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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg isosorbide mononitrate.
Also contains 154 mg lactose (as monohydrate).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, circular, flat, bevelled-edge tablets with scoreline, marked ‘E/10’ on one side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and long term management of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults
One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. The dosage may be
increased up to 120 mg per day. Dosage regime should be designed according to the clinical response of the patient.
Tablets should be taken after meals, unchewed with a little fluid.
The lowest effective dose should be used.
Elderly
There is no evidence to suggest that an adjustment of the dosage is necessary.
Children
The safety and efficacy of Elantan has yet to be established in children.
Treatment with Elantan, as with any other nitrate, should not be stopped suddenly. Both the frequency and dosage
should be tapered gradually (see section 4.4).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/11/2011_
_CRN 2107252_
_page number: 1_
4.3 CONTRAINDICATIONS
Elantan 10 should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure
(shock, vascular collapse), or very low blood pressure, hypertrophic obstructive cardiomyopathy (HOCM), constrictive
pericar
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