GSL: General Sales Licence
This information is intended for use by health professionals
Respiratory:In patients suffering from or with a previous history of bronchial asthma or allergic disease, bronchospasm may be precipitated.Other NSAIDS:The use of Junior Ibuprofen for Children 100mg/5ml (Care Ibuprofen for Children Oral Suspension) with concomitant NSAIDS including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5)
SLE and mixed connective tissue disease:Systemic lupus erythematosus and mixed connective tissue disease increased risk of aseptic meningitis (see section 4.8).
Renal:Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children.Hepatic:Hepatic dysfunction (see sections 4.3 and 4.8).
Cardiovascular and cerebrovascular effectsCaution (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 high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200mg daily) 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. Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. 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. Gastrointestinal: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).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.The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3.) 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 at the initial stages of treatment.Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5)When bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
Dermatological:Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDS (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Junior Ibuprofen Suspension 100mg/5ml (Care Ibuprofen for Children Oral Suspension) should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity
The label will include:Read the enclosed leaflet before taking this product.Do not give to your child if they:• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding• are allergic to ibuprofen or any other ingredients of the product, aspirin or other related painkillers• are taking other NSAID painkillers, or aspirin with a daily dose above 75mgSpeak to a pharmacist or your doctor before taking, if the person taking the product:• Has or has had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems• are a smoker• are pregnant If symptoms persist or worsen, consult your doctorThis product is intended for children aged between 6 months and 12 years.
If you are an adult taking this product:Speak to your doctor or pharmacist before taking if;You are pregnant; you are trying to get pregnant; are elderly; are a smokerDo not exceed the stated dose
Ibuprofen should be used with caution in combination with:Anticoagulants: NSAIDS may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs and may cause hyperkalemia in patients under these treatments. Diuretics can increase the risk of nephrotoxicity of NSAIDs.Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4)Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.Lithium: There is evidence for potential increases in plasma levels of lithium.Methotrexate: There is a potential for an increase in plasma methotrexate.Ciclosporin: Increased risk of nephrotoxicity.Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen. Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Hypersensitivity reactions:Uncommon: Hypersensitivity reactions with urticaria and pruritus.Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).Exacerbation of asthma and bronchospasm.
Gastrointestinal:The most commonly-observed adverse events are gastrointestinal in nature.Uncommon: abdominal pain, nausea, dyspepsia.Rare: diarrhoea, flatulence, constipation and vomitingVery rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. Exacerbation of colitis and Crohn's disease (see section 4.4).
Nervous System:Uncommon: Headache and dizzinessVery rare: Aseptic meningitis single cases have been reported very rarely.
Renal:Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
Hepatic:Very rare: liver disorders.Haematological: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, bruising and purpura.
Dermatological:Uncommon: Various skin rashesVery rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System:In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4).
Cardiovascular and Cerebrovascular:Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Ear & Labyrinth disordersRare: Hearing disturbance
WarningsMedicines such as [product] may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment [x days OTC products only]. If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Side effectsMedicines such as [product] may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
SymptomsMost patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, hyperkalaemia and/or metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
ManagementManagement should be symptomatic and supportive and include the maintainance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.