DIAZEPAM Uncoated tablets (2018)
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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effective dose should be employed; dosage regimes should not exceed beyond 4 weeks and treatment should be gradually withdrawn.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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