Essential Information
Evana® Heavy Period Relief 500mg Tablets (Tranexamic acid) - PL 14251/0300. Indications: Reduction of heavy menstrual bleeding over several cycles in women with regular, 21-35 day cycles with no more than 3 day variation. Posology: Two tablets to be taken, 3 times a day at the onset of heavy menstrual bleeding, for a maximum of 4 consecutive days. Maximum daily dose of 8 tablets. Contraindications: Hypersensitivity to the active substance or any of the excipients, severe renal impairment, mild to moderate renal insufficiency, active thromboembolic disease, previous thromboembolic event and a family history of thrombophilia, haematuria, irregular menstrual bleeding, those taking warfarin, anticoagulants or oral contraceptives, pregnancy, fibrinolytic conditions following DIC, or history of convulsions. Precautions: Women aged over 45, those who are diabetic or obese, polycystic ovary syndrome, a family history of endometrial cancer, and those receiving unopposed oestrogen or tamoxifen, breastfeeding. Side effects: Common (≥1/100 to <1/10): Nausea, vomiting, diarrhoea. Uncommon (≥1/1,000 to <1/100): Allergic skin reactions. Very rare (<1/10,000): Hypersensitivity reactions including anaphylaxis. Frequency unknown: thromboembolic events, retinal/artery occlusion, impaired colour vision or visual disturbances, seizures. MA holder: Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, CV34 5YA, UK. Classification: P. RRP: 18 tablets: £14.95. Date: January 2024 – For full information see: https://evanaperiods.com/hcp/evana/smpc
Reporting of suspected adverse reactions
Healthcare professionals should report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk./yellowcard or search for MHRA Yellow Card in the Google Play