IBUPROFEN

For oral administration and short term use only:

Adults, the elderly and children over 12 years: The minimum effective dose should be used for the shortest time necessary to relieve symptoms. Swallow 200mg – 400mg (1-2 capsules), preferably with water, up to three times a day, as required.

Leave at least four hours between doses and do not take more than 1200mg (6 capsules) in any 24 hour period. If in adults this medicinal product is required for more than 10 days, or if symptoms worsen the patient should consult a doctor.

If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, of if symptoms worsen a doctor should be consulted. Not to be given to children under 12 years. 4).

). 8 Undesirable effects). There is risk of renal impairment in dehydrated adolescents. 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.

8 Undesirable effects).

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

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

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. 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 limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. 8 Undesirable effects). GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

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

5 Interactions). Where GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8 Undesirable Effects). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

Masking of symptoms of underlying infections:

This medicine can caplets 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 this medicine is 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.

Information about some of the ingredients in this medicine:

This medicine contains 80mg lactose per 400mg dose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 72mg of sucrose per 400mg dose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per caplet, that is to say essentially ‘sodium- free’.

The label will include:

Please read the enclosed leaflet carefully before use. Do not take if you: have or have had a stomach ulcer, perforation or bleeding of the stomach are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers are taking other NSAID painkillers, or aspirin with a daily dose above 75mg If you are pregnant do not take this product and ask your doctor for advice.

Talk to a pharmacist or your doctor before taking this product if you: are elderly […]

). Last trimester of pregnancy (see section

Hypersensitivity to ibuprofen or any of the excipients in the product. g. asthma, rhinitis, 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 upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section