ANOFEN Tablet

Rheumatoid arthritis, osteoarthritis, relief of pain due to musculoskeletal inflammation.

Ibuprofen is also indicated for the treatment of primary dysmenorrhoea.

Dosage and Administration

1. Do not exceed 3200mg total daily dose. If gastrointestinal complaints occur, administer Ibuprofen with meals or milk.

2. Analgesic & antipyretic 600-1200mg daily, in divided doses.

3. For rheumatoid arthritis and osteoarthritis: 1200-3200mg daily in divided doses. When treating patients with 3200mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk. In general, patients with rheumatoid arthritis seem to require higher doses of Ibuprofen than patients with osteoarthritis.

4. Dysmenorrhoea: 400mg every 4 hours when necessary for relief of pain.

5. A suggested dose for children:

20mg/kg daily, in divided doses.

Not recommended for children under the age of 1 year or for children weighing less than 7kg. For short term use only.

Should not be used in patients who have previously exhibited hypersensitivity to the drugs, or in individuals with the symptoms of nasal polyps, angioedema and bronchospastic reactivity to Aspirin or other NSAIDs.

Gastrointestinal: Nausea, epigastric pain, heartburn, diarrhoea.

Others: Dizziness, dyspepsia, headache, nervousness, pruritus, tinnitus, depression, insomnia, blurred vision and other ocular reactions.

Thrombocytopenia, agranulocytosis, hypersensitivity reaction, abnormalities of liver function test, impairment of renal function including interstitial nephritis or nephrotic syndrome.

Because of the known effects of NSAIDs on the fetal cardiovascular system, use during late pregnancy should be avoided.

1. Should not be used in patients who have previously exhibited hypersensitivity to the drugs, or in individuals with the symptoms of nasal polyps, angioedema and bronchospastic reactivity to Aspirin or other NSAIDs.

2. Ibuprofen should be given under close supervision to patients with a history of upper gastrointestinal tract disease.

3. Fluid retention and edema have been reported with Ibuprofen, therefore, the drug should be used with caution in patients with cardiac decomposition or hypertension.

4. Ibuprofen, like other NSAIDs, can inhibit platelet aggregation but the effect is less than that seen with Aspirin.

5. It should be used with caution in patients with intrinsic coagulation defects and that on anticoagulation therapy because Ibuprofen may prolong bleeding time.

6. May mask diagnostic signs in detecting complications of non-infectious non-inflammatory painful conditions.

7. Severe hepatic reactions have been reported with Ibuprofen as with other NSAIDs. Discontinue use if liver disease develops.

8. Since Ibuprofen is eliminated primarily by the kidneys, patients with significantly impaired renal functions should be closely monitored.

9. Because of the known effects of NSAIDs on the fetal cardiovascular system, use during late pregnancy should be avoided.

WARNINGS!

Risk of GI ulceration, bleeding and perforation with NSAID: See the package insert about the details.

In clinical studies in patients with rheumatoid arthritis and osteoarthritis, Ibuprofen has been shown to be comparable to Aspirin in controlling pain and inflammation and with a statistically significant reduction in the milder gastrointestinal side effects.