SPC, UK: Frisium Tablets 10 mg (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης :
SANOFI
Διεύθυνση :
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Name of the medicinal product
FrisiumTM.
Qualitative and quantitative composition
Clobazam 10 mg.
Pharmaceutical form
Tablet.
Therapeutic indications
Frisium is a 1,5-benzodiazepine indicated for the short-term relief (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association ...
Posology and method of administration
Treatment of anxiety The usual anxiolytic dose for adults is 20-30 mg daily in divided doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of adult in-patients ...
Contraindications
Frisium must not be used: In patients with hypersensitivity to benzodiazepines or any of the excipients of Frisium. In patients with any history of drug or alcohol dependence (increased risk of development ...
Special warnings and precautions for use
Amnesia may occur with benzodiazepines. In case of loss or bereavement psychological adjustment may be inhibited by benzodiazepines. Special caution is necessary if clobazam is used in patients with myasthenia ...
Interaction with other medicinal products and other forms of interaction
Especially when clobazam is administered at higher doses, an enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, ...
Pregnancy and lactation
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the product if she intends to become pregnant or suspects that ...
Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. If insufficient sleep duration occurs, the likelihood of impaired ...
Undesirable effects
Clobazam may cause sedation, leading to fatigue and sleepiness, especially at the beginning of treatment and when higher doses are used. Side-effects such as drowsiness, dizziness or dryness of the mouth, ...
Overdose
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, ...
Pharmacodynamic properties
Clobazam is a 1,5-benzodiazepine. In single doses up to 20mg or in divided doses up to 30mg, clobazam does not affect psychomotor function, skilled performance, memory or higher mental functions.
Pharmacokinetic properties
Absorption of clobazam is virtually complete after oral administration. Approximately 85% is protein bound in man. It is metabolised by demethylation and hydroxylation. It is excreted unchanged and as ...
Preclinical safety data
None applicable.
List of excipients
Lactose monohydrate Maize starch Colloidal silicon dioxide Talc Magnesium stearate
Incompatibilities
None.
Shelf life
Five years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Blister pack (Alufoil/PVC) containing 30 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS
Marketing authorization number(s)
PL 04425/0214
Date of first authorization / renewal of the authorization
15 January 2002
Date of revision of the text
April 2011