Ibuprofen 200 mg Tablets BP

Ibuprofen 200.00 mg

For excipients, see 6.1.

Coated tablets

A round pink sugar coated tablet, plain on one side, IB2 on the other side.

Rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease) Ankylosing spondylitis

Osteoarthritis

Sero-negative arthropathies

Pain relief of peri-articular disorders

Pain relief of soft tissue injuries

To be taken preferably with or after food

Adults: 1200 to 1800 mg daily in divided doses. Some patients can be maintained on

600-1200 mg daily. Total daily dosage must not exceed 2400 mg even in divided doses.

Children: 20 mg/kg body weight daily in divided doses. For juvenile rheumatoid arthritis, up to 40 mg/kg body-weight daily in divided doses. Children under 30 kg must not receive more than 500 mg daily even in divided doses.

Elderly: No special dose modification required unless renal or hepatic function is impaired,in which case dose should be assessed individually.

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest dose should be used and the patient should be monitored for GI bleeding for 4 weeks following initiation of NSAID therapy.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Hypersensitivity to Ibuprofen or to any of the tablet constituents.

NSAIDs should not be administered to patients with a history of, or active, peptic ulceration.

NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, or urticaria) in response to ibuprofen, aspirin and other nonsteroidal anti-inflammatory drugs.

Severe heart failure.

Caution is required if administered to patients suffering from, or with a previous history of bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients.

NSAIDs should only be given with care to patients with a history of gastro-intestinal disease.

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).

The elderly are at risk of the serious consequences of adverse reactions.

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 as low as possible and renal function should be monitored in these patients. NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with NSAID 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).

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, reduced GFR and increase plasma glycoside levels.

Lithium: Decreased elimination of lithium Methotrexate: Decreased elimination of methotrexate Ciclosporin: Increased risk of nephrotoxicity

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Other analgesics: Avoid concomitant use of two or more NSAIDs (including aspirin). 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 GI 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.

Whilst no teratogenic effects have been demonstrated in animal toxicology studies, the use of NSAIDs during pregnancy should if possible be avoided. 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 discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (a closure of the ductus arteriosus), use in late pregnancy should be avoided. In the limited studies so far available, NSAIDs can appear in breast milk in very low concentrations and are unlikely to affect the breast-fed infant.

Dizziness, drowsiness, visual disturbances or headaches are possible undesirable effects after taking NSAID's, if affected, patients should not drive or operate machinery.

Gastro-intestinal: the most commonly-observed adverse events are gastro-intestinal in nature. Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and gastro-intestinal haemorrhage have been reported following administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastro-intestinal perforation have been observed.

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, angiodema and, less commonly, bullous dermatoses (including epidermal necrolysis, erythema multiforme and exfoliative dermatitis).

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 include:

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.

Renal: Nephrotoxicity in various forms, including intestinal nephritis, nephrotic syndrome and renal failure.

Dermatological: photosensitivity.

Symptoms include headache, vomiting, drowsiness, dizziness and fainting. Gastric lavage and correction of severe electrolyte abnormalities may need to be considered.

Ibuprofen is a phenylpropionic acid derivative, which has analgesic, anti- inflammatory and antipyretic actions. Ibuprofen inhibits prostaglandin synthesis. It is used in the treatment of rheumatoid arthritis and other musculoskeletal disorders. It has also been used in the treatment of acute gout.

Ibuprofen is usually administered in doses of 0.6 to 2.4 g daily in divided doses. Maintenance doses of 0.6 to 1.2 g daily may be effective in some patients. If gastro- intestinaldisturbances occur, ibuprofen should be given with food or milk. A suggested dose for children is 20 mg per kg body weight daily in divided doses with a maximum of 500 mg, for those weighing less than 30 kg.

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.

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. It is rapidly excreted in the urine as metabolites and their conjugates. About 1% is excreted in urine as unchanged ibuprofen and about 14% as conjugated ibuprofen.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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)

None stated.

3 years

Tablet container: Do not store above 25°C. Store in the original container tightly closed.

Blister: Do not store above 25°C. Store in the original package.

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

Nothing stated.

ACCORD HEALTHCARE LIMITED

SAGE HOUSE

319 PINNER ROAD

HARROW

MIDDLESEX

HA1 4HF

UNITED KINGDOM

PL 20075/0053

19/03/2009

19/03/2009