Prasugrel Krka 5 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Prasugrel

Available from:

KRKA, d.d., Novo mesto

ATC code:

B01AC; B01AC22

INN (International Name):

Prasugrel

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Platelet aggregation inhibitors excl. heparin; prasugrel

Authorization status:

Marketed

Authorization date:

2018-08-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRASUGREL KRKA 5 MG FILM-COATED TABLETS
PRASUGREL KRKA 10 MG FILM-COATED TABLETS
prasugrel
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 Prasugrel Krka is and what it is used for
2.
What you need to know before you take Prasugrel Krka
3.
How to take Prasugrel Krka
4.
Possible side effects
5.
How to store Prasugrel Krka
6.
Contents of the pack and other information
1.
WHAT PRASUGREL KRKA IS AND WHAT IT IS USED FOR
Prasugrel Krka, which contains the active substance prasugrel, belongs
to a group of medicines called
antiplatelet agents. Platelets are very small cell particles that
circulate in the blood. When a blood
vessel is damaged, for example if it is cut, platelets clump together
to help form a blood clot
(thrombus).
Therefore, platelets are essential to help stop bleeding. If clots
form within a hardened blood vessel
such as an artery they can be very dangerous as they can cut off the
blood supply, causing a heart
attack (myocardial infarction), stroke or death. Clots in arteries
supplying blood to the heart may also
reduce the blood supply, causing unstable angina (a severe chest
pain).
Prasugrel Krka inhibits the clumping of platelets and so reduces the
chance of a blood clot forming.
You have been prescribed Prasugrel Krka because you have already had a
heart attack or unstable
angina and you have been treated with a procedure to open blocked
arteries in the heart. You may also
have had one or more stents placed to keep open a blocked or narr

Summary of Product characteristics

Health Products Regulatory Authority
03 March 2023
CRN00D4C4
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prasugrel Krka 5 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg prasugrel.
Excipient with known effect
Each 5 mg film-coated tablets contains 1.5 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale brownish yellow, oval, biconvex, film-coated tablets, dimensions
8.5 mm x 4.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prasugrel Krka, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of atherothrombotic events in
adult patients with acute coronary syndrome (i.e. unstable angina,
non-ST segment elevation myocardial infarction
[UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI])
undergoing primary or delayed percutaneous coronary
intervention (PCI).
For further information please refer to section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Prasugrel Krka should be initiated with a single 60 mg loading dose
and then continued at 10 mg once a day. In UA/NSTEMI
patients, where coronary angiography is performed within 48 hours
after admission, the loading dose should only be given at
the time of PCI (see sections 4.4, 4.8 and 5.1). Patients taking
Prasugrel Krka should also take ASA daily (75 mg to 325 mg).
In patients with acute coronary syndrome (ACS) who are managed with
PCI, premature discontinuation of any antiplatelet
agent, including Prasugrel Krka, could result in an increased risk of
thrombosis, myocardial infarction or death due to the
patient’s underlying disease. A treatment of up to 12 months is
recommended unless the discontinuation of Prasugrel Krka is
clinically indicated (see section_s _4.4 and 5.1).
_Patients _≥ _75 years old_
The use of Prasugrel Krka in patients ≥ 75 years of age is generally
not recommended. If, after a careful individual benefit/risk
evaluati