CALPROFEN IBUPROFEN

For oral administration and short-term use only.

Children:

For pain and fever - 20mg/kg/day in divided doses (including OTC use). 5ml three times a day. 5ml three to four times a day Children 3-7 years: 5ml three to four times a day Children 8-12 years: 10ml three to four times a day. 5ml (50mg) six hours later if necessary.

No more than 2 doses in 24 hours. If fever is not reduced, consult a doctor.

For Juvenile Rheumatoid Arthritis (prescription only use):

Doses up to 30- 40mg/kg/day may be taken in three or four divided doses.

Elderly:

No special dosage modifications are required unless renal or hepatic function is impaired, in which case dosage should be assessed individually. Do not give to children under 3 months of age. 4). For children aged ≥3 months to ≤5 months: if the child’s symptoms worsen or if the symptoms persist for more than 24 hours, consult a doctor.

For children aged 6 months and over: if symptoms worsen or if the symptoms persist for more than 3 days, consult a doctor .

g. g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). The following list of adverse events 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. The adverse drug reactions (ADRs) observed in patients treated with ibuprofen are listed below by System Organ Class.

Frequencies are defined in accordance with current guidance 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 frequency (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, when available, or 2) when incidence is unavailable, frequency category is listed as ‘Not Known’.

System Organ Class Incidence Adverse Drug Reaction Blood & lymphatic system disorders Very rare Haematopoietic disorders (Anaemia, Leucopenia, Thrombocytopenia, Pancytopenia, Agranulocytosis). 4). **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.

4. Special warning and precautions for use Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to relieve symptoms (see GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

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 nonhospital settings, the patient should consult a doctor if symptoms persist or worsen.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8). 8) 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 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.

1 . g. asthma, rhinitis, angioedema 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 gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 4). 6).