ASACARD 162.5 mg prolonged release hard capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Acetylsalicylic acid

Verfügbar ab:

New Haven Pharma (UK) Limited

ATC-Code:

B01AC; B01AC06

INN (Internationale Bezeichnung):

Acetylsalicylic acid

Dosierung:

162.5 milligram(s)

Darreichungsform:

Prolonged-release capsule, hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1999-10-01

Gebrauchsinformation

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACARD® 162.5 MG PROLONGED RELEASE HARD CAPSULES
ASPIRIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
. Always take this medicine exactly as described in this leaflet or as
your pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor before you start taking this medicine.
-
If you get any of side effects talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What Asacard® is and what it is used for
2.
What you need to know before you take Asacard®
3.
How to take Asacard®
4.
Possible side effects
5.
How to store Asacard®
6.
Contents of the pack and otherurther information
1.
WHAT ASACARD® IS AND WHAT IT IS USED FOR
The name of your medicine is Asacard® 162.5 mg prolonged release hard
capsules (called Asacard® in this
leaflet). Asacard® contains the active substance aspirin
(acetylsalicylic acid).
Asacard® is used in patients who have already suffered a heart
attack, a stroke or have had coronary artery
bypass surgery. It is used to prevent further:

Heart attacks

Strokes including mini strokes

Stable and unstable angina (chest pain due to reduced oxygen supply to
the heart).

Problems following coronary angioplasty (procedure used to treat
narrowed (diseased) coronoary
arteries to improve the blood flow to the heart muscle).
Asacard® affects ‘platelets’, which are tiny cells in your blood
that make your blood clot. Asacard® works
by helping to stop the platelets in your blood fron sticking together
and making a clot.
Do not take Asacard® for headaches or other pains. This is because
the amount of aspirin in Asacard® is
too low for pain-relief.
There is a special coating around the small particles in Asacard®.
This helps to stop the aspirin in
Asacard® fr

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ASACARD 162.5 mg prolonged release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains acetylsalicylic acid 162.5 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard
The capsules have a white body and red cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASACARD 162.5 mg Capsules are indicated for secondary prophylaxis
after a first coronary or cerebrovascular
ischemic event:
Myocardial infarction Stable and unstable angina
Coronary angioplasty
Transient ischemic attack (TIA)
Non-haemorrhagic stroke
Reduction of graft patency occlusion after CABG
In situations where a rapid onset of action is required (such as acute
treatment of myocardial infarction or unstable
angina) then conventional (immediate release acetylsalicylic acid)
should be given.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ASACARD 162.5 mg Capsules should not be taken without first seeking
medical advice on the suitability of treatment.
Treatment should be long-term and under medical supervision.
_Adults:_
One ASACARD 162.5 mg capsule per day (162.5 mg). It is recommended
that the capsules are taken at the same time
each day e.g. in the morning, approximately 15 minutes before food.
_Elderly:_
The usual adult dose is recommended in the absence of severe renal or
hepatic insufficiency (see sections 4.3 and 4.4).
_Paediatric population:_
FLAMASACARD should not be used in children under16 years old because
of safety concerns (see section 4.4).
Method of administration
Swallow the capsule with water.
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