Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diazepam
Alliance Healthcare (Distribution) Ltd
N05BA01
Diazepam
10mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
REGULATORY AUTHORITY APPROVAL CONFIRMATION Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Waymade Plc have license approval to distribute this component for sale in the relevent market. Accept Artwork ................................................................ Reject Artwork ................................................................. Signature .......................................................................... Name ................................................................................ Date .................................................................................. PAGE 1 OF 2 Received Date: 09/07/2019 CDL JOB No. : 67635 Required By : 12/7/2019 PRODUCT NAME: Diazepam Tabs 2, 5, 10mg 28s PIP CODE: GB 674-7299-APIL COMPONENT: Leaflet SIZE: 210x550 mm MARKET: Grat Britain PRODUCT SITE: TBC SCALE: 100% COLOURS: Black DATE: 26/07/2016 FONT SIZE: 9 pt VERSION NO: 1 AMENDED BY: SP PROJECT: Sovereign Medical GB 674-7299-APIL PACKAGE LEAFLET: INFORMATION FOR THE USER DIAZEPAM 2 mg, 5 mg and 10 mg Tablets Diazepam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Diazepam Tablets are and what they are used for 2. What you need to know before you take Diazepam Tablets 3. How to take Diazepam Tablets 4. Possible side effects 5. How to store Diazepam Tablets 6. Contents of the pack and other information 1. WHAT DIAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Diazepam 2 mg, Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diazepam 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg diazepam. Excipient(s) with known effect Each 10 mg tablet contains 130.86 mg of lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Flat, blue tablets with bevelled edges, 8 mm diameter. One face embossed with “DZ” and “10” separated by a breakline. The reverse face is plain. 4 CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Adults Benzodiazepines, including diazepam, are indicated for the short-term relief (up to 4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. Cerebral palsy. Muscle spasm. As an adjunct to certain types of epilepsy (eg myoclonus). Symptomatic treatment of acute alcohol withdrawal. As oral premedication for the nervous dental patient. For premedication before surgery. Children Control of tension and irritability in cerebral spasticity in selected cases. As an adjunct to the control of muscle spasm in tetanus. Oral premedication (see section 4.4). _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Recommended dose and dosage schedule: As directed by a physician. POSOLOGY As an anxiolytic, the lowest dose which can control symptoms should be used. It should not be continued beyond 4 weeks. Long-term chronic use is not recommended. Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced. ADULTS Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: 5 – 30 mg daily in divided doses. Alcohol withdrawal: 5-20 mg, repeated if necessary in 2-4 hours. Insomnia associated with anxiety: 5-15 mg before bedtime. Cerebral palsy: 5-60mg daily in divided doses. Upper motor neuronic spasticity: 5-60mg daily in divided d Soma hati kamili