Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sulpiride
Sanofi-Aventis Ireland Limited T/A SANOFI
N05AL; N05AL01
Sulpiride
200 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Benzamides; sulpiride
Marketed
1987-04-08
*704064* PACKAGE LEAFLET : INFORMATION FOR THE USER DOLMATIL® 200MG T A BLETS DOLMATIL® 400MG FILM-COATED T A BLETS sulpiride Is this leaf let hard to see or r ead? Phone 01 403 5600 for help READ ALL OF THIS LEAFLET CAREFULLY BEFOR E YOU START TAKING THIS MEDICINE • Keep this leaflet. You may need to read it ag ain • 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 y our s • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. Wha t Dolmatil Tablets are and what they are used for 2. Before you take Dolmatil T a blets 3. How to take Dolmatil T a blets 4. Possible side effects 5. How to store Dolmatil T a blets 6. Further Information 1. WHAT DOLMATIL TABLETS ARE AND WHAT THEY ARE USED FOR Dolmatil Tablets contains a medicine called sulpiride. This belongs to a group of medicines called ‘benzamides’. It wor k s by blocking the effect of a chemical in the brain. Dolmatil Tablets are used to treat Schizophrenia. 2. BEFORE YOU TAKE DOLMATIL T A BLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: X You are allergic (hypersensitive) to sulpi- ride or any of the other ingredients of Dolmatil Tablets (listed in Section 6 Further Informa tion) Signs of an allergic reaction include: a rash, s w allowing or breathing problems, s w elling of your lips, face, throat or tongue X You have a tumour on the adrenal gland called ‘phaechromocytoma’ X You have a rare illness called ‘porphyria’ which affects your metabolism X You have breast cancer or cancer in the pituitary gland X You are taking levodopa or ropinirole used for Par k inson’ s disease (see ‘T ak ing 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 Dolmatil T a blets. TAKE SPECIAL CARE WITH DOLMA TIL T A BLETS Read the complete document
Health Products Regulatory Authority 20 January 2020 CRN0093GJ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dolmatil 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg sulpiride. Excipient: Lactose monohydrate 23 mg/tablet. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Plain, white, round tablet with a transverse breaking line on one side and the mark ‘D200’ on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute and chronic schizophrenia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS A starting dose of 400 mg to 800 mg daily, given as one or two tablets daily (morning and early evening) is recommended. Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400 mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200 mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement. Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond to doses below 800 mg daily; therefore, a starting dose of 400 mg twice daily is recommended. Reducing this dose towards 200 mg twice daily will normally increase the alerting effect of Dolmatil. Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-600 mg twice daily. CHILDREN Clinical experience in children under 14 years of age is insufficient to permit specific recommendations. ELDERLY The same dose ranges may be required in the elderly, but should be reduced if there is evidence of renal impairment. 4.3 CONTRAINDICATIONS Phaeochromocytoma and acute porphyria. Hypersensitivity to the active substance or any of the excipients listed in section 6.1 C Read the complete document