ibuprofen + paracetamol


AFT Pharmaceuticals


The Glory Medicina
Concise Prescribing Info
Paracetamol 500 mg, ibuprofen 150 mg
Temporary relief of pain associated w/ headache, migraine, backache, period, dental & muscular pain, cold & flu symptoms, sore throat & fever.
Dosage/Direction for Use
Adult 1-2 tab every 6 hr, up to a max of 6 tab in 24 hr.
Should be taken with food:  
Hypersensitivity to paracetamol, ibuprofen or other NSAIDs. Patients w/ active alcoholism; those who have experienced asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs; active or history of GI bleeding, peptic ulcer/haemorrhage or perforation related to previous NSAID therapy; severe heart failure (NYHA Class IV), hepatic or renal failure; cerebrovascular or other active bleeding; blood-forming disturbances. Peri-op pain treatment in the setting of CABG surgery. Should not be taken w/ other products containing paracetamol, ibuprofen, acetylsalicylic acid, salicylates or any other anti-inflammatory medicines unless advised by a physician. 3rd trimester of pregnancy.
Special Precautions
Monitor hepatic function at regular intervals in patients w/ impaired liver function or history of liver disease, or who are on long-term ibuprofen or paracetamol therapy. Not recommended in patients w/ advanced renal disease. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair female fertility. Not recommended in women attempting to conceive. Should not be used during the 1st 6 mth of pregnancy. Paracetamol: Higher than recommended dose can lead to hepatotoxicity. May interfere w/ the determination of 5-hydroxyindoleacetic acid. Ibuprofen: Use w/ caution in patients w/ dehydration. Can inhibit platelet aggregation; perform regular haematological monitoring in patients on long-term therapy. Increased risk of serious GI adverse events; serious CV thrombotic events, MI, & stroke. May lead to onset of new HTN or worsening of pre-existing HTN; fluid retention & oedema; very rarely, serious cutaneous adverse events eg, exfoliative dermatitis, toxic epidermal necrolysis & Stevens-Johnson syndrome; adverse ophthalmological effects. Do not administer to patients w/ acetylsalicylic acid sensitive asthma; use w/ caution in patients w/ pre-existing asthma. Risk of aseptic meningitis especially in patients w/ SLE or other connective tissue disorders. May mask the usual signs of infection. Patients who have been on prolonged corticosteroid therapy. Combination w/ ACE inhibitors or angiotensin receptor antagonists, anti-inflammatory drugs & thiazide diuretics. Renal impairment. Elderly.
Adverse Reactions
Oedema, fluid retention; tinnitus (for medicines containing ibuprofen); abdominal pain, diarrhea, dyspepsia, nausea, stomach discomfort & vomiting; increased ALT, γ-glutamyltransferase, blood creatinine & blood urea; liver function tests abnormal (w/ paracetamol); dizziness, headache, nervousness; rash (including maculopapular type), pruritus.
Drug Interactions
Paracetamol: Dosage reduction may be required w/ anticoagulants (warfarin). Increased absorption w/ substances that increase gastric emptying (eg, metoclopramide). Decreased absorption w/ substances that decrease gastric emptying (eg, propantheline, antidepressants w/ anticholinergic properties, & narcotic analgesics). May increase plasma conc of chloramphenicol. Increased risk of toxicity w/ other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes eg, alcohol & anticonvulsant agents. Altered excretion & plasma conc w/ probenecid. Reduced absorption w/ cholestyramine if given w/in 1 hr of paracetamol. Severe hepatotoxicity at therapeutic doses or moderate overdoses of paracetamol w/ INH alone or w/ other drugs for TB. Severe hepatotoxicity w/ zidovudine & co-trimoxazole. Ibuprofen: Interference w/ INR stability & increased risk of severe bleeding w/ anticoagulants, including warfarin. May decrease renal clearance & increase plasma conc of lithium. May reduce the anti-hypertensive effect of ACE inhibitors, β-blockers & diuretics; may cause natriuresis & hyperkalemia in patients under these treatments. Reduced methotrexate clearance. May increase plasma levels of cardiac glycosides. Increased risk of GI bleeding w/ corticosteroids. Prolonged bleeding time w/ zidovudine. May interact w/ probenecid, antidiabetic medicines & phenytoin; tacrolimus, ciclosporin, sulphonylureas & quinolone antibiotics. Increased adverse effects w/ acetylsalicylic acid.
ATC Classification
M01AE51 - ibuprofen, combinations ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
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