Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Astellas Pharma Co. Ltd
M01AB05
DICLOFENAC SODIUM
25 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances
Authorised
2006-06-13
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. 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. This includes any possible side effects not listed in this leaflet, see section 4. WHAT IS IN THIS LEAFLET: 1. What Difene is and what it is used for 2. What you need to know before you take Difene 3. How to take Difene 4. Possible side effects 5. How to store Difene 6. Contents of the pack and other information 1. WHAT DIFENE IS AND WHAT IT IS USED FOR Difene contains diclofenac sodium as the active ingredient which is a non-steroidal anti-inflammatory drug (NSAID). This means that it is a “painkilling” medicine which reduces inflammation and swelling, but it does not contain any steroid medicine. Difene is used to relieve pain and inflammation. It is used to relieve painful conditions associated with your bones and joints and to reduce swelling and inflammation (e.g. arthritis) and for sprains, strains and bruising of tendons and ligaments, and in acute gout. It can also be used to reduce pain or inflammation after surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFENE DO NOT TAKE DIFENE: • if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of Difene listed in section 6. • if you have ever had an allergic reaction (skin reaction, difficulty in breathing or runny nose) to aspirin (acetylsalicylic acid) or any other NSAID such as ibuprofen. • if you suffer from an upset stomach or irritation of the gut, if you have or have ever suffered from a stomach ulcer or bleeding from the stomach. • if you have been told that you have bleeding in the brain or other bleeding elsewhere. • if you have a history of gastro-i Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difene 25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diclofenac Sodium 25mg Each capsule contains 25mg of diclofenac sodium Excipients with known effect: sucrose (71.34mg/capsule) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant hard capsule. Size 3 hard gelatin capsules with dark blue opaque caps and colourless transparent bodies, printed with “D25” in white on both cap and body and containing white to cream coloured pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Difene can be used in the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis, osteoarthritis, ankylosing spondylitis, psoriatic arthropathy, low back pain and acute musculoskeletal disorders including peri-arthritis, tendinitis, tenosynovitis, bursitis, sprains, strains, dislocations and in acute gout. It can also be of use in the management of post operative pain and inflammation in orthopaedic, dental and other minor surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. Swallow whole, do not chew. Adults: The usual daily dose is 100 mg in divided doses. This may be increased to 150 mg daily. Children aged 9 years (min. 35 kg body weight) or over and adolescents should be given up to 2 mg/kg body weight per day in 3 divided doses, depending on the severity of the disorder. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. See also Section 4.4, Special warnings and precautions for use. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance oc Read the complete document