Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DIAZEPAM
Roche Products Ltd
5 Milligram
Tablets
1977-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valium 5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg Diazepam. Excipients: Also contians 100mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, pale yellow tablet with “ROCHE” imprinted on one face and a single break-bar on the other. 5 The tablet can be divided into equal halves to facilitate dosing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Anxiety. 2. Insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 3. In the control of muscle spasm including that associated with cerebral spasticity. In the management of epilepsy. 4. As pre-operative medication in minor surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _STANDARD DOSAGE_ For optimal effect, the dosage should be carefully individualised. Treatment should begin at the lowest effective dose appropriate to the particular condition. _DURATION OF TREATMENT_ The duration of treatment should be as short as possible (see _section 4.4_) depending on the indication, but should not exceed 4 weeks for insomnia and eight to twelve weeks in cases of anxiety, 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 minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. There are indications, Preberite celoten dokument