Ibuprofen 400mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400mg Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen BP 400mg Also contains lactose, sucrose and sunset yellow.
For excipients see section 6.1
3 PHARMACEUTICAL FORM
Pink sugar coated tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2 Posology and method of administration
Adults, the elderly and children over 12 years: 1 tablet to be taken every four hours if necessary, up to three times a day, with or after food. Tablets should be swallowed with water. The dosage should not be repeated more frequently than every four hours and no more than 3 tablets should be taken in any 24 hour period.
4.3 Contraindications
Hypersensitivity to any of the constituents.
Hypersensitivity reactions to Aspirin or other non-steroidal anti-inflammatory drugs, including asthma, rhinitis or urticaria.
Current or previous peptic ulceration.
Stomach bleeding.
Severe heart failure.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption should not take this medicine.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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.
Ibuprofen should only be given with care to patients with a history of gastrointestinal disease.
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.
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.
Caution is required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate. The dose should be as low as possible and renal function monitored.
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. < 1200mg daily) is associated with an increased risk of myocardial infarction.
4.5 Interaction with other medicinal products and other forms of interaction
Concurrent aspirin or other NSAIDs may result in an increased incidence of adverse reactions. May enhance the effects of anti-coagulants and Lithium. NSAIDs may diminish the effect of anti-hypertensives or thiazide diuretics.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of 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).
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.
There is an increased risk of gastrointestinal bleeding with corticosteroids and an increased risk of nephrotoxicity with cyclosporin.
NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
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.
4.6 Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal studies, ibuprofen should be avoided during pregnancy.
The onset of labour may be delayed and duration of labour increased.
Ibuprofen appears in breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
4.7 Effects on ability to drive and use machines
No or negligible effects.
4.8 Undesirable effects
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Abdominal pain, nausea, vomiting, diarrhoea, melaena, haematemesis, ulcerative stomatitis and dyspepsia. Occasionally, gastritis, duodenal ulcer, intestinal perforation, peptic ulcer and
gastrointestinal haemorrhage have been observed. Epidemiological data indicate that of the seven most widely-used oral non-aspirin NSAIDs, ibuprofen presents the lowest risk of gastrointestinal toxicity.
Cardiovascular: 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).
Renal: papillary necrosis which can lead to renal failure.
Other adverse events reported less commonly and for which causality has not necessarily been established include:
Haematological: thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Others: rarely hepatic dysfunction, headache, dizziness, hearing disturbance, photosensitivity, visual disturbances, optic neuritis, paraesthesia, depression, confusion, hallucinations, vertigo, malaise, fatigue and drowsiness.
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angiodema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
4.9 Overdose
Symptoms of overdose include headache, nausea, vomiting, epigastric pain, vertigo, sleepiness, hypotension, ataxia and very occasionally coma.
No specific antidote is available. Treatment is supportive with gastric lavage and correction of serum electrolyte imbalance if required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: M01A E01
Pharmacotherapeutic group: Antiinflammatory and antirheumatic product, non steroid, propionic acid derivative
Ibuprofen has analgesic, antipyretic and anti-inflammatory properties Ibuprofen inhibits prostaglandin synthesis.
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 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of 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 like 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 peak levels are observed after 1 to 2 hours.
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
There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients Tablet core:
Lactose, starch, hypromellose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate.
Tablet coating:
Sucrose, talc, starch, titanium dioxide (E171), Mastercote SP0478 (sucrose, titanium dioxide (E171), sunset yellow (E110), erythrosine (E127), sodium benzoate (E211), purified water).
6.2 Incompatibilities
None stated.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Store below 25°C.
Blister packaging: Store in the original package. Securitainer/Pharmapac bottles: Keep the bottle tightly closed.
6.5 Nature and contents of container
Ibuprofen Tablets are available in blister packs of 6, 12, 24, 48, 84 and 96 tablets.
Specification details of blister packs:
PVC (white, rigid, opaque): 250 microns Aluminium foil (hard tempered): 20 microns Primer (nitrocellulose): 1.5 -2.5 gsm Heat seal lacquer: 6.5 - 8.5 gsm
The tablets are also available in a Securitainer pack of 250 and in a Pharmapac bottle of 12.
Specification for Securitainer/Pharmapac: High density polypropylene containers with low density polyethylene caps.
Special precautions for disposal
No special requirements.
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MARKETING AUTHORISATION HOLDER
Intrapharm Laboratories Limited Kidwells Park House Kidwells Park Drive Maidenhead Berkshire SL6 8AQ United Kingdom
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