| COMPOSITION |
| Each film coated tablet contains :50 mg Diclofenac Potassium. |
| MECHANISM OF ACTION |
• Diclofenac Potassium tablets contain the potassium salt of diclofenac, a non-steroidal compound with pronounced and clinically demonstrable analgesic, anti-inflammatory and anti-pyretic properties.
• Diclofenac is a potent inhibitor of prostaglandin biosynthesis and a modulator of arachidonic acid release and uptake.
• Diclofenac Potassium has a rapid onset of action and is therefore suitable for the treatment of acute episodes of pain and inflammation.
• In migraine attacks Diclofenac Potassium have been shown to be effective in relieving the headache and in improving the accompanying symptom of nausea.
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| INDICATIONS AND USAGE |
· Rheumatoid arthritis
· Osteoarthrosis
· Low back pain
· Migraine attacks
· Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures
· Ankylosing spondylitis
· Acute gout
· Control of pain and inflammation in orthopaedic, dental and other minor surgery
· Pyrophosphate arthropathy and associated disorders |
| CONTRAINDICATIONS |
• Hypersensitivity to diclofenac or any of the excipients.
• Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
• Severe heart failure, hepatic failure and renal failure.
• History of gastro-intestinal bleeding or perforation, relating to previous NSAID therapy.
• During the last trimester of pregnancy.
• This product contains soya. If you are allergic to peanut or soya, do not use this medicinal product. |
| WARNINGS |
· Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
· The use of Diclofenac potassium with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
· Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history suggestive of gastric or intestinal ulceration, with ulcerative colitis, or with Crohn's disease as these conditions may be exacerbated.
· Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).
· GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
Caution should be advised in patients receiving concomitant medications which increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin. When GI bleeding or ulceration occurs in patients receiving diclofenac potassium, the treatment should be withdrawn.
· NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
· In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
· Hepatic: Close medical surveillance is imperative in patients suffering from severe impairment of hepatic function.
· Hypersensitivity reactions: As with other non-steroidal anti-inflammatory drugs, allergic reactions, including anaphylactic reactions, can occur without earlier exposure to the drug.
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| PRECAUTIONS |
· Cardiovascular, Renal and Hepatic Impairment: The administration of an NSAlD may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.
Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.
· Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur, Diclofenac Potassium tablets should be discontinued. Hepatitis may occur without prodromal symptoms. Using of Diclofenac Potassium tablets in patients with hepatic porphyria may trigger an attack.
· Hematological: Diclofenac Potassium tablets may reversibly inhibit platelet aggregation. Patients with defects of homeostasis, bleeding diathesis or hematological abnormalities should be carefully monitored.
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| INTERACTIONS |
· Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAlDs (including aspirin) as this may increase the risk of adverse effects.
· Anti-hypertensives: Reduced anti-hypertensive effect.
· Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
· Cardiac glycosides: NSAlDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
· Lithium: Decreased elimination of lithium.
· Methotrexate: Decreased elimination of methotrexate.
· Ciclosporin: lncreased risk of nephrotoxicity.
· Mifepristone: NSAlDs should not be used for 8-12 days after mifepristone administration as NSAlDs can reduce the effect of mifepristone.
· Corticosteroids: lncreased risk of gastrointestinal ulceration or bleeding.
· Anti-coagulants: NSAlDs may enhance the effects of anti-coagulants, such as warfarin.
· Quinolone antibiotics: Patients taking NSAlDs and quinolones may have an increased risk of developing convulsions.
· Anti-platelet agents and selective serotonin reuptake inhibitors (SSRls): lncreased risk of gastrointestinal bleeding.
· Zidovudine: lncreased risk of haematological toxicity when NSAlDs are given with zidovudine. There is evidence of an increased risk of hemarthrosis and hematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
· Tacrolimus: Possible increased risk of nephrotoxicity when NSAlDs are given with tacrolimus
· Antidiabetic agents: Clinical studies have shown that Diclofenac Potassium tablets can be given together with oral antidiabetic agents without influencing their clinical effect.
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| PREGNANCY AND LACTATION |
Pregnancy: Congenital abnormalities have been reported in association with NSAID administration; however, these are low in frequency and do not appear to follow any discernible pattern.
In view of the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of the ductusarteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labor may be delayed and the duration increased with an increased bleeding tendency. NSAIDs should not be used during the first two trimesters of pregnancy or labor unless the potential benefit to the patient outweighs the potential risk to fetus.
Lactation
In limited studies so far available, NSAlDs can appear in breast milk in very low concentrations. NSAlDs should, if possible, be avoided when breastfeeding.
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| UNDESIRABLE EFFECTS |
If serious side-effects occur, Diclofenac Potassium tablets should be withdrawn.
Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcer particularly in the elderly may occur.
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain.
melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) nonspecificallergic reactions bronchospasm, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Other adverse reactions reported less commonly include:
Renal: interstitial nephritis
Hepatic: abnormal liver function.
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| DOSAGE & ADMINISTRATION |
· To be taken preferably with or after food.
· The tablets should be swallowed whole with liquid
Adults
· The recommended daily dose is 100 – 150 mg in two or three divided doses.
· For milder cases, 75 – 100 mg daily in two or three divided doses is usually sufficient.
· In migraine an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4 – 6 hours, not exceeding a total dose of 200 mg per day.
Children
· For children of 12 years and over, the recommended daily dose is 75 – 100 mg in two or three divided doses.
· Diclofenac Potassium 50 mg tablets should not be indicated for use in children less than 12 years of age.
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| OVERDOSE |
· Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea, disorientation, drowsiness, tinnitus, fainting, occasionally convulsions. In rare cases of significant poisoning acute renal failure and liver damage are possible.
· Therapeutic measure
Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Good urine output should be ensured. Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient's clinical condition.
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| PACKAGING |
· 10 Film Coated Tablets packed in opaque PVC /Aluminum blister inside a cartoon box with a leaflet.
· 20 Film Coated Tablets packed in two opaque PVC /Aluminum blisters inside a cartoon box with a leaflet.
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| STORAGE CONDISITONS |
Store at room temperature below 30°C. Keep away from light .Keep away from children.
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