ASASANTIN SR dipyridamole 200mg and aspirin 25mg sustained release capsule bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

aspirin,dipyridamole

Commercializzato da:

Boehringer Ingelheim Pty Ltd

Stato dell'autorizzazione:

Registered

Foglio illustrativo

ASASANTIN
® SR
_SUSTAINED RELEASE CAPSULES_
_dipyridamole and aspirin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Asasantin SR. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Asasantin SR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ASASANTIN SR IS
USED FOR
Asasantin SR contains dipyridamole
and aspirin. It is used to help prevent
the recurrence of stroke in people
who have had a previous stroke or
transient ischaemic attack (TIA).
This type of medication is called an
antithrombotic agent. An
antithrombotic agent is a drug that
reduces the formation of blood clots
(thrombi).
Dipyridamole and aspirin work by
preventing blood clots from forming.
These drugs work on the blood cells
which help blood to clot (platelets)
and help prevent them from
clumping and sticking together. This
reduces the risk of forming blood
clots that can lead to a stroke. The
effects of these drugs are additive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
ASASANTIN SR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ASASANTIN SR IF YOU
HAVE AN ALLERGY TO:
•
any medicines containing
dipyridamole or aspirin
•
any of the ingredients listed at the
end of this leaflet
•
any other NSAIDs (non-steroidal
anti-inflammatory drugs).
Some

Scheda tecnica

ASASANTIN SR
PI0069-12
1
AUSTRALIAN PRODUCT INFORMATION – ASASANTIN SR (DIPYRIDAMOLE /
ASPIRIN)
SUSTAINED-RELEASE CAPSULES
1 NAME OF THE MEDICINE
dipyridamole and aspirin
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Each ASASANTIN SR sustained-release capsule contains dipyridamole 200
mg in modified release
form and aspirin 25 mg in standard release form. The gelatin shell of
the capsule consists of a red
opaque cap and an ivory opaque body.
Excipients with known effect:
Each ASASANTIN SR 200 mg / 25 mg capsule contains 53 mg of lactose
monohydrate.
Each ASASANTIN SR 200 mg / 25 mg capsule contains 11.3 mg of sucrose.
For the full list of excipients, see Section 6.1 List of excipients.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASASANTIN SR sustained-release capsules are indicated for the
prevention of recurrent ischaemic
stroke and transient ischaemic attacks.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one capsule twice daily, usually one in the
morning and one in the
evening, preferably with meals.
The capsules should be swallowed whole without chewing.
ALTERNATIVE REGIMEN IN CASE OF INTOLERABLE HEADACHES
In the event of intolerable headaches during initial treatment, switch
to one capsule at bedtime and
low-dose aspirin (for example, 75-150 mg) in the morning. Because
there are no long-term, clinical
outcome data with this regimen and headaches become less of a problem
as treatment continues,
patients should return to the usual regimen as soon as possible,
usually within one week (see
Section 4.4 Special Warnings and Precautions for use and Section 4.8
Adverse Effects (Undesirable
Effects)).
PAEDIATRIC POPULATION
ASASANTIN
SR
is
not
recommended
for
children (see
Section
4.4
Special
Warnings
and
Precautions for use, Paediatric use).
4.3 CONTRAINDICATIONS
•
Hypersensitivity to any of the components of the product or
salicylates
•
Patients with rare hereditary conditions of fructose intolerance
and/or galactose intolerance
(e.g. galactosaemia) should no