Europe — EMA
Harmonet
Learn about Harmonet combined oral contraceptive – active ingredients ethinylestradiol and gestodene, uses, side effects, precautions, and drug interactions.
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What is Ethinylestradiol, Gestodene?
Harmonet is a combined oral contraceptive tablet that contains the synthetic estrogen ethinylestradiol and the progestogen gestodene. It is marketed in the European Union and supplied as oral tablets. The formulation works by suppressing ovulation, thickening cervical mucus, and altering the endometrium to prevent pregnancy. Each tablet delivers a dose of each hormone, designed for a 21‑day active regimen followed by an interval. Harmonet is classified under ATC code G03AA09.
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.
- As a combined oral contraceptive for typical 21‑day cycles. - For cycle regulation and reduction of menstrual‑related symptoms. - As part of a prescribed contraceptive regimen following medical evaluation. - May be used in women without contraindications to estrogen‑containing contraceptives. - Provides a reversible method of birth control when taken as directed. - Can be combined with non‑hormonal barrier methods for added protection against sexually transmitted infections. - Suitable for women who desire a predictable menstrual pattern and are able to adhere to daily dosing.
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, typically occurring during the first few cycles as the body adjusts to the hormones.
Common: - Nausea or mild gastrointestinal discomfort. - Breast tenderness or enlargement. - Headache or mild migraine. - Irregular spotting or breakthrough bleeding. - Mood changes or mild depression. - Weight gain or fluid retention. - Decreased libido or sexual desire changes. - Skin changes such as acne or melasma.
Serious: - Deep vein thrombosis, pulmonary embolism, or other thromboembolic events. - Severe hypertension or cardiovascular complications. - Allergic reactions such as rash, itching, or swelling. - Liver dysfunction or jaundice. - Severe abdominal pain indicating possible ectopic pregnancy.
What precautions apply to Ethinylestradiol, Gestodene?
Before prescribing Harmonet, clinicians assess individual risk factors and contraindications to ensure safe use.
- Contraindicated in women who are pregnant, breastfeeding, or have known or suspected pregnancy. - Not for use in individuals with a history of thromboembolic disorders, stroke, or myocardial infarction. - Caution in smokers over 35 years of age due to increased cardiovascular risk. - Avoid in patients with uncontrolled hypertension, liver disease, or estrogen‑dependent tumors. - Review any history of migraine with aura before initiating therapy. - Assess for gallbladder disease or severe diabetes complications. - Ensure patient can adhere to daily dosing schedule.
What does Ethinylestradiol, Gestodene interact with?
Harmonet can interact with several medicines, affecting its efficacy or increasing the risk of adverse events.
Avoid: - Combined hormonal contraceptives with other estrogen‑containing products (e.g., hormone replacement therapy) – may increase estrogen exposure. - Strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, or St. John’s wort – may reduce contraceptive effectiveness. - Certain antiviral agents (e.g., protease inhibitors) that alter hormone metabolism – may require alternative contraception.
Use with caution: - Antifungal azoles (ketoconazole, itraconazole) – may increase hormone levels. - Antidepressants like sertraline – may affect bleeding patterns. - Anticonvulsants with moderate enzyme induction (e.g., valproate) – monitor for reduced efficacy. - Herbal supplements such as ginseng – limited data, monitor closely.
Frequently asked questions
What hormones are contained in Harmonet tablets?+
How does Harmonet prevent pregnancy?+
Is Harmonet available over the counter in the EU?+
Can I start Harmonet immediately after my period begins?+
What are the most common side effects of Harmonet?+
Are there serious risks associated with taking Harmonet?+
Who should not use Harmonet?+
How does smoking affect the safety of Harmonet?+
Can other medications reduce the effectiveness of Harmonet?+
Should I use a backup method while taking Harmonet?+
What should I do if I miss a Harmonet tablet?+
Is Harmonet suitable for women with migraines?+
Product details
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