Harmonette – Dragees (Ethinylestradiol, Gestodene)

Harmonette dragees are indicated for the prevention of pregnancy in women of reproductive age.

• Regular, once‑daily oral administration as part of a 28‑day cycle (21 active tablets, 7 placebo or hormone‑free days).
• Use in women seeking a reversible, hormone‑based contraceptive method.
• May be prescribed for cycle regulation when contraception is the primary goal.
• Suitable for women without contraindications to estrogen‑progestogen combinations.
• Can be used in conjunction with counseling on barrier methods for added protection.

Like other combined oral contraceptives, Harmonette dragees may cause a range of hormonal side effects, most of which are mild and transient.

Common

• Nausea or mild gastrointestinal discomfort.
• Breast tenderness or enlargement.
• Headache, including tension‑type.
• Irregular menstrual bleeding or spotting, especially during the first cycles.
• Mood changes such as mild irritability or emotional fluctuations.
• Weight gain or fluid retention, usually modest.

Serious

• Signs of venous thromboembolism such as leg pain, swelling, or shortness of breath.
• Severe allergic reaction manifested by rash, itching, swelling of the face or throat, or difficulty breathing.
• Liver dysfunction signs, including jaundice, dark urine, or severe abdominal pain.
• Elevated blood pressure or hypertension detected during routine monitoring.

Before prescribing Harmonette dragees, clinicians should evaluate patient history and consider several precautionary factors to minimize risks.

• History of thromboembolic disorders, such as deep‑vein thrombosis or pulmonary embolism.
• Known or suspected estrogen‑dependent neoplasms, including breast or endometrial cancer.
• Uncontrolled hypertension or cardiovascular disease.
• Smoking in women over 35 years of age.
• Liver disease that impairs hormone metabolism.
• Migraines with aura or other neurological conditions that increase stroke risk.
• Breastfeeding women, as hormonal contraception may affect milk production.

Harmonette dragees can interact with other medicines, altering their effectiveness or increasing the risk of adverse events.

Avoid

• Enzyme-inducing anticonvulsants such as carbamazepine, phenytoin, or rifampicin, which may reduce contraceptive efficacy.
• Certain antibiotics like rifampin that increase hepatic metabolism of estrogen.
• St. John’s wort, a herbal supplement known to induce CYP3A4 enzymes.

Use with caution

• Antifungal agents (e.g., ketoconazole, itraconazole) that can increase hormone levels.
• Antiretroviral drugs, especially protease inhibitors, which may affect hormone concentrations.
• Diuretics or antihypertensives that may influence fluid balance and blood pressure.