Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
DIAZEPAM
Actavis Group PTC ehf
N05BA01
DIAZEPAM
5 Milligram
Rectal Solution
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives
Authorised
2008-02-18
V013 - ADR update to section 4 STESOLID® RECTAL SOLUTION 5 MG AND 10 MG diazepam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 of the side effects, talk to 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 STESOLID IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID 3. HOW TO USE STESOLID 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE STESOLID 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT STESOLID IS AND WHAT IT IS USED FOR Stesolid rectal solution contains diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat: • severe anxiety and agitation • epilepsy or febrile convulsions • tetanus Stesolid rectal solution may also be used to cause relaxation and sleepiness before an operation or dental procedure, or in other circumstances where a rapid effect is required but where intravenous injection is impracticable or undesirable. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID DO NOT USE Stesolid rectal tubes and TELL your doctor if you: • are ALLERGIC to diazepam, to other benzodiazepine or to any of the other ingredients of this medicine (listed in section 6) • HAVE SEVERE BREATHING PROBLEMS OR HAVE DIFFICULTY BREATHING • SUFFER FROM DEPRESSION (with or without anxiety) or Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stesolid rectal solution 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diazepam 2 mg/ml Each tube contains 5 mg of diazepam Excipients with known effect: Benzoic acid 1 mg/ml and Propylene Glycol 400 mg/ml For the full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Rectal Solution. Clear, colourless to yellowish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stesolid rectal tubes 5 mg may be used in acute severe anxiety and agitation, epileptic and febrile convulsions, tetanus, as a sedative in minor surgical and dental procedures, or in other circumstances in which a rapid effect is required but where intravenous injection is impracticable or undesirable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage depends on age, weight, individual reactions, the indications and the severity of the conditions. If the patient does not respond within 5 minutes, the dose may be repeated. Further doses of Stesolid rectal tubes should be administered only after consultation with a physician. If convulsions have not been brought adequately under control with diazepam, other measures should be instituted. 4.3 CONTRAINDICATIONS Stesolid is contraindicated for patients with: Hypersensitivity to benzodiazepines or to one or more of the excipients (see section 6.1) Myasthenia gravis Sleep apnoea syndrome Severe respiratory insufficiency Severe hepatic insufficiency Children 1 to 3 years of age: 5 mg Children above 3 years of age: 10 mg Adults: 10 mg Elderly patients: 5 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочетете целия документ