Europe — EMA
Novadien (Dienogest, Ethinylestradiol)
GNH USA supplies Novadien (Dienogest/Ethinylestradiol), an oral contraceptive for preventing pregnancy and regulating menstrual cycles. Request a quote.
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What is Dienogest, Ethinylestradiol?
Dienogest/Ethinylestradiol, the active ingredient in Novadien, is a combined oral contraceptive presented as an oral tablet for oral use. It is indicated for preventing pregnancy and for regulating menstrual cycles in women of reproductive age, offering a reliable hormonal method of birth control.
GNH USA supplies Novadien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑assured products that meet European Union regulatory standards. The company provides comprehensive logistics and regulatory support for global distribution.
What is Dienogest, Ethinylestradiol used for?
Novadien, a combined oral contraceptive, acts on the hypothalamic‑pituitary‑ovarian axis to manage reproductive health. - Prevention of pregnancy: provides reliable contraception for women of childbearing age. - Regulation of menstrual cycles: helps achieve more predictable bleeding patterns. - Management of endometriosis‑related pain: reduces estrogen‑driven endometrial tissue activity.
What are the side effects of Dienogest, Ethinylestradiol?
Novadien may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort of the breasts. - Spotting or irregular bleeding: breakthrough bleeding between periods. - Mood changes: irritability or mild depressive symptoms. - Weight gain: modest increase in body weight.
Serious or Rare Side Effects: - Deep vein thrombosis: blood clot formation in deep veins. - Pulmonary embolism: clot migration to the lungs. - Stroke: cerebrovascular accident due to clot or hemorrhage. - Myocardial infarction: heart attack caused by coronary blockage. - Severe allergic reaction: anaphylaxis with rash, swelling, or breathing difficulty. - Liver dysfunction: jaundice or abnormal liver enzyme levels.
What precautions apply to Dienogest, Ethinylestradiol?
Before prescribing Novadien, clinicians should evaluate individual risk factors and contraindications. - Contraindication: Do not use in women with a history of thromboembolic disorders. - Smoking restriction: Avoid in women over 35 who smoke regularly. - Pregnancy: Discontinue immediately if pregnancy is confirmed; the product is not intended for use during pregnancy. - Liver disease: Use with caution in patients with severe hepatic impairment. - Store at ambient temperature: keep below 25 °C, retain in original packaging, and protect from moisture.
What does Dienogest, Ethinylestradiol interact with?
Novadien can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce contraceptive effectiveness. - Anticoagulants (e.g., warfarin): hormonal changes can affect clotting parameters.
Moderate Interactions (Monitor Closely): - Antifungal agents (e.g., ketoconazole): may increase hormone levels. - Certain antibiotics (e.g., macrolides): can modestly affect contraceptive reliability. - Selective serotonin reuptake inhibitors (e.g., fluoxetine): may require monitoring for mood changes.



