PEROFEN Coated / Film-coated tablet Ref.[28046] Active ingredients: Ibuprofen

For oral administration and short-term use only.

Adults, the elderly and children and adolescents between 12 and 18 years

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Adults should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Children and adolescents between 12 and 18 years: Take 1 tablet with water, up to three times a day as required.

Adults: Take 1 tablet with water, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 3 tablets in any 24 hour period.

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. In serious poisoning metabolic acidosis may occur.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5 years.

Store below 25ºC.

Protect from light and moisture.

Perofen 400 mg coated tablets:

PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 tablets.

PP containers with PE closure. Pack-size of 1000 tablets.

Perofen 400 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 20, 30, 100 and 1000 tablets.

PP containers with PE closure. Pack-size of 1000 tablets.

Not all pack-sizes may be marketed.

Not applicable.