Europe — EMA
Ospen (Drospirenone, Ethinylestradiol)
GNH USA supplies Ospen (Drospirenone/Ethinylestradiol), a combined oral contraceptive for pregnancy prevention and menstrual regulation.
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What is Drospirenone, Ethinylestradiol?
Drospirenone, the active ingredient in Ospen, is a combined oral contraceptive presented as a 3 mg/0.02 mg tablet for oral use. It prevents pregnancy and helps regulate menstrual cycles in women of reproductive age.
GNH USA supplies Ospen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Drospirenone, Ethinylestradiol used for?
Ospen is a hormonal contraceptive that acts on the reproductive endocrine system. - Contraception: Prevents ovulation and thereby avoids pregnancy. - Menstrual cycle regulation: Provides more predictable bleeding patterns. - Acne management: Reduces androgen‑driven skin lesions in some women.
What are the side effects of Drospirenone, Ethinylestradiol?
Side effects vary in frequency and severity.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: temporary swelling or discomfort. - Weight change: slight fluid‑related gain or loss. - Mood changes: irritability or emotional lability. - Spotting: breakthrough bleeding between periods.
Serious or Rare Side Effects: - Venous thromboembolism: deep‑vein thrombosis or pulmonary embolism. - Arterial thrombosis: stroke or myocardial infarction. - Hypertension: new‑onset high blood pressure. - Severe liver dysfunction: jaundice or abnormal liver enzymes. - Allergic reaction: rash, itching, swelling, or anaphylaxis. - Gallbladder disease: inflammation or stones.
What precautions apply to Drospirenone, Ethinylestradiol?
Before starting Ospen, consider the following safety points. - Smoking status: avoid use if over 35 and a regular smoker. - Cardiovascular risk: assess history of clotting, hypertension, or stroke. - Liver function: evaluate for active liver disease. - Migraine history: caution in women with migraine with aura. - Pregnancy potential: discontinue if pregnancy is confirmed or suspected. - Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.
What does Drospirenone, Ethinylestradiol interact with?
Ospen may interact with several medicines; monitoring is advised.
Major Interactions (Avoid): - Antifungal azoles (ketoconazole, itraconazole): increase estrogen exposure. - Antiretroviral protease inhibitors (ritonavir): raise plasma levels of both components. - Enzyme‑inducing anticonvulsants (phenytoin, carbamazepine): reduce contraceptive effectiveness.
Moderate Interactions (Monitor Closely): - St. John’s wort: may lower efficacy, consider alternative contraception. - Antibiotics (rifampicin, rifabutin): possible reduction in hormone levels. - Diuretics (spironolactone): additive antimineralocorticoid effect, monitor electrolytes.



