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SPC, UK: Frisium Tablets 10 mg (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
SANOFI
Διεύθυνση :
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Δωρεάν εγγραφή

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