देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Rowex Ltd
M01AB05
DICLOFENAC SODIUM
25 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances
Authorised
2004-10-29
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLAC 25MG & 50MG 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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Diclac is and what it is used for 2. What you need to know before you take Diclac 3. How to take Diclac 4. Possible side effects 5. How to store Diclac 6. Contents of the pack and other information 1 WHAT DICLAC IS AND WHAT IT IS USED FOR Diclac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammation. Diclac relieves symptoms of inflammation, such as swelling and pain and also reduces fever. It has no effect on the cause of inflammation or fever. Diclac can be used to treat the following conditions: • inflammatory conditions such as rheumatoid arthritis, osteoarthritis • acute musculoskeletal disorders such as frozen shoulder or tendinitis • other painful conditions such as fractures, low back pain, sprains, strains, dislocations, orthopaedic or dental surgery pain and swelling after surgery • painful menstrual periods • attacks of gout painful ear, nose and throat infections. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLAC DO NOT TAKE DICLAC IF: - you are allergic to diclofenac sodium or any of t पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac 25 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Diclofenac Sodium 25 mg. Excipients: Each tablet contains lactose monohydrate 15mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets. Yellow-brown, round film coated gastro resistant tablets. 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 and spondylarthritis. 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: DICLAC 25 mg: 75-150mg daily in two or three divided doses. The tablets should be swallowed whole with liquid. The recommended maximum daily dose of DICLAC is 150 mg. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ पूरा दस्तावेज़ पढ़ें