STILNOCT Coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Stilnoct 5 mg film-coated Tablets.
Qualitative and quantitative composition
Round white film-coated tablets containing 5 mg zolpidem tartrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Coated tablets for oral administration.
Therapeutic indications
Stilnoct is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.
Posology and method of administration
Posology The treatment should be taken in a single intake and not be re-administered during the same night. The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The lowest ...
Contraindications
Zolpidem tartrate is contraindicated in patients with a hypersensitivity to zolpidem tartrate or any of the excipients listed in section 6.1. Obstructive sleep apnoea. Myasthenia gravis. Severe hepatic ...
Special warnings and precautions for use
The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. The failure of insomnia to remit after a 7–14 day course of treatment may ...
Interaction with other medicinal products and other forms of interaction
Not recommended Concomitant intake with alcohol The sedative effect may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines. Take into account ...
Pregnancy and lactation
Pregnancy The use of zolpidem is not recommended during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Zolpidem crosses the placenta. ...
Effects on ability to drive and use machines
Stilnoct has major influence on the ability to drive and use machines. Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, ...
Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common ≥10%, Common ≥1 and <10%, Uncommon ≥0.1 and <1%, Rare ≥0.01 and <0.1%, Very rare <0.01%, Not known: cannot be estimated based ...
Overdose
Signs and symptoms In cases of overdose involving zolpidem tartrate alone or with other CNS-depressant agents (including alcohol), impairment of consciousness ranging from somnolence to coma, and more ...
Pharmacodynamic properties
(GABA-A receptor modulator selective for omega-1 receptor subtype hypnotic agent). Zolpidem tartrate is an imidazopyridine which preferentially binds the omega-1 receptor subtype (also known as the benzodiazepine-1 ...
Pharmacokinetic properties
Zolpidem tartrate has both a rapid absorption and onset of hypnotic action. Bioavailability is 70% following oral administration and demonstrates linear kinetics in the therapeutic dose range. Peak plasma ...
Preclinical safety data
No data of therapeutic relevance.
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose Hypromellose Sodium starch glycollate Magnesium stearate Film coating: Hypromellose Titanium dioxide (E171) Polyethylene glycol 400
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Store in a dry place below 30°C.
Nature and contents of container
Cartons of 4, 14, 28 or 56 tablets in PVC/foil blister strips of 7 or 14 tablets.
Special precautions for disposal and other handling
Please consult the package insert before use. Do not use after the stated expiry date on the carton and blister. KEEP OUT OF THE REACH OF CHILDREN.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK
Marketing authorization number(s)
PL 04425/0618
Date of first authorization / renewal of the authorization
03 December 2009
Date of revision of the text
24/10/2019
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