Europe — EMA
Kelzy (Dienogest, Ethinylestradiol | Lactose)
GNH USA supplies Kelzy (Dienogest/Ethinylestradiol), a combined oral contraceptive for prevention of pregnancy.
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What is Dienogest, Ethinylestradiol | Lactose?
Dienogest, the active ingredient in Kelzy, is a combined oral contraceptive presented as a tablet for oral use. It prevents pregnancy in women of reproductive age. GNH USA supplies Kelzy as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Dienogest, Ethinylestradiol | Lactose used for?
Kelzy, a combined oral contraceptive, acts on the hypothalamic‑pituitary‑ovarian axis to prevent pregnancy.
Contraception: prevents unintended pregnancy by inhibiting ovulation and fertilisation. Family planning: enables controlled timing of pregnancies for women seeking to plan childbearing. Ovulation suppression: blocks the mid‑cycle surge of luteinising hormone, stopping egg release.
What are the side effects of Dienogest, Ethinylestradiol | Lactose?
Common Side Effects: - Nausea or vomiting - Breast tenderness or enlargement - Headache or migraine - Weight gain or fluid retention - Mood changes or irritability - Irregular bleeding or spotting
Serious or Rare Side Effects: - Venous thromboembolism (deep‑vein thrombosis, pulmonary embolism) - Arterial thrombosis (stroke, myocardial infarction) - Severe hypertension - Liver disorders (cholestasis, hepatic adenoma) - Anaphylactic or severe allergic reactions - Visual disturbances or eye pain
What precautions apply to Dienogest, Ethinylestradiol | Lactose?
Kelzy should be used only after a medical evaluation of individual risk factors.
Medical evaluation: assess personal and family history of thromboembolic events. Smoking: avoid use if over 35 years old and a smoker. Blood pressure: monitor regularly; discontinue if hypertension develops. Liver disease: use with caution in patients with hepatic impairment. Pregnancy: discontinue immediately if pregnancy is confirmed. Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Dienogest, Ethinylestradiol | Lactose interact with?
Kelzy may interact with several medicines that affect its efficacy or safety.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine): may markedly reduce contraceptive effectiveness. - Anticoagulants (e.g., warfarin): combined use may increase risk of thrombosis.
Moderate Interactions (Monitor Closely): - Antifungal agents (ketoconazole, itraconazole): may increase hormone levels. - Certain antibiotics (macrolides, tetracyclines): may slightly reduce contraceptive effect. - Herbal supplements (St. John’s wort): may lower plasma concentrations of the hormones. - Antidepressants (SSRIs): may exacerbate mood‑related side effects.



