Persantin Retard 200 mg Modified Release Capsules, Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dipyridamole

Available from:

Boehringer Ingelheim Limited

ATC code:

B01AC; B01AC07

INN (International Name):

Dipyridamole

Dosage:

200 milligram(s)

Pharmaceutical form:

Capsules Modified Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Platelet aggregation inhibitors excl. heparin; dipyridamole

Authorization status:

Not marketed

Authorization date:

1998-08-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Persantin Retard 200 mg 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.
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 treatment with dipyridamole.
(See Section 4.5 Interactions with other medicinal products and other
forms of interaction).
PERSANTIN should be used with caution in patients with coagulation
disorders.
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