Abridged Prescribing Information:
Composition: Diclomol® SR : Each sustained-release film-coated tablet contains : Diclofenac Sodium BP 100 mg Colour: Red Oxide of Iron and Titanium Dioxide. . Clinical Pharmacology: Diclomol® SR tablets for oral administration contain a non steroidal compound with pronounced anti-inflammatory, analgesic and antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation, pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic properties of Diclomol® SR elicit a clinical response characterised by marked relief from signs and symptoms such as pain at rest, pain on movement, morning stiffness and swelling of the joints, as well as by an improvement in function. Diclomol® SR is particularly suitable for patients in whom a daily dosage of 100 mg is appropriate to the clinical picture. The possibility of prescribing the drug in a single dose considerably simplifies long-term treatment and helps to avoid the possibility of dosage errors.
Indication: Due to its anti-inflammatory and analgesic effects, Diclomol® SR is indicated for the treatment of : • Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylosis, intervertebral disc syndrome & sciatica. • Non-articular rheumatic conditions such as fibrositis, myositis, bursitis, low back pain etc. • Soft tissue injuries such as sprains, strains and sports injuries. • Painful inflammatory conditions in gynaecology. •Post-operative and post-traumatic inflammation and swelling. • Pain and inflammation following dental surgery. • Acute attacks of gout.
Dosage & Administration:
Adults : 1 tablet of Diclomol®SR daily. Where the symptoms are most pronounced during the night or in the morning, Diclomol® SR should preferably be taken in the evening. The tablets of Diclomol® SR should neither be broken nor chewed.They should be taken whole with liquid, preferably at meal times.
Warning & Precautions :
• Close medical surveillance is required in patients with symptoms indicative of gastro-intestinal disease, a history of dyspepsia, Crohn’s disease, ulcerative colitis, etc. and in patients with blood coagulation disorders and those with severe cardiac, hepatic or renal disease.
• Caution should be exercised in elderly patients, who are generally more likely to experience side effects.
Contraindications:
• Hypersensitivity to diclofenac sodium.
• Peptic ulcer.
• In asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetyl salicylic acid or by other drugs with prostaglandin synthetase inhibiting activity.
Side Effects: At recommended doses, Diclomol® SR is generally well tolerated. At the start of treatment, however, patients may sometimes complain of epigastric pain, nausea, diarrhoea,dizziness or headache. These unwanted effects are usually of a mild nature. Peripheral oedema and skin reactions such as drug rash, urticaria and eczema, have also been observed. The following side effects have seldom been reported with Diclomol, although they have been observed in response to other non-steroidal, anti-inflammatory drugs: Central nervous system side effects, such as tiredness, insomnia and irritability, have occurred in rare instances. There have been a few reports of gastro-intestinal ulceration or haemorrhage, hypersensitivity reactions (e.g. bronchospasm, anaphylactoid reactions), elevated transaminase levels, hepatitis, renal failure and nephrotic syndrome, isolated cases of leucopenia and thrombocytopenia have also been observed.
Use in pregnancy and lactation: The use of Diclomol® SR during pregnancy should, if possible, be avoided. Diclofenac sodium in oral doses of 150 mg daily passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.
Drug interaction:
Aspirin: When Diclomol® SR is administered with aspirin, its protein binding is reduced.
Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.
Cyclosporine: Diclomol® SR, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Diclomol® SR may increase cyclosporine’s nephrotoxicity.
ACE Inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors.
Furosemide: Clinical studies, as well as postmarketing observations, have shown that Diclomol® SR can reduce the natriuretic effect of furosemide and thiazides in some patients.
Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either.
Overdose: Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Storage: Store at or below 30°C, in a dry place, protected from light. Keep out of reach of children.
Presentation: Diclomol® SR : Box of 100 tablets (10 Blisters x 10 Tablets each).