IBUCALM Coated tablet Ref.[50636] Active ingredients: Ibuprofen

Source: Web Search  Revision Year: 2021  Publisher: Aspar Pharmaceuticals Ltd, Albany House, Acrewood Way, St Albans, AL4 0JY, United Kingdom

4.1. Therapeutic indications

Rheumatic or muscular pain, pain of non-serious arthritic conditions,
backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea,
feverishness, symptoms of colds and influenza.

4.2. Posology and method of administration

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

For oral administration and short-term use only.

Adults, the elderly and children over 12 years

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Adults, the elderly and children over 12 years

One or two tablets to be taken three times a day as required. These tablets should be taken with water. Leave at least four hours between doses and do not take more than 1200mg (6 tablets) in any 24hour period.

Not to be given to children under 12 years of age.

4.9. Overdose

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half life in overdose 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 vertigo, headache, respiratory depression, dyspnoea, 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.

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.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25ยบC. Store in the original package (blisters) to protect
from moisture).

6.5. Nature and contents of container

Cartons of 24, 48 or 96 tablets in blister packs of aluminium foil/upvc.

6.6. Special precautions for disposal and other handling

Not applicable.

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