GNH USA

Europe — EMA

Harmonet

Learn about Harmonet combined oral contraceptive, its uses, side effects, precautions, and drug interactions.

Ethinylestradiol, Gestodene

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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 supplied as an oral tablet, with the specific strength not disclosed in the source data, and is marketed in the European Union. The product works by preventing ovulation and creating cervical and endometrial conditions unfavorable for fertilisation and implantation. It requires a prescription and is intended for women of reproductive age.

What is Ethinylestradiol, Gestodene used for?

Harmonet is indicated for hormonal contraception and is commonly prescribed to prevent pregnancy.

- Prevention of pregnancy in women of child‑bearing potential when taken as directed. - Regulation of menstrual cycles, providing more predictable bleeding patterns. - Reduction of menstrual‑related symptoms such as dysmenorrhea and heavy bleeding. - Management of acne associated with hormonal fluctuations in some users. - Potential benefit in reducing the risk of ovarian cyst formation.

What are the side effects of Ethinylestradiol, Gestodene?

Like other combined oral contraceptives, Harmonet may cause side effects, most of which are mild and transient.

Common: - Nausea or mild gastrointestinal discomfort, often occurring during the first cycles. - Headache or migraine, which may vary in intensity. - Breast tenderness or enlargement, typically resolving after continued use. - Irregular spotting or breakthrough bleeding, especially in the initial months. - Weight gain or fluid retention, usually modest and temporary.

Serious: - Deep vein thrombosis or pulmonary embolism, presenting with leg pain, swelling, or shortness of breath. - Severe hypertension, stroke, or myocardial infarction, requiring immediate medical attention. - Liver dysfunction or jaundice, indicated by yellowing of the skin or eyes.

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 other cardiovascular disease. - Current or past breast cancer or other estrogen‑dependent tumors. - Uncontrolled hypertension or diabetes. - Liver disease or impaired liver function. - Smoking in women over 35 years of age. - Pregnancy or planning to become pregnant. - Severe migraine with aura.

What does Ethinylestradiol, Gestodene interact with?

Harmonet can interact with other medicines, which may alter its effectiveness or increase risks.

Avoid: - Antibiotics such as rifampicin, certain antiepileptics, and herbal St John’s wort that reduce hormone levels. - Medications that induce hepatic enzymes, potentially decreasing contraceptive efficacy.

Use with caution: - Antifungal agents like ketoconazole, which may increase hormone concentrations. - Some HIV protease inhibitors and certain antidepressants that can affect hormone metabolism. - Medications that may increase the risk of thrombosis, requiring careful monitoring.

Frequently asked questions

What is Harmonet and what are its active ingredients?+
Harmonet is a combined oral contraceptive tablet that contains the synthetic estrogen ethinylestradiol and the progestogen gestodene.
How does Harmonet prevent pregnancy?+
It suppresses ovulation by inhibiting the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH) and also alters cervical mucus and the endometrium to reduce fertilisation and implantation.
Who can safely use Harmonet?+
Harmonet is prescribed for women of reproductive age who have no history of blood clots, cardiovascular disease, estrogen‑dependent tumors, uncontrolled hypertension, or severe migraine with aura.
What are the most common side effects of Harmonet?+
Common side effects include nausea, headache, breast tenderness, irregular spotting, and mild weight gain, especially during the first few cycles.
What serious adverse events should prompt immediate medical attention?+
Serious events include signs of deep vein thrombosis, pulmonary embolism, severe hypertension, stroke, myocardial infarction, or liver dysfunction such as jaundice.
Can Harmonet be used while breastfeeding?+
Women who are breastfeeding should discuss use with their healthcare provider, as hormonal contraceptives may affect milk production and infant exposure.
Does smoking affect the safety of Harmonet?+
Smoking, especially in women over 35, increases the risk of cardiovascular complications and is a contraindication for combined oral contraceptives like Harmonet.
Are there any medications that reduce the effectiveness of Harmonet?+
Yes, enzyme‑inducing drugs such as rifampicin, certain antiepileptics, and St John’s wort can lower hormone levels and reduce contraceptive efficacy.
Which drugs should be used with caution when taking Harmonet?+
Antifungal agents like ketoconazole, some HIV protease inhibitors, and certain antidepressants may increase hormone concentrations and should be used with caution.
What should I do if I miss a dose of Harmonet?+
If a dose is missed, follow the instructions on the patient information leaflet or contact a healthcare professional for guidance on backup contraception.
Is Harmonet available over the counter?+
No, Harmonet is a prescription‑only medication and must be prescribed by a qualified healthcare professional.
Can Harmonet be used to treat acne?+
While not a primary indication, some users experience improvement in hormonal acne while taking Harmonet.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ethinylestradiol, Gestodene
Route
Oral Use
Manufacturer
Laboratórios Pfizer Lda.
Origin
EU

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