IBUPROFEN

Method of administration For oral administration To be taken preferably with or after food. For short-term use only. 4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than ten days.

If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Adults, the elderly and children over 12 years 200mg – 400mg, up to three times a day as required. Leave at least four hours between doses and do not take more than 1200mg in any 24 hour period.

Do not give to children under 12 years of age, except on the advice of a doctor.

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.

Immune system disorders:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens- Johnson syndrome and toxic epidermal necrolysis).

Cardiac disorders and vascular disorders:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). 4). Exacerbation of infection-related inflammations coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to go to a doctor without delay.

Skin and subcutaneous tissue disorders:

In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection (see also "Infections and infestations") The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency convention and system organ classification.

Frequency groupings are classified according to the subsequent conventions: very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

2, and GI and cardiovascular risks below). As with other NSAIDs, ibuprofen may mask the signs of infection. The use of ibuprofen product with concomitant NSAIDs including cyclo- oxygenase-2 specific inhibitors should be avoided due to the increased risk of ulceration or bleeding (See section

Ibuprofen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy.

Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.

4). 6).