Specifications: In-house

Formula
Each tablet contains nimesulide 100 mg and excipients q.s. (dioctyl sodium sulfosuccinate, lactose monohydrate, sodium starch glycolate, hydroxypropyl cellulose, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate).

Dosage form
Tablets.

Presentation
Box of 1 bottle x 100 tablets.
Box of 2 blisters x 5 tablets.
Box of 6 blisters x 10 tablets.

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 nimesulid 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: 1 tablet x 2 times a day, this may be increased to 2 tablets x 2 times a day if necessary.
This drug should be swallowed with liquid after a meal.

Shelf-life
48 months.

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

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