ASPIRIN Tablets 300 mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
ACETYLSALICYLIC ACID
Available from:
Chanelle Medical
Dosage:
300 mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
1998-09-16
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin (Acetylsalicylic acid) Tablets 300 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg of Aspirin (also known
as acetylsalicylic acid)
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Tablet
White, circular, biconvex plain tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to moderate pain in headaches,
toothache and neuralgia.
For reduction of temperature.
For reduction of inflammation in lumbago.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults only: 300mg to 600mg three to four times daily.
Do not give to children or adolescents aged under 16
years, except on medical advice,
where the benefit outweighs the
risk.
Elderly: Non steroidal anti-inflammatory drugs should be used with
particular caution in elderly patients who are more
prone to adverse events. The lowest dose compatible with
adequate clinical control should be employed. See also
section 4.4.
Route of administration
Oral.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients or to
other non-steroidal anti-flammatory drugs.
Not to be taken by children under 12 years, unless on
medical advice.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 02/09/2005_
_CRN 2014464_
_page number: 1_
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
i)
Aspirin may precipitate bronchospasm and
induce attacks of asthma or hypersensitivity in
susceptible subjects.
ii)
If the person is taking any
other medicine or is under doctor’s care, he should
consult the physician
before using aspirin.
iii)
Prolonged use except under medical direction may be harmful.
iv)
Interference with laboratory tests: Salicylates may
produce falsely increased results for blood creatinine,
urate (
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