Ibuprofen Caplets 400mg

00506052

4 years from date of manufacture

Ibuprofen 400 mg

Microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, colloidal silicon dioxide, red ferric oxide, magnesium stearate, and carnauba wax.

Brown, capsule shaped, biconvex film-coated tablet with "IBU 400" on one side.

Diameter: 0.3000 x 0.6560 mod. capsule
Thickness: 0.212" - 0.230"

Store at room temperature (15 to 30°C).

For the temporary relief of menstrual pain (dysmenorrhea), toothache (dental pain), minor aches and pains in muscles, bones and joints, fever and headache and pain due to arthritis or rheumatism.

Adults and children over 12 year of age: 1 caplet (400mg) every 4 hours to a maximum daily dose of 3 caplets (1200mg), except as directed by a doctor or dentist.

Consult your doctor, dentist or pharmacist before taking this drug if you suffer from peptic ulcers, high blood pressure, asthma, heart failure, kidney or liver disease, alcoholism, have a history of stomach bleeding, have any other serious disease or condition, are pregnant or nursing, or are taking any other drug.

Caution should be exercised when taking ibuprofen with any other products that may cause bleeding (e.g. anticoagulants, other NSAIDs and certain herbal products). Ibuprofen may decrease the effect of some antihypertensive agents (ACE inhibitors and ARBs) as well as diuretics and may increase cyclosporine, digoxin, lithium, and methotrexate levels. Ibuprofen may potentiate adverse renal effects of ACE inhibitors. Ibuprofen is a minor substrate of CYP2C8/9 and a major inhibitor of CYP2C8/9.

Ibuprofen should not be used in patients who have previously exhibited hypersensitivity to it or in individuals who are known to have a sensitivity (manifested as asthma, bronchospasm, hypotension, angioedema, laryngeal edema, swelling, shock or urticaria) to ASA or other NSAIDs. Ibuprofen should not be used during pregnancy, especially during the 3rd trimester. Ibuprofen should not be used in patients with acute peptic ulcer or gastrointestinal bleeding.

Edema, nausea, epigastric pain, heartburn, headache, nervousness, diarrhea, dizziness, rash, bleeding disorders are the more common adverse reactions. Rare adverse reactions include: acute renal failure, agranulocytosis, anaphylaxis, blurred vision, bone marrow suppression, decreased creatinine clearance, GI bleed, hypertension, inhibition of platelet aggregation, Stevens-Johnson syndrome, and vision changes.

Symptoms: May may include apnea, metabolic acidosis, nausea, vomiting, abdominal pain, drowsiness, nystagmus, diplopia, headache, tinnitus, impaired renal function, coma and hypotension. Generally, full recovery can be expected with appropriate symptomatic management.

Treatment: Appropriate interventions to decontaminate the gastrointestinal tract may be beneficial within the first 4 hours after ingestion. Routine symptomatic and supportive treatment is then recommended. Fluid therapy that may help manage hypotension is commonly effective. Physicians should contact the Regional Poison Control Centre for additional guidance about ibuprofen overdose management.