Europe — EMA
Harmonet (Ethinylestradiol, Gestodene)
Learn about Harmonet, a combined oral contraceptive containing ethinylestradiol and gestodene, its uses, side effects, precautions, and drug interactions.
Request sourcing
What is Ethinylestradiol, Gestodene?
Harmonet is a combined oral contraceptive tablet that contains the synthetic estrogen ethinylestradiol together with the progestogen gestodene. The product is marketed in the European Union and is supplied by prescription only. Harmonet is formulated as a tablet intended for oral administration to provide hormonal contraception for women of reproductive age.
What is Ethinylestradiol, Gestodene used for?
Harmonet is indicated for the prevention of pregnancy in women who choose an oral hormonal method. It is used as part of a regular monthly dosing schedule to inhibit ovulation and create a cervical environment that reduces the chance of fertilization.
- Primary contraceptive method for women seeking reversible birth control. - May be used to regulate menstrual cycles when prescribed. - Can help reduce menstrual-associated dysmenorrhea. - May provide modest improvement in acne related to hormonal fluctuations. - Often chosen for its low-dose estrogen component compared with older formulations.
What are the side effects of Ethinylestradiol, Gestodene?
Side effects of Harmonet vary in frequency and severity. Most are mild and transient, while serious reactions are uncommon but require medical attention.
Common: - Nausea or mild gastrointestinal upset. - Breast tenderness or enlargement. - Headache or migraine onset. - Spotting or breakthrough bleeding, especially during the first months. - Weight fluctuations or fluid retention. - Mood changes or mild depressive symptoms.
Serious: - Signs of venous thromboembolism such as leg pain or swelling. - Sudden severe chest pain or shortness of breath. - Visual disturbances or severe headache suggesting stroke. - Persistent high blood pressure. - Severe allergic reaction with rash, itching, or swelling.
What precautions apply to Ethinylestradiol, Gestodene?
Before starting Harmonet, certain health considerations should be reviewed with a healthcare professional. The following precautions are commonly advised:
- Do not use if you have a history of thromboembolic disorders, stroke, or myocardial infarction. - Caution is needed for smokers over 35 years of age. - Discuss any liver disease, gallbladder disease, or uncontrolled hypertension. - Inform your provider about any history of breast cancer or estrogen‑dependent tumors. - Review all current medications, including over‑the‑counter products, for potential interactions. - Regularly monitor blood pressure and lipid profiles while on therapy.
What does Ethinylestradiol, Gestodene interact with?
Harmonet can interact with several medicines, affecting its efficacy or increasing risk of adverse events. Interaction categories are outlined below.
Avoid: - Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin) that may reduce contraceptive effectiveness. - Certain antibiotics such as rifampin that increase hepatic metabolism. - Antiretroviral agents (e.g., efavirenz) known to lower hormone levels.
Use with caution: - Antifungal agents like ketoconazole that may increase hormone concentrations. - St. John’s wort and other herbal supplements that affect cytochrome P450 activity. - Selective serotonin reuptake inhibitors (SSRIs) that may alter bleeding patterns. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) that can increase blood pressure.



