1. Name Of The Medicinal Product
Cuprofen for Children
2. Qualitative And Quantitative Composition
Ibuprofen 100mg / 5ml
For excipients, see 6.1
3. Pharmaceutical Form
Oral Suspension
White, opaque smooth suspension
4. Clinical Particulars
4.1 Therapeutic Indications
For reduction in fever (including post immunization 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.
4.2 Posology And Method Of Administration
For oral administration and short term use only, as required:
• Children over 7 years: 10ml three times daily.
• Children 4 to 7 years: 7.5ml three times daily.
• Children 1 to 4 years: 5ml three times daily.
• Infants 6 months to 1 year: 2.5ml three to four 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.
4.3 Contraindications
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 (see section 4.4 Special Warnings and Precautions for Use).
Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).
4.4 Special Warnings And Precautions For Use
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 (see section 4.8 Undesirable effects).
Renal:
Renal impairment as renal function may further deteriorate (see section 4.3 Contraindications and section 4.8 Undesirable effects).
Hepatic:
Hepatic dysfunction (see section 4.3 Contraindications and section 4.8 Undesirable effects).
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.
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 (see section 4.8 Undesirable effects).
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 (see section 4.3 Contraindications) 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 (see section 4.5 Interactions).
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 (see section 4.8 Undesirable Effects). 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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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 (see section 4.3 Contraindications).
Other NSAIDs including cyclooxegenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.3 Contraindications).
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 Special Warnings and Precautions for Use).
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 (see section 4.4 Special Warnings and Precautions for Use).
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(see section 5.1).
4.6 Pregnancy And Lactation
Children under 9 years are unlikely to become pregnant or breast feed. However, whilst no teratogenic effects have been demonstrated in animal experiments, the use of the suspension should, if possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3 Contraindications).
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
See section 4.4 regarding female fertility.
4.7 Effects On Ability To Drive And Use Machines
None expected at recommended doses and duration of therapy.
4.8 Undesirable Effects
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 (see section 4.4 Special Warnings and Precautions for Use).
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) (see section 4.4 Special Warnings and Precautions for Use).
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 (see section 4.4 Special Warnings and Precautions for Use).
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.
4.9 Overdose
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Symptoms
Most 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 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.
Management
Management should be symptomatic and supportive and include the maintenance 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids, propionic acid derivatives.
ATC code: M01A E01
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever, furthermore Ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8h before or within 30min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. 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.
5.2 Pharmacokinetic Properties
Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, high peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.
The half life of ibuprofen is about 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.
5.3 Preclinical Safety Data
No relevant information additional to that contained elsewhere in the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium Methyl Parahydroxybenzoate (E219)
Sodium Propyl Parahydroxybenzoate (E217)
Citric Acid Anhydrous
Saccharin Sodium
Sodium Benzoate (E211)
Dispersible Cellulose
Juicy Orange Flavour
Polysorbate 80
Liquid Maltitol (E965)
Xanthan Gum
Purified Water.
6.2 Incompatibilities
None.
6.3 Shelf Life
Amber glass or PET bottles with PP closures: 2 years.
6.4 Special Precautions For Storage
Do not store above 25oC. Store in the original container.
6.5 Nature And Contents Of Container
Amber glass or PET bottles with polypropylene child resistant screw closures, containing 100, 150 or 200ml enclosed in an outer carton. A measuring spoon is provided.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Galpharm Healthcare Ltd
Hugh House
Upper Cliffe Road
Dodworth Business Park
Dodworth
South Yorkshire
S75 3SP
8. Marketing Authorisation Number(S)
PL 16028/0075
9. Date Of First Authorisation/Renewal Of The Authorisation
10/02/2006
10. Date Of Revision Of The Text
03/11/2010
No comments:
Post a Comment