Ibuprofen 200mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200 mg.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Coated tablets.
Appearance
White, circular, biconvex, sugar coated tablet embossed with IBU 200 and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of rheumatic or muscular pain, backache, neuralgia, headache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and influenza.
4.2 Posology and method of administration
Adults and children over 12 years:
The initial dose is 2 tablets, and then if necessary 1 or 2 tablets every four hours. Do not exceed 6 tablets daily.
Do not use in children under 12 years of age.
Elderly:
The usual adult dose.
Method of administration:
The tablets should be swallowed with a drink of water. To be taken preferably with or after food.
4.3 Contraindications
Use in patients with a known hypersensitivity to ibuprofen or any of the constituents.
This drug should not be given to patients with active peptic ulceration, a history of recurrent ulceration or chronic dyspepsia.
Ibuprofen is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
Severe heart failure.
4.4 Special warnings and precautions for use
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since ibuprofen has been reported to cause bronchospasm in such patients.
In patients with renal, cardiac or hepatic impairment caution is required since the use of NSAIDs may result in deterioration of renal function.
The elderly are at increased risk of the serious consequences of adverse reactions.
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).
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:
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, pregnant or suffer from asthma speak to your doctor before taking ibuprofen.
Do not exceed the stated dose.
Keep all medicines out of the reach of children.
If symptoms persist, consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
NSAIDs may enhance the effects of anticoagulants and diminish the effect of antihypertensives or thiazide diuretics.
Concurrent use of aspirin or other NSAIDs may result in an increased incidence of adverse reactions.
Concomitant administration of ibuprofen may result in the potentiation of the action of lithium.
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
Whilst no teratogenic effects have been demonstrated in animal toxicology 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 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, abdominal pain and dyspepsia have been reported following administration. Less frequently peptic ulcer and gastrointestinal haemorrhage have been observed.
Skin:
Rarely exfoliative dermatitis and epidermal necrolysis.
Haematological:
Thrombocytopenia.
Renal:
Papillary necrosis which can lead to renal failure.
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 of asthma, aggravated asthma, bronchospasm or dyspnoea, or
(c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Others:
Rarely hepatic dysfunction, headache, dizziness and 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
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
Ibuprofen, a derivative of propionic acid, has useful anti-inflammatory, analgesic and antipyretic activity. Similar to other propionic acid derivatives such as naproxen and fenoprofen it can cause gastrointestinal erosions (gastric, duodenal and intestinal) in experimental animals. All produce gastrointestinal side effects in man but are usually less severe than with aspirin. The propionic acid derivatives are all effective inhibitors of the cyclo-oxygenase responsible for the biosynthesis of prostaglandins. All of these agents alter platelet function and prolong bleeding time.
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 oral administration to man, and peak concentrations in plasma are observed after 1 to 2 hours. The half life in plasma is about 2 hours.
Ibuprofen is extensively (99 %) and firmly bound to plasma proteins, but the drug occupies only a fraction of the total drug-binding sites at usual concentrations. Ibuprofen passes slowly into the synovial spaces and may remain there in higher concentration as the concentrations in plasma decline. In experimental animals, ibuprofen and its metabolites pass easily across the placenta. The excretion of ibuprofen is rapid and complete. Greater than 90 % of an ingested dose is excreted in the urine as metabolites or their conjugates, and no ibuprofen per se is found in the urine. The major metabolites are a hydroxylated and a carboxylated compound.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate, maize starch, methylcellulose (M450), sodium starch glycollate (Type A), magnesium stearate, colloidal anhydrous silica, polyvinylacetate phthalate, stearic acid, talc, calcium carbonate, acacia, titanium dioxide E171, sucrose, yellow carnauba wax, white beeswax, shellac.
Incompatibilities
6.2
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Blister packs consisting of clear PVC and hard temper aluminium foil, contained in a carton.
Pack size: 24, 30, 48, 96 tablets
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Founts (UK) Pharmacare Ltd First Floor,
2 Victoria Road,
Harpenden,
Hertfordshire,
A15 4EA,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 39484/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13 January 2003
10 DATE OF REVISION OF THE TEXT
20/06/2011