Panamor At 50mg Tablets 9 is a nonsteroidal anti-inflammatory drug used to treat pain and other symptoms such as inflammation, swelling, stiffness, and joint pain.
COMPOSITION: Film-coated tablets (which are also enteric coated) containing 25 mg or 50 mg diclofenac sodium, and film-coated tablets containing 75 mg or 100 mg diclofenac sodium tablets in a sustained-release form. These are also enteric-coated. Each 3 mL ampoule contains 25 mg/mL diclofenac sodium with 4% v/v benzyl alcohol as preservative. Each suppository contains 12,5 mg, 25 mg or 100 mg diclofenac sodium.
PHARMACOLOGICAL CLASSIFICATION: A 3.1: Anti-rheumatics (anti-inflammatory agents).
PHARMACOLOGICAL ACTION: Diclofenac sodium is a non-steroidal anti-inflammatory compound with analgesic, anti-inflammatory, antirheumatic and antipyretic properties. Plasma concentrations show a linear relationship to the size of the dose. Peak levels are attained in 1 to 4 hours with the tablets, and in the case of the suppositories, less than 1 hour. The peak-plasma concentration of Panamor - 75 SR and 100 - SR tablets, though comparable to that reached after a single coated tablet of 25 mg, is maintained over a longer period due to the larger quantity of active substance. Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy derivative of diclofenac sodium. The amount excreted in urine accounts for 20 - 30% of the dose, and that in bile for 10 - 20%. The mean terminal elimination half-life is 1,2 to 1,8 hours.
CONTRA-INDICATIONS: Patients with porphyria. Children under the age of 2 years. Patients with a history of active gastro-intestinal bleeding or peptic ulceration. Severe hepatic or renal impairment. Contra-indicated in aspirin-sensitive patients, patients sensitive to any other non-steroidal anti-inflammatory agent, and in patients hypersensitive to any of the ingredients in these products. Safety during pregnancy and lactation has not been established. The use of the suppositories is contra-indicated in proctitis.
WARNINGS: Serious interactions have been reported after the use of high dose methotrexate with diclofenac.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal disorders, including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include vertigo, headache, skin rashes, pruritis, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, oedema, palpitations, blurred vision and other ocular reactions. Sensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed. Dizziness, eczema and haemolytic anaemia may also occur. It is advisable to perform blood counts in patients undergoing prolonged treatment. Panamor should be given with care to patients with cardiovascular disease, bleeding disorders, in those who are receiving coumarin anticoagulants, and in patients with impaired hepatic or renal function. Allergic reactions which include angio-oedema, bronchospasm, urticaria and anaphylactic reactions have occurred. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-intlammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds. Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of aspirin. When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations. Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents may aggravate gastro-intestinal side-effects. Concurrent administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects. Should be used, with caution in patients with asthma or bronchoconstriction. Use carefully in elderly patients. Decreased platelet aggregation with increased bleeding time may occur. May increase the half-life of probenecid. Use with care together with other protein-bound medicines e.g. tolbutamide, coumarin and hydantoin. In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Protect from moisture.
Protect ampoules from heat and light.
Store below 25°C.
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