Elantan 10 mg Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

ISOSORBIDE MONONITRATE

Доступна з:

Merus Labs Luxco II S.à.R.L.

Код атс:

C01DA; C01DA14

ІПН (Міжнародна Ім'я):

ISOSORBIDE MONONITRATE

Дозування:

10 milligram(s)

Фармацевтична форма:

Tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Organic nitrates; isosorbide mononitrate

Статус Авторизація:

Marketed

Дата Авторизація:

1991-10-11

інформаційний буклет

Font size body text: 8pt
Pharma code: 1411
Colours: Tech Colours:
NOTE:
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Ensure the artwork has been thoroughly checked for textual accuracy
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Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK
Product name: Elantan 10mg IE
Creation date: 18/09/2017
DCMF No: N/A
Operator: MW
Commodity: N/A
Ref no: 4021407
CMO Code: 1008497
Core spec size: 140x260
Revision: CCDS Update
Page no: 1 of 2
Amended by: MW
Modification date: 25/10/2017
Proof no: 02
BLACK
ELANTAN
®
10
MG
TABLETS
ISOSORBIDE MONONITRATE
4021407 10/388 1411
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ELANTAN
DO NOT TAKE ELANTAN:
•
if you are allergic

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg isosorbide mononitrate.
Excipients with known effect: lactose monohydrate 154mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Elantan 10 mg tablets: white, round tablet, flat with bevelled edge,
score and engraving (E/10) 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.
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 water
The lowest effective dose should be used.
In patients taking one tablet twice daily the second dose should be
taken 8 hours after the first 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
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