Ibuprofen ..................................... 400 mg
Excipients q.s ……………….………… 1 tablet
Film coated tablet.
Product description: A capsule-shaped, orange-colored film-coated tablet, scored on one side, plain on the other side, undamaged edges.
Box of 10 blisters x 10 film coated tablets.
ATC code: M01A E01
Hagifen contains the active ingredient Ibuprofen which is a propionic acid derivative NSAID. Ibuprofen has shown anti-inflammatory, antipyretic, and analgesic activity. The mechanism of action of the drug appears to be associated with the inhibition of cyclooxygenase enzymes. Ibuprofen may involve inhibition of synthesis of prostaglandins which cause inflammation, pain, and fever. Ibuprofen has a good anti-inflammatory and analgesic activity in the treatment of rheumatoid arthritis.
Ibuprofen is considered to be among the safest NSAIDs.
Ibuprofen is well absorbed from the gastrointestinal tract. Maximum plasma concentrations are reached 1 - 2 hours after ingestion. The half-life of ibuprofen is about 2 hours. Ibuprofen is rapidly excreted in the urine.
The drug should be used with caution by drivers, machinery operators because of possibility of dizziness, vertigo.
Use of ibuprofen is not recommended during pregnancy. Ibuprofen may inhibit uterine contractions and delay parturition; increase the risk of bleeding; cause possible severe pulmonary hypertension and severe respiratory failure in neonates.
Ibuprofen appears in breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
Ibuprofen can increase the ADR on CNS associated with quinolone antibiotics and the toxicity of methotrexate and digoxin.
Concomitant use with other NSAIDs causes an increased risk of gastrointestinal bleeding and ulcers.
Magnesium hydroxide increases the initial absorption of ibuprofen, but if ibuprofen and aluminum hydroxide are present concomitantly, the effect does not work.
Ibuprofen may reduce the natriuretic effect of furosemide or diuretics.
Common: fever, fatigue, abdominal distention, nausea, vomiting, headache, vertigo, dizziness, restlessness, pruritus, rash.
Uncommon: allergic reactions, rhinitis, urticaria, abdominal pain, GI bleeding, gastric ulcer, drowsiness, insomnia, tinnitus, visual disturbances, decreased hearing, prolonged bleeding time.
Rare: edema, rash, Stevens-Johnson syndrome, alopecia, depression, blurred vision, dyschromatopsia, amblyopia due to drug poisoning.
Please inform your doctor of all undesirable effects upon drug administration.
Treatment should be symptomatic and supportive. When acute overdosage of ibuprofen occurs, the following measures should be applied to increase elimination and inactivate the drug: gastric lavage, induced emesis and diuresis, oral administration of activated charcoal or saline cathartic. In case of severe cases, hemodialysis or blood transfusion should be considered. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis.
Store in dry places, not exceeding 300C, protect from light.
The drug should be used with caution in the elderly.
Ibuprofen should be used with caution in patients who may be adversely affected by a prolonged bleeding time, since the drug may inhibit platelet aggregation.
Cardiovascular thrombotic events: Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses. Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. To minimize the potential risk for an adverse cardiovascular event in Hagifen-treated patients, use the lowest effective daily dose for the shortest duration possible.
The product contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase Lapp deficiency or glucose-galactose malabsorption should not take this medicine.
The product contains orange E110 which can cause allergic reactions.
For mild to moderate analgesia and anti-inflammation associated with headache, toothache, dysmenorrhea, arthralgia, pain from soft tissue injuries and postoperative pain.
Patients with a known hypersensitivity to one of the ingredients of the drug.
Patients with progressive gastric ulcers.
Patients with severe liver failure or kidney failure, asthma, bronchospasm, bleeding disorders, cardiovascular disease, connective tissue disease.
Patients receiving coumarin anticoagulant.
Patients with hypersensitivity to aspirin or other NSAIDs.
Patients with congestive heart failure, reduced circulatory volume caused by diuretics or kidney failure.
Last trimester of pregnancy.
The drug should be taken after meals.
Adults: The recommended oral dosage is 1 tablet, twice to three times daily.
Or as directed by the physician.
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