(and dosage form):
Each tablet contains: 100 mg Diclofenac sodium in a sustained release formulation.
A 3.1 Anti-Rheumatics (anti-inflammatory agents).
Diclofenac sodium is a non-steroidal compound with analgesic, anti-inflammatory, antirheumatic and anti-pyretic properties.
Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucoronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy diclofenac, other hydroxylated metabolites are formed after glucuronidation and sulfation, the metabolites are excreted in the urine (65% ) and bile (35% ). There is a substantial first-pass effect, such that only about 50% of diclofenac is systemically available. The drug is extensively bound to plasma proteins (99% ), and its half-life in plasma is 1 to 2 hours. Diclofenac accumulates in synovial fluid after oral administration, which may explain the duration of therapeutic effect that is considerably longer than the plasma half-life.
Inflammatory and degenerative rheumatic diseases, as well as for painful conditions due to inflammation of non-rheumatic origin, painful musculoskeletal conditions, painful post-operative and post-traumatic swelling and pain following dental surgery.
Diclofenac sodium is contra-indicated in patients with a history of active gastro-intestinal bleeding or peptic ulceration or severe hepatic or renal impairment. It is further contra-indicated in aspirin-sensitive patients, and in patients hypersensitive to any of the ingredients. Safety in pregnancy has not been established.
Patients with porphyria.
Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other medicines with prostaglandin synthetase inhibiting activity.
Serious interactions have been reported after the use of a high dose methotrexate with diclofenac.
DOSAGE AND DIRECTIONS FOR USE:
Children: The tablets are not suitable for use in children.
Adults: One tablet in the morning or evening.
Tablets to be swallowed whole, with a full glass of water.
Avoid alcoholic beverages.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most frequent adverse effects are gastro-intestinal disorders, abdominal discomfort, abdominal pain to serious gastro-intestinal bleeding or activation of peptic ulcer; nausea and vomiting may occur. Central nervous system related side-effects include vertigo, headache, tinnitus, depression, drowsiness, nervousness and insomnia.
Hypersensitivity reactions may occur occasionally which include fever, skin rashes and pruritus.
Hepatotoxicity and aseptic meningitis which occur rarely may also be hypersensitivity reactions.
Abnomalities of liver function tests, impairment of renal function, anaemias, agranulocytosis, thrombocytopenia, neutropenia and eosinophilia have been observed. It is advisable to perform blood counts in patients undergoing prolonged treatment.
Diclofenac and other non-steroidal anti-inflammatory drugs may cause cystitis and haematuria.
Other adverse effects include blurred vision, changes in visual colour perception and toxic amblyopia.
Diclofenac should be given with care to the elderly, to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, a history of peptic ulceration and in liver or renal failure.
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients. Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion, and therefore these patients are at great risk of developing renal dysfunction due to non-steroidal anti-inflammatory therapy which induce the inhibition of renal prostaglandin synthesis.
Acute allergic reactions have been reported. Because of the possibility of cross-sensitivity due to structural relationships which exists among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations.
Concomitant administration of glucocorticoids or other NSAID may aggravate gastro-intestinal side-effects. Concurrent administration with two or more NSAID may promote the occurrence of side-effects.
The half-life of probenecid may be increased. Use with care together with other protein binding medicines eg. tolbutamide and coumarin. It has been reported that diclofenac, unlike some of the other NSAID, does not potentiate the effects of oral anticoagulants or hypoglycaemics.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to "Side-effects and Special precautions".
Treatment is symptomatic and supportive.
Round, white tablet marked with Clonmel Logo on the one side and with "DSR" on the reverse.
In cartons containing 30 blister packed tablets (in strips of 10's) and in securitainers of 100.
Store below 25°C, in a cool place.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
Triomed (Pty) Ltd
2 Bella Rosa Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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