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SPC, UK: DIAZEPAM Uncoated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

DIAZEPAM TABLETS BP 10mg.

Qualitative and quantitative composition

Each tablet contains 10mg Diazepam Ph.Eur. Excipient with known effect: Each tablet contains 147.00mg lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Blue uncoated tablets.

Therapeutic indications

Adults The short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term ...

Posology and method of administration

Posology As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 4 weeks and treatment should be gradually withdrawn. Patients who have received benzodiazepines ...

Contraindications

Diazepam is contra-indicated for patients with: Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1. Phobic or obsessional states; chronic psychosis, ...

Special warnings and precautions for use

The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of diazepam possibly including severe sedation, ...

Interaction with other medicinal products and other forms of interaction

Not recommended Alcohol Diazepam should not be used together with alcohol (CNS inhibition enhanced sedative effects: impaired ability to drive/ operate machinery). Sodium oxybate Avoid concomitant use ...

Fertility, pregnancy and lactation

The safety of diazepam in human pregnancy has not been established. It should not be used in the first and third trimesters. There may be a small increase in the risk of congenital malformation, particularly ...

Effects on ability to drive and use machines

Sedation, amnesia and impaired muscular function may adversely effect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see also ...

Undesirable effects

Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision predominantly occur at the start of therapy but usually disappear with ...

Overdose

Features The symptoms of diazepam overdose are mainly an intensification of the therapeutic effects (ataxia, drowsiness, dysarthria, sedation, muscle weakness, profound sleep, hypotension, bradycardia, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Benzodiazepine derivatives ATC code: N05BA01 Diazepam is a benzodiazepine tranquilliser with anticonvulsant, sedative, muscle relaxant and amnesic properties. Benzodiazepines, ...

Pharmacokinetic properties

Absorption Diazepam is readily and completely absorbed from the GI tract. Peak plasma concentrations occurring within about 30-90 minutes of oral administration, a steady plasma concentration is reached ...

Preclinical safety data

Not applicable.

List of excipients

Also contains: Lactose Magnesium stearate Maize starch Stearic acid E132

Incompatibilities

None known.

Shelf life

Shelf-life: Three years from the date of manufacture. Shelf-life after dilution/reconstitution: Not applicable. Shelf-life after first opening: Not applicable.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and press fit polyethylene lids; in case any supply difficulties should arise the alternative ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS

Marketing authorization number(s)

PL 00142/0089

Date of first authorization / renewal of the authorization

Date of first authorization: 15 July 1977 Date of latest renewal: 06 September 2004

Date of revision of the text

14/11/2018

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