Flurazepam

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 and hypothermia and moderate respiratory depression in the neonate.

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

There is insufficient information on the excretion of flurazepam and/or metabolites into human milk. However, in common with other benzodiazepines, its passage into breast milk might be expected. The use of flurazepam in mothers who are breast-feeding is not recommended.

Patients should be advised that, like all medicaments of this type, Dalmane might modify patients' performance at skilled tasks (driving, operating machinery, etc) to a varying degree depending upon dosage, administration, and sleep pattern and individual susceptibility. 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 somnolence during the day, emotional poverty, reduced alertness, confusional state, fatigue, headache, dizziness, muscle weakness, ataxia and diplopia. These phenomena are dose-related and are likely to be uncommon with the recommended dosage; they occur predominantly at the start of therapy and usually disappear with repeated administration or after dose adjustment. The elderly are particularly sensitive to the effects of centrally depressant drugs.

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using 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), Frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders

Frequency not known: blood disorders (e.g. thrombocytopenia, leukopenia, agranulocytosis, pancytopenia).

Immune system disorders

Rare: Hypersensitivity (e.g. angioedema)

Psychiatric disorders

Uncommon: Emotional poverty,

Frequency not known: Confusional state, hallucinations, dependence, withdrawal syndrome, rebound effect, depression, paradoxical drug reactions (e.g. anxiety, sleep disorders, insomnia, nightmares, restlessness, agitation, irritability, aggression, delusion, psychotic disorder, abnormal behaviour, emotional disturbances, suicide attempt, suicidal ideation).

Nervous system disorders

Common: Somnolence, reduced alertness, ataxia, dizziness, headache, dysgeusia

Frequency not known: Extrapyrimidal disorder, anterograde amnesia

Eye disorders

Rare: Visual impairment (e.g. diplopia)

Ear and labyrinth disorders

Rare: Vertigo

Vascular disorders

Rare: Hypotension

Respiratory, thoracic and mediastinal disorders

Rare: Respiratory depression (particularly at night)

Gastrointestinal disorders

Rare: Abdominal discomfort, nausea

Hepatobiliary disorders

Very rare: Jaundice, hepatic enzyme increase

Skin and subcutaneous tissue disorders

Rare: Skin reactions (e.g. rash)

Musculoskeletal and connective tissue disorders

Common: Muscle weakness. Due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly.

Renal and urinary disorders

Rare: Urinary retention

Reproductive system and breast disorders

Rare: Libido disorder

General disorders and administration site conditions

Uncommon: Fatigue