IBUPROFEN FOR CHILDREN

For oral administration and short term use only, as required:

Children over 7 years: 10ml three times daily. 5ml three times daily. Children 1 to 4 years: 5ml three times daily. 5ml three to four times daily. 4). If in children (aged from 6 months and above) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

5ml three times daily. For infants aged 3-5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. Doses should usually be given every 6-8 hours. Leave at least four hours between doses.

Not to be given to children under 3 months of age. Not recommended for children weighing less than 5kg. 5ml 6 hours later, if necessary. No more than 2 doses (5ml) in 24 hours. If fever is not reduced, consult your doctor. 4). The product can cause a transient burning sensation, tingling or numbness in the mouth or throat.

A drink of water taken soon after the medicine is swallowed may help to minimise these effects. Babies under 6 months can be given boiled, cooled water from a baby bottle. Older children can have water from a baby bottle, top cup or open-top beaker as appropriate to the child’s age.

). 8 Undesirable effects). There is risk of renal impairment in dehydrated children & 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. g. ≤ 1200mg daily) is associated with an increased risk of myocardial infarction. 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 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. In exceptional cases, use of ibuprofen is associated with an increased risk of developing serious cutaneous and soft tissue infectious complications of varicella (chicken pox).

To date, the contributing role of NSAIDs in the worsening of these infections is unclear. Thus, it is advisable to avoid use of ibuprofen in children with varicella.

Information about some of the ingredients in this medicine:

Contains Liquid Maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains 5mg Sodium benzoate (E 211) in each 100mg/5ml. This medicine also contains Sodium Methylparahydroxybenzoate (E219) and Sodium Propylparahydroxybenzaote (E217) which may cause allergic reactions (possible delayed).

This medicine contains less than 1 mmol sodium (23 mg) per 10ml, that is to say essentially `sodium- free'.

The label will include:

Please read the enclosed leaflet carefully before using this […]

). 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