GNH USA

Europe — EMA

Harmonet

Learn about Harmonet oral contraceptive – ethinylestradiol/gestodene tablet, uses, side effects, precautions, and drug interactions.

Ethinylestradiol, Gestodene

Request sourcing

1
Pack/s

What is Ethinylestradiol, Gestodene?

Harmonet is a combined oral contraceptive tablet containing the synthetic estrogen ethinylestradiol and the progestogen gestodene. It is supplied in tablet form and marketed in the European Union as a prescription‑only medication. The product works by suppressing ovulation and altering cervical mucus and the endometrial lining to prevent pregnancy. Harmonet is classified under ATC code G03AA07. It is intended for women seeking birth control and to help regulate menstrual cycles.

What is Ethinylestradiol, Gestodene used for?

Harmonet is prescribed primarily for hormonal contraception and menstrual cycle management.

- Prevention of pregnancy in women of reproductive age. - Regulation of irregular menstrual bleeding. - Reduction of dysmenorrhea associated with ovulatory cycles. - Management of acne that improves with estrogen‑progestogen therapy. - May be used as part of a post‑abortion or postpartum contraceptive plan under medical supervision.

What are the side effects of Ethinylestradiol, Gestodene?

Like other combined oral contraceptives, Harmonet can cause a range of side effects that vary in frequency and severity.

Common: - Nausea or mild stomach upset. - Breast tenderness or enlargement. - Headache or mild migraine. - Spotting or breakthrough bleeding between periods. - Weight fluctuation or fluid retention. - Mood changes such as irritability.

Serious: - Deep vein thrombosis or pulmonary embolism. - Stroke or transient ischemic attack. - Severe hypertension. - Liver dysfunction or jaundice. - Allergic reactions with rash or swelling.

What precautions apply to Ethinylestradiol, Gestodene?

Before starting Harmonet, healthcare providers assess several health factors to ensure safe use.

- History of thromboembolic disorders, stroke, or myocardial infarction. - Uncontrolled hypertension or diabetes with vascular complications. - Current or past smoking in women over 35 years of age. - Known liver disease or severe gallbladder disease. - Pregnancy or suspected pregnancy (category X). - Breast cancer or estrogen‑dependent tumors. - Migraine with aura.

What does Ethinylestradiol, Gestodene interact with?

Harmonet may interact with other medicines, affecting its effectiveness or increasing health risks.

Avoid: - Strong enzyme inducers such as rifampicin, carbamazepine, phenytoin, and St John’s wort. - Anticoagulants like warfarin, which may have reduced efficacy. - Certain antiviral agents (e.g., protease inhibitors) that alter hormone metabolism.

Use with caution: - Antidepressants (SSRIs) that can increase bleeding risk. - Antifungal agents (ketoconazole, itraconazole) that may raise hormone levels. - Diuretics or antihypertensives that may affect blood pressure control.

Frequently asked questions

What is the mechanism of action of Harmonet combined oral contraceptive?+
Harmonet delivers ethinylestradiol and gestodene, which suppress the hypothalamic‑pituitary‑ovarian axis, lowering LH and FSH secretion, thereby inhibiting ovulation and producing cervical mucus and endometrial changes that prevent fertilization and implantation.
How should a missed dose of Harmonet be handled?+
If a tablet is missed, the usual recommendation is to take the missed tablet as soon as remembered and continue with the regular schedule, using backup contraception for the next 7 days. Specific guidance should be obtained from a healthcare professional.
Can Harmonet be used to treat acne?+
Harmonet contains an estrogen component that can improve acne in some women, but it is not primarily indicated for acne treatment. Any benefit is considered a secondary effect and should be discussed with a prescriber.
Is Harmonet safe for women who smoke?+
Smoking, especially in women over 35, increases the risk of cardiovascular events with combined oral contraceptives. Harmonet is generally contraindicated for smokers in this age group and should be used with caution in younger smokers.
What are the recommendations for using Harmonet after childbirth?+
Harmonet may be started postpartum once bleeding has ceased and the woman is not breastfeeding, typically after 6 weeks. If breastfeeding, a progestogen‑only method is usually preferred.
Does Harmonet interact with antibiotics?+
Most antibiotics do not affect the efficacy of combined oral contraceptives. However, enzyme‑inducing antibiotics such as rifampicin can reduce hormone levels and should be avoided or supplemented with additional contraception.
Can Harmonet cause weight gain?+
Some users report mild weight fluctuation or fluid retention, which is listed as a common side effect. Significant weight gain is not a typical effect of Harmonet.
Is it necessary to take a placebo tablet with Harmonet?+
Harmonet is usually packaged in a 21‑day active tablet regimen followed by a hormone‑free interval. Some formulations include placebo tablets to maintain a 28‑day cycle, but the specific packaging should be confirmed on the product label.
What should a woman do if she becomes pregnant while taking Harmonet?+
If pregnancy is confirmed, Harmonet should be discontinued immediately. The woman should seek prenatal care and discuss any potential risks with her healthcare provider.
Are there any dietary restrictions while taking Harmonet?+
There are no specific dietary restrictions, but excessive alcohol consumption can increase the risk of liver problems and should be avoided. A balanced diet supports overall health while using hormonal contraception.
Can Harmonet be used by women with a history of migraine with aura?+
Migraine with aura is a contraindication for combined estrogen‑progestogen contraceptives because of an increased risk of stroke. Women with this history should consider alternative non‑estrogen methods.
How should Harmonet be stored?+
Store Harmonet tablets at room temperature, away from moisture and heat, and keep them out of reach of children. Do not use tablets that are discolored or past the expiration date.
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
Pfizer Spol. S R.O.
Origin
EU

Related products