Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sulpiride
A A H Pharmaceuticals Ltd
N05AL01
Sulpiride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5037563004133
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: t/FXSFHVMBUPSZUFYU 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 The name of your medicine is Sulpiride Tablets. It contains sulpiride. This belongs to a group of medicines called benzamides. It works by blocking the effect of a chemical in the brain. Sulpiride is used for treating acute and chronic schizophrenia. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS DO NOT TAKE SULPIRIDE TABLETS: ,I\RXDUHDOOHUJLFWRVXOSLULGHRUDQ\RWKHU ingredients of this medicine (listed in Section 6). The signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, throat or tongue. ,I\RXKDYHDWXPRXURQWKHDGUHQDOJODQG called ‘phaeochromocytoma’ ,I\RXKDYHDUDUHLOOQHVVFDOOHGµSRUSK\ULD¶ which affects your metabolism ,I\RXKDYHEUHDVWFDQFHURUFDQFHULQWKH pituitary gland ,I\RXDUHWDNLQJ/HYRGRSDRUURSLQLUROHXVHG for Parkinson's Disease 'RQRWWDNHWKLVPHGLFLQHLIDQ\RIWKHDERYH apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. WARNINGS AND PRECAUTIONS Talk your doctor or pharmacist before taking Sulpiride Tablets: ,I\RXKDYHERXWVRIDJJUHVVLYHEHKDYLRXURU agitation ,I\RXKDYHNLGQH\SUREOHPV ,I\RXKDYHKHDUWSUREOHPVRUDIDPLO\KLVWRU\ of heart problems. Your doctor may test your heart function before you take this medicine. ,I\RXKDYHHYHUKDGDVWURNH ,I\RXRUVRPHRQHHOVHLQ\RXUIDPLO\KDVD history of blood clots, as medicines like WKHVHKDYHEHHQDVVRFLDWHGZLWKIRUPDWLRQ of blood clots ,I\RXKDYHORZOHYHOVRISRWDVVLXPLQ\RXU body (hypokalaemia) Lue koko asiakirja
1. NAME OF THE MEDICINAL PRODUCT Sulpiride 200mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of the active substance sulpiride. Also contains 128mg of Lactose Monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, c ircular tablet marked S200 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 PRECAUTIONS FOR USE WARNINGS: Increased motor Lue koko asiakirja