Europe — EMA
Harmonet
Harmonet combined oral contraceptive containing ethinylestradiol and gestodene – EU prescription tablet for pregnancy prevention.
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What is Ethinylestradiol, Gestodene?
Harmonet is a combined oral contraceptive tablet that contains the estrogen ethinylestradiol and the progestogen gestodene. It is marketed in the European Union and is supplied as a prescription oral tablet. The product is formulated to deliver a fixed dose of each hormone per tablet, although specific strength details may vary by region. Harmonet works by preventing ovulation and creating cervical and endometrial changes that reduce the chance of pregnancy.
What is Ethinylestradiol, Gestodene used for?
Harmonet is indicated for the prevention of pregnancy in women of reproductive age.
- Primary indication: combined hormonal contraception to prevent pregnancy. - Used in a regular 21‑day active tablet regimen followed by a hormone‑free interval. - May help regulate menstrual cycle timing and flow. - Can be prescribed after childbirth, abortion, or miscarriage when no contraindications exist. - Suitable for women who are non‑smokers or light smokers under 35 years of age. - May be considered for women seeking a reversible, user‑controlled contraceptive method.
What are the side effects of Ethinylestradiol, Gestodene?
Side effects of Harmonet vary in frequency and severity.
Common: - Nausea or mild gastrointestinal discomfort. - Breast tenderness or enlargement. - Headache, including tension‑type headaches. - Irregular vaginal bleeding or spotting between periods. - Mood changes such as irritability or mild depression. - Weight fluctuations or fluid retention.
Serious: - Venous thromboembolism (deep‑vein thrombosis, pulmonary embolism). - Arterial thrombosis leading to stroke or myocardial infarction. - Severe hypertension or hypertensive crisis. - Liver dysfunction, including cholestatic jaundice. - Allergic reactions such as rash, angioedema, or anaphylaxis. - Visual disturbances or ocular migraines.
What precautions apply to Ethinylestradiol, Gestodene?
Before prescribing Harmonet, clinicians should evaluate several safety considerations.
- Not recommended for women over 35 who smoke heavily (≥15 cigarettes per day). - Contraindicated in individuals with a history of thromboembolic disorders or clotting disorders. - Caution in patients with uncontrolled hypertension, diabetes with vascular disease, or migraine with aura. - Avoid use in women with known or suspected estrogen‑dependent tumors (e.g., breast cancer). - Liver disease, especially severe hepatic impairment, requires careful assessment. - Women who are pregnant or suspect pregnancy should not start Harmonet. - Regular monitoring is advised for women with gallbladder disease or lipid abnormalities.
What does Ethinylestradiol, Gestodene interact with?
Drug interactions can affect the efficacy of Harmonet or increase adverse event risk.
Avoid: - Strong enzyme inducers such as rifampin, phenytoin, carbamazepine, and St. John's wort, which may reduce contraceptive effectiveness. - Concomitant use with selective serotonin reuptake inhibitors (SSRIs) that significantly increase bleeding risk.
Use with caution: - Antiepileptic drugs (e.g., valproate, lamotrigine) that may require dose adjustments. - Azole antifungals (ketoconazole, fluconazole) that can increase hormone levels. - HIV protease inhibitors (ritonavir) that may alter hormone metabolism. - Certain antibiotics (e.g., griseofulvin) that have modest enzyme‑inducing properties. - Herbal supplements that affect liver enzymes, such as ginseng or black cohosh.
Frequently asked questions
What hormones are combined in Harmonet?+
How does Harmonet prevent pregnancy?+
Who is an appropriate candidate for Harmonet?+
Can smokers use Harmonet safely?+
What are the most common side effects of Harmonet?+
What serious health risks are associated with Harmonet?+
Does Harmonet protect against sexually transmitted infections (STIs)?+
Can Harmonet be taken together with antibiotics?+
Which medications should be avoided while using Harmonet?+
How long after stopping Harmonet can fertility return?+
Is Harmonet safe for women with a history of blood clots?+
What should a woman do if she misses a Harmonet tablet?+
Product details
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