Irish Medicines Board
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Nortem 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of temazepam
Excipients: Each tablet contains 140.0mg lactose, anhydrous.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to pale yellow, flat bevel edged tablets with a breakline on one side, 5K1 on reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
As a hypnotic for the short-term management of insomnia only when it is severe, disabling or subjecting the individual to
For pre-medication prior to minor surgery or other related procedures.
4.2 Posology and method of administration
The treatment period should be of the shortest duration possible. This may vary from a few days to two weeks with a
maximum (including tapering off) of four weeks. The dose reduction process should be tailored to the individual. In
certain cases extension beyond the maximum treatment period may be necessary; if this is the case it should not take place
without re-evaluation of the patient's status. The product should be taken on retiring or up to 30 minutes before going to
Adults: 10 - 20 mg. In exceptional circumstances, the dose may be increased to 30 - 40 mg.
Elderly: 10 mg. In exceptional circumstances, the dose may be increased to 20 mg.
Pre-medication: The usual dose is 20 - 40 mg 30 to 60 minutes before the procedure.
Children: Not recommended for use in children.
Treatment should be started with the lowest, recommended dose. The maximum dose should not be exceeded. Patients
suffering from renal or hepatic impairment should receive a reduced dose.
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Irish Medicines Board
Hypersensitivity to temazepam, benzodiazepines or to any of the excipients.
Severe respiratory insufficiency.
Sleep apnoea syndrome.
Severe hepatic insufficiency.
4.4 Special warnings and precautions for use
Some loss in efficacy to the hypnotic effects of short-acting benzodiazepines may develop after reported use for a few
Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products. The risk
of dependence increases with dose and duration of treatment; it is also greater in patients with a history of drug and
Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly. Therefore, the drug
should always be discontinued gradually.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe
cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the
extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound Insomnia and anxiety
A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, and
may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety, sleep
disturbances and restlessness. Since the risk of withdrawal/ rebound phenomena is greater after abrupt discontinuation of
treatment, it is recommended that the dosage is decreased gradually.
Duration of treatment
The duration of treatment should be as short as possible depending on the indication. Treatment should not exceed 4
weeks, including the tapering off period. 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 is aware of
the possibility of rebound phenomena, thereby minimising anxiety while the product is being discontinued.
There are indications that, in the case of benzodiazepines with a short elimination half-life, withdrawal phenomena can
become manifest within the dosage interval, especially when the dosage is high.
Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the
product and therefore to reduce the risk of this occurring, patients should ensure that they will be able to have an
uninterrupted sleep for 7 - 8 hours.
Psychiatric and ‘paradoxical’ reactions
Reactions like restlessness, agitation, irritability, aggressiveness, delusions, rages, hallucinations, psychoses, inappropriate
behaviour are known to occur when using benzodiazepines. Should this occur, use of the product should be
discontinued. These are more likely to occur in children and the elderly.
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