Europe — EMA
Gynovel (Norethisterone Acetate, Estradiol)
Gynovel combines norethisterone acetate and estradiol in an oral tablet for hormone therapy; see uses, side effects, precautions, and drug interactions.
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What is Norethisterone Acetate, Estradiol?
Gynovel is an oral prescription medication that combines norethisterone acetate and estradiol in a single tablet. It belongs to the combined estrogen‑progestogen class and is marketed in the European Union. The formulation is intended for systemic hormonal therapy and is taken by mouth under medical supervision. The product is supplied without a specified strength, and its dosage form is a solid oral tablet designed for consistent absorption.
What is Norethisterone Acetate, Estradiol used for?
Gynovel may be prescribed when a combined estrogen‑progestogen regimen is appropriate, as determined by a healthcare professional. Typical clinical contexts include hormone replacement therapy, menstrual cycle management, and certain contraceptive strategies.
- Hormone replacement therapy (HRT) for menopausal symptoms - Management of irregular or heavy menstrual bleeding - Treatment of secondary amenorrhea - Adjunct in specific contraceptive protocols - Endometrial protection during estrogen therapy
What are the side effects of Norethisterone Acetate, Estradiol?
Side effects of combined estrogen‑progestogen therapy vary in frequency and severity.
Common: - Nausea or vomiting - Breast tenderness - Headache - Mood changes - Spotting between periods
Serious: - Deep vein thrombosis or pulmonary embolism - Stroke or transient ischemic attack - Severe hypertension - Liver dysfunction - Allergic reactions such as rash or angioedema
What precautions apply to Norethisterone Acetate, Estradiol?
Before starting Gynovel, certain health conditions and risk factors should be evaluated to ensure safe use.
- History of thromboembolic disease or clotting disorders - Current or past breast, uterine, or ovarian cancer - Uncontrolled hypertension - Smoking in women over 35 years of age - Liver disease or impaired hepatic function - Pregnancy or breastfeeding status - Known hypersensitivity to norethisterone acetate, estradiol, or excipients
What does Norethisterone Acetate, Estradiol interact with?
Gynovel can interact with several medication classes; some combinations should be avoided while others require careful monitoring.
Avoid: - Other estrogen‑containing products, including combined oral contraceptives - Anticoagulants such as warfarin - Certain antiretroviral drugs (e.g., protease inhibitors) - St. John’s wort (enzyme inducer) - Seizure medications that lower hormone levels
Use with caution: - Antifungal agents (e.g., ketoconazole) - Anticonvulsants (e.g., carbamazepine, phenytoin) - Thyroid hormone therapy - Diuretics affecting electrolyte balance - Rifampin and other enzyme‑inducing antibiotics



