Ibuprofen Tablets Bp 600mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Tablets B.P. 600 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 600 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pink capsule shaped, biconvex 22 x 10 mm, film coated tablets marked with “LPC I 600” on one side and decorative scoreline on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ibuprofen is indicated for its analgesic and anti-inflammatory effect in rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathies.
In non-articular rheumatoid conditions, ibuprofen is indicated in periarticular conditions e.g. frozen shoulder, bursitis, tendinitis, tenosynovitis and low back pain.
Ibuprofen can be used in soft-tissue injuries, e.g. sprains and strains.
It is also indicated for the relief of mild to moderate pain, e.g. dental and postoperative pain and dysmenorrhoea.
It is also indicated for the relief of migraine.
4.2 Posology and method of administration
For oral administration. To be taken preferably with or after food.
Adults:
Initial dosage is 1800 mg daily in divided doses. Some patients can be maintained on 600 -1800 mg daily. In severe or acute conditions it may be advantageous to increase the dosage provided that the total daily dosage does not exceed 2400 mg in divided doses.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Children:
Ibuprofen BP 600 mg tablets are not suitable for children.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Do not break the tablet in half.
4.3 Contraindications
Hypersensitivity to any of the constituents.
NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs.
Severe hepatic, renal and cardiac failure (See section 4.4 Special warnings and precautions for use).
Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).
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 heart failure.
4.4 Special warnings and precautions for use
All patients:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2 Posology and method of administration).
Respiratory disorders
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. The possibility of cross-sensitivity with aspirin and other NSAIDs should be borne in mind.
Cardiovascular, renal and hepatic impairment
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3
For POM:
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).
For OTC:
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 (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.
4.5 Interaction with other medicinal products and other forms of interaction
Other analgesics: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4.3 Contraindications)
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).
Antihypertensives: Reduced anti-hypertensive effect.
Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs. NSAIDs may increase risk of hyperkalaemia with potassium-sparing diuretics and may also antagonise thiazides, and reduce anti-hypertensive effect of furosemide.
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
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.
Corticosteroids: Increased risk of GI bleeding (see section 4.4 Special warnings and precautions for use)
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (sse section 4.4 Special warnings and precautions for use).
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antobiotics. Patients taking NSAIDS and quinolones may have an increased risk of developing convulsions.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Phenytoin Sodium: Phenytoin concentration and toxicity have been increased by Ibuprofen.
Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
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).
4.6 Pregnancy and lactation
Pregnancy:
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernable pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of ductus arteriosus), use in the last trimester of pregnancy is contraindicated. 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). NSAIDs should not be used in the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Lactation:
In limited studies so far available, NSAIDs can appear in the breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
See section 4.4 Special warnings and precautions for use regarding female fertility.
4.7 Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
Gastrointestinal:
The most commonly observed adverse effects are gastrointestinal in nature. Peptic and duodenal ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4 Special warnings and precautions for use). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see section 4.4) have been reported following administration. Less frequently, gastritis has been observed.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs.
These may consist of:
a) Non-specific allergic reactions and anaphylaxis
b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea
c) Assorted skin reactions, including rashes of various types, pruritis, urticaria, purpurea, angiodema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme).
Cardiovascular
Oedema has been reported in association with NSAID treatment. Fluid retention may rarely precipitate congestive heart failure in elderly patients.
Other adverse events reported less commonly include:
Renal
Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Haematuria.
Hepatic
Abnormal liver function, hepatitis and jaundice.
Neurological and special senses
Visual disturbances, optic neuritis, headaches, parasthesia, rarely reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4), depression, nervousness, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, insomnia, fatigue and drowsiness.
Very rarely toxic amblyopia has occurred; on cessation of treatment recovery occurred.
Haematological
Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological
Photosensitivity.
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).
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: Anti-inflammatory and anti-rheumatic products, nonsteroids, propionic acid derivatives. ATC code: MO1AE
Ibuprofen is a phenylpropionic acid derivative which has analgesic, antiinflammatory and anti-pyretic actions.
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 absorbed from the gastro-intestinal tract and peak plasma concentrations occur about 1 to 2 hours after ingestion. Ibuprofen is extensively bound to plasma proteins and has a half-life of about 2 hours. The excretion of Ibuprofen is rapid and complete.
5.3 Preclinical safety data
Ibuprofen has been used in general medicine over a long period exceeding 20 years.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cores: Pregelatinised starch, maize starch, maize starch as a 22% paste, Aerosil, magnesium stearate
Coating: hypromellose, macrogol 6000, erythrosine lake FD & C Red No.3 E127, titanium dioxide E171, dioctyl sodium sulphosuccinate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Three years when packed in tablets containers.
Two years when packed in blister packs.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container/outer carton
6.5 Nature and contents of container
Tablet container:
Pack sizes: 12, 21, 24, 28, 48, 56, 84, 96, 100, 250, 500 and 1000 Packaging composition: high density polyethylene.
Blister packs
Pack sizes: 12, 21, 24, 28, 48, 56,84, 96, 100
Packaging composition: rigid white PVC and 20pm aluminium foil.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
N/A
7 MARKETING AUTHORISATION HOLDER
Fourrts (Uk) Pharmacare Ltd First Floor,
2 Victoria Road,
Harpenden,
Hertfordshire,
A15 4EA,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 39484/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22 April 2002
10 DATE OF REVISION OF THE TEXT
17/06/2011