NUROFEN FOR CHILDREN

For oral administration and short-term use only. For children weighing more than 20kg, the daily dosage is 20mg/kg bodyweight in divided doses. Using the dosing device provided this can be achieved as follows; If the child’s symptoms persist for more than three days, consult a doctor.

This product should only be given to children between 7-12 years of age and weighing more than 20kg. Leave at least four hours between doses and do not give more than the recommended amount in any 24 hours period. For patients with sensitive stomachs it is recommended that Nurofen for Children 200 mg/5 ml Orange is taken during a meal.

If in children aged 7 to 12 years this medicinal product is required for more than three days, or if symptoms worsen, a doctor should be consulted. This product should only be given to children who weigh more than 20kg. 3). 3). Method of administration For oral use.

The list of the following undesirable effects comprises all undesirable effects that have become known under treatment with ibuprofen, also those under high-dose long- term therapy in rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.

With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary inter-individually. Adverse events which have been associated with Ibuprofen are given below. Listed by system organ class and frequency.

Frequencies are defined as:

Very common: ≥ 1/10 Common: ≥1/100 to < 1/10 Uncommon: ≥1/1,000 to < 1/100 Rare: ≥1/10,000 to < 1/1,000 Very rare: < 1/10,000 Not known: cannot be estimated from the available data Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent in particular the risk of occurrence of gastrointestinal bleeding which is dependent on the dose range and duration of treatment.

4). 4) have been reported following administration. Less frequently, gastritis has been observed. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). g development of necrotizing fasciitis) coinciding with the use of nonsteroidal anti-inflammatory drugs has been described.

This is possibly associated with the mechanism of action of the nonsteroidal anti-inflammatory drugs. If signs of an infection occur or get worse during use of Nurofen for Children 200 mg/5 ml Strawberry, the patient is recommended to go to a doctor without delay.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. The elderly are at increased risk of the consequences of adverse reactions. g. 8) - Directly after major surgery - Hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk for them of allergic reactions occurring.

These may be present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria. - In patients who have already reacted allergically to other substances, as an increased risk of hypersensitivity reactions occurring also exists for them on use of this product.

Respiratory Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. Other NSAIDs Use with concomitant NSAIDs including cyclo-oxygenase-2 selective inhibitors should be avoided.

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

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

5). When gastrointestinal 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).

1. g bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory medicinal products. • In patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy.

• In patients with active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • In patients with cerebrovascular or other active bleeding. • In patients with severe hepatic failure or severe renal failure • In patients with severe heart failure (NYHA IV) • In patients with unclarified blood-formation disturbances.

6). • In patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).