Ibuprofen Tablets Bp 200mg
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Tablets BP 200 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
Pink biconvex tablets marked with ‘LPC’ on one side and ‘I 200’ on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2 Posology and method of administration
For oral administration and short term use only.
The minimum effective dose should be used for the shortest time necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Adults, the elderly and children over 12 years:
Two tablets with water up to three times a day, as required. Take with or after food. Leave at least 4 hours between doses and do not take more than six tablets in any 24 hour period.
Children under 12 years:
Not to be administered to children under 12 years.
4.3 Contraindications
Hypersensitivity to Ibuprofen or any of the constituents in the product.
Previous 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-oxydenase-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).
Bleeding disorders.
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. The possibility of cross-sensitivity with aspirin and other NSAIDs should be borne in mind.
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 erythematous 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. The dose should be kept as low as possible and renal function should be monitored.
Renal impairment as renal function may further deteriorate (see sections 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 impair cyclo-oxygenase/ prostoglandin 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 (prothrombin time should be monitored daily for the first few days of combined treatment) 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.
Treatment should be discontinued in patients reporting blurred or diminished vision, scotomata and /or changes in colour vision.
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.
The label will state:
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 NSAID painkillers, or aspirin with a daily dose above 75 mg
• Are in the last 3 months of pregnancy
• Speak to your pharmacist or doctor before taking this product if you:
• Have asthma, liver, heart, kidney or bowel problems
• Are in the first 6 months of pregnancy
Do not exceed the stated dose. 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 75 mg) has been advised by a doctor, 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).
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:
Aminoglycosides: Increased renal toxicity has been reported in patients receiving concomitant ibuprofen and aminoglycoside therapy.
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (See section 4.4 Special warnings and precautions)
Antihypertensives: NSAIDs may diminish the effect of these drugs.
Cardiac Glycosides: NSAIDs may exacerbate heart failure, reduce GFR and increase plasma cardiac glycoside concentration.
Cyclosporin: Increased risk of nephrotoxicity.
Corticosteroids: May increase the risk of adverse reactions in the gastrointestinal tract (see section 4.4 Special warnings)
Diuretics: NSAIDs may diminish the effect of these drugs. They may increase the risk of hyperkalaemia with potassium-sparing diuretics and may also antagonise thiazides. The risk of nephrotoxicity of NSAIDs is increased.
Lithium: There is evidence for potential increases in plasma levels of lithium
Methotrexate: There is potential for an increase in plasma methotrexate.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration, as NSAIDs can reduce the effects of mifepristone.
Phenytoin Sodium: Phenytoin concentration and toxicity have been increased by Ibuprofen.
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.
Sulphonylureas: Ibuprofen may interfere with the efficacy of sulphonylureas.
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
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen should, if possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as 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.
See section 4.4 regarding female fertility.
4.7 Effects on ability to drive and use machines
None at the 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, angiodema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme).
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/Psychiatric disorders
Uncommon: headache, dizziness, nervousness, depression, drowsiness and insomnia.
Renal
Very rare: acute renal failure, interstitial nephritis, nephrotic syndrome, papillary necrosis, especially in long term use, associated with increased serum urea and oedema. Haematuria.
Fluid retention may rarely precipitate congestive heart failure in elderly patients.
Hepatic
Very rare: liver disorders, abnormalities of liver function tests.
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 (see Immune system)
Very rare: severe forms of skin reaction such as erythema multiforme and epidermal necrolysis can occur.
Hypersensitivity reactions
Uncommon: hypersensitivity reactions with urticaria and pruritis.
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.
Immune system
Rarely symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed with NSAIDs. Patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) may be especially susceptible (see section 4.4 Special warnings and precautions for use).
Other
Rare: vertigo, tinnitus.
Very rare: toxic amblyopia, reversible on cessation of treatment.
In the treatment of chronic conditions, under long term use, additional adverse effects may occur.
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 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 clearly 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
Pharmacodynamic group: anti-inflammatory and anti-rheumatic products, nonsteroids, propionic acid derivatives (ATC code: MO1 AE)
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostoglandin synthesis. In humans ibuprofen reduces pain, swelling 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 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 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 1-2 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
Ibuprofen has been used in general medicine over a long period exceeding 20 years. No relevant information additional to that already included elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised starch Maize starch
Colloidal anhydrous silica 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
2 years for container.
3 years for blisters.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Polypropylene tablet containers with a low density polyethylene tamper evident lid, containing either 8, 12 or 16 tablets.
Blister packs of 8, 12 or 16 consisting of rigid white PVC and 20pm aluminium foil. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
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 39484/0025
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8 July 2002
10 DATE OF REVISION OF THE TEXT
04/06/2011