ESSENTIAL WAITROSE & PARTNERS IBUPROFEN

Method of administration For oral administration and short-term use only. Do not chew. 4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. Take one or two capsules (200 mg – 400 mg), up to three times a day as required (maximum dose 400 mg).

Leave at least four hours between doses and do not take more than 6 capsules (1200 mg) in any 24 hour period.

Paediatric population Children under 12 years:

Not recommended.

g. g. pruritus, 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 side-effects are listed below per system/organ class and frequency. Adverse reactions have been ranked under headings of frequency using the following convention: 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 (cannot be estimated from the available data).

4). System organ class Side effect Frequency Blood and lymphatic system disorders 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 Very rare Hypersensitivity reactions consisting of1: Urticaria and pruritus Uncommon Severe hypersensitivity reactions.

Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Very rare Immune system disorders Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.

Not known System organ class Side effect Frequency Headache UncommonNervous system disorders Aseptic meningitis2 Very rare Cardiac disorders Cardiac failure and oedema Kounis syndrome. Not known Vascular disorders Hypertension Not known Abdominal pain, nausea and dyspepsia.

Uncommon Diarrhoea, flatulence, constipation and vomiting. Rare Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. 4). Not known Hepatobiliary disorders Liver disorders.

Very rare Various skin rashes Uncommon Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome and toxic epidermal necrolysis). Very rare Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Acute generalised exanthematous pustulosis (AGEP). Photosensitivity reactions. Not known Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. Very rareRenal and urinary disorders Renal insufficiency, ureteric colic, dysuria, renal tubular acidosis Not known Investigations Decreased haemoglobin levels Very rare Decreased appetite Not knownMetabolism and Nutrition Disorders Hypokalaemia3 Not known Description of Selected Adverse Reactions 1 Hypersensitivity reactions have been reported following treatment with ibuprofen.

These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or (c) assorted skin disorders, including rashes of various types pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

2 The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation).

Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).

3 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). The elderly have an increased frequency of adverse reactions to NSAIDs, especially GI bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8). 8). There is a risk of renal impairment in dehydrated adolescents. 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. 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 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. 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). 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).

Ponceau 4R (E124) contained as excipient in the product may cause allergic reactions.

Masking of symptoms of underlying infections:

Ibucaps 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 Ibucaps is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non- hospital settings, the patient should consult a doctor if symptoms persist or worsen. 63 mg of sorbitol in each capsule.

Patients with rare hereditary problems of fructose intolerance should not take this medicine because of the presence of sorbitol. Ibucaps contains lecithin originating from soya oil. Patients who are allergic to peanut or soya should not use this medicinal product.

This medicine contains Ponceau 4R (E124). It may cause allergic reactions.

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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). Severe heart failure (NYHA Class IV). 6).