DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules bottle

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

aspirin,dipyridamole

Dostupno od:

Arrow Pharma Pty Ltd

INN (International ime):

Aspirin,Dipyridamole

Status autorizacije:

Registered

Uputa o lijeku

Page 1 of 4
DIASP SR SUSTAINED RELEASE CAPSULES
_dipyridamole and aspirin_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIASP SR. It does
not contain all available information.
It does not take the place of talking to
your doctor or pharmacist.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS OR
QUESTIONS ABOUT TAKING THIS
MEDICINE.
KEEP THIS INFORMATION WITH YOUR
CAPSULES.
You may need to read it again.
WHAT DIASP SR IS USED FOR
DIASP SR helps to prevent
recurrence of stroke in people who
have had a previous stroke or
transient ischaemic attack (TIA).
DIASP SR works by preventing
blood clots from forming. The ability
of DIASP SR to prevent blood clots is
due to its effect on blood cells known
as platelets.
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 DIASP SR
_WHEN YOU MUST NOT TAKE IT_
_ _
DO NOT TAKE DIASP SR IF YOU HAVE
AN ALLERGY TO:
•
aspirin or non-steroidal anti-
inflammatory medicines (NSAIDs)
•
dipyridamole
•
any of the other ingredients listed
at the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE DIASP SR IF YOU:
•
have fructose intolerance. Each
capsule contains 4.56 mg
sucrose, resulting in 9.12 mg
sucrose per maximum daily dose.
•
have severe kidney disease
•
are taking the medicine ketorolac
•
are more than 6 months pregnant
•
have an ulcer of the stomach or
intestine, or
•
any condition that increases your
risk of bleeding.
DO NOT TAKE THIS MEDICINE IF
YOU ARE PREGNANT.
It may affect your developing baby
if you take it during pregnancy.
DO NOT BREASTFEED IF YOU
ARE TAKING THIS MEDICINE.
The active ingredient in DIASP SR
passes into breast milk.
DO NOT GIVE THIS MEDICINE TO A
CHILD.

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – DIASP SR (DIPYRIDAMOLE
AND ASPIRIN) SUSTAINED-RELEASE CAPSULE
1
NAME OF THE MEDICINE
dipyridamole and
aspirin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DIASP SR sustained release capsule contains dipyridamole 200 mg
and aspirin 25 mg.
Excipients with known effects: sodium benzoate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Each DIASP 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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DIASP SR sustained-release capsules are indicated for the prevention
of recurrent
ischaemic stroke
and transient ischaemic attacks.
4.2
D
OSE 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.
2
4.3
C
ONTRAINDICATIONS
•
Hypersensitivity to any of the components of the product or
salicylates
•
Patients with rare hereditary problems of fructose intolerance and/or
galactose intolerance
(e.g. galactosaemia) should not take this medicine.
•
Concurrent use with ketorolac
•
Severe renal impairment
•
Patients with active gastric or duodenal ulcers or bleeding disorders
•
Patients in the last trimester of pregnancy
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
BLEEDING DISORDERS
Due to the risk of bleeding, as with other antiplatelet agents,
dip