Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
DE Pharmaceuticals
M01AB05
Diclofenac sodium
25mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
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. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET 1. What DICLOFENAC SODIUM 25MG is and what it is used for 2. What you need to know before you take DICLOFENAC SODIUM 25MG 3. How to take DICLOFENAC SODIUM 25MG 4. Possible side effects 5. How to store DICLOFENAC SODIUM 25MG 6. Contents of the pack and other information 1. WHAT DICLOFENAC SODIUM IS AND WHAT IT IS USED FOR Diclofenac sodium, the active ingredient in DICLOFENAC SODIUM 25MG, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. DICLOFENAC SODIUM 25MG tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including: • Rheumatoid arthritis, osteoarthritis, acute gout (painful inflammation of the joints especially in the feet and hands), ankylosing spondylitis (form of spinal arthritis). • Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures • Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis. They are also used to treat pain and inflammation associated with dental and minor surgery. In children aged 1-12 years DICLOFENAC SODIUM 25 mg tablets are used to treat juvenile chronic arthritis. In children aged 9 years and above DICLOFENAC SODIUM 25 mg tablets are used for short term treatment of fever related to infections of the ear, nose or throat, and for relief of acute post-operative pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DI Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac Sodium 25 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each enteric-coated tablet contains Diclofenac Sodium 25 mg. Each tablet contains 30.00 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant Tablets. The tablets are 6.60 to 7.00 mm in diameter, round, pale yellow, enteric coated tablets, plain on both the sides. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS _Adults and Elderly: _ Relief of all grades of pain and inflammation in a wide range of conditions, including: i. arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, ii. acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis, iii. other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. _Children (aged 1-12 years): _Juvenile chronic arthritis. 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). For oral administration 75-150mg daily in two or three divided doses. The recommended maximum daily dose of diclofenac is 150mg. SPECIAL POPULATIONS ELDERLY Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also precautions) and the patient should be monitored for GI bleeding during NSAID therapy. RENAL IMPAIRMENT Diclofenac is contraindicated in patients with severe renal imp Lugege kogu dokumenti