Europe — EMA
Harmonet
Harmonet combined oral contraceptive containing ethinylestradiol and gestodene – EU prescription tablet for pregnancy prevention and menstrual regulation.
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What is Ethinylestradiol, Gestodene?
Harmonet is a combined oral contraceptive tablet containing the synthetic estrogen ethinylestradiol and the progestogen gestodene. It is marketed in the European Union as a prescription medication for hormonal contraception. The product is supplied in tablet form for oral administration. Harmonet works by inhibiting ovulation and altering cervical mucus and the endometrial lining to prevent pregnancy. It is intended for regular daily use as part of a defined cycle.
What is Ethinylestradiol, Gestodene used for?
Harmonet is prescribed primarily for the prevention of unintended pregnancy in women of reproductive age.
- Primary use as a combined hormonal contraceptive taken once daily for 21 consecutive days followed by a hormone‑free interval. - Regulation of menstrual cycle timing and reduction of menstrual flow when used continuously. - Management of moderate acne associated with androgen excess, as an off‑label therapeutic option in some jurisdictions. - Potential benefit in reducing the risk of ovarian cyst formation during long‑term use. - Adjunctive therapy for endometriosis symptom control under physician supervision.
What are the side effects of Ethinylestradiol, Gestodene?
Like all combined oral contraceptives, Harmonet may cause a range of side effects, most of which are mild and transient.
Common: - Nausea or mild stomach upset. - Breast tenderness or enlargement. - Headache or mild migraine. - Irregular vaginal bleeding or spotting between periods. - Weight fluctuations due to fluid retention.
Serious: - Deep vein thrombosis or pulmonary embolism. - Severe hypertension or stroke.
What precautions apply to Ethinylestradiol, Gestodene?
Before starting Harmonet, women should discuss their medical history with a healthcare professional to ensure safe use.
- Contraindicated in women who are pregnant, have a history of thromboembolic disorders, or known estrogen‑dependent tumors. - Avoid use in smokers over 35 years of age due to increased cardiovascular risk. - Screen for hypertension, diabetes, liver disease, or migraine with aura prior to prescribing. - Inform the prescriber of any recent major surgery or prolonged immobilization. - Use an additional barrier method during the first 7 days of treatment. - Regularly monitor blood pressure and lipid profile during long‑term therapy.
What does Ethinylestradiol, Gestodene interact with?
Harmonet can interact with several medications, affecting its efficacy or increasing the risk of adverse events.
Avoid: - Antibiotics such as rifampin or griseofulvin that induce hepatic enzymes and reduce contraceptive effectiveness. - Anticonvulsants like carbamazepine, phenytoin, or phenobarbital that increase hormone metabolism. - Antiretroviral drugs (e.g., efavirenz) that lower plasma levels of ethinylestradiol. - St. John’s wort, a herbal CYP3A4 inducer, which may diminish contraceptive protection.
Use with caution: - Antifungal agents (e.g., ketoconazole) that inhibit CYP3A4 and may increase hormone levels. - Selective serotonin reuptake inhibitors (SSRIs) that can affect bleeding risk. - Diuretics that may alter fluid balance and blood pressure. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) that can increase cardiovascular risk when combined with estrogen.
Frequently asked questions
What is Harmonet and how does it work?+
Who can be prescribed Harmonet?+
Is Harmonet suitable for smokers?+
How should Harmonet be taken?+
Can Harmonet be used to treat acne?+
What are the most common side effects of Harmonet?+
What serious adverse events are associated with Harmonet?+
Does Harmonet interact with antibiotics?+
Can I take herbal supplements while using Harmonet?+
What should I do if I miss a dose of Harmonet?+
Is Harmonet safe for women with a history of blood clots?+
Can Harmonet be used during breastfeeding?+
Product details
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