Elantan 40 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:

40 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:

1983-08-02

Patient Information leaflet

R
Font size body text: 8pt
Pharma code: 1415
Colours: Tech Colours:
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Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK
Product name: ELANTAN 40 mg - IE
Creation date: 18/09/2017
DCMF No: N/A
Operator: MW
Commodity: N/A
Ref no: 4021409
CMO Code: 1008499
Core spec size: 140x260
Revision: CCDS Update
Page no: 1 of 2
Amended by: MW
Modification date: 25/10/2017
Proof no: 04
BLACK
TECHNICAL
(do not print)
ELANTAN
®
40
MG
TABLETS
ISOSORBIDE MONONITRATE
4021409 10/392 1415
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 is and what it 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 IT 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 40mg tablets may also be used in
conjunction with other

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2021
CRN00C3H8
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan 40 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of isosorbide mononitrate.
Excipients with known effect: lactose monohydrate 131.7mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Elantan 40 mg tablets: white, round tablet, flat with bevelled edge,
score and engraving (E/40) 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 Elantan 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).
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.
Health Products Regulatory Authority
12 January 2021
CRN00C3H8
Page 2 of 8
Elantan should not be