1. Name Of The Medicinal Product
Nurofen for Children Singles
2. Qualitative And Quantitative Composition
Ibuprofen 100mg/ 5ml (equivalent to 2.0% w/v)
For excipients, see 6.1.
3. Pharmaceutical Form
Oral suspension
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of rheumatic or muscular pain, headache, dental pain, feverishness, or symptoms of colds and influenza.
4.2 Posology And Method Of Administration
For pain and fever: The daily dosage of Nurofen For Children Singles is 20-30 mg/kg bodyweight in divided doses. This can be achieved as follows:
Infants 3 - 6 months weighing more than 5kg: One 2.5ml dose may be taken 3 times in 24 hours. Infants 6 - 12 months: One 2.5ml spoonful may be taken 3 to 4 times in 24 hours. Children 1 - 3 years: One 5ml spoonful may be taken 3 times in 24 hours. Children 4 - 6 years: 7.5ml ( 5ml + 2.5ml spoonful ) may be taken 3 times in 24 hours. Children 7 - 9 years: Two 5ml spoonfuls may be taken 3 times in 24 hours.
Doses should be given approximately every 6 to 8 hours, (or with a minimum of 4 hours between each dose if required).
Not suitable for children under 3 months of age unless advised by your doctor. If the fever is not reduced, consult your doctor
For oral administration.
For short term use only. If the child's (aged over 6months) symptoms persist for more than 3 days, consult your doctor. For children under 6 months medical advice should be sought after 24 hours use (3 doses) if the symptoms persist.
4.3 Contraindications
Hypersensitivity to ibuprofen or any of the constituents in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or previous peptic ulcer . History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (See section 4.5 Interactions). Severe hepatic failure, renal failure or heart failure (See section 4.4, Special warnings and precautions for use) Last trimester of pregnancy (See section 4.6 Pregnancy and lactation). Severe heart failure.
4.4 Special Warnings And Precautions For Use
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).
The elderly are at increased risk of the serious consequences of adverse reactions.
Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis (see section 4.8 Undesirable effects)
Chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease) – as these conditions may be exacerbated (See section 4.8 Undesirable effects).
Hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.
Renal impairment as renal function may further deteriorate (See section 4.3 Contraindications and Section 4.8 Undesirable effects)
Hepatic dysfunction (See section 4.3 Contraindications and Section 4.8 Undesirable effects)
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.
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.
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 corticosteroids, or anticoagulants such as warfarin or anti-platelet agents such as aspirin (see section 4.5 Interactions).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
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.
Cardiovascular and cerebrovascular effects
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.
The label will include:
Read the enclosed leaflet before taking this product.
Do not take if you
• have or have ever had a stomach ulcer, perforation or bleeding
• are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers
• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
• are in the last 3 months of pregnancy
Speak to a pharmacist or your doctor before taking this product if you
• have asthma , liver, heart, kidney or bowel problems
• are in the first 6 months of pregnancy If symptoms persist or worsen, consult 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: As these 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).
Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs.
Corticosteroids: May increase the risk of adverse reactions in the gastrointestinal tract (See section 4.4 Special warnings).
Lithium: There is evidence for potential increases in plasma levels of lithium.
Methotrexate: There is a potential for an increase in plasma methotrexate.
Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
4.6 Pregnancy And Lactation
Children under 9 years are unlikely to become pregnant or breast feed. Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen for Children Singles should, if possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as there is 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
Hypersensitivity reactions have been reported and these may consist of:
(a) Non-specific allergic reactions and anaphylaxis
(b) Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea
(c) Various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)
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.
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:
Uncommon: abdominal pain, nausea and dyspepsia. Rare: diarrhoea, flatulence, constipation and vomiting. Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly. Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4).
Nervous System:
Uncommon: Headache
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 and bruising.
Skin:
Uncommon: Various skin rashes
Very rare: Severe forms of skin reactions such as erythema multiforme and 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)
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).
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 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ibuprofen has analgesic, antipyretic and antiinflammatory properties. ibuprofen inhibits prostaglandin synthesis.
5.2 Pharmacokinetic Properties
Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is both rapid and complete via the kidneys.
Maximum plasma concentrations are reached 1-2 hours after ingestion if taken on an empty stomach. The half life of Ibuprofen is about two hours.
5.3 Preclinical Safety Data
There are no preclinical safety data of relevance to the consumer
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric acid
Sodium citrate
Sodium chloride
Sodium saccharin
Domiphen bromide
Purified water
Polysorbate 80
Maltitol syrup
Xanthan gum
Orange flavour
Glycerin.
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
2 years
6.4 Special Precautions For Storage
Do not store above 25°C
6.5 Nature And Contents Of Container
The suspension is packed in laminated sachets consisting of:
1. Polyethylene (contact material)/ 12 micron aluminium/ paper or
2. Polyethylene (contact material)/ 12 micron aluminium/ polyester or
3. Polyethylene (contact material) 15 micron aluminium/ paper
Pack sizes of 2,3,4,5, 8,10,12,15,16,18,20 sachets in a cardboard carton.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Crookes Healthcare Limited 1
Thane Road West
Nottingham NG2 3AA
United Kingdom
8. Marketing Authorisation Number(S)
PL 00327/0140
9. Date Of First Authorisation/Renewal Of The Authorisation
12 April 2002
10. Date Of Revision Of The Text
21/03/2007
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