Company: Consilient Health Ltd.
Legal category: Prescription. Sport permitted.
Active ingredients: Ethinylestradiol/drospirenone 0.02/3mg.
Description: White, round, biconvex film-coated tablet marked G73.
Presentation: 3×21, €13.00 (PTW).
Indication: Oral contraception.
Pharmacology: Ethinylestradiol/drospirenone inhibits ovulation and changes the endometrium. Drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties.
Dosage: Adult: One daily at about same time for 21 days starting on first day of menstruation, then 7 tablet free days.
Contraindications: Hypersensitivity to the active substances or to any of the excipients. Presence/risk of venous thromboembolism (VTE) or arterial thromboembolism (ATE), presence/history of severe hepatic disease as long as liver function values not normal, severe renal insufficiency or acute renal failure, liver tumours (or history), sex-steroid influenced malignancies (or suspected), undiagnosed vaginal bleeding. Pregnancy, lactation.
Special precautions: Renal impairment (check serum potassium). Increases plasma renin activity and plasma aldosterone. Risk of VTE, ATE. Hypertriglyceridaemia (or family history; risk of pancreatitis), suspend treatment if a sustained hypertension develops, hereditary angioedema. Major surgery with prolonged immobilisation. May occur or deteriorate: Jaundice and/or pruritus related to cholestasis; gallstones; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss. Worsening of endogenous depression, epilepsy, Crohn’s disease, ulcerative colitis reported. Avoid sun/UV in tendancy to chloasma. Exclude malignancy/pregnancy if bleeding irregularities persist or occur after previously regular cycles. Diabetes. Contains lactose, lecithin (soya).
Drug interactions: Add a barrier method during and for 7 days after administration of antibiotics or for 28 days after administration of hepatic enzyme inducers or rifampicin. Ciclosporin, lamotrigine. Aldosterone antagonists or potassium-sparing diuretics.
Adverse drug reactions: Emotional lability, headache, abdominal pain, acne, breast pain, breast enlargement, breast tenderness, dysmenorrhea, metrorrhagia, weight increase.
Full prescribing information and references available from Consilient Health Ltd. Telephone: (01) 2057760.