Europe — EMA
Oedien (Dienogest, Ethinylestradiol | Lactose Monohydrate)
GNH USA supplies Oedien (Dienogest/Ethinylestradiol), a combined estrogen‑progestogen oral contraceptive for prevention of pregnancy and menstrual cycle
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What is Dienogest, Ethinylestradiol | Lactose Monohydrate?
Dienogest, the active ingredient in Oedien, is a combined estrogen‑progestogen oral contraceptive presented as a tablet for oral use. It works to prevent pregnancy and may be used to regulate the menstrual cycle in women of reproductive age. The formulation also contains ethinylestradiol, a synthetic estrogen, which together with dienogest provides reliable hormonal contraception.
GNH USA supplies Oedien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides batch‑tested products for global distribution.
What is Dienogest, Ethinylestradiol | Lactose Monohydrate used for?
Oedien, a combined estrogen‑progestogen oral contraceptive, is indicated for hormonal management of reproductive health.
- Prevention of pregnancy: provides reliable contraceptive protection for women of childbearing potential. - Regulation of menstrual cycle: helps achieve more predictable bleeding patterns and reduces menstrual flow. - Management of ovulatory disorders: assists in establishing regular ovulation cycles in women with irregular periods.
What are the side effects of Dienogest, Ethinylestradiol | Lactose Monohydrate?
Adverse reactions may occur with any hormonal contraceptive. The following lists reported events.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Breast tenderness: discomfort or swelling of the breasts. - Headache: occasional tension‑type or migraine‑like pain. - Weight change: slight increase or decrease in body weight. - Mood changes: irritability or mood swings. - Breakthrough bleeding: unscheduled spotting between periods.
Serious or Rare Side Effects: - Venous thromboembolism: blood clots in deep veins or lungs. - Arterial thrombosis: clot formation in arteries, potentially causing stroke or myocardial infarction. - Hypertension: new‑onset or worsening high blood pressure. - Liver dysfunction: abnormal liver enzymes or cholestasis. - Severe allergic reaction: rash, swelling, or anaphylaxis. - Visual disturbances: sudden loss of vision or eye pain.
What precautions apply to Dienogest, Ethinylestradiol | Lactose Monohydrate?
Before prescribing Oedien, clinicians should consider several safety factors.
- Contraindicated in pregnancy: product is Category X and must not be used. - Avoid in women with a history of thromboembolic disorders: increased risk of clot formation. - Screen for hypertension: monitor blood pressure prior to initiation and during use. - Assess liver function: hepatic disease may alter drug metabolism. - Do not use in smokers over 35 years: smoking adds cardiovascular risk. - Store at room temperature: keep in the original pack, protect from moisture and heat.
What does Dienogest, Ethinylestradiol | Lactose Monohydrate interact with?
Oedien may interact with other medicines, altering its effectiveness or safety.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine): may markedly reduce contraceptive efficacy. - Anticoagulants (e.g., warfarin): hormonal components can enhance anticoagulant effect and increase INR.
Moderate Interactions (Monitor Closely): - Antibiotics such as tetracycline or fluoroquinolones: may slightly decrease absorption of estrogen. - Herbal supplements like St. John's wort: can lower plasma levels of ethinylestradiol. - Anticonvulsants (e.g., phenobarbital): may reduce hormonal concentrations, requiring additional contraceptive measures.
Frequently asked questions
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Product details
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