Zuellig Pharma


EP Plus Group
Concise Prescribing Info
Ibuprofen (as l-arginine salt)
Headache including migraine, toothache, dysmenorrhoea, neuralgia, osteoarticular & muscular pain, episiotomy & post-partum pain, pain following tooth extraction, post-op pain, soft tissues injuries & traumatisms. RA, ankylosing spondylitis, Still's disease. OA (cervical, dorsal & lumbar arthritis, gonarthritis, coxarthritis, polyarthritis, etc). Tendonitis, fibrositis, bursitis, myalgia, lumbago, scapolohumeral periarthritis, sciatica, radiculoneuritis.
Dosage/Direction for Use
Adult Initially 1 tab bd-qds. Max daily dose: Not to exceed 1,600 mg.
Should be taken with food.
Hypersensitivity. ASA- & other NSAIDs-induced allergic reactions eg, bronchospasms, urticaria/allergy-like symptoms. Active gastric/duodenal ulcers; GI haemorrhage/perforation; inflammatory bowel disease eg, Crohn's disease, ulcerative colitis; cerebrovascular bleeding; haemorrhagic diathesis; severe heart failure (NYHA III-IV). Post-op pain following coronary bypass surgery. Severe hepatic &/or renal impairment. 3rd trimester of pregnancy.
Special Precautions
Discontinue use if GI haemorrhage or ulceration occur; at 1st sign of rash, mucosal lesions or any other signs of hypersensitivity reactions. History of bronchial asthma, chronic rhinitis, allergic disease; serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy. Uncontrolled HTN, heart failure (NYHA II), established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease; fluid retention w/ oedema &/or arterial HTN, cardiac impairment or other conditions predisposing to fluid retention; severe dehydration or post-op vol shifts; aseptic meningitis, SLE, collagenosis. May mask symptoms of infections. Perform ophth exam in patients w/ visual disturbances. May produce increased LFT results. Avoid high-dose use (2,400 mg daily). Long-term treatment of patients w/ risk factors for CV events eg, HTN, hyperlipidemia, DM, smoking. Patients on controlled Na diet. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Avoid combination w/ NSAIDs including selective COX-2 inhibitors. Concomitant use w/ medicines increasing risk of ulceration or haemorrhage eg, oral corticosteroids, anticoagulants (eg, warfarin), SSRIs, platelet aggregation inhibitors (eg, ASA); diuretics, ACE inhibitors. Renal insufficiency, papillary necrosis & toxicity. Hepatic insufficiency. Not recommended in women of childbearing potential, during 1st & 2nd trimesters of pregnancy. Not to be used during lactation. Elderly or debilitated patients.
Adverse Reactions
Dyspepsia, diarrhoea. Headache, dizziness; GI side effects eg, nausea, abdominal fullness & pain, heartburn, anorexia, constipation, flatulence, vomiting, erosive gastritis, rectal blood loss; hypersensitivity reactions eg, urticaria, purpura, pruritus, exanthem.
Drug Interactions
Augmented GI effects & increased risk of haemorrhage w/ other NSAIDs including COX-2 inhibitors &/or glucocorticoids, alcohol. Inhibited efficacy of ASA on platelet aggregation. Delayed elimination & attenuated uricosuric effect w/ probenecid, sulfinpyrazone. Increased effect of anticoagulants eg, warfarin. Increased risk of GI haemorrhage w/ platelet aggregation inhibitors. Enhanced hypoglycemic effect of oral antidiabetics, insulin. Decreased excretion of aminoglycosides. Decreased efficacy of furosemide & thiazide diuretics. Weakened efficacy of antihypertensives eg, ACE inhibitors or β-blockers. Increased plasma conc of digoxin, phenytoin, lithium. Increased MTX toxicity. Increased risk of haemarthrosis & haematoma in HIV+ haemophilic patients w/ zidovudine. Increased risk of nephrotoxicity w/ tacrolimus. Increased exposure & plasma conc w/ voriconazole, fluconazole. Increased NSAID exposure w/ mifepristone. Increased baclofen toxicity. Increased seizures risk w/ quinolone. Increased toxic kidneys effect w/ ciclosporin. Potentiated NSAID-associated risk of bleeding w/ ginkgo biloba.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Spedifen FC tab 400 mg
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