CIRCADIN Prolonged-release tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Circadin 2 mg prolonged-release tablets.
Qualitative and quantitative composition
Each prolonged-release tablet contains 2 mg melatonin. Excipient with known effect: each prolonged-release tablet contains 80 mg lactose monohydrate. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Prolonged-release tablet. White to off-white, round, biconvex tablets.
Therapeutic indications
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.
Posology and method of administration
Posology 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. Paediatric population The safety and efficacy of Circadin ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Circadin may cause drowsiness. Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. No clinical data exist concerning the use ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Pharmacokinetic interactions Melatonin has been observed to induce CYP3A in vitro at supra-therapeutic concentrations. The clinical relevance of ...
Pregnancy and lactation
Pregnancy For melatonin, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Circadin has moderate influence on the ability to drive and use machines. Circadin may cause drowsiness, therefore the product should be used with caution if the effects of drowsiness are likely to be ...
Undesirable effects
Summary of the safety profile In clinical trials (in which a total of 1,931 patients were taking Circadin and 1,642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists ATC code: N05CH01 Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. ...
Pharmacokinetic properties
Absorption The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly. The kinetics of melatonin are linear over the range of 2-8 mg. Bioavailability ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and ...
List of excipients
Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com
Marketing authorization number(s)
EU/1/07/392/001 EU/1/07/392/002 EU/1/07/392/003 EU/1/07/392/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 June 2007 Date of latest renewal: 20 April 2012
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