IBUPROFEN MEDLEY

4). For short term use only. The recommended daily dose of the product is 20 – 30 mg per kg of body weight, divided into equal doses, with dosing intervals of 6 to 8 hours. Leave at least 4 hours between doses and do not take more than the recommended dose in 24 hours.

The recommended dose should not be exceeded. 5 ml spoonful) may be taken 3 times in 24 hours Children 7-9 years 21-30 two 5 ml doses may be taken 3 times in 24 hours Children 10- 12 years 31-40 three 5ml doses may be taken 3 times in 24 hours Not suitable for children under 3 months of age unless advised by a doctor.

Do not use this product in children weighing less than 5 kg. For infants aged 3-6 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children aged from 6 months this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

For children under 6 months medical advice should be sought after 24 hours use (3 doses) if the symptoms persist. Method of administration For oral administration. For patients with sensitive stomachs the product can be taken with or after food.

). 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.

8).

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 upon withdrawal of treatment. 8). Gastrointestinal 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. 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). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). 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 If signs and symptoms suggestive of these reactions appear, ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate).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 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. Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications.

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 have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8).

Cardiovascular and cerebrovascular effects:

Cases of Kounis syndrome have been reported in patients treated with Nurofen for Children. 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.

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 trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

g. ≤ 1200mg daily) is associated with an increased risk of myocardial infarction. 8 Undesirable effects). 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.

8).

Impaired female fertility:

g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs. Active or a 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. 4, Special warnings and precautions for use). 6 Pregnancy and lactation).