IBUPROFEN

4). Adults, the elderly and children over 12 years: 1 or 2 tablets, up to three times a day as required. The dose should not be repeated more frequently than every four hours and no more than 6 tablets in any 24-hour period. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Paediatric population:

Do not give to children under 12 years. 3 – Contraindications). 3 – Contraindications). Method of administration For oral use. It is recommended that patients with sensitive stomachs take Ibuprofen with food. If taken shortly after eating the onset of Ibuprofen may be delayed.

To be taken preferably with or after food, with plenty of fluid. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. 4).

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 dyspnea, 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 associations 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 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 (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data). g. 4) Cardiac disorders Not known Kounis syndrome Vascular disorders Very rare Hypertension Metabolism and Nutrition Disorders Not known Hypokalaemia* *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.

2, and GI and cardiovascular risks below). The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of analgesic medication. Patients with medication overuse headache should not be treated by increasing the dose of the analgesic.

In such cases the use of analgesics should be discontinued. The concomitant consumption of excessive alcohol with NSAIDs, including ibuprofen may increase the risk of adverse effects on gastrointestinal tract, such as GI haemorrhage or the central nervous system, possible due to an additive effect.

Masking of symptoms of underlying infections Ibuprofen Tablets can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella.

When Ibuprofen Tablets are administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. 5). 2). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents.

Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

5). When GI bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn. 8). Respiratory disorders and hypersensitivity reactions Caution is required if Ibuprofen is administered to patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic diseases since NSAIDs have been reports to precipitate bronchospasm, urticaria or angioedema in such patients.

1. g. asthma, angioedema, rhinitis, or urticaria) after taking ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. 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).