Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Rowex Ltd
M01AB; M01AB05
Diclofenac sodium
75 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances; diclofenac
Marketed
1999-05-27
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLAC 75MG PROLONGED RELEASE 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 75 mg is a prolonged release tablet. 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. 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 to any other NSAID, or to any of the other ingredients of Diclac. (They 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 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 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 - you have established heart disease and/or cerebrovascular disease e.g. if you have had read_full_document
Health Products Regulatory Authority 07 December 2022 CRN00D6H1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac 75 mg Prolonged-release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75mg diclofenac sodium. Each tablet also contains 41.75mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Round, flat, two - layered pink and white coloured, prolonged release tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (i) inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, psoriatic arthropathy, painful syndromes of the vertebral column, non-articular rheumatis (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis, bursitis; (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery; (iv) post-traumatic and post operative pain, inflammation and swelling e.g. following dental or orthopaedic surgery; (v) painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhea or adnexitis and menorrhagia (vi) acute gout. 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 Special warnings and special precautions for use). Route of Administration: Oral. The tablets should be swallowed whole with liquid, preferably with meals and must not be divided or chewed. Recommended Dosage Schedule: ADULTS: the recommended initial daily dose is 100 to 150mg, administered as 1 tablet of diclofenac prolonged-released 100mg or 2 tablets of diclofenac prolonged-released 75mg. This may be administered using a combination of dosage forms, e.g. tablets and suppositories. The recommended maximum daily dose is 150mg. Healt read_full_document