NITRAZEPAM Tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Nitrazepam 5mg tablets.
Qualitative and quantitative composition
Each tablet contains 5mg of nitrazepam. Excipients with known effect: Each tablet contains 504.17mg lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, circular, flat bevelled-edge uncoated tablets impressed C and the identifying letters NA on either side of a central division line on one face.
Therapeutic indications
Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable. An underlying cause for insomnia should be sought ...
Posology and method of administration
Adults 5 mg before retiring. This dose may, if necessary, be increased to 10 mg. Elderly Elderly or debilitated patients: the elderly or patients with impaired renal and/or hepatic function will be particularly ...
Contraindications
Patients with hypersensitivity to benzodiazepines, nitrazepam or to any of the excipients listed in section 6.1. Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypertension ...
Special warnings and precautions for use
In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced. Benzodiazepines are contraindicated in patients with severe hepatic ...
Interaction with other medicinal products and other forms of interaction
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs such as neuroleptics, tranquillisers, antidepressants, hypnotics, analgesics and anaesthetics, ...
Pregnancy and lactation
Pregnancy There is no evidence as to drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Do not use during pregnancy, especially during the first and last ...
Effects on ability to drive and use machines
Patients should be advised that, like all medicaments of this type, Nitrazepam Tablets may modify patients' performance at skilled tasks. Sedation, amnesia, impaired concentration and impaired muscle function ...
Undesirable effects
Common adverse effects include drowsiness during the day, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia and double vision. These phenomena are dose ...
Overdose
When taken alone in overdosage nitrazepam presents few problems in management and should not present a threat to life unless combined with other CNS depressants (including alcohol). In the management of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Hypnotics and Sedatives, Benzodiazepine derivatives ATC code: N05CD02 Nitrazepam is a benzodiazepine compound with sedative properties. It acts in 30 to 60 minutes to produce ...
Pharmacokinetic properties
Absorption The drug is well absorbed form the GI tract with peak blood levels being achieved within 2 hours of administration. Two hours after administration, the concentration of nitrazepam in the cerebrospinal ...
Preclinical safety data
None stated.
List of excipients
Lactose Magnesium stearate Maize starch Stearic acid
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad and snap-on polyethylene lids; in case any supply difficulties ...
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
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/0086
Date of first authorization / renewal of the authorization
September 1977 September 1997
Date of revision of the text
07/02/2020
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