Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Rowex Ltd
M01AB; M01AB05
Diclofenac sodium
100 milligram(s)
Suppository
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 100 MG SUPPOSITORIES 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 low back pain, sprains, strains, dislocations, orthopaedic or dental surgery • pain and swelling after surgery • painful menstrual periods • migraine • 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 allergic type reaction. If you think you may be allergic, ask your doctor for advice. - 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. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Läs hela dokumentet
Health Products Regulatory Authority 07 December 2022 CRN00D6H1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac 100mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 100mg of diclofenac sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository White to cream coloured torpedo shaped suppositories, odourless. 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, psoriatic arthropathy, painful syndromes of the vertebral column, non-articular rheumatism. 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. Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis, bursitis. Migraine attacks. 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 Special warnings and precautions for use). The suppositories should be inserted well into the rectum. It is recommended to use the suppository after passing stools. Not to be taken by mouth as for rectal use only. ADULTS: The recommended initial daily dosage is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 Läs hela dokumentet