Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sulpiride
Kent Pharma (UK) Ltd
N05AL01
Sulpiride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
PACKAGE LEAFLET: INFORMATION FOR THE USER SULPIRIDE TABLETS 200 MG & 400 MG (sulpiride) 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Sulpiride is and what it is used for 2. Before you take Sulpiride 3. How to take Sulpiride 4. Possible side effects 5. How to store Sulpiride 6. Further information 1. WHAT SULPIRIDE IS AND WHAT IT IS USED FOR Sulpiride belongs to a group of medicines called benzamides. These act on the brain to reduce abnormal behaviour. Sulpiride is used for treating schizophrenia. Symptoms can include sensing, seeing or hearing things that do not exist, becoming withdrawn and having mistaken beliefs or suspicions. 2. BEFORE YOU TAKE SULPIRIDE DO NOT TAKE SULPIRIDE AND TELL YOUR DOCTOR IF YOU • are allergic (hypersensitive) to sulpiride or any of the other ingredients in these tablets. The signs of an allergic reaction include a rash, itching or shortness of breath • have high blood pressure due to a growth on your adrenal glands (phaeochromocytoma) • have porphyria, which is a problem with your metabolism which can cause skin blisters, pain in and around your stomach (abdomen) and brain or nervous system problems • have ever had breast cancer or a type of brain tumour called ‘pituitary prolactinoma’ • are taking a medicine called Levodopa (see “Taking other medicines”) • suffer from CNS depression – a condition where the activity of your central nervous system is reduced. Symptoms include feeling sleepy and uncoordinated, staggering, blurred vision, slurred speech, slowed reflexes and breathing, unconsciousness and coma. Read the complete document
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 Read the complete document