Specifications: In-house

Formula
Each sachet contains nimesulide 100 mg and excipients q.s. (macrogol 1000, sucrose, maltodextrin, citric acid, orange flavour).

Dosage form
Granules.

Presentation
Box of 20 sachets x 2 g of granules.
Box of 60 sachets x 2 g of granules.

Indications 
For a variety of conditions requiring anti-inflammatory, analgesic, antipyretic activities, e.g. osteoarthritis, extra-articular rheumatic diseases, pain and inflammation after operative intervention and following acute trauma, relief of fever and pain associated with acute respiratory tract inflammation and dysmenorrhea.

Contra-indications
Sensitivity to nimesulide, acetyl salicylic acid, other Non-Steroidal Anti-Inflammatory Drugs.
Acute stomach ulcers.
Moderate to severe hepatic impairment, severe renal impairment.
Pregnant women (at the third trimester) and breast-feeding women, children under 12 years of age.

Precautions
Allergic to Non-Steroidal Anti-Infammatory Drugs (NSAIDs) or acetyl salicylic acid.

Side effects
Gastro-intestinal disturbances: Gastralgia, heartburn, nausea. However, these symptoms are rare.
Skin: Skin rash, itching.
Central nervous system: Headache, vertigo.
The physician should be informed any side effects during the treatment with B-NALGESINE.

Drug interactions: 
- Concomitant nimesulide may reduce the bioavailability of furosemide. Nimesulide may displace salicylic acid from plasma proteins, increase hypoglycemic action of glibenclamide and decrease plasma theophylline levels.
- Do not concomitant nimesulide with other NSAIDs, anticoagulants (po.), heparin (inj.), Ticlopidine, lithium and methotrexate (<= 15 mg/week).
- When diuretics or methotrexate (>= 15 mg/week) or pentoxifylline are administered to patient receiving nimesulide, the patient should be observed closely.

Dosage and Administration
Adults and children > 12 years old: 1 sachet of granules miced with water x 2 times a day, dose may be increased to 2 sachets x 2 times a day if necessary.
This drug should be taken after meal.

Shelf-life
36 months.

Storage
Store in a dry and cool place (<25 degree C). Keep out of reach of children.

Read leaflet carefully before use. 
For more information, consult your physician