PERSANTIN RETARD 200 Milligram Capsules Modified Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
DIPYRIDAMOLE
Available from:
LTT Pharma Limited
INN (International Name):
DIPYRIDAMOLE
Dosage:
200 Milligram
Pharmaceutical form:
Capsules Modified Release
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-03-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Persantin Retard 200mg Modified-release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dipyridamole 200 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Modified-release Capsules, Hard
_Product imported from the UK:_
Hard gelatin capsules consisting of a red cap and an orange body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Secondary prevention of ischaemic stroke and transient ischaemic attacks either alone or in conjunction with aspirin.
As an adjunct to oral anti-coagulation for prophylaxis of thromboembolism associated with prosthetic heart valves.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults, including the Elderly_
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.
_Children_
Persantin Retard is not suitable for use in children.
4.3 CONTRAINDICATIONS
Hypersensitivity to any components of the product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Among other properties, dipyridamole acts as a potent vasodilator. It should therefore be used with caution in patients
with severe coronary artery disease including unstable angina and recent myocardial infarction, left ventricular outflow
obstruction or haemodynamic instability (e.g. decompensated heart failure).
Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress
testing with intravenous dipyridamole should discontinue drugs containing oral dipyridamole for twenty-four hours
prior to stress testing. Failure to do so may impair the sensitivity of the test.
In patients with myasthenia gravis, readjustment of therapy may be necessary during treat
Read the complete document
