Loading…
NITRAZEPAM is a brand name for Nitrazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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 before deciding upon the use of benzodiazepines for symptomatic relief. Benzodiazepines are not recommended for…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
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 susceptible to the adverse effects of Nitrazepam tablets.
Doses should not exceed half those normally recommended. If organic brain changes are present, the dosage of Nitrazepam tablets should not exceed 5 mg in these patients. Other populations In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, the dosage may need to be reduced.
Paediatric population Nitrazepam tablets are contraindicated for use in children. Dosage should be adjusted on an individual basis. Treatment should, if possible, be on an intermittent basis. Treatment should be as short as possible and should be started with the lowest recommended dose.
The maximum dose should not be exceeded. Generally the duration of treatment varies from a few days to two weeks with a maximum of four weeks; including the tapering off process. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced.
Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status.
Long-term chronic use is not recommended. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena (see Undesirable Effects) thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.
Nitrazepam tablets therapy should not be stopped abruptly, but the dose tapered off. The product should be taken just before going to bed. In addition, for long acting benzodiazepines, it must be stated that the patient should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
System organ class Common (≥1/100 to <1/10) Uncommo n (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1000) Very rare (<1/10,000 ) Not known (cannot be estimated from the available data) Blood and lymphatic system disorders Blood dyscrasias Psychiatric disorders Change in libido Dependence and abuse of benzo- diazepines, amnesia (2), depression (3), withdrawal symptoms (1) Nervous system disorders Dizziness, ataxia, drowsiness, numbed emotions reduced alertness, confusion, fatigue, headache (4) Eye disorders Double vision Visual disturbances Ear and labyrinth disorders Vertigo Vascular disorders Hypotension Gastrointestina l disorders Gastrointestina l upsets Hepatobiliary disorders Jaundice Skin and subcutaneous tissue disorders Skin rashes Musculoskeleta l and connective tissue disorders Muscle weakness Renal and urinary disorders Urinary retention (1) Use (even at therapeutic doses) may lead to the development of physical and psychological dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena, a transient syndrome whereby the symptoms that led to treatment with benzodiazepine or benzodiazepine-like agent recur in an enhanced form.
It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually (2) Anterograde amnesia may occur at therapeutic dosages, the risk increasing at higher dosages.
Amnesiac effects may be associated with inappropriate behaviour. (3) Pre-existing depression may be unmasked during benzodiazepine use. (4) These phenomena are dose related and occur predominantly at the start of therapy, they usually disappear with repeated administration.
The elderly are particularly sensitive to the effects of centrally-depressant drugs. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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 insufficiency. Nitrazepam tablets should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients.
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. Benzodiazepines are not recommended for the primary treatment of psychotic illness. If the patient is awoken during the period of maximum drug activity, recall may be impaired.
In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. Use of benzodiazepines may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases when high doses are used, especially when given over long periods.
This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders. Regular monitoring in such patients is essential; routine repeat prescriptions should be avoided and treatment should be withdrawn gradually.
Symptoms such as depression, headaches, muscle weakness, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia, irritability, sweating and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.
When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact and hallucinations or epileptic seizures.
1 Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypertension have been reported on rare occasions in susceptible patients. Use of this drug is also contraindicated in patients with acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis; myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency; use in children.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nitrazepam in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Method of administration:
Nitrazepam tablets are for oral administration.
uk/yellowcardor search for MHRA Yellow Card in the Google Play or Apple App Store.
In rare instances, withdrawal following excessive dosages may produce confusional states and psychotic manifestations and convulsions. Abuse of the benzodiazepines has been reported. Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.
Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioural effects include paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and the uncovering of depression with suicidal tendencies.
Extreme caution should therefore be used in prescribing benzodiazepines to patients with personality disorders. If any of these reactions occur, use of the drug should be discontinued. These reactions may be quite severe and are more likely to occur in the elderly.
Benzodiazepines may induce anterograde amnesia. The condition usually occurs 1 to 2 hours after ingesting the product and may last up to several hours. Therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 to 8 hours.
Due to myorelaxant effect there is a risk of falls and consequently of hip fractures particularly for elderly patients when they get up at night.
Risk from concomitant use of opioids:
Concomitant use of Nitrazepam tablets and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Nitrazepam tablets with opioids should be reserved for patients for whom alternative treatment options are not possible.
2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Nitrazepam tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.