BAYER ASPIRIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

ACETYLSALICYLIC ACID

Available from:

Bayer PLC

Dosage:

300 Milligram

Pharmaceutical form:

Tablets

Authorization date:

1978-04-01

Summary of Product characteristics

                                Irish Medicines Board
______________________________________________________________________________________________________________________
Date Issued 22/08/2005
CRN 2012521
page number: 1Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Bayer Aspirin 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 300 mg of Acetylsalicylic acid.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet
White tablet with the word 'Aspirin' and '0.3' on one surface and the Bayer cross on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the symptomatic relief of headache, neuralgia, musculoskeletal aches, rheumatism, common cold, influenza and
menstrual pain.
4.2 Posology and method of adminstration
The usual dose in adults and children aged 12 and over is 600 to 900mg. The dose may be repeated at four hourly
intervals if necessary.The daily maximum dose is 12 tablets (3.6g).
Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs
the risk.
Elderly
Aspirin should be used with particular caution in elderly patients who are more prone to adverse events. The lowest
dose compatible with adequate safe clinical control should be employed.See also section 4.4.
4.3 Contraindications
Aspirin should not be administered to patients:

With a history of hypersensitivity reactions (e.g. bronchospasm, rhintis, urticaria) in response to asprin, other
salicylates or substances with similar actions e.g. non-steroidal anti -inflammatory drugs.

With known hypersensitivity to any of the other ingredients, refer to section 6.1.

With active peptic ulceration or a history of peptic ulceration.

With haemorrhagic diseases such as haemophilia.

You are pregnant of breast -feeding.

Receiving a dose of methrotrexate at 15mg/week or greater.
                                
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