国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Novartis Ireland Limited
M01AB; M01AB05
Diclofenac sodium
50 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances; diclofenac
Marketed
1979-10-03
PACKAGE LEAFLET: INFORMATION FOR THE USER VOLTAROL® 50 MG GASTRO-RESISTANT TABLETS (diclofenac sodium) 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 onto 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. • This medicine will be referred to as Voltarol in this leaflet. WHAT IS IN THIS LEAFLET 1. What Voltarol is and what it is used for 2. What you need to know before you take Voltarol 3. How to take Voltarol 4. Possible side effects 5. How to store Voltarol 6. Contents of the pack and other information 1. WHAT VOLTAROL IS AND WHAT IT IS USED FOR Diclofenac sodium, the active ingredient in Voltarol is one of a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs). NSAIDs reduce pain and inflammation. They have no effect on the causes of inflammation. Voltarol is used to treat a number of painful conditions including: • joint or muscle pain • attacks of gout • pain and swelling after surgery • sprains, strains and other injuries • gynaecology problems such as period pain • painful ear, nose and throat infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLTAROL DO NOT TAKE VOLTAROL IF: • you think you may be allergic to diclofenac sodium or to any of the other ingredients of Voltarol (listed in Section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction • you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the gut (digestive tract). This can include blood in vomit, bleeding 阅读完整的文件
Health Products Regulatory Authority 07 October 2022 CRN00D6H5 Page 1 of 11 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 bevelled 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 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. _Children and adolescents_ Children aged 1 year 阅读完整的文件