Estellis

• Oral contraception

Drospirenone + Estetrol Monohydrate is an oral contraceptive containing synthetic progestin (drospirenone) and synthetic estrogen (estetrol) that prevents pregnancy by inhibiting ovulation.

Adult Dose: One tablet daily for 28 days: one pink active tablet (3 mg drospirenone/14.2 mg estetrol) daily for the first 24 days and one white inactive tablet daily for the following 4 days. Take at the same time every day.

Common Side Effects (≥2%):

• Bleeding irregularities
• Mood disturbance
• Headache
• Breast symptoms (pain, tenderness)
• Dysmenorrhea
• Acne
• Weight increased
• Libido decreased

Discontinue if pregnancy occurs, as there is no reason to use hormonal contraceptives during pregnancy.

• Thromboembolic Disorders: Discontinue if thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery.
• Hyperkalemia: DRSP has antimineralocorticoid activity. Check serum potassium during first cycle in women on medications that may increase potassium.
• Hypertension: Monitor blood pressure and stop if significant increase.
• Migraine: Discontinue if new, recurrent, persistent or severe migraines occur.
• Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.
• Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in prediabetic or diabetic women.

Overdose may cause nausea, vomiting, and severe headaches. Thromboembolic complications and vaginal bleeding reported rarely. Consider short-term prophylactic anticoagulation for high VTE risk. Monitor serum potassium, sodium, and for metabolic acidosis.

Store at 20°C-25°C in a frost-free place, away from light. Excursions permitted to 15°C-30°C. Keep out of reach of children.