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Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Telephone: +44 (0)208 8631 427
Fax: +44 (0)208 863 1426
WWW: http://www.accord-healthcare.eu
Medical Information Direct Line: +44 (0)208 901 3370
Medical Information e-mail: uk@accord-healthcare.com
Customer Care direct line: +44 (0)208 863 1427
Medical Information Fax: +44 (0)208 863 1426

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Summary of Product Characteristics last updated on the eMC: 03/02/2012
SPC Ibuprofen 200 mg Tablets


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1. Name of the medicinal product

Ibuprofen 200 mg Tablets BP


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2. Qualitative and quantitative composition

Ibuprofen 200.00 mg

For excipients, see 6.1.


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3. Pharmaceutical form

Coated tablets

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


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4. Clinical particulars

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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.


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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.


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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.


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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.


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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.


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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.


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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.


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4.8 Undesirable effects

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).


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4.9 Overdose

Symptoms include headache, vomiting, drowsiness and hypotension. Gastric lavage and correction of severe electrolyte abnormalities should be considered.


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5. Pharmacological properties

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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.


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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.


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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.


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6. Pharmaceutical particulars

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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)


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

3 years


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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.


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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.


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6.6 Special precautions for disposal and other handling

Nothing stated.


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7. Marketing authorisation holder

ACCORD HEALTHCARE LIMITED

SAGE HOUSE

319 PINNER ROAD

HARROW

MIDDLESEX

HA1 4HF

UNITED KINGDOM


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8. Marketing authorisation number(s)

PL 20075/0054


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9. Date of first authorisation/renewal of the authorisation

19/03/2009


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10. Date of revision of the text

19/03/2009



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25771/SPC/


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