Ibuprofen 100mg/5ml

Oral Suspension. White, opaque, smooth suspension

For reduction of fever (including post immunisation fever); and relief of mild to moderate pain such as headache, sore throat, earache, teething pain and toothache, cold and flu symptoms, minor aches and sprains.

For oral administration and short term use only, as required:

• Children 8 to 12 years: 10ml three to four times daily.

• Children 3 to 8 years: 5ml three to four times daily.

• Children 1 to 3 years: 2.5ml three to four times daily.

• Infants 6 months to 1 year: 2.5ml three times daily.

If the child's symptoms persist for more than 3 days, consult your doctor.

• Babies 3 to 6 months: 2.5ml three times daily.

Do not give to babies aged 3 to 6 months for more than 24 hours.

Doses should usually be given every 6-8 hours. Leave at least four hours between doses.

Not to be given to children under 3 months of age. Not recommended for children weighing less than 5kg.

For post immunisation fever: 2.5ml followed by one further 2.5ml 6 hours later, if necessary. No more than 2 doses (5ml) in 24 hours. If fever is not reduced, consult your doctor.

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, 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 upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe heart failure, renal failure or hepatic failure.

Last trimester of pregnancy.

Undesirable effects may be minimized 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 NSAID's especially gastrointestinal 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.

Other NSAIDs:

The use of Ibuprofen for children 100mg/5ml oral suspension with concomitant NSAIDs including cyclooxengenase-2-selective inhibitors should be avoided.

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis.

Renal:

Renal impairment as renal function may further deteriorate.

Hepatic:

Hepatic dysfunction.

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 trial and epidemiological data 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 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 on 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.

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.

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 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.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or anti-platelet agents such as aspirin.

Where GI 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. 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. Ibuprofen for children 100mg/5ml oral suspension should be discontinued at the first appearance of skin rash mucosal lesions, or any other sign of hypersensitivity.

Information about some of the ingredients in this medicine:

Contains Liquid Maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The label will include:

Please read the enclosed leaflet carefully before using this product.

Do not give this product if your child:

• has or has had a stomach ulcer, perforation or bleeding of the stomach

• is allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers

• is taking other NSAID painkillers, or aspirin with a daily dose above 75mg

Talk to a pharmacist or your doctor before giving this product if your child:

• has or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney, stomach or bowel problems

If you are an adult:

• if you are pregnant do not take this product and ask your doctor for advice

• consult your doctor or pharmacist before taking this product if you are elderly or if you are a smoker

Do not exceed the stated dose. Keep all medicines out of the reach and sight of children.

If your child's symptoms persist for more than 3 days, or if new symptoms occur, talk to your doctor.

Ibuprofen should not be used in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions.

Other NSAIDs including cyclooxegenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects.

Ibuprofen should be used with caution in combination with:

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin.

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity to NSAID's.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

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.

Cyclosporin: Increased risk of nephrotoxicity

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone.

Administration of NSAID's can reduce the effect of mifepristone.

Tacrolimus: Possible risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological activity 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 NSAID's can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increase risk of developing convulsions.

Aspirin: Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dose concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

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.

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:

Non-specific allergic reactions.

Respiratory tract reactivity (e.g. asthma, aggravated asthma and bronchospasm).

Various skin reactions including exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could include: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

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. 

Nervous System Disorders:

Uncommon: Headache.

Vary rare: Aseptic Meningitis – single cases have been reported very rarely.

Cardiac Disorders and Vascular Disorders:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data 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).

Gastrointestinal Disorders:

The most commonly observed side effects of ibuprofen are gastrointestinal in nature.

Uncommon: Abdominal pain, nausea and dyspepsia.

Rare: Diarrhoea, flatulence, constipation and vomiting.

Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly, ulcerative stomatitis, gastritis.

Exacerbation of ulcerative colitis and Crohn's disease.

Hepatobiliary Disorders:

Very rare: Liver disorders.

Skin and Subcutaneous Tissue Disorders:

Uncommon: Various skin rashes.

Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.

Renal and Urinary Disorders:

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

SSL International plc

P – Pharmacy

19 October 2010