Circadin® /Vigisom® (melatonin) Prolonged Release tablets 2mg. INDICATION: Monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 or over. CONTRAINDICATIONS: Known hypersensitivity to any ingredient in the product. PRECAUTIONS: renal insufficiency, use in the elderly. Not recommended in patients with autoimmune diseases, hepatic impairment, galactose intolerance, LAPP lactase deficiency, glucose-galactose malabsorption, children <18 years, pregnancy (Category B3) and lactation. Patients should avoid engaging in hazardous activities (eg driving/operating machinery) after taking Circadin/Vigisom. COMMON SIDE EFFECTS: Headache, nasopharyngitis, back pain and arthralgia. DOSAGE AND ADMINISTRATION: One tablet daily after food 1-2 hours before bedtime. Treat for up to thirteen weeks. Circadin/Vigisom is an unfunded medicine. Prescription Medicine except when supplied by a Registered Pharmacist. Normal Doctors fees and Pharmacy Charges apply. Special Authority funding criteria may apply. Circadin/Vigisom is listed on the HML. Please review Data Sheet before prescribing/supplying, available at www.medsafe.govt.nz. Circadin®/Vigisom® is a registered trademark of Neurim Pharmaceuticals Limited used under licence by Aspen New Zealand C/O Pharmacy Retailing (NZ) Ltd, Auckland. TAPS BG1594-SEP21. INSIGHT 11045.