Europe — EMA
Kelzyn (Dienogest, Ethinylestradiol | Lactose)
GNH USA supplies Kelzyn (Dienogest/Ethinylestradiol), a combined oral contraceptive for contraception and menstrual cycle regulation.
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What is Dienogest, Ethinylestradiol | Lactose?
Dienogest, the active ingredient in Kelzyn, is a combined oral contraceptive presented as an oral tablet for oral use. Together with ethinylestradiol, it provides hormonal regulation for contraception and menstrual cycle control in women of reproductive age, and the formulation includes lactose as an inactive filler complying with EU standards.
GNH USA supplies Kelzyn as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality assurance, regulatory compliance, and reliable logistics for global distribution.
What is Dienogest, Ethinylestradiol | Lactose used for?
Kelzyn, a combined oral contraceptive, acts on the hormonal regulation of the female reproductive system.
- Contraception: provides effective prevention of pregnancy by inhibiting ovulation. - Menstrual cycle regulation: helps achieve more predictable and lighter bleeding patterns. - Dysmenorrhea management: reduces menstrual pain and associated symptoms in women.
What are the side effects of Dienogest, Ethinylestradiol | Lactose?
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort. - Spotting: irregular light bleeding. - Weight gain: mild fluid retention. - Mood changes: irritability or emotional fluctuations.
Serious or Rare Side Effects: - Deep‑vein thrombosis: blood clot formation in legs. - Pulmonary embolism: clot traveling to lungs. - Stroke: cerebrovascular event. - Myocardial infarction: heart attack. - Severe allergic reaction: rash, swelling, difficulty breathing. - Liver dysfunction: jaundice or abnormal liver enzymes.
What precautions apply to Dienogest, Ethinylestradiol | Lactose?
Kelzyn should be used only after a medical assessment of individual risk factors. - Smoking: avoid if over 35 years of age due to increased thrombotic risk. - Cardiovascular disease: assess history of hypertension, heart disease, or stroke before prescribing. - History of thromboembolism: contraindicated in patients with prior clotting events. - Liver disease: use with caution in active hepatic disorders. - Migraine with aura: contraindicated due to elevated stroke risk. - Store at ambient temperature: keep below 25 °C in the original pack, protect from moisture.
What does Dienogest, Ethinylestradiol | Lactose interact with?
Kelzyn may interact with several medicines that affect its efficacy or safety.
Major Interactions (Avoid): - Enzyme inducers (e.g., rifampin, carbamazepine): reduce contraceptive effectiveness. - Anticoagulants (e.g., warfarin): may alter clotting parameters. - Antiretrovirals (protease inhibitors): decrease hormone levels. - St. John’s wort: diminishes contraceptive protection.
Moderate Interactions (Monitor Closely): - Antifungals (e.g., ketoconazole): may increase hormone concentrations. - Antibiotics (e.g., tetracycline): possible reduced efficacy. - SSRIs (e.g., fluoxetine): may affect hormone metabolism. - Diuretics (e.g., hydrochlorothiazide): monitor blood pressure changes.



