Temazepam Tablets 20mg

Each tablet contains 20mg Temazepam PhEur

Excipient with known effect

Each 20mg tablet contains 282.20mg lactose PhEur.

For the full list of excipients, see section 6.1.

White to pale yellow, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “ZN” on either side of a central division line on one face and blank on the reverse.

Indicated for:

1) The short-term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme stress, especially for those patients in whom the persistence of a hypnotic effect would be undesirable.

2) The premedication before minor surgical and investigative procedures particularly when hospital admission is not essential.

Posology

Treatment to be given

• under close medical supervision

• at the lowest effective dose

• for the shortest possible duration (not exceeding 4 weeks).

Treatment should be tapered off gradually (see section 4.4). Extension of use should not take place without further clinical evaluation.

Chronic use not recommended (little is known of the long-term safety and efficacy: potential for dependence- see section 4.4).

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.

Patients who have received benzodiazepines for a long time may require an extended withdrawal period. | TEMAZEPAM 20MG PRICE

The recommended doses are as follows:

Insomnia

Adults

10-20mg at bedtime. A dose of 20mg will be found satisfactory for most patients. In extreme cases this may be increased to 30-40mg in patients who do not respond to the lower dose.

Elderly or debilitated or those with cerebrovascular disease or hepatic or renal impairment

5mg at bedtime. This may be increased to 10mg or to 20mg in extreme cases.

Premedication

Adults

The normal dose is 20-40mg, half an hour to one hour before the procedure.

It is recommended that patients should be accompanied home after medication with Temazepam prior to surgical or investigative procedures.

Elderly and patients suffering from cerebrovascular disease

Dosage should be reduced to possibly half the normal adult dose (10-20 mg, one hour before the procedure). In general hypnotics should be avoided in the elderly as they are at risk of becoming ataxic and confused. This may lead to falls and injury.

Paediatric population

Temazepam tablets are not recommended for use in children. The safety and efficacy in children less than 18 years old has not been established.

Method of Administration

For oral administration.

• Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1.

• Acute pulmonary insufficiency; severe respiratory depression, sleep apnoea (risk of further respiratory depression) or CNS depression

• Acute narrow angle glaucoma (due to anticholinergic effects of temazepam)

• Phobic or obsessional states; chronic psychosis (paradoxical reactions may occur. Inadequate evidence of safety and efficacy)

• Mild anxiety states

• Severe hepatic insufficiency (may precipitate encephalopathy. Elimination half-life of temazepam may be prolonged)

• Neuromuscular respiratory weakness including myasthenia gravis (condition may be exacerbated)

• Breast-feeding

• Children aged 18 years or under

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

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.

Severe anaphylactic and anaphylactoid reactions, including rare fatal cases of anaphylaxis, have been reported in patients receiving temazepam. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam.

When temazepam is used for pre-medication, patients should be accompanied home afterwards.

Duration of Treatment

The duration of treatment should be as short as possible (see section 4.2) depending on the indication, but should not exceed 4 weeks for insomnia, including tapering off process. Extension beyond these periods should not take place without re-evaluation of the situation.

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 progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while temazepam is being discontinued.

There are indications that, in the case of benzodiazepines with a short duration of action such as temazepam, withdrawal phenomena can become manifest between doses, especially when the dosage is high.

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.

Tolerance

Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardiorespiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.

Loss of efficacy to the hypnotic effects may develop after repeated use for a few weeks.

Care should be taken in patients with chronic renal or hepatic disease (elimination half-life of temazepam may be prolonged). Sedatives given to patients with cirrhosis may precipitate encephalopathy.

Alcohol should be avoided during treatment with temazepam (additive CNS depression).

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.

Withdrawal effects

If physical dependence has developed, abrupt termination of treatment results in withdrawal symptoms. These include headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbance, diarrhoea and mood changes. In severe cases the following may occur: a feeling of unreality or of being separated from the body, depersonalisation, hyperacusis, 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. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. As this is greater after abrupt discontinuation, the dose should be decreased gradually (see section 4.2).

Amnesia

Anterograde amnesia may occur, most often several hours after ingestion. To reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see also section 4.8). Insufficient sleep may adversely affect the ability to drive/operate machinery etc. (see section 4.7).

Bereavement/ loss

Psychological adjustment may be inhibited by benzodiazepines.

Psychiatric and paradoxical reactions

Reactions such as restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusions, rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects can occur. These reactions are more likely in children and the elderly, and extreme caution should be used in prescribing benzodiazepines to patients with personality disorders. Should they occur, treatment should be discontinued.

Complex sleep behaviour-related events such as ‘sleep driving‘ (i.e. driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients who are not fully awake after taking a sedative-hypnotic, including temazepam. These events can occur with sedative-hypnotics, including temazepam, alone at therapeutic doses. The use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report such events.