Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Medicines Authority
DIAZEPAM
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N05BA01
DIAZEPAM 10 mg
TABLET
DIAZEPAM 10 mg
POM
PSYCHOLEPTICS
Withdrawn
2013-07-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIAZEPAM ACTAVIS 2 MG TABLETS DIAZEPAM ACTAVIS 5 MG TABLETS DIAZEPAM ACTAVIS 10 MG TABLETS Diazepam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Diazepam Actavis are and what they are used for 2. Before you take Diazepam Actavis 3. How to take Diazepam Actavis 4. Possible side effects 5. How to store Diazepam Actavis 6. Further information 1. WHAT DIAZEPAM ACTAVIS IS AND WHAT IT IS USED FOR Diazepam Actavis contains the active substance diazepam which belongs to a group of medicines called benzodiazepines. Diazepam has anxiolytic, sedative and muscle relaxant effect. Diazepam Actavis is used: - in the treatment of anxiety. - in the treatment of muscle spasms, including those caused by cerebral spasticity (originates in the brain). - for symptoms of alcohol withdrawal. - to provide sedation before operations (premedication). Your doctor may prescribe Diazepam Actavis for other uses. Please follow your doctor’s instructions. BEFORE YOU TAKE DIAZEPAM ACTAVIS DO NOT TAKE Diazepam Actavis if you: - are ALLERGIC (hypersensitive) to diazepam or to other benzodiazepine medicines or to any of the other ingredients in your tablets (see section 6). - have a cond Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diazepam Actavis 2 mg tablets Diazepam Actavis 5 mg tablets Diazepam Actavis 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg diazepam. Each tablet contains 5 mg diazepam. Each tablet contains 10 mg diazepam. Excipient: Each Diazepam Actavis 2 mg tablet contains 64.10 mg lactose monohydrate. Each Diazepam Actavis 5 mg tablet contains 160.25 mg lactose monohydrate. Each Diazepam Actavis 10 mg tablet contains 320.50 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Diazepam Actavis 2 mg: White, round, flat and bevelled tablets, 5.0 mm in diameter, with ‘D’ engraved on one side and ‘2’ engraved on the other. Diazepam Actavis 5 mg: White, round, flat and bevelled tablets, 8.0 mm in diameter, with a scoreline on one side and ‘D5’ engraved on the other. The tablet can be divided into equal halves. Diazepam Actavis 10 mg: White, round, flat and bevelled tablets, 11.0 mm in diameter, with a scoreline on one side and ‘D10’ engraved on the other. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Anxiety. - Adjunct in the control of skeletal muscle spasm, including spasticity caused by upper motor neuron disorders (such as cerebral palsy). - Alcohol withdrawal symptoms. - Premedication before general anaesthesia or for sedation during minor surgical or investigative procedures. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINI Կարդացեք ամբողջական փաստաթուղթը