ELANTAN 20 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
ISOSORBIDE MONONITRATE
Available from:
UCB (Pharma) Ireland Limited
INN (International Name):
ISOSORBIDE MONONITRATE
Dosage:
20 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
CCDS ISOSORBIDE MONONITRATE
C2013-033
APPROVED: 25 MAR 2013
PROPOSED PIL JULY 2013
SUBMITTED TO IMB
ELANTAN® 20MG TABLETS
Isosorbide mononitrate
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
• 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.
Do not pass it on to others. It may harm them, even
if their symptoms are the same as
yours.
IN THIS LEAFLET:
1. What Elantan is for
2. Before you take Elantan
3. How to take Elantan
4. Possible side effects
5. How to store Elantan
6. Further information.
1. WHAT ELANTAN IS 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.
2. BEFORE YOU TAKE ELANTAN
DO NOT TAKE ELANTAN IF:
• You are allergic to isosorbide
mononitrate, other nitrates or any of the other ingredients
of Elantan (see section 6)
• You suffer from severe anaemia (reduction in red blood
cells which can make the skin
pale and cause weakness or breathlessness)
• You have had a heart attack (myocardial infarction)
• You have had a brain haemorrhage (bleeding)
• You have had a head injury (trauma)
• You have severely low blood volume (hypovolaemia)
• You have severely low blood pressure
• Your are suffering from ‘shock’ as the blood
has stopped circulating prope
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Summary of Product characteristics
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: Contains Lactose Monohydrate 151.7mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Elantan 20 mg tablets correspond to a 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
For oral administration
Elantan should be swallowed whole with water.
Elantan 20 mg: one tablet twice daily or three times daily.
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
three times daily, take one every 6 hours. This provides a nitrate-free period of 6 – 8 hours.
Elderly
There is no evidence to suggest that an adjustment of the dosage is necessary in elderly.
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 dosage and frequency
should be tapered gradually (
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