IBUPROFEN

Posology For short-term use only. The dosage should be adjusted to the severity of the disorder and the complaints of the patient. 4). If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Children and Adolescents between 12 and 18 years:

Take 1 or 2 soft capsules with water, up to three times a day as required. Adults should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Adults:

Take 1 or 2 soft capsules with water, up to three times a day as required. The maximum single dose is 400 mg, the maximum daily dose is 1200 mg ibuprofen with dosage frequency of up to three times a day. Leave at least 4 hours between doses.

Do not take more than 6 capsules, soft containing 200 mg ibuprofen in any 24 hour period. Method of administration Ibuprofen capsule is for oral use. Capsule should not be chewed.

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 1200mg per day), for short-term use.

In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur. The adverse events observed most often 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). System Organ Class Frequency Adverse Event Blood and 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.

Immune System Disorders Uncommon Hypersensitivity reactions consisting of1:

Urticaria and pruritus Very rare Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Not Known Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.

Uncommon HeadacheNervous System Disorders Very rare Aseptic meningitis2 Cardiac Disorders Not Known Cardiac failure and oedema, Kounis syndrome Vascular Disorders Not Known Hypertension Uncommon Abdominal pain, nausea, dyspepsia Rare Diarrhoea, flatulence, constipation and vomiting Very rare Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly.

2 and 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. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

g. < 1200 mg daily) is associated with an increased risk of myocardial infarction. Respiratory Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. 5). 8). There is a risk of renal impairment in dehydrated children and 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.

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.

Patients with uncontrolled hypertension, congestive heart failure (NYHA IIIII), 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. Impaired female fertility There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation.

g. acetylsalicylic acid or other NSAIDs) precipitate attacks of asthma, rhinitis, or cause urticaria or angioneurotic oedema. - with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. - with active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

- with severe heart failure (NYHA Class IV). - with renal failure. - with hepatic failure. 6). - Ibuprofen capsules, lecithin (soya lecithin). If you are allergic to soya, do not use this medicinal product.