Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diazepam
Actavis UK Ltd
N05BA01
Diazepam
400microgram/1ml
Oral solution
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. DIAZEPAM 2MG/5ML ORAL SOLUTION SUGAR FREE PIL - UK Black BBBA0066 S.Anson 04.10.16 25/01/17 C.Grant 296 x 170 8pts Martindale Pharma 04.10.16 10.10.16 08 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 effects not listed in this leaflet. See section 4. • The full name of this medicine is Diazepam 2mg/5ml Oral Solution Sugar Free but within this leaflet it will be referred to as Diazepam Oral Solution. WHAT IS IN THIS LEAFLET 1. WHAT DIAZEPAM ORAL SOLUTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM ORAL SOLUTION 3. HOW TO TAKE DIAZEPAM ORAL SOLUTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DIAZEPAM ORAL SOLUTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DIAZEPAM ORAL SOLUTION IS AND WHAT IT IS USED FOR Diazepam belongs to a group of medicines called benzodiazepines. Diazepam helps in the treatment of anxiety, muscle spasms and convulsions (fits). It is used to treat: IN ADULTS • short term relief (14 days) of severe anxiety and may occur alone or with insomnia (trouble sleeping) or mental health problems • cerebral palsy • muscle spasm caused by tetanus (when Baca dokumen lengkap
OBJECT 1 DIAZEPAM 2MG/5ML ORAL SOLUTION SUGAR FREE Summary of Product Characteristics Updated 16-Mar-2017 | Accord-UK Ltd 1. Name of the medicinal product DIAZEPAM 2mg/5ml ORAL SOLUTION SUGAR FREE 2. Qualitative and quantitative composition Each 5ml spoonful contains 2mg Diazepam. EXCIPIENTS WITH KNOWN EFFECT Each 5ml contains: 3.000ml (1.91g to 2.58g) Sorbitol, liquid (Non-crystallising) (E420) PhEur 2.500mg of Propyl parahydroxybenzoate (E216) PhEur 5.000mg of Methyl parahydroxybenzoate (E218) PhEur 5.00ml (0.63g) of Glycerol (E422) PhEur. For the full list of excipients, see section 6.1. 3. Pharmaceutical form A pink syrup with an odour of raspberries. 4. Clinical particulars 4.1 Therapeutic indications Diazepam has potent anxiolytic, anticonvulsant and central muscle-relaxing properties; these effects are probably mediated through special areas in the CNS. It also has uses in pre-operative medication and is used in the treatment of skeletal-muscle spasm, and the associated pain. The main uses are: _Adults:_ 1) The short term relief (14 days) only of anxiety which 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. The use of benzodiazepines to treat short-term anxiety is considered to be inappropriate. 2) Cerebral palsy. 3) Muscle spasm; as an adjunct to the control of muscle spasm in tetanus. 4) As an adjunct to the management of certain types of epilepsy (e.g. myoclonus). 5) Symptomatic treatment of acute alcohol withdrawal. 6) As oral premedication for the nervous dental patient. _Paediatric population:_ 1) Control of tension and irritability in cerebral spasticity in selected cases. 2) Oral premedication. 4.2 Posology and method of administration Posology As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 14 days. Patients who have received benzodiazepines for a long time may require an extended withdrawal period. Long-term Baca dokumen lengkap