Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
A A H Pharmaceuticals Ltd
M01AB05
Diclofenac sodium
50mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5025903000495
Effects on the stomach and digestive system: Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Ischaemic colitis or Crohn’s disease). Effects on the heart, chest or blood: Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, blood disorders (including anaemia). Effects on the liver or kidneys: Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine. Effects on skin or hair: Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Hair loss. OTHER SIDE EFFECTS THAT HAVE ALSO BEEN REPORTED INCLUDE: Inflammation of the pancreas, impotence. Facial swelling, inflammation of the lining of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves of the eye. REPORTING OF SIDE EFFECTS: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE DICLOFENAC TABLETS KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. T Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac Sodium 50 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each enteric coated tablet contains Diclofenac Sodium 50 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets. 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:_ Not recommended. 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 ADULTS: 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 impairment (see section 4.3). No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advis Lire le document complet