IBUPROFEN

4). For oral administration. Adults and children aged over 12 years The recommended dose is one tablet to be taken three or four times daily. Some patients can be maintained on one tablet two or three times daily. In severe or acute conditions it can be advantageous to increase the dose until the acute phase is brought under control provided the daily dose does not exceed six tablets per day in divided doses.

Children Not suitable for children under 12 years. The Elderly The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.

The patient should be monitored regularly for GI bleeding during NSAID therapy. Directions The tablets must be dissolved in half a glass of water (100ml). The tablets dissolve more quickly in warm water, or if stirred. To be taken preferably with or after food.

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature. 4). 4 Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.

Immune system disorders:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens- Johnson syndrome and toxic epidermal necrolysis).

Cardiac disorders and vascular disorders:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). 4). Exacerbation of infection-related inflammations coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of ibuprofen the patient is therefore recommended to go to a doctor without delay.

Skin and subcutaneous tissue disorders:

In exceptional cases, severe skin infections and soft- tissue complications may occur during a varicella infection (see also "Infections and infestations") The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency convention and system organ classification.

Frequency groupings are classified according to the subsequent conventions: 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) and Not known (cannot be estimated from the available data).

4) Cardiac disorders Not known Kounis Syndrome Vascular disorders Very rare Hypertension Metabolism and nutrition disorders Not known Hypokalaemia* *Renal Tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of ibuprofen 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.

2, and GI and cardiovascular risks below). As with other NSAIDs, ibuprofen may mask the signs of infection. 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.

Gastrointestinal bleeding, ulceration and perforation:

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.

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 400mg Effervescent Tablets, the treatment should be withdrawn.

8).

Respiratory disorders and hypersensitivity reactions:

Caution is required if ibuprofen is administered to patients suffering from, or with a previous history of, bronchial asthma, chronic Rhinitis or allergic disease since NSAIDs have been reported to precipitate bronchospasm, urticaria or angioedema in such patients.

Cardiac, Renal and Hepatic Impairment:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases this risk. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.

3). Ibuprofen 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 advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200mg/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.

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. 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 […]

Hypersensitivity to ibuprofen or to any of the excipients. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy.

Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.

4 – Special warnings and precautions for use). 6 – Pregnancy and lactation).