LOWASA 75 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ACETYLSALICYLIC ACID

Available from:

Mayne Pharma (Ireland) Limited

INN (International Name):

ACETYLSALICYLIC ACID

Dosage:

75 Milligram

Pharmaceutical form:

Tablets

Authorization status:

Withdrawn

Authorization date:

2006-01-10

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lowasa Tablets 75 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg Aspirin (acetylsalicylic acid)
3 PHARMACEUTICAL FORM
White, uncoated tablets
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Aspirin has analgesic, antipyretic and anti-inflammatory
actions and an antithrombotic effect through inhibition of 
platelet activation. This preparation is indicated
for the prophylactic management of cardiovascular disease or 
myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The tablets should be dispersed in water before administration,
and taken immediately.
Adults including elderly: The usual dose is 75-150mg daily.
Children: Do not give to children and adolescents under 16 years,
except on medical advice, where the benefit 
outweighs the risk.
4.3 CONTRAINDICATIONS
Aspirin should not be taken by patients with a known idiosyncrasy
to aspirin or other nonsteroidal anti-inflammatory 
drugs or those suffering from active peptic ulceration
or coagulation disorders. Children particularly those under 16 
years of age, unless advised by a doctor.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Patients treated with Aspirin long-term should undergo
regular medical supervision to monitor for adverse events. 
Elderly patients are particularly susceptible to
the adverse effects of NSAIDs. 
There is possible association between aspirin and
Reye’s syndrome when given to
children. Reye’s syndrome is a very 
rare disease, which affects the brain and liver, and can
be fatal. For this reason aspirin should not be given
to children 
and adolescents under 16 years unless specifically indicated.
Aspirin should be used with caution in patients with a history
of peptic ulceration, inflammatory bowel disease or 
coagulation abnormalities. It may
induce gastrointestina