IBUSOLVE

4). For oral administration and short-term use only.

Adults and the elderly and children and adolescents between 12 and 18 years:

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. Adults Initial dose - One or two tablets to be taken. The initial dose may be followed by further doses of one or two tablets every four hours.

Leave at least four hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period. To be taken preferably after food. Adults should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Children and Adolescents (age range: ≥ 12 years to < 18 years) Initial dose - One or two tablets to be taken. The initial dose may be followed by further doses of one or two tablets every four hours. If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Leave at least four hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period. To be taken preferably after food. Children Not suitable for children under 12 years. Directions The tablets must be dissolved in half a glass of water (100ml).

The tablets dissolve more quickly in warm water, or if stirred.

Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse events are presented in order of decreasing seriousness. The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses (maximum 1200 mg per day), for short-term use.

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

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.

4). 4). 4) have been reported following ibuprofen 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) Blood and lymphatic system disorders Very Rare Haemotopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia) First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

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

Immune system disorders Not known Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea. Uncommon Insomnia, anxietyPsychiatric disorders Rare Depression, confusional state Common Headache, dizziness Uncommon Paraesthesia.

Somnolence Aseptic meningitis2 Nervous system disorders Rare Optic neuritis Uncommon Visual impairmentEye disorders Rare Toxic optic neuropathy Ear and labyrinth disorders Uncommon Hearing impaired, tinnitus, vertigo Respiratory, thoracic and mediastinal disorders Uncommon Asthma, bronchospasm, dyspnoea Gastrointestinal disorders Common Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage Uncommon Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation Very rare Pancreatitis, peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly.

Ulcerative stomatitis, gastritis Not known Exacerbation of colitis and Crohn´s disease Uncommon Hepatitis, jaundice, hepatic function abnormal liver disorders Hepatobiliary disorders Very rare Hepatic failure Common Various skin rashes Uncommon Urticaria, pruritus, purpura, angioedema, photosensitivity reaction Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Skin and subcutaneous tissue disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised […]

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 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. 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, 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 diseases 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, hypertension and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at high doses (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 (2400mg/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 maintenance of renal perfusion. In […]

Ibuprofen is contraindicated in patients with hypersensitivity to active substance or to any of the excipients. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. 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). 6).