Aspirin 75mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acetyl salicylic acid

Available from:

Clonmel Healthcare Ltd

ATC code:

B01AC; B01AC06

INN (International Name):

Acetyl salicylic acid

Dosage:

75 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

Authorization status:

Marketed

Authorization date:

2014-02-14

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPIRIN 75 MG GASTRO-RESISTANT TABLETS
Acetylsalicylic acid (aspirin)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aspirin 75 mg Gastro-resistant Tablets are and what they are used
for
2.
What you need to know before you take Aspirin 75 mg Gastro-resistant
Tablets
3.
How to take Aspirin 75 mg Gastro-resistant Tablets
4.
Possible side effects
5.
How to store Aspirin 75 mg Gastro-resistant Tablets
6.
Contents of the pack and other information
1.
WHAT ASPIRIN 75 MG GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE USED
FOR
Aspirin 75 mg Gastro-resistant Tablets contains acetylsalicylic acid,
which in low doses belong to a group of
medicines called anti-platelet agents. Platelets are tiny cells in the
blood that cause the blood to clot and are
involved in thrombosis. When a blood clot occurs in an artery it stops
the blood flowing and cuts off the
oxygen supply. When this happens in the heart it can cause a heart
attack or angina; in the brain it can cause
a stroke.
Aspirin 75 mg Gastro-resistant Tablets are taken to reduce the risk of
blood clots forming and thereby
prevent further:
-
heart attacks
-
strokes
-
cardiovascular problems in patients who suffer from stable or unstable
angina (a type of chest pain).
Aspirin 75 mg Gastro-resistant Tablets are also used to prevent the
formation of blood clots after certain
types of heart surgery in order to widen or to unblock the blood
vessels.
This medicinal product is not recommended fo

Summary of Product characteristics

Health Products Regulatory Authority
24 February 2020
CRN008K3H
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin 75mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 75mg acetylsalicylic acid
(aspirin)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Oval, white, biconvex film-coated tablets, 9.2 x 5.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Secondary prevention of myocardial infarction.
- Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris.
- History of unstable angina pectoris, except during the acute phase.
- Prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG).
- Coronary angioplasty, except during the acute phase.
- Secondary prevention of transient ischaemic attacks (TIA) and
ischaemic cerebrovascular accidents (CVA) provided
intracerebral haemorrhages have been ruled out.
Aspirin 75mg Gastro-resistant Tablets are not recommended in emergency
situations. They are restricted to secondary
prevention with chronic treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Secondary prevention of myocardial infarction:_
The recommended dose is 75-160mg once daily.
_Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris:_
The recommended dose is 75-160mg once daily.
_History of unstable angina pectoris, except during the acute phase:_
The recommended dose is 75-160mg once daily.
_Prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG):_
The recommended dose is 75-160mg once daily.
_Coronary angioplasty, except during the acute phase:_
The recommended dose is 75-160mg once daily.
_Secondary prevention of transient ischaemic attacks (TIA) and
ischaemic cerebrovascular accidents_
_(CVA) provided intracerebral haemorrhages have been ruled out:_
The recommended dose is 75-325mg once daily.
Elderly
Health Products Regulatory Authority
24 Febru