Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Diazepam
Actavis Group PTC ehf
N05BA; N05BA01
Diazepam
10 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; diazepam
Marketed
2012-02-24
* 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@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details PRODUCT STRENGTH FORM PACK SIZE COMPONENT - MARKET Black BBBA2716 D Braund 10.08.18 13.08.18 D. Braund 150 x 440 7.3pt Actavis Jakarta n/a n/a 2 Version 2 01.11.2017 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 only. 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, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT DIAZEPAM IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM 3 HOW TO TAKE DIAZEPAM 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE DIAZEPAM 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT DIAZEPAM IS AND WHAT IT IS USED FOR Diazepam contains the active substance diazepam which belongs to a group of medicines called benzodiazepines. Diazepam has anxiolytic, sedative and muscle relaxant effect. Diazepam 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 for other uses. Please follow your doctor’s ins Прочетете целия документ
Health Products Regulatory Authority 26 November 2018 CRN008JM3 Page 1 of 19 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 Diazepam 10 mg tablet contains 320.50 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 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 doses. 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 ADMINISTRATION Posology 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). The patient should be re‑evaluated after a period of no more than 4 weeks and then Health Products Regulatory Authority 26 November 2018 CRN008JM3 Page 2 of 19 regularly thereafter in order to assess the need for continued treatment, especially in case the patient is symptom free. In general, treatment must not last longer than 8 to 12 weeks, including tapering off process. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re‑evaluation of the patient‘s status with special expertise. Tapering off Treatment should always be tapered off gradually. Patients who have taken benzodi Прочетете целия документ