CARE IBUPROFEN FOR CHILDREN

Posology Children 8 to 12 years: 10ml three to four times daily. Children 3 to 7 years: 5ml three to four times daily. 5ml three to four times daily. 5ml three times daily. If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Not to be given to children under six months of age except on the advice of a doctor. 5ml 6 hours later, if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult your doctor. 4). 4). Method of administration To be taken with or after food.

For oral administration and short term use only.

Hypersensitivity reactions have been reported following treatment with Ibuprofen. , pruritis, urticaria, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use.

In the treatment of chronic conditions, under long- term treatment, additional adverse effects may occur.

In this section, frequencies of undesirable effects are defined as follows:

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).

Infections and infestations:

Not known: Exacerbation of infections related inflammation has been described, in exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.

Skin and subcutaneous tissue disorders:

Very rare: Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis).

Not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome); acute generalised exanthematous pustulosis (AGEP).

Blood and lymphatic system disorders:

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising and purpura.

Immune System disorders:

Uncommon: Hypersensitivity reactions with urticaria and pruritus. Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).

Exacerbation of asthma and bronchospasm. 4).

Nervous System disorders:

Uncommon: Headache and dizziness Very rare: Aseptic meningitis – single cases have been reported very rarely.

Ear & Labyrinth disorders:

Rare: Hearing disturbance Cardiac disorders: Not known: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4).

Gastrointestinal disorders:

Uncommon: abdominal pain, nausea, dyspepsia. Rare: diarrhoea, flatulence, constipation and vomiting Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly.

Ulcerative stomatitis, gastritis. 4).

Hepatobiliary disorders:

Very rare: liver disorders.

Skin and subcutaneous tissue disorders:

Uncommon: Various skin rashes Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.

Not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP), Photosensitivity reactions.

Renal and urinary disorders:

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Not Known:

Ureteric colic, dysuria, renal tubular acidosis* Metabolism and Nutrition Disorders Not Known: Decreased appetite, Hypokalaemia* *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

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). Should be used with care in patients with renal, hepatic or cardiac impairment as the use of non-steroidal anti-inflammatory drugs may result in the deterioration of renal function.

The dose should be kept as low as possible. For short term use only. The elderly have an increased frequency of adverse reactions to NSAIDS especially gastrointestinal bleeding and perforation which may be fatal Respiratory: In patients suffering from or with a previous history of bronchial asthma or allergic disease, bronchospasm may be precipitated.

8). 8). There is a risk of renal impairment in dehydrated children. 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). 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 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 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. 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 upon withdrawal of treatment. 8). 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.

) 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 at the initial stages of treatment.

5) When 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 of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

In exceptional cases, 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 this medicine in cases of varicella.

Masking of symptoms of underlying infections:

Care Ibuprofen for Children 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 Care Ibuprofen for Children Oral Suspension is administered for fever or pain relief in relation […]

1. g. asthma, bronchospasm, rhinitis, angioedema or urticaria) particularly associated with therapy with aspirin or other anti-inflammatory drugs. Active or 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). 6). Children under 6 months.