Aspirin Krka 75 mg gastro-resistant tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Acetylsalicylic acid

Dostupné z:

KRKA, d.d., Novo mesto

ATC kód:

B01AC; B01AC06

INN (Medzinárodný Name):

Acetylsalicylic acid

Dávkovanie:

75 milligram(s)

Forma lieku:

Gastro-resistant tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2017-03-10

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPIRIN KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Aspirin Krka
3.
How to take Aspirin Krka
4.
Possible side effects
5.
How to store Aspirin Krka
6.
Contents of the pack and other information
1.
WHAT ASPIRIN KRKA IS AND WHAT IT IS USED FOR
Aspirin Krka 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 Krka 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 Krka 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. It can only
be used as a preventive
treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN KRKA
DO NOT TAKE ASPIRIN KRKA:
-
if you are allergic to acetylsalicylic acid or any of the other
ingredients of this medicine (listed
in s

Súhrn charakteristických

Health Products Regulatory Authority
16 March 2023
CRN00C87S
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin Krka 75 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 75 mg acetylsalicylic acid.
Excipients with known effect:
Lactose
monohydrate.........................................................................................
45 mg per tablet.
Sunset yellow
(E110)..................................................................................
0.0006 mg per tablet.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Pink, round biconvex film-coated tablets with a diameter of about 7.2
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 Krka is not recommended in emergency situations. It is
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 75-160 mg once daily.
_Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris:_
The recommended dose is 75-160 mg once daily.
_History of unstable angina pectoris, except during the acute phase:_
The recommended dose is 75-160 mg once daily.
_Prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG):_
The recommended dose is 75-160 mg once daily.
Health Products Regulatory Authority
16 March 2023
CRN00C87S
Page 2 of 10
_Coronary angiop