Feclo 400
FECLO 4OO TABLETS
Ibuprofen 400mg
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COMPOSITION
Each sugar coated tablet contains:
Ibuprofen 400mg
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PHARMACOLOGICAL CLASSIFICATION
Anti-rheumatics (anti-inflammatory agents) -
PHARMACOLOGICAL ACTION
Chemically, ibuprofen is described as 2-(4-isobutlyphenyl) propionic acid and is a non-steroidal compound which exhibits anti-inflammatory, analgesic and antipyretic activities.Ibuprofen is well absorbed on oral administration. An oral dose taken on an empty stomach by human volunteers produced peak serum levels after three quarters of an hour. Absorption was slower and peak serum levels lower after food.
Excretion is rapid with no evidence of accumulation. The levels in human serum of both metabolites haw been measured after single and repeated doses. About 60% of a dose is excreted in the urine and the excretory products are in the form of either free or conjugated metabolites A and B. No Ibuprofen found.
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INDICATIONS
Ibuprofen is indicated for its analgesic and anti-inflammatory effect in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing, spondylitis and ostheoarthritis and acute gouty arthritis.
Ibuprofen is indicated in the treatment of non-articular rheumatism including fibrositis. Ibuprofen is indicated in peri-articular conditions such as frozen shoulder (capsulitis), bursitis tendinitis, tenosynovitis and low-back pain. Ibuprofen can also be used in soft tissue injuries such as sprains and strains.
Ibuprofen is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental, post-episiotomy pain and postpartum pain. Ibuprofen may also be absorbed as antipyretic.
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CONTRA INDICATIONS
Ibuprofen should not be given to patients with peptic ulceration The safety of Ibuprofen in pregnancy has not been established.
Hypersensitivity to Ibuprofen, aspirin or any other non-steroidal anti-inflammatory agent. Because of the possibility of cross-sensitivity due to structural relationship which exist among non- non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
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DOSAGE AND DIRECTIONS FOR USE
Adults: The recommended dosage of Ibuprofen is 1200mg daily in divided doses. Some patients can he maintained on 600mg to 1200mg daily. In severe conditions, it can he advantageous to increase the dosage until the acute phase has been brought under control.
To relieve early morning stiffness, the first dose of the day can be given immediately after the patient awakes.
For the relief of mild to moderate pain, the following doses are recommended:
Dysmenorrhoea: 1200mg per day in three divided doses. In cases of dental or post-episiotomy pain, an initial dose of 800mg may be given. The total daily dose of Ibuprofen should not exceed 2400mg. Once acute phase has been brought under control, it is normal practice to revert to a maintenance dosage.
Acute gout: 24mg daily either as 800 mg 8 hourly or 600mg 6 hourly until the acute symptoms have been relieved. If the acute symptoms do not resolve within three days, consult a doctor.
Children: In Juvenile Rheumatoid Arthritis, the total daily dosage of Ibuprofen is 20 mg/kg of body mass given in divided doses.
Safety in children under one year of age has not been proven. Pain: Initial dose 5 mg/kg of bodyweight.
A second dose of 5mg/kg may be given after 2 hours if pain is not controlled, thereafter 5 mg/kg every 4 - 6 hours. DO NOT EXCEED 20 mg/kg of bodyweight per day. If pain persists for more than 3 days, consult your doctor.
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SIDE EFFCTS AND SPECIAL PRECAUTIONS
The most frequent side effects occurring with ibuprofen are gastro-intestinal disturbances.
Reactions range front abdominal discomfort, nausea and vomiting and abdominal pain to serious gastrointestinal bleeding or activation of peptic ulcer.
CNS-related side effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia. Hypersensitivity reactions may occur less frequently and include fever and rashes. Hepatotoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions. Ibuprofen can provoke bronchospasm in patients with asthma. Ibuprofen may cause cystitis and haematuria. They may also cause acute renal failure, interstitial nephritis, and nephrotic syndrome.
Other side effects include anaemia, thrombocytopenia. Neutropenia, cosinophilia, agranulocytosis, abnormalities in liver function tests, blurred vision, changes in visual colour perception and time amblyopia.
Precautions: Ibuprofen should be given with care to the elderly; patients with asthma or Bronchospasm, bleeding disorders, cardiovascular disease; a history of peptic ulceration; and in liver or renal failure. 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 greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
Care is required in those who are also receiving coumarin anticoagulants. Patients who are sensitive to aspirin or other NSAIDs should generally not be given Ibuprofen.
Ibuprofen should be discontinued in patients who experience blurred or diminished vision or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.
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KNOWN SYMTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The most likely symptoms of over dosage are epigasiric pain and nausea. If recently taken, gastric lavage will remove any unabsorbed ibuprofen. Electrolytes may he corrected by intravenous infusions if necessary. There is no specific the antidote to Ibuprofen.
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PRESENTATION
Blister Pack containing 100 tablets.
White plastic bucket with lid containing 500 or 1000 tablets. -
STORAGE INSTRUCTIONS
Store below 25°C.
Protect against light.
KEEP OUT OF REACH OF CHILDREN