Nitrazepam

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 trimesters, unless there are compelling reasons.

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 pregnant.

Administration of benzodiazepines in the last trimester of pregnancy or during labour has been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking, hypothermia and moderate respiratory depression in the neonate.

Infants born to mothers who took benzodiazepines chronically in the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Since benzodiazepines are found in the breast milk, the use of nitrazepam in mothers who are breast-feeding should be avoided.

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 may adversely affect the ability to drive or use machinery. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Patients should further be advised that alcohol may intensify any impairment, and should therefore be avoided during treatment.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive.
• Do not drive until you know how the medicine affects you.
• It is an offence to drive while under the influence of this medicine.
• However, you would not be committing an offence (called ‘statutory defence’) if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
  • It was not affecting your ability to drive safely.

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 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.

The following undesirable effects have been divided into the following categories: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 to<1/100 Rare: ≥1/10,000 to <1/1,000, Very rare: <1/10,000, not known (cannot be estimated from the available data).

Blood and the lymphatic system disorders

Rare: Blood dyscrasias

Immune system disorders

Very rare: Hypersensitivity reactions (anaphylaxia and angiooedema)

Psychiatric disorders

Uncommon: Sleeping disorders, including insomnia.

Rare: Psychiatric and paradoxical reactions⁴, Muscular cramps, libido fluctuations

Not known: Dependence and abuse of benzo-diazepines, amnesia², depression³, withdrawal symptoms¹

Nervous system disorders

Common: Dizziness, ataxia, drowsiness

Uncommon: Tremor

Not known: Dysarthria

Eye disorders

Rare: Visual disturbances

Ear and labyrinth disorders

Rare: Vertigo

Vascular disorders

Rare: Hypotension

Respiratory, thoracic and mediastinal disorders

Rare: Respiratory depression

Gastrointestinal disorders

Rare: Nausea, gastrointestinal upsets

Hepato-biliary disorders

Rare: Jaundice

Skin and subcutaneous tissue disorders

Rare: Rash and other allergic skin reactionsStevens-Johnson syndrome

Renal and urinary disorders

Rare: Urinary retention

Musculoskeletal, connective tissue and bone disorders

Uncommon: Muscular weakness

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 during the use of therapeutic doses since the risk is increased at higher doses. Amnesia may be combined with behavioural problems.
³ Pre-existing depression may be revealed during the use of benzodiazepins.
⁴ Reactions such as restlessness, excitation, irritability, aggressiveness, delusions, rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other behavioural side effects may occur during benzodiazepine treatment. They can be very serious with this product. These side effects are observed more frequently in children and elderly patients.

Abuse of benzodiazepines has been reported.