ELANTAN LA
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
30-04-2024
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Virkt innihaldsefni:
ISOSORBIDE MONONITRATE
Fáanlegur frá:
UCB (Pharma) Ireland Limited
Skammtar:
25 Milligram
Lyfjaform:
Prolonged Release Capsules
Leyfisdagur:
2009-06-12
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan LA 25mg Prolonged Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule contains 25 mg isosorbide mononitrate.
Excipients: Each prolonged release capsule contains 6.71mg lactose monohydrate and 8.17-11.96mg sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged- release capsule, hard
Hard capsule with brown cap and white body, containing white to off-white pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the prophylaxis of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
ADULTS
One capsule to be taken in the morning.
For patients with higher nitrate requirement, the dose may be increased to two capsules taken simultaneously. 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 LA 25 has yet to be established in children.
Attenuation of effect has occurred in some patients being treated with prolonged release preparations. In such patients
intermittent therapy may be more appropriate (see section 4.4).
Treatment with Elantan LA, as with any other nitrate, should not be stopped suddenly. Both dosage and frequency
should be tapered gradually (see section 4.4).
4.3 CONTRAINDICATIONS
Elantan LA25 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 pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases
associated with a raised intra-cranial pressure e.g. following
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