Ibuprofen Tablets Bp 400mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sugar coated tablet contains Ibuprofen 400 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets
A round pink sugar coated tablet, plain on one side, IB4 on the other side
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ibuprofen is indicated for its analgesic and anti-inflammatory effects in the treatment of - Rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), Ankylosing spondylitis, Osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, Ibuprofen is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low back pain; Ibuprofen can also be used in soft tissue injuries such as sprains and strains.
Ibuprofen is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including migraine headache
Posology and method of administration
4.2
4.3
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Adults: the recommended dosage of Ibuprofen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided doses.
Children: the daily dosage of Ibuprofen is 20 mg/kg of body weight in divided doses. In juvenile rheumatoid arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.
Not recommended for children weighing less than 7 kg.
Elderly: no special dosage modifications are required unless renal or hepatic function is impaired, in which case dosage should be assessed individually.
For oral administration
Contraindications
Patients with a history of or active peptic ulceration.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis or urticaria) in response to ibuprofen, aspirin or other NSAIDs.
Ibuprofen is contraindicated in patients with severe heart failure
4.4 Special warnings and precautions for use
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
Caution is required if Ibuprofen is administered to patients suffering from, or with a previous history of, bronchial asthma since ibuprofen has been reported to cause bronchospasm in such patients. Ibuprofen should only be given with care to patients with a history of gastrointestinal disease.
Caution is required in patients with renal, hepatic or cardiac impairment since the use of NSAIDs may result in deterioration of renal function. The dose should be kept as low as possible and renal function should be monitored in these patients.
Ibuprofen should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration.
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial data suggest that use of ibuprofen; particularly at a high dose (2400 mg/ 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. ^ 1200 mg daily) is associated with an increased risk of myocardial infarction.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking)
4.5 Interaction with other medicinal products and other forms of interaction
Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients.
Antihypertensives: reduced antihypertensive effect.
Diuretics: reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.
Lithium: decreased elimination of lithium.
Methotrexate: decreased elimination of methotrexate.
Cyclosporin: increased risk of nephrotoxicity with NSAIDs.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.
Other analgesics: avoid concomitant use of two or more NSAIDs.
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).
Corticosteroids: increased risk of gastrointestinal bleeding.
Anticoagulants: enhanced anticoagulant effect.
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
4.6 Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal toxicology studies, the use of ibuprofen during pregnancy should, if possible, be avoided. Congenital abnormalities have been reported in association with ibuprofen administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (closure of ductus arteriosus), use in late pregnancy should be avoided.
In the limited studies so far available, ibuprofen appears in the breast milk in very low concentrations and is unlikely to adversely affect the breast-fed infant
4.7 Effects on ability to drive and use machines
No adverse effects known
4.8 Undesirable effects
Gastrointestinal: the most commonly-observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and gastrointestinal haemorrhage have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed. Epidemiological data indicate that of the seven most widely used oral, non-aspirin NSAIDs; ibuprofen presents the lowest risk of upper gastrointestinal toxicity.
Hypersensitivity: 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 asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
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 dose (2400 mg/ 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).
Other adverse events reported less commonly and for which causality has not necessarily been established include:
Renal: nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
Hepatic: abnormal liver function, hepatitis and jaundice.
Neurological and special senses: visual disturbances, optic neuritis, headaches, paraesthesia, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological: thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological: photosensitivity (see 'hypersensitivity' for other skin reactions)
Overdose
4.9
Symptoms include nausea, vomiting, dizziness and rarely, loss of consciousness. Large overdoses are generally well tolerated when no other drugs are involved.
Treatment consists of gastric lavage and, if necessary, correction of serum electrolytes and appropriate supportive measures.
There is no specific antidote to ibuprofen
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. The drug's therapeutic effects as an NSAID are thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in 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 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), 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 likely for occasional ibuprofen use.
5.2 Pharmacokinetic properties
Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2 hours after administration. The elimination half-life is approximately 2 hours.
Ibuprofen is metabolised in the liver to two inactive metabolites and these, together with unchanged ibuprofen, are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete.
Ibuprofen is extensively bound to plasma proteins
Preclinical safety data
5.3
There are no Preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone K 30 (E1201); Lactose monohydrate; Starch ( Maize ); Microcrystalline cellulose (E460 (i)); Sodium starch glycollate; Colloidal anhydrous silica ;
Sugar coating components:
Opaglos NA7150 ; Shellac (E904) , Acetylated monoglyceride (E472(a)); Povidone ( E1201); Sucrose , Titanium dioxide ( E171); Starch ( Maize ); Talc ( E553(b)) ; Calcium Carbonate; Sodium benzoate (E211); Acacia; Opalus AS-F-1537: ( Sucrose, Titanium dioxide (E171), Erythrosine (E127) and Sodium benzoate (E211))Sugar syrup 70 %; Sodium benzoate (E211). Opaglos 6000P; Beeswax (E901); Carnuba wax (E903); Shellac (E904)
6.2 Incompatibilities
None Stated
6.3 Shelf life
3 Years: Securitainers, Tampertainers or Opaque screw cap plastic containers
2 Years: Blister packs (Blister strips are composed of PVDC coated PVC and aluminium foil)
6.4
Special precautions for storage
Tablet containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Blister: Do not store above 25°C. Store in the original package
6.5 Nature and contents of container
Securitainers, Tampertainers or Opaque screw cap plastic containers: 500, 250, 100 , 84,70,56,50,42,28,21 , 15 and 14 tablets
Blister packs (Blister strips are composed of PVDC coated PVC and aluminium foil ): 84,70,56,42,28,21,15 , 14 tablets
Polyethylene lined polypropylene or polyethylene buckets with snap on polypropylene or polyethylene lids: 5000 and 15000 tablets (Bulk supply to Ashbourne)
6.6 Special precautions for disposal
Nothing stated
7 MARKETING AUTHORISATION HOLDER
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow , Middlesex HA1 4HF United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 20075/0056
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28th Oct 2002
10 DATE OF REVISION OF THE TEXT
03/02/2009