Europe — EMA
Harmonet (Ethinylestradiol, Gestodene)
Learn about Harmonet combined oral contraceptive – uses, side effects, precautions, and drug interactions for effective hormonal birth control.
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What is Ethinylestradiol, Gestodene?
Harmonet is a combined oral contraceptive tablet containing ethinylestradiol and gestodene. It is supplied in tablet form, marketed in the EU, and prescribed for hormonal contraception. The product provides a regulated dose of estrogen and progestogen to prevent pregnancy. Each tablet is intended for daily oral intake as part of a 21‑day active regimen followed by a hormone‑free interval. It is available only by prescription.
What is Ethinylestradiol, Gestodene used for?
Harmonet is indicated for the prevention of pregnancy in women of reproductive age who choose an oral hormonal method.
- Primary use as a combined oral contraceptive to inhibit ovulation. - Provides cycle control and reduces menstrual flow. - May be used to manage moderate acne related to androgen excess. - Can be prescribed for treatment of dysmenorrhea associated with ovulatory cycles.
What are the side effects of Ethinylestradiol, Gestodene?
Like other combined oral contraceptives, Harmonet may cause a range of side effects, most of which are mild and transient.
Common: - Nausea or mild stomach upset. - Headache or migraine. - Breast tenderness. - Spotting or breakthrough bleeding.
Serious: - Deep vein thrombosis or pulmonary embolism. - Stroke or myocardial infarction. - Severe hypertension. - Liver disorders such as cholestatic jaundice.
What precautions apply to Ethinylestradiol, Gestodene?
Before starting Harmonet, certain health considerations should be evaluated to ensure safe use.
- History of blood clots, stroke, or heart disease. - Smoking, especially in women over 35 years of age. - Uncontrolled hypertension or diabetes. - Liver disease or severe gallbladder disease. - Migraine with aura. - Pregnancy or suspected pregnancy (contraindicated).
What does Ethinylestradiol, Gestodene interact with?
Harmonet can interact with other medicines, affecting its efficacy or increasing risk of adverse events.
Avoid: - Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin). - Rifampin and other potent antibiotics (e.g., griseofulvin). - St. John’s wort herbal supplement.
Use with caution: - Antifungal agents such as ketoconazole. - Certain HIV protease inhibitors. - Selective serotonin reuptake inhibitors (SSRIs).
