Mekophar Ibuprofen 600 mg Tablets

IBUPROFEN 600mg
Film-coated tablets

 

COMPOSITION

Ibuprofen 600mg

Excipients s.q. for 1 tablet

(Colloidal silicon dioxide, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, crospovidone, lactose, methacrylic acid copolymer, hypromellose, talc, titanium dioxide, erythrosine, polyethylene glycol 6000, ethanol 96%).

 

ACTIONS

Ibuprofen, a propionic acid derivative, is an nonsteroidal anti-inflammatory drug (NSAID), has analgesic, antipyretic and anti-inflammatory properties.

 

INDICATIONS

– It is indicated as anti-inflammatory and analgesic medication in headache, dysmenorrhea, toothache, myodynia, sprains, rheumatoid arthritis, osteoarthritis.

– Fever relief in fever, cold conditions.

 

DOSAGE AND ADMINISTRATION

– Taken this drug after meals.

– Recommended dosage for adults:

+ Analgesic and anti-inflammatory: 1 tablet, 2 – 4 times daily. Maximum dosage not exceeding 4 tablets a day.

+ Antipyretic: ½ tablet/time, repeat the dose every 6 hours if necessary. Maximum dosage not exceeding 2 tablets a day.

 

CONTRAINDICATIONS

– Hypersensitivity to ibuprofen, the other NSAIDs, or aspirin (asthma, rhinitis, urticaria after taking aspirin).

– Active gastro-duodenal ulcer.

– Patients with asthma or bronchospasm, bleeding disorders, heart disease, a history of gastro-duodenal ulcer, liver or renal impairment (glomerular filtration rate below 30mL/min).

– Patients that are taking anticoagulant coumarin.

– Patients with congestive heart failure, those with extracellular fluid depletion (e.g. patients receiving diuretics) or renal dysfunction (increased risk of renal dysfunction).

– Patients with connective tissue disease (at risk of aseptic meningitis, it is noteworthy that all of those that developed aseptic meningitis are with history of autoimmune disease).

 

PRECAUTIONS

– Drivers or operators of machinery, elderly.

– Ibuprofen may increase blood transaminases, but it is transient and reversible upon drug discontinuance.

– Visual disturbances, such as blurred vision is subjective signs that linked to adverse effect of the drug that gradually improved when the drug is discontinued.

– Ibuprofen can inhibit platelet aggregation and may prolong bleeding time.

 

PREGNANCY AND LACTATION

Contraindicated in pregnancy (especially the last trimester during pregnancy) and lactation.

 

SIDE-EFFECTS

– Common: fever, fatigue, abdominal distention, nausea, vomiting, headache, dizziness, restlessness, rashes, erythema.

– Uncommon: allergic reactions (especially bronchospasm in patients with asthma), rhinitis, urticaria, abdominal pain, gastro-intestinal bleeding, active peptic ulcer, lethargy, insomnia, tinnitus, visual disturbances, decreased hearing, prolonged bleeding time.

– Rarely: edema, rash, Stevens-Johnson syndrome, hair loss, depression, aseptic meningitis, blurred vision, color disorder, decreased visual acuity, leukopenia, thrombocytopenia, neutropenia, eosinophilia, granulocytopenia, anemia, gallbladder contractility disorder, abnormal liver function test, liver toxicity, cystitis, hematuria, acute renal failure, interstitial nephritis, nephrotic syndrome.

– Inform your doctor about side-effects when using this medicine.

 

INTERACTIONS

– Ibuprofen and NSAIDs may increase CNS adverse effects of the quinolone antibacterials and may result in convulsion.

– Magnesium hydroxide may increase initial absorption of ibuprofen, but if there is aluminium hydroxide in the combination that effect is lacked.

– Concurrent with other NSAIDs: increased risk of bleeding and GI ulceration.

– Methotrexate: ibuprofen may increase methotrexate toxicity.

– Furosemide: ibuprofen may decrease diuretic effect of furosemide and other diuretics.

– Digoxin: ibuprofen may increase digoxin concentration in the plasma.

 

OVERDOSAGE AND MANAGEMENT

Treatment of acute toxicity associated with ibuprofen overdosage mainly is supportive. When acute overdosage occurs measures that increase the drug elimination or inactivation such as gastric lavage, induced emesis and forced diuresis should be instituted, administration of activated charcoal or saline laxative may be useful. Hemodialysis or blood transfusion in severe cases. Since ibuprofen is acidic and is excreted in the urine, forced alkaline diuresis and infusion should be theoretically beneficial.

 

SHELF-LIFE

36 months from the manufacturing date.

Never use after the expiry date clearly indicated on the outer packaging.

 

STORAGE

Store in a dry place (RH ≤ 70%), not exceeding 30oC. Protect from light.

 

PRESENTATION

Blister of 10 film-coated tablets. Box of 10 blisters.

 

Always keep out of reach of children.

Read the directions carefully before use.

For further information, please refer to your doctor.

 

Manufactured by

MEKOPHAR CHEMICAL PHARMACEUTICAL JOINT-STOCK COMPANY

297/5 Ly Thuong Kiet Street – District 11 – Ho Chi Minh City – Vietnam

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