Aspirin Rowex 75mg gastro-resistant tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Acetylsalicylic acid

זמין מ:

Rowex Ltd

קוד ATC:

B01AC; B01AC06

INN (שם בינלאומי):

Acetylsalicylic acid

כמות:

75 milligram(s)

טופס פרצבטיות:

Gastro-resistant tablet

מסלול נתינה (של תרופות):

Oral use

יחידות באריזה:

Pack sizes of 10, 20, 28, 30, 50, 56, 60, 90, 100 gastro-resistant tablets

סוג מרשם:

Product subject to prescription which may be renewed (B)

תוצרת:

Actavis Ltd, Balkanpharma Dupnitsa AD, Actavis hf

קבוצה תרפויטית:

Antithrombotic agents: platelet aggregation inhibitors excl. heparin

איזור תרפויטי:

Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

סממני תרפויטית:

It is used for: 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.

מצב אישור:

Authorised

תאריך אישור:

2015-05-08

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPIRIN ROWEX 75 MG GASTRO-RESISTANT TABLETS
Acetylsalicylic acid
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aspirin Rowex
is and what it is used for
2.
What you need to know before you take Aspirin Rowex
3.
How to take Aspirin Rowex
4.
Possible side effects
5.
How to store Aspirin Rowex
6.
Contents of the pack and other information
1.
WHAT ASPIRIN ROWEX IS AND WHAT IT IS USED FOR
Aspirin Rowex
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 Rowex
can only be used as a preventive treatment. It is 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 Rowex
is 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 for emergencies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN ROWEX
DO NOT TAKE ASPIRIN ROWEX IF YOU
-
are allergic to acetylsalicylic acid or any of the other ingredients
of this medicine (

מאפייני מוצר

Health Products Regulatory Authority
21 November 2019
CRN0090CM
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin Rowex 75mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 75 mg acetylsalicylic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Oval, white, biconvex film-coated tablet, 9.2 x 5.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aspirin Rowex is restricted to secondary prevention with chronic
treatment:

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 Rowex is not recommended in emergency situations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Secondary prevention of myocardial infarction:_
The recommended dose is 75-150 mg once daily.
_Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris:_
The recommended dose is 75-150 mg once daily.
_History of unstable angina pectoris, except during the acute phase:_
The recommended dose is 75-150 mg once daily.
_Prevention of graft occlusion after CABG (Coronary Artery Bypass
Grafting):_
The recommended dose is 75-150 mg once daily.
_Coronary angioplasty, except during the acute phase:_
The recommended dose is 75-150 mg once daily.
_Secondary prevention of TIA (transient ischaemic attacks) and
ischaemic cerebrovascular accidents (CVA), provided intracerebral _
_haemorrhages have been ruled out:_
The recommended dose is 75-300 mg once daily.
Health Products Regulatory Authority
21 Novembe