SUSCARD BUCCAL 3.0 mg Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
GLYCERYL TRINITRATE
Available from:
Forest Laboratories UK Ltd
INN (International Name):
GLYCERYL TRINITRATE
Dosage:
3.0 mg Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2012-12-31
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suscard Buccal Tablet 3 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg of glyceryl trinitrate as Diluted Nitroglycerin.
Also contains 37mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release Buccal Tablet.
White, biconvex, round tablets having the number ‘3’ imprinted on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management and treatment of angina pectoris. This product may also be of benefit in the in-patient
management of unstable angina.
For the treatment of acute and congestive cardiac failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults (including the elderly)
_Angina:_
Administration of Suscard Tablets should start with the 2mg strength. If angina occurs while the tablet is in place, the
dosage strength used should be increased to 3mg where necessary. The 5mg dosage strength should be reserved for
patients with severe angina pectoris refractory to treatment with the lower dosage strengths. A 1 mg dosage strength is
also available and may be considered for the small number of patients who may initially show intolerance to the 2 mg
strength as a starting dose.
Suggested dosage frequency in angina:
a) For patients suffering only occasional angina pectoris – the tablets may be administered on a p.r.n. basis to relieve the
acute attack.
b) For patients suffering angina pectoris in response to known stimuli - the tablet should be administered a few minutes
prior to encountering the angina-precipitating stimulus.
c) For patients in whom chronic therapy is indicated - the tablet should be administered on a thrice-daily basis or as
indicated by the dissolution rate of the tablet in
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