty breathing, or severe leg pain, immediate medical attention is necessary.

General data about BELARA 2mg / 0.03mg

Substance: chlormadinone + ethinyl estradiol

Date of last drug list: 01-06-2025

Commercial code: W58349001

Concentration: 2mg / 0.03mg

Pharmaceutical form: tablets

Quantity: 21

Product type: original

Price: 63.68 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: GRUNENTHAL GMBH - GERMANIA

Holder: GEDEON RICHTER ROMÂNIA S.A. - ROMANIA

Number: 750/2008/01

Shelf life: 3 years

Concentrations available for chlormadinone + ethinyl estradiol

200mcg/30mcg, 2mg/0.03mg