LOPRAZOLAM Tablets (2020)
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Περιεχόμενα
Name of the medicinal product
Loprazolam 1mg Tablets. Dormonoct.
Qualitative and quantitative composition
Each tablet contains loprazolam mesylate equivalent to 1mg loprazolam. For the full list of excipients, see section 6.1.
Pharmaceutical form
Light yellow, biconvex, round tablets, 7mm in diameter marked with an A and 026 separated by a score line on one side. The other side is blank.
Therapeutic indications
Loprazolam is indicated for the short-term treatment of insomnia including difficulty in falling asleep and/or frequent nocturnal awakenings. Benzodiazepines should be used to treat insomnia only when ...
Posology and method of administration
Adults The recommended dose is 1mg at bedtime. This may be increased to 1.5mg or 2mg if necessary. Elderly Dosage in the elderly should be limited to 1mg at bedtime. Frail, debilitated or aged patients ...
Contraindications
Sensitivity to benzodiazepines, acute pulmonary insufficiency, severe respiratory insufficiency, myasthenia gravis, phobic or obsessional states and sleep apnoea syndrome. Monotherapy in depression or ...
Special warnings and precautions for use
Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients who are depressed and who exhibit aggressive behaviour towards self and others. Extreme caution should therefore ...
Interaction with other medicinal products and other forms of interaction
Loprazolam may be potentiated by alcohol or other drugs acting on the CNS or with Cisapride. Additive synergy has been observed with neuromuscular depressants (curare-like drugs and muscle relaxants). ...
Pregnancy and lactation
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is ...
Effects on ability to drive and use machines
Attention should be drawn to the risk of drowsiness, sedation, amnesia, impaired concentration and muscular weakness, especially in drivers of vehicles and operators of machines, when taking the product ...
Undesirable effects
In general, Loprazolam is very well tolerated. However, the common side effects of benzodiazepines, including headaches, nausea, drowsiness, hypotonia, blurring of vision, dizziness and ataxia may occur ...
Overdose
As with other benzodiazepines, overdosage does not usually present a threat to life. Treatment is symptomatic and gastric lavage may be of use if performed shortly after ingestion. Use of a specific antidote ...
Pharmacodynamic properties
Benzodiazepines have a widespread action as a result of their enhancing the release of gamma-aminobutyric acid (GABA). They are effective as anti-convulsants, muscle relaxants, anti-anxiety agents, pre-medications ...
Pharmacokinetic properties
The pharmacokinetics of oral Loprazolam given in a single dose or in repeated doses on 7 consecutive nights were studied in a balanced cross-over trial in six healthy male subjects aged 22-37 years. The ...
Preclinical safety data
No additional data of relevance to the prescriber.
List of excipients
Povidone Lactose Colloidal silicon dioxide Maize starch Microcrystalline cellulose Magnesium stearate
Incompatibilities
None.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store below 25°C in a dry place. Protect from light.
Nature and contents of container
UPVC/aluminium foil blisters, packaged in cartons of 10, 28 or 30 tablets.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Marketing authorization number(s)
PL 17780/0306
Date of first authorization / renewal of the authorization
17 March 2009
Date of revision of the text
24 June 2020
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