BANIMAX

Posology Adults: 2 tablets three to four times a day every 4 to 6 hours to a maximum of 8 tablets during any 24 hour period.

Elderly:

A reduced dosage may be required see precautions and warnings. g. for Kawasaki's disease).

Method of administration:

Oral The tablets should be swallowed whole and not broken or crushed.

Banimax may cause gastric irritation and dyspepsia. In some cases of intensive use gastric bleeding may occur. Nausea and vomiting, diarrhoea, tinnitus, vertigo, mental confusion. There have been reports of blood disorder, in particular thrombocytopenia and more rarely, agranulocytosis and of acute pancreatitis.

Hypersensitivity reactions such as skin reactions, dyspnoea and bronchospasms. Rhinitis, angioedema, severe cutaneous skin eruptions have been reported and pre-orbital oedema may occur. Very rare cases of serious skin reactions have been reported.

Metabolism and nutrition disorders:

Not known - High anion gap metabolic acidosis with frequency. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4 Special Warnings and Special Precautions for Use Patients suffering from glucose-6-phosphate dehydrogenase deficiency. Banimax should not be used before or after dental extractions and it should not be taken before or after alcohol consumption.

Care is advised in the administration of Banimax to patients with severe renal disease. The hazards of overdosage are greater in those with alcoholic liver disease. Do not exceed the stated dose. Patients should be advised not to take other paracetamol or aspirin-containing products concurrently.

If symptoms persist consult your doctor. Keep out of the reach of children. There is a possible association between Aspirin and Reye's Syndrome when administered to children. Reye's Syndrome is a very rare disease which affects the brain and liver, and can be fatal.

g. for Kawasaki's disease). The label should contain the statement "do not give to children under 16 years of age, unless on the advice of a doctor", "immediate medical advice should be sought in the event of an overdose, even if you feel well", and "Do not take with any other paracetamol containing products".

g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin . If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Important information regarding the ingredients in this medicine Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1 - Patients with asthma or allergic reactions to other non-steroidal anti- inflammatory drugs. - Patients with active of chronic or recurrent gastric or duodenal ulcers with/without concomitant bleeding. - Patients with haemorrhagic disease such as haemophilia.

- Patients with severe renal and liver disorders. - Aspirin must not be given to children under 16 years of age. - The last 3 months of pregnancy. (Doses > 100 mg/day during the third trimester of pregnancy)