Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acamprosate calcium
Dowelhurst Ltd
N07BB03
Acamprosate calcium
333mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04100100
Myriad Pro 10.5 pt 10.5 pt Acamprosate_333mg_168 Leaflet 1936962 N/A 1936962 PL 04569/1610 Mylan Laboratories Ltd (Aurangabad - IN) 75068816 TBC N/A 102864316/0020 3 United Kingdom KLD_Acamprosate Tabs 333mg_ Leaflet (Blister Pack)_170 x 320mm N/A 1 170 x 320 mm BLACK 1 / 2 N/A v3/Jul 2017 Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Affiliate Item Code 3D Render ID 15:57 19 Sep 19 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACAMPROSATE 333 MG GASTRO-RESISTANT TABLETS acamprosate calcium 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 Acamprosate is and what it is used for 2. What you need to know before you take Acamprosate 3. How to take Acamprosate 4. Possible side effects 5. How to store Acamprosate 6. Contents of the pack and other information 1. WHAT ACAMPROSATE IS AND WHAT IT IS USED FOR Acamprosate is a medicine which acts on the central nervous system (the brain and the spinal cord). Acamprosate is used for the treatment of alcohol dependence. It helps to maintain abstinence in alcohol-dependent patients. Acamprosate in combination with counselling will help you to not drink alcohol. It does this by acting on the chemical changes that have taken place in the bra Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acamprosate 333 mg Gastro-resistant Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains acamprosate calcium 333.0 mg as the active ingredient. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. White, round, biconvex coated tablet with “M” over “AC” printed in black ink on one side of the tablet and blank on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults within the age range 18-65 years _ - 2 tablets three times daily with meals (2 tablets in the morning, noon and night) in subjects weighing 60kg or more. - In subjects weighing less than 60kg, 4 tablets divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night). _Paediatric population and older people _ Acamprosate should not be administered to children, adolescents and the elderly. _Duration of treatment _ The recommended treatment period is one year. Treatment with acamprosate should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses. Acamprosate does not prevent the harmful effects of continuous alcohol abuse. Continued alcohol abuse negates the therapeutic benefit; therefore acamprosate treatment should only be initiated after weaning therapy, once the patient is abstinent from alcohol. Method of administration For oral use. Swallow this tablet whole. Do not chew or crush the tablet as this may damage the gastro-resistant coating. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding women (see section 4.6) Patients with renal impairment (serum creatinine >120 micromol/l) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The safety and Read the complete document