Europe — EMA
Omisson (Dienogest, Ethinylestradiol)
GNH USA supplies Omisson (Dienogest/Ethinylestradiol), a combined hormonal contraceptive for contraception and menstrual regulation.
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What is Dienogest, Ethinylestradiol?
Dienogest, the active ingredient in Omisson, is a synthetic progestogen presented as a combined oral tablet for systemic hormonal use. It works in conjunction with ethinylestradiol to manage hormonal conditions in women of reproductive age. GNH USA supplies Omisson as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Omisson as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Dienogest, Ethinylestradiol used for?
Omisson combines dienshest and ethinylestradiol to treat estrogen‑dependent conditions within the hormonal contraceptive pathway.
- Contraception: provides reliable, reversible birth control for women seeking oral hormonal contraception. - Menstrual disorders: helps regulate irregular cycles and reduce heavy menstrual bleeding. - Endometriosis‑related pain: alleviates pelvic pain associated with endometriosis. - Acne vulgaris: improves skin lesions by modulating androgen activity. - Polycystic ovary syndrome (PCOS) symptoms: assists in cycle regulation and androgen reduction.
What are the side effects of Dienogest, Ethinylestradiol?
Adverse reactions may vary in frequency and severity.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: transient swelling or discomfort. - Weight gain: modest increase in body weight. - Mood changes: irritability or emotional lability. - Spotting between periods: light vaginal bleeding.
Serious or Rare Side Effects: - Venous thromboembolism: deep‑vein clot or pulmonary embolism. - Arterial thrombosis: stroke or myocardial infarction. - Severe hypertension: sudden rise in blood pressure. - Liver dysfunction: abnormal liver enzymes or jaundice. - Allergic reactions: rash, itching, swelling, or anaphylaxis. - Visual disturbances: blurred vision or retinal vein occlusion.
What precautions apply to Dienogest, Ethinylestradiol?
Before starting Omisson, consider the following safety measures:
- Smoking status: avoid use if you smoke >15 cigarettes/day and are over 35 years old. - Cardiovascular risk: assess history of hypertension, thrombosis, or heart disease. - Liver function: evaluate hepatic health prior to therapy. - Migraine history: caution if you have migraine with aura. - Pregnancy and lactation: discontinue if pregnant or planning pregnancy; not recommended while breastfeeding. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Dienogest, Ethinylestradiol interact with?
Omisson may interact with several medicines, requiring clinical awareness.
Major Interactions (Avoid): - Anticoagulants: may reduce effectiveness of warfarin, requiring INR monitoring. - Enzyme inducers: carbamazepine, phenytoin, rifampicin can lower hormonal levels, decreasing efficacy. - Antifungal azoles: ketoconazole may increase plasma concentrations, raising side‑effect risk.
Moderate Interactions (Monitor Closely): - Antidepressants: SSRIs such as fluoxetine may increase bleeding risk. - Antibiotics: broad‑spectrum agents like tetracycline may slightly reduce contraceptive reliability. - Herbal supplements: St. John’s wort may diminish hormonal exposure.



