Essential Information
Essential Information
Ultravana Period Pain Relief 250mg Gastro-resistant tablets (Naproxen) PL 20075/0619. Indication: Treatment of primary dysmenorrhoea in women aged 15-50 years. Posology: Day one: two tablets (500mg) to be taken, followed by one tablet (250mg) every 6-8 hours, if needed. Days 2 and 3: one tablet (250mg) to be taken every 6-8 hours. Maximum daily dose of 3 tablets (750mg), for a maximum of 3 days continuous use in any one cycle. Contraindications: hypersensitivity to the active substance or any of the excipients, patients with a history of, or active peptic ulcers and active gastrointestinal (GI) bleeding, history of GI bleeding or perforation related to previous NSAID therapy, aspirin or NSAID sensitivity, patients with severe heart, hepatic or renal failure, or those in the third trimester of pregnancy. Precautions: Not recommended in the elderly, in the first 6 months of pregnancy, when breast-feeding or in women attempting to conceive. Caution in patients with bronchial asthma or allergic disease, cardiac impairment, hypertension, impaired renal function, liver dysfunction, peripheral arterial or cerebrovascular disease, history of GI disease (e.g., ulcerative colitis, Crohn’s disease), coagulation disorders, and those taking oral corticosteroids, anticoagulants, antiplatelet agents, SSRIs or other NSAIDs. Contains lactose, not for patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose- galactose malabsorption. Side effects: Hypersensitivity reactions including non-specific allergic reactions and anaphylaxis, respiratory tract reactivity e.g., asthma, bronchospasm, dyspnoea, various skin reactions e.g., pruritus, urticaria, purpura, angioedema, exfoliative bullous dermatoses (including epidermal necrolysis, erythema multiforme, Stevens-Johnson Syndrome). GI ulceration or haemorrhage, peptic ulceration, or perforation, hyperkalaemia, cardiac and congestive heart failure, myocardial infarction, stroke, renal failure, jaundice, hepatitis, meningitis. MA Holder: Accord Healthcare Limited, Sage House, 319 Pinner Road, HA1 4HF, UK. Classification: P. RRP: 9 tablets £5.95. Date: January 2024. For full information see https://evanaperiods.com/hcp/ultravana/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 or Apple App store.