Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com
Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and after food. This dosage may be continued for up to thirteen weeks.
The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established. No data are available.
The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.
Caution should be used when melatonin is administered to such patients.
There is no experience of the use of Circadin in patients with liver impairment. Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment. Therefore, Circadin is not recommended for use in patients with hepatic impairment.
Oral use. Tablets should be swallowed whole to maintain prolonged release properties. Crushing or chewing should not be used to facilitate swallowing.
Several cases of overdose have been reported post-marketing. Somnolence was the most reported adverse event. Most were mild to moderate in severity. Circadin has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported.
Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
If overdose occurs, drowsiness is to be expected. Clearance of the active substance is expected within 12 hours after ingestion. No special treatment is required.
Shelf life: 3 years.
Do not store above 25°C. Store in the original package in order to protect from light.
The tablets are packed in PVC/PVDC opaque blister strips with aluminium foil backing. The pack consists of one blister strip containing 7, 20 or 21 tablets, or two blister strips containing 15 tablets each (30 tablets). The blisters are then packed in cardboard boxes.
Not all pack sizes may be marketed.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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