IBUPROFEN

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. 5ml) may be taken 3 times in 24 hours) Children 7 - 9 years 21-30 200 mg (10 ml) two 5ml doses may be taken 3 times in 24 hours Children 10-12 years 31-40 300mg (15ml) 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. 4). Method of administration For oral administration and short-term use only. To be taken preferably with or after food.

A plastic syringe (5 ml) is provided with the bottle to aid correct dosing.

The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis has been observed. Undesirable effects are mostly dose-dependent. Especially the risk for the occurrence of gastrointestinal bleedings depends on the dosage range and duration of the treatment.

4. g. g. pruritus, urticaria, purpura, angioedema and very rarely exfoliative and bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis). g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described.

If signs of an infection occur or get worse during use of IBUPROFEN, the patient is recommended to go to a doctor without delay. In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.

4). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Adverse events at least possibly related to ibuprofen are displayed by MedDRA frequency convention and system organ class.

The following frequency groupings are used:

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) and Not known (cannot be estimated from the available data). System Organ Class Frequency Adverse Reaction Uncommon RhinitisInfections and infestations Very rare Aseptic meningitis Blood and lymphatic system disorders Very rare Leucopoenia, thrombocytopenia, neutropenia, agranulocytosis aplastic anaemia and haemolytic anaemia.

The first symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion unexplained bleeding and bruising. Uncommon Hypersensitivity reactions such as urticaria, pruritus, purpura and exanthema as well as asthma attacks (sometimes with hypotension) Rare Lupus erythematosus syndrome Immune system disorders Very rare Severe hypersensitivity reactions.

The use of IBUPROFEN with concomitant NSAIDs, including cyclooxygenase 2 selective inhibitors, should be avoided. Asthmatic patients are to seek their doctor’s advice before using ibuprofen (see below). 2, and GI and cardiovascular risks below).

Higher than recommended doses may cause serious risks. g. 6) Special care has to be taken in the following cases: - Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease) - Cardiac insufficiency and hypertension - Reduced renal function - Hepatic dysfunction - Disturbed haematopoiesis - Blood coagulation defects - Allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease or bronchial asthma as an increased risk of allergic reactions occurring in these patients.

These allergic reactions may present as asthma attacks (so-called analgesic asthma) Quincke’s oedema or urticaria - Immediately after major surgical interventions Gastrointestinal bleeding, ulceration and perforation 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.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). 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). 2). 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.

1. , asthma, rhinitis, angioedema, or urticaria) in response to acetylsalicylic acid or other non-steroidal anti- inflammatory drugs. Active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 4). Bleeding diathesis and coagulation disorders. Significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). Cerebrovascular or other active bleeding.

Children under 3 months of age. 6).