Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Novartis Pharmaceuticals UK Ltd
M01AB05
DICLOFENAC SODIUM
50 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances
Authorised
1994-10-03
1 of 2 Live Text: Yes / No / Both Production Site: Kurtkoy WO: 1555093 CTM: Vural, Merve Comp. Description: LFT_VOLTAROL FCT 50MG IE Printing Colours: Black Comp. No. New: 1813396 IE Comp. No. Old: 1809086 IE Format/Dimension: 594 x 148 mm Tech. Drawing No.: N/A Technical Colours: Cutting Guides Min. Font Size Text: 10 pt Font Type: News Gothic Version No.: 2 Date: 17 Nov 2016 J.N.: 295112 Braille: N/A ! PLEASE TURN OVERPRINTING ON ! Telephone +353 (0)1 440 3222 novartis@perigord-as.com www.perigord-as.com Unit 1, Lyncon Court IDA Business & Technology Park Snugborough Rd Blanchardstown Dublin 15 1813396 IE (1236) RISK OF HEART ATTACK OR STROKE WITH VOLTAROL There is a small increased risk of heart attack or stroke when you are taking any medicine like Voltarol. The risk is higher when you are taking higher doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for. If, at any time while taking Voltarol you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately. SIGNS OF INFECTION Because it is an anti-inflammatory medicine, Voltarol may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Voltarol. TESTS AND CHECKS If you have significant risks for heart disease, your doctor will periodically re-evaluate whether you should continue treatment with Voltarol. If you have any liver impairment, kidney impairment or blood impairment, you will have blood tests during treatment. These will monitor the function of your liver, kidney or your blood count. Your doctor will take these blood tests into consideration to decide if Voltaral needs to be discontinued or if the dose needs to be changed. IF YOU ARE ELDERLY OR UNDERWEIGHT If you are e Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Voltarol 50 mg Gastro-Resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Voltarol Tablets 50 mg contain 50mg diclofenac sodium. Each tablet also contains 25mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Circular, slightly biconvex, light brown, gastro-resistant tablet with beveled edges, embossed ‘CG’ on one side and ‘GT’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of all grades of pain and inflammation in a wide range of conditions. Treatment of: • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis and psoriatic arthropathy. • Acute attacks of gout. • Post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery. • Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis and associated menorrhagia. • As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed. _ADULTS:_ Voltarol 25mg and 50mg gastro-resistant tablets: 75-150mg daily in two or three divided doses. The recommended maximum daily dose of Voltarol is 150mg. This may be administered using a combination of dosage forms, e.g. tablets and suppositories. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Leggi il documento completo