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NORTEM

Information leaflet

                                                   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

 Tablet.
 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
 extreme distress.

 For pre-medication prior to minor surgery or other related procedures.

 4.2 Posology and method of administration

 Oral.

 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
 bed.

 Dosage

 Insomnia
 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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Date Printed 13/01/2012                               CRN 2085483                                         page number: 1
                                                      Irish Medicines Board




 4.3 Contraindications

 Myasthenia Gravis.

 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

 Tolerance
 Some loss in efficacy to the hypnotic effects of short-acting benzodiazepines may develop after reported use for a few
 weeks.

 Dependence
 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
 alcohol abuse.

 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.

 Amnesia
 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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Date Printed 13/01/2012                               CRN 2085483                                         page number: 2
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