Ibucine Paediatric Suspension 5 ml Suspension

Ibucine is indicated for the management of mild to moderate pain and inflammation. Ibucine is also used to reduce fever. Ibucine is used in the management of mild to moderate pain and inflammation in, musculoskeletal and joint disorders such as rheumatoid arthritis, peri-articular disorders such as bursitis, and tensosynovitis, and soft tissue disorder such as pains and sprains.

Children: Juvenile Rheumatoid Arthritis - 20 mg/kg of body mass daily in divided doses with up to 40 mg/kg being given daily if necessary. Ibucine is not recommended for children under 1 year of age or in those weighing less than 7 kg. Pain: 5 mg/kg of body mass. A second dose of 5 mg/kg may be given after 2 hours if pain is not controlled, thereafter 5 mg/kg every 4-6 hours. If pain persists for more than 7 days, consult your physician. Fever: 5 mg/kg of body mass every 4-6 hours. If fever persists more than three days consult your doctor.

Age Daily Dosage Body Mass

• 1 - 2 years 2,5ml 3 u2013 4 times daily 7 - 12 kg
• 3 - 7 years 2,5-5ml 3 u2013 4 times daily 14 - 23 kg
• 8 - 12 years 10 ml 3 - 4 times daily 25 - 40 kg

Ibucine should not be given to patients with peptic ulceration and should be used with caution in patients with a history of such disorder. Ibucine should not be administered during the third trimester of pregnancy. Hypersensitivity to Ibuprofen. There is considerable cross reactivity between aspirin and other non-steroidal anti-inflammatory medicines and it is generally recommended that patients who have had a hypersensitivity reaction to one particular non-steroidal anti-inflammatory medicine should avoid all non-steroidal anti-inflammatory medicines.

Ibucine should be used with caution in patients with a history of peptic ulceration. Other precautions to be observed include patients with haemorrhagic disorders, asthma, a history of hypersensitivity reactions to aspirin or other NSAIDs, hypertension, and impaired renal, hepatic or cardiac function. Patients should be monitored for the development of blood, kidney, liver or eye disorders. Ibucine should be used with caution in the elderly.

Care is required in those receiving oral anti-coagulants, lithium, methotrexate and cardiac glycosides. Patients with collagen disease may be at increased risk of developing aseptic meningitis. Ibucine should be discontinued in patients who experience blurred or diminished vision, or changes in colour vision. Ibucine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Ibucine contains sucrose and sorbitol. This should also be taken into account in patients with diabetes mellitus. May be harmful to the teeth.

There is considerable cross reactivity between aspirin and other non-steroidal anti-inflammatory medicines (see 4.3).

Ibucine should not be administered during the third trimester of pregnancy (see 4.3).

The most common side effects with Ibucine are gastro-intestinal disturbances; these are usually mild and reversible but in some patients peptic ulcer and gastro-intestinal bleeding have been reported.

CNS -related side effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia. Hypersensitivity reactions may occur and include fever, asthma and rashes. Hepatotoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions. Some patients may experience visual disturbances, such as blurred vision, changes in visual colour perception and toxic amblyopia. Haematological adverse effects include anaemias, thrombocytopenia, neutropenia, eosinophilia, and agranulocytosis. They may cause nephrotoxicity such as interstitial nephritis, nephrotic syndrome and renal failure. Ibucine can provoke bronchospasm in patients with asthma. Ibuprofen may cause cystitis and haematuria.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: http://www.sahpra.org.za/publications/index/8

Epigastric pain and nausea, electrolites may be corrected by intravenous infusions, if necessary.