Ibuprofen 200mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200 mg Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200.00 mg For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Coated tablets
A round pink sugar coated tablet, plain on one side, IB2 on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of cold and influenza.
4.2 Posology and method of administration
To be taken orally preferably with or after food
Adults the elderly and children over 12 years:
One or two tablets (200-400 mg) up to three times a day. The dose should not be repeated more frequently than every 4 hours and no more than 1200 mg should be taken in any 24 hour period.
Children 8- 12 years :
200 mg up to 4 times a day
If the child’s symptoms persist for more than 3 days, consult a doctor.
4.3 Contraindications
Hypersensitivity to Ibuprofen or to any of the tablet constituents
Ibuprofen is contraindicated in patients, who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, or urticaria) in response to aspirin or other non steroidal anti-inflammatory drugs.
Current or previous peptic ulceration.
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 risk of the serious consequences of adverse reactions. Caution is required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate.
Caution (discussion with doctor or pharmacist) is required prior to starting treatment inpatients 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:
Do not use if you have ever had a stomach ulcer or are allergic to ibuprofen or aspirin. If you are allergic to or are taking any other painkiller, are pregnant or suffer from asthma, speak to your doctor before taking ibuprofen. Do not exceed the stated dose. Keep out of reach of children. If symptoms persist, consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Concurrent aspirin or other NSAID’s may result in an increased incidence of adverse reactions.
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 enhance the effects of anticoagulants and diminish the effect of antihypertensives or diuretics.
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 the duration of labour increased. Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.
4.7 Effects on ability to drive and use machines
Dizziness or headaches are possible undesirable effects after taking NSAID’s, and may affect the patient’s ability to drive or operate machinery.
Undesirable effects
4.8
Gastro-intestinal: abdominal pain, nausea and dyspepsia. Occasionally peptic ulcer and gastro-intestinal haemorrhage.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. 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, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis, erythema multiforme and exfoliative dermatitis).
Haematological: thrombocytopenia.
Renal: papillary necrosis, which can lead to renal failure.
Others: rarely hepatic dysfunction, headache, dizziness, hearing disturbances.
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
Symptoms include headache, vomiting, drowsiness and hypotension. Gastric lavage and correction of severe electrolyte abnormalities should be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ibuprofen has analgesic, anti-inflammatory and antipyretic 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 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 to 2 hours. Thesetimes 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
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 K30 (E1201)
Lactose monohydrate Starch (Maize)
Microcrystalline Cellulose Sodium Starch Glycollate (E469(i))
Colloidal Anhydrous Silica
Sugar coating components
Opaglos NA 7150: Shellac (E904), Acetylated monoglyceride (E472a), Povidone (E1201)
Sucrose
Titanium Dioxide (E171)
Starch (Maize)
Talc
Calcium Carbonate Sodium Benzoate Acacia
Opalux AS-F-1537: Sucrose, Titanium Dioxide (E171),
Erythrosine (E127) and Sodium Benzoate (E211)
Sugar Syrup 70%: Mineral Water Sugar and Sodium Benzoate (E211).
Opaglos 6000P: Beeswax (E901), Carnauba Wax (E903), Shellac (E904)
Ink Composition:
Ferric Oxide Black Isopropyl Alcohol Ethyl Alcohol Shellac (E904)
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Tablet container: 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
Securitainer, Tampertainer 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, 48, 42, 28, 24, 21, 15, 14 tablets.
6.6 Special precautions for disposal
Nothing stated.
7 MARKETING AUTHORISATION HOLDER
ACCORD HEALTHCARE LIMITED
SAGE HOUSE
319 PINNER ROAD
HARROW
MIDDLESEX
HA1 4HG
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 20075/0054
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28 October 2002
10
DATE OF REVISION OF THE TEXT
03/02/2009