Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Rowex Ltd
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
1992-03-05
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLAC 50MG GASTRO-RESISTANT TABLETS DICLOFENAC SODIUM 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 • SOME PEOPLE MUST NOT USE DICLAC. TALK TO YOUR DOCTOR IF: - you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclac. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash, or any other type of allergic 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 when emptying bowels, fresh blood in stools or black tarry stools. This may have been when you used an NSAID before. - you suffer from severe kidney or liver disease - you suffer from severe heart failure READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT Aqra d-dokument sħiħ
Health Products Regulatory Authority 07 December 2022 CRN00D6H1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac 50 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains diclofenac sodium 50 mg. Excipients: Each tablet contains lactose monohydrate 30mg. For the 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, 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). As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration. Route of Administration: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed. ADULTS: DICLAC 50 mg: 75-150mg daily in two or three divided doses. The recommended maximum daily dose is 150 mg. This may be administered using a combination of dosage forms, e.g. tablets and suppositories Aqra d-dokument sħiħ