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Prescribing information

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Circadin® (melatonin) Tablets

Prescribing Information: Please refer to the Summary of Product Characteristics before prescribing, particularly in relation to side effects, precautions and contra-indications.

Presentation: Circadin 2mg prolonged-release tablets containing 2mg melatonin.

Indication: Monotherapy for the short-term treatment of primary insomnia characterized by poor quality sleep in patients aged 55 or over.

Dosage and administration: 2mg orally once-daily, 1-2 hours before bedtime and after food. This dosage may be continued for up to thirteen weeks.

Children and adolescents (<18 years): Safety and efficacy not yet established.

Contraindications: Hypersensitivity to the active substance or to any excipients.

Special warnings and precautions for use: Not recommended for use in children and adolescents under the age of 18. Use caution when administered to patients with renal insufficiency. Not recommended for use in patients with hepatic impairment. May cause drowsiness, therefore use with caution if the effects of drowsiness are likely to be associated with a risk to safety. Not recommended in patients with autoimmune diseases. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Fertility, pregnancy and lactation: Use in pregnancy and in women intending to become pregnant is not recommended and breast-feeding not recommended in women receiving melatonin.

Interactions: Fluvoxamine should be avoided. Caution should be used in patients on 5- or 8-methoxypsoralen (5- and 8-MOP), cimetidine and oestrogens. Cigarette smoking may decrease melatonin levels. CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure. CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced melatonin exposure. Alcohol should not be taken with Circadin. Sedative properties of benzodiazepines and non-benzodiazepine hypnotics may be enhanced.

Undesirable effects: In clinical trials the rate of patients with adverse reactions per 100 patient weeks was higher for placebo than Circadin (5.743 placebo vs. 3.013 Circadin). The most common (?1/100 to <1/10) adverse reactions were headache, nasopharyngitis, back pain, and arthralgia. Other events have also been reported. Frequency ?1/1,000 to <1/100; hypertension, chest pain, abnormal liver function tests. Frequency ?1/10,000 to <1/1,000; leukopenia, thrombocytopenia, angina pectoris, palpitations, hypocalcaemia, hyponatraemia, syncope, prostatitis, haematuria, abnormal blood electrolytes, increased hepatic enzymes and priapism. Prescribers should consult the full Summary of Product Characteristics in relation to other side effects.

Legal category: POM. Packs and Prices: Circadin 2mg, 21 tablets, £10.77.

Marketing Authorisation number: EU/1/07/392/001

Marketing Authorisation holder: RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB.

Further information available from: Lundbeck Limited, Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG.

Date of last revision of PI: Jan 2011.

Adverse event should be reported. Reporting forms and information can be found at Adverse events should also be reported to Lundbeck Limited. Tel: Medical Information, on: 01908 638972.

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Prescribing information