CALPROFEN

To be taken orally. For short term use only. Massage the sachet before opening.

Children aged 3 months to 12 years:

For pain and fever – 20mg/kg/day in divided doses. 5 ml (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. 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 Discard any unused portion of an opened sachet.

g. asthma, aggravated asthma, bronchospasm or dyspnoea. g. pruritis, urticaria, angioedema 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. 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). First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

4) Uncommon Headache Very rare Aseptic meningitis – single cases have been reported very rarely. 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.

Undesirable effects may be minimised by using the lowest effective dose for the shortest 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.

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. Avoid use immediately before or after heart surgery. Caution should be exercised in patients taking a diuretic.

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. The use of ibuprofen is therefore not recommended in women attempting to conceive.

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. 3), 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 in the initial stages of treatment. 5). Caution should be taken when using ibuprofen with excessive alcohol or heavy alcohol drinkers.

Alcohol may increase the risk of gastrointestinal bleeding. When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash or blisters.

If any of these symptoms occur, patients should stop use and seek medical help right away. 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be […]

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).