Elantan LA 50 mg Prolonged Release Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ISOSORBIDE MONONITRATE

Available from:

Merus Labs Luxco II S.à.R.L.

ATC code:

C01DA; C01DA14

INN (International Name):

ISOSORBIDE MONONITRATE

Dosage:

50 milligram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Organic nitrates; isosorbide mononitrate

Authorization status:

Marketed

Authorization date:

1987-07-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ELANTAN® LA 50 MG PROLONGED RELEASE CAPSULES, HARD
ISOSORBIDE MONONITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Elantan LA 50 is and what it is used for
2. What you need to know before you take Elantan LA 50
3. How to take Elantan LA 50
4. Possible side effects
5. How to store Elantan LA 50
6. Contents of the pack and other information.
1. WHAT ELANTAN LA 50 IS AND WHAT IT IS USED FOR
Elantan LA 50 belongs to a group of medicines called organic nitrates.
Organic nitrates
work by widening the blood vessels in your heart to allow an increased
amount of blood
to flow to areas which need it.
Elantan LA 50 is used to prevent angina pectoris. Angina usually feels
like a tight pain in
the chest, neck or arm area. The pain comes from the heart muscle and
is a sign that
part of it is not getting enough oxygen for the amount of work it is
doing.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELANTAN LA 50
DO NOT TAKE ELANTAN LA 50:
• if you are allergic to isosorbide mononitrate, other nitrates or
any of the other
ingredients of this medicine (listed in section 6)
• if you suffer from severe anaemia
• if you have had a heart attack (myocardial infarction)
• if you have had a brain haemorrhage (bleeding)
• if you have had a head injury (trauma)
• if you have very low blood volume (hypovolaemia)
• if you have severely low blood pressure
• if you are suffering from “shock” as the blood has stopped
circulating properly around
your

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan LA 50 mg Prolonged Release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release hard capsule contains 50 mg isosorbide
mononitrate.
Excipients with known effect: lactose monohydrate 13.42 mg and sucrose
16-24 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard (prolonged release capsule).
Size 3 hard gelatin opaque capsules. Brown capsule cap and flesh
coloured body, containing white to beige odourless pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and long term management of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One capsule to be taken in the morning.
The dose may be increased up to two capsules per day, to be taken
together in the morning, for patients with higher nitrate
requirements.
Dosage regime should be designed according to the clinical response of
the patient. The lowest effective dose should be used.
_Elderly_
There is no evidence to suggest an adjustment of the dosage is
necessary in elderly.
_Paediatric population_
The safety and efficacy of Elantan LA 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).
Methods of administration
For oral administration
Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 2 of 9
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Elantan LA should not be used in cases of acute myocardial infarction
with low filling pressure, acute circulatory failure (shock,
vascular colla