TEMAZEPAM

Route of administration: oral Treatment to be given • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks). 4). Extension of use should not take place without further clinical evaluation.

4). When treatment is started the patient should be informed that • treatment will be of limited duration • the dosage will be progressively decreased • there is the possibility of rebound phenomena. Treatment should be initiated with the lowest recommended dose.

Never exceed the maximum dose. g. arteriosclerosis) or impaired liver function. Insomnia These tablets should be taken on retiring or up to 30 minutes before going to bed. Adults: 10-20 mg daily. In exceptional circumstances, the dose may be increased to 30-40 mg daily.

Children:

The safety and efficacy of Temazepam in children less than 18 years of age has not been established and as such is not recommended for use. The Elderly: 10 mg daily. In exceptional circumstances, the dose may be increased to 20 mg.

Pre-medication Adults:

The usual dose is 20-40 mg. This should be taken 30 to 60 minutes before surgery.

Children:

The safety and efficacy of Temazepam in children less than 18 years of age has not been established and as such is not recommended for use.

The Elderly:

Lower doses may be required by elderly patients, up to half the normal adult dose may be adequate. Patients should be accompanied home when Temazepam has been used as a pre- medicant prior to surgery or other procedures on a day attendance basis.

The following phenomena occur predominantly at the start of therapy and usually disappear thereafter:- Drowsiness during the day, drowsiness and light-headedness the next day, numbed emotions, reduced alertness, confusion and ataxia (especially in the elderly), fatigue, dizziness, muscle weakness, and double vision.

More rarely, headache, vertigo, hypotension, salivation changes, visual disturbances, dysarthria, tremor, incontinence, urinary retention, blood disorders, jaundice, vivid dreams/nightmares, restless sleep, palpitations, change in libido, skin reactions, sedation, impaired muscular function, dry mouth and gastrointestinal disturbances may occur.

Pre-existing depression may be unmasked during benzodizapine use. Blood dyscrasias and increased liver enzymes have also been reported to occur occasionally. If any of these effects do occur, treatment should be discontinued. Rarely reported adverse reactions include hypersensitivity reactions.

Psychiatric and 'paradoxical' effects including paradoxical aggressiveness, restlessness, agitation, irritability, delusion, rages, nightmares, hallucinations, psychoses, excitement, confusion, and other changes in behaviour are known to occur when using benzodiazepines.

Should this occur, use of the product should be discontinued. The reactions are more likely to occur in the elderly. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. 4). 4). Psychological dependence may occur.

Abuse has been reported in polydrug abusers. 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.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The cause for insomnia should be determined prior to the use of temazepam, and it should not be used for first line treatment of psychotic illness. When temazepam is used for pre-medication, patients should be accompanied home afterwards.

2 for duration of therapy). Dependence The risk of dependence (physical or psychological) increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse, or in patients with a marked personality disorder.

Therefore • regular monitoring of such patients is essential • routine repeat prescriptions should be avoided • treatment should be withdrawn gradually. 2) If physical dependence has developed, abrupt termination of treatment results in withdrawal symptoms.

These include headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbance, diarrhoea and mood change. In severe cases the following may occur, a feeling of unreality or of being separated from the body, depersonalisation, confusional states, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, psychotic manifestations including hallucinations or epileptic seizures.

Withdrawal symptoms will be worse in patients who have been dependent on alcohol or other narcotic drugs in the past, but can occur following abrupt cessation of treatment in patients receiving normal therapeutic doses for a short period of time.

Rebound symptoms Symptoms including insomnia and anxiety may occur on withdrawal of treatment. 2). Amnesia Anterograde amnesia may also occur, most often several hours after ingestion. 8). 7). Bereavement/loss Psychological adjustment may be inhibited by benzodiazepines.

2 – reduced dosage elderly patients). Psychiatric and 'paradoxical reactions' Reactions such as restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusions, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects can occur.

6). Temazepam should not be used alone in depression or anxiety with depression (may precipitate suicide).