Elantan 20 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isosorbid-5-mononitrat

Available from:

Merus Labs Luxco II S.à.R.L.

ATC code:

C01DA; C01DA14

INN (International Name):

Isosorbid-5-mononitrat

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Organic nitrates; isosorbide mononitrate

Authorization status:

Marketed

Authorization date:

1983-04-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ELANTAN® 20MG TABLETS
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 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 is and what is used for
2. What you need to know before you take Elantan
3. How to take Elantan
4. Possible side effects
5. How to store Elantan
6. Contents of the pack and other information.
1. WHAT ELANTAN IS AND WHAT IS USED FOR
Elantan 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 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.
Elantan 20mg tablets may also be used in conjunction with other
treatments after heart
attack or heart failure
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELANTAN
DO NOT TAKE ELANTAN:
• 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 (reduction in red blood cells
which can make the skin
pale and cause weakness or breathlessness)
• 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 severely low blood volume (hypovolaemia)
• if you have severe lo

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of isosorbide mononitrate.
Excipients with known effect: lactose monohydrate 151.7mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Elantan 20 mg tablets: white, round tablet, flat with bevelled edge,
score and engraving (E/20) on the upper side and rounded
on the lower side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and long term management of angina pectoris.
As adjunctive therapy after acute myocardial infarction and chronic
congestive heart failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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.
In patients taking one tablet twice daily the second dose should be
taken 8 hours after the 1st dosage. If the dose is one tablet
three times daily, take one every 6 hours and ensure 12 hours
treatment-free interval every 24 hours
_Elderly_
There is no evidence to suggest that an adjustment of the dosage is
necessary in elderly.
_Paediatric population_
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 dosage and frequency should be
tapered gradually (see section 4.4)
Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 2 of 8
Method of administration
For oral administration
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Elantan should not be used