Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sulpiride
Medreich Plc
N05AL01
Sulpiride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 05060292740539
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, 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 SULPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS 3. HOW TO TAKE SULPIRIDE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SULPIRIDE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SULPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR Sulpiride belongs to a group of medicines called ‘benzamides’. It works by blocking the effect of a chemical in the brain. Sulpiride tablets are used to treat Schizophrenia. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS DO NOT TAKE SULPIRIDE TABLETS: • If you are allergic (hypersensitive) to sulpiride or any other ingredients in this product (_see Section 6 and end of Section_ 2). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • If you have a rare illness called ‘porphyria’ which affects your metabolism. • If you have tumour on the adrenal gland called ‘phaeochromocytoma’ • If you have breast cancer or cancer in the pituitary gland. • You are taking levodopa or ropinirole used for Parkinson’s disease (see ‘Taking other medicines’ below) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sulpiride Tablets. TAKE SPECIAL CARE AND TELL TO YOUR DOCTOR OR PHARMACIST IF YOU: • have kidney problems • have high blood pressure • have epilepsy or have Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Sulpiride 400mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400mg of the active substance sulpiride. Also contains 256mg of Lactose Monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated Tablet. White, oval, film coated tablets marked S400 and break line on one face and plain on the reverse. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS This medicinal product is for the treatment of acute and chronic schizophrenia. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adults: The initial dose depends on the nature of the symptoms. In patients with predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy, as well as depression) the usual starting dose is 400 mg twice daily. This can be reduced to 200mg twice daily as a response occurs, increasing the alerting effect of sulpiride that occurs at lower doses. In patients with predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) the usual starting dose is 400mg twice daily increasing if necessary to a suggested maximum of 1200mg twice daily. In patients with positive and negative symptoms, with neither predominating, a dose of 400mg-600mg twice daily is recommended. Elderly: Initially one quarter to one half of the adult dose. Children: Clinical experience in children under 14 years of age is insufficient to permit specific recommendations. Renal impairment: The dosage should be reduced or the dosage interval increased. 4.3 CONTRAINDICATIONS Phaeochromocytoma Acute porphyria Hypersensitivity to sulpiride or to any of the excipients listed in section 6.1. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer (See section 4.8 Undesirable effects). Association with levodopa or antiparkinsonian drugs (including ropinirole) (See section 4.5 Interactions with other medicinal products and other forms of interaction). 4.4 SPECIAL WARNINGS AND PRECAUTION Les hele dokumentet