IBUPROFEN

For oral administration and short-term use only. 4).

Children aged 3 months to 12 years:

For pain and fever - 20mg/kg/day in divided doses. 5 ml dose may be given 3 times in 24 hours. 5 ml three to four times a day. 5 ml three times a day Children from 7 up to 12 years: 10 ml threetimes a day. Doses should be given every 6 to 8 hours if required.

Leave as least 4 hours between doses. 5ml (50mg) six hours later if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult a doctor. Do not give to children under 3 months of age. For infants aged 3 - 5 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 and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

). Respiratory disorders and hypersensitivity reactions Ibuprofen should be used with caution in patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic disease, since such patients may have NSAID – sensitive asthma which has been associated with severe bronchospasm, urticaria or angioedema.

Cardiac, renal and hepatic impairment Administration of NSAID’S such as Ibuprofen may cause dose dependent in prostaglandin formation and precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases this risk.

Patients at greater risk of this reaction include those with impaired renal function, cardiac impairment or liver dysfunction, those taking diuretics and the elderly. 3). Ibuprofen 100mg/5ml Oral Suspension should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration.

Cardiovascular and Cerebrovascular effects:

Appropriate monitoring and caution (discussion with doctor or pharmacist) are required prior to starting treatment in patients with a history of hypertension and/or mild to moderate congestive 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 100mg/5ml Oral Suspension.

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. Renal effects Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration.

There is a risk of renal impairment especially in dehydrated children, adolescents and the elderly. 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.

As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.

In these patients, administration of an NSAID may cause a dose dependant reduction in prostaglandin formation and, secondarily, in renal blood flow, which may cause renal failure. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly.

Discontinuation of NSAID therapy is usually followed by recovery to the pre- treatment state. 8 Undesirable effects). 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).

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of ibuprofen in case of varicella (chickenpox).

Haematological effects Ibuprofen, like other NSAIDs, can interfere with platelet aggregation and prolong bleeding time in normal subjects. Aseptic meningitis Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy.

Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. Masking of symptoms of underlying infections Ibuprofen 100mg/5ml Oral Suspension 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 Ibuprofen 100mg/5ml Oral Suspension is administered for fever or pain relief in relation to infection, monitoring […]

2, and GI and cardiovascular risks below). 5). The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of analgesic medication. Patients with medication overuse headache should not be treated by increasing the dose of the analgesic.

In such cases the use of analgesics should be discontinued. The concomitant consumption of excessive alcohol with NSAIDs, including ibuprofen, may increase the risk of adverse effects on the gastrointestinal tract, such as GI haemorrhage or the central nervous system possibly due to an additive effect.

2). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents. Impaired female fertility The use of Ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Ibuprofen should be considered.

Gastrointestinal bleeding, ulceration and perforation 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), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal 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 Undesirable effects). Respiratory disorders and hypersensitivity reactions Ibuprofen should be used with caution in patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic disease, since such patients may have NSAID – sensitive asthma which has been associated with severe bronchospasm, urticaria or angioedema.

Cardiac, renal and hepatic impairment Administration of NSAID’S such as Ibuprofen may cause dose dependent in prostaglandin formation and precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases this risk.

Patients at greater risk of this reaction include those with impaired renal function, cardiac impairment or liver dysfunction, those taking diuretics and the elderly. 3). Ibuprofen 100mg/5ml Oral Suspension should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration.

Cardiovascular and Cerebrovascular effects:

Appropriate monitoring and caution (discussion with doctor or pharmacist) are required prior to starting treatment in patients with a history of hypertension and/or mild to moderate congestive 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 100mg/5ml Oral Suspension.

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. Renal effects Caution should be used when initiating treatment with ibuprofen in […]

1. g. asthma, rhinitis, angioedema or urticaria) after taking ibuprofen, aspirin or other non-steroidal anti- inflammatory drugs (NSAIDs). History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active or history of recurrent peptic ulcer/gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

Patients with conditions involving an increased tendency to bleeding. 4, Special warnings and precautions for use). 6 Pregnancy and lactation).