Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diazepam
Accord-UK Ltd
N05BA01
Diazepam
2mg/1ml
Enema
Rectal
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200; GTIN: 5029801000014
BBBB4216 STESOLID® RECTAL TUBES 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT STESOLID RECTAL TUBES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID RECTAL TUBES 3 HOW TO USE STESOLID RECTAL TUBES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE STESOLID RECTAL TUBES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT STESOLID RECTAL TUBES ARE AND WHAT THEY ARE USED FOR Stesolid rectal tubes contain diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat: • severe anxiety and agitation • muscle spasms • epilepsy or febrile convulsions • symptoms of alcohol withdrawal Stesolid rectal tubes can also be used to provide sedation before operations (premedication). Your doctor may prescribe Stesolid rectal tubes for other uses. Please follow your doctor’s instructions. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID RECTAL TUBES DO NOT USE Stesolid rectal tubes if you • are ALLERGIC to diazepam or to other benzodiazepine medicines or to any of the other ingredients of this medicine (listed in section 6) • have ACUTE RESPIRATORY DEPRESSION (slow and/ or shallow breathing) • SUFFER FROM DEPRESSION (with or without anxiety) or HYPERACTIVITY • have a PHOBIA (a fear of a particular object or situation) or other mental illness • have a condition called MYASTHENIA GRAVIS which causes muscles to weaken and tire easily • suffer from SLEEP APNOEA (a sleep disorder where you have abnormal pauses in Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stesolid ® rectal tubes 5 mg. Diazepam 5mg Rectal Tubes 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diazepam 2 mg/ml. Excipients with known effect: Each 5mg tube contains: Benzoic acid (E210) - 2.50mg Sodium benzoate (E211) - 122.50mg Benzyl alcohol – 37.50mg Propylene glycol (E 1520) - 1.00g Ethanol – 250mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Enema 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diazepam has anticonvulsant, sedative, and muscle relaxant properties. It is used in the treatment of severe anxiety and tension states, as a sedative and premedication, in the control of muscle spasm, and in the management of alcohol withdrawal symptoms. This medicine may be used for 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. This medicine may be of particular value for the immediate treatment of convulsions in infants and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Sensitivity to diazepam varies with age. _Adults: _ _ _ _ _ _ _ _ _ _0.5 mg/kg body weight _ _Elderly patients: _ _ _ _ _ _0.25 mg/kg body weight _ A maximum dose of 30mg diazepam is recommended, unless adequate medical supervision and monitoring are available. Paediatric population _Children above 1 year of age: _ _ _ _0.5 mg/kg body weight _ 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance, benzodiazepines or any of the excipients listed in section 6.1 • Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur) • Acute pulmonary insufficiency; respiratory depression, acute or chronic severe respiratory insufficiency (ventilatory failure may be exacerbated) • Myasthenia gravis (condition may be exacerbated) • Sleep apnoea (condition may be exacerbated) Lees het volledige document