IBUPROFEN

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. If this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. The patient should consult a pharmacist or 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 tablet 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 (3 tablets) in any 24hour period. Not to be given to children under 12 years of age.

, pruritis, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). The following list of adverse effects relates to those experienced with Ibuprofen at OTC doses, for short-term use.

In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Infections and infestations:

Very rare: Aseptic meningitis Immune system reactions: Uncommon: hypersensitivity reactions with urticaria and pruritus.

Very rare:

Exacerbation of asthma and bronchospasm. In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.

Severe hypersensitivity reactions:

Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

Psychiatric disorders:

Very rare: Nervousness.

Gastrointestinal disorders:

The most commonly-observed adverse events are gastrointestinal in nature.

Uncommon:

Abdominal pain, abdominal distension, nausea and dyspepsia.

Rare:

Diarrhoea, flatulence, constipation and vomiting. 4) Mouth ulceration. 4) Nervous system: Uncommon: Headache Eye disorders: Very rare: Visual disturbance Ear and labyrinth disorders: Very rare: Tinnitus and vertigo Renal and urinary disorders: Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly are at an increased risk of the serious consequences of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

There is a risk of renal impairment in dehydrated children and adolescents.

Caution is required in patients with certain conditions:

Respiratory: Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8). 8) Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

5). Clinical studies suggest that use of ibuprofen, particularly at high dose (2400 mg daily) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. < 1200 mg daily) is associated with an increased risk of arterial thrombotic events.

Cases of Kounis syndrome have been reported in patients treated with Ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.

Impaired female fertility:

There is some evidence that drugs which inhibit cyclo- oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment. 8). 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 including ulcerative colitis, Crohn’s Disease.

Hypersensitivity to Ibuprofen or any of the excipients in the product. g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 6).