PERSANTIN SR dipyridamole 200mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dipyridamole

Available from:

Boehringer Ingelheim Pty Ltd

Authorization status:

Registered

Patient Information leaflet

PERSANTIN
® SR 200 MG
_SUSTAINED RELEASE CAPSULES_
_dipyridamole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Persantin 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 Persantin 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 PERSANTIN SR IS
USED FOR
Persantin SR contains dipyridamole.
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
anticoagulant. Some people refer to
anticoagulant medicines as “blood
thinners”.
Dipyridamole works by preventing
blood clots from forming. It works
on the blood cells that help blood to
clot (platelets) and prevents them
from clumping and sticking together.
This reduces the risk of forming
blood clots that can lead to a stroke.
Dipyridamole also widens the blood
vessels of the heart.
Persantin SR is prescribed either
alone or in conjunction with aspirin.
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
PERSANTIN SR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PERSANTIN SR IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
dipyridamole
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may includ

Summary of Product characteristics

PERSANTIN SR PI0061-08
1
AUSTRALIAN PRODUCT INFORMATION – PERSANTIN SR (DIPYRIDAMOLE)
SUSTAINED-
RELEASE CAPSULES
1 NAME OF THE MEDICINE
dipyridamole
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Each PERSANTIN SR 200 mg sustained-release capsule contains
dipyridamole 200 mg. The
gelatin shell of the capsule consists of a red opaque cap and an
orange opaque body.
For the full list of excipients, see Section 6.1 List of excipients.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PERSANTIN SR
200 mg sustained-release capsules are
indicated
for
the
secondary
prevention of ischaemic stroke and transient ischaemic attacks in
conjunction with low-dose
aspirin. PERSANTIN SR can be used alone if aspirin is not tolerated.
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 food.
The capsules should be swallowed whole without chewing.
4.3 CONTRAINDICATIONS
Hypersensitivity to dipyridamole or to any excipients in the product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CARDIOVASCULAR DISORDERS
Because PERSANTIN SR is a potent vasodilator, it should be used with
caution in patients
with severe coronary artery disease (e.g. unstable angina or recently
sustained myocardial
infarction), subvalvular aortic stenosis, or haemodynamic instability
(e.g. decompensated
heart failure).
STRESS TESTING WITH INTRAVENOUS DIPYRIDAMOLE AND OTHER ADENOSINERGIC
AGENTS
Patients treated with regular oral doses of PERSANTIN SR should not
receive additional
intravenous dipyridamole. If pharmacological stress testing with
intravenous dipyridamole or
other adenosinergic agents (e.g. adenosine, regadenoson) is considered
necessary, drugs
containing oral dipyridamole (e.g. ASASANTIN SR, PERSANTIN) should be
interrupted for 24
hours prior to administration of intravenous dipyridamole or 48 hours
prior to administration of
other adenosinergic agents because the risk of cardiovascular side
effects may increase.
Intake of