Elantan LA 50mg Prolonged-Release Capsules, hard

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

ISOSORBIDE MONONITRATE

Διαθέσιμο από:

Imbat Limited

Φαρμακολογική κατηγορία (ATC):

C01DA; C01DA14

INN (Διεθνής Όνομα):

ISOSORBIDE MONONITRATE

Δοσολογία:

50 milligram(s)

Φαρμακοτεχνική μορφή:

Prolonged-release capsule

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Organic nitrates; isosorbide mononitrate

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2008-09-26

Φύλλο οδηγιών χρήσης

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ELANTAN
® LA 50MG
PROLONGED RELEASE CAPSULES, HARD
(isosorbide mononitrate)
Your medicine is available using the above name but will be
referred to as Elantan LA 50 throughout this leaflet.
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 severely low blood volume (hypovolaemia)

if you ha

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
07 November 2018
CRN008KC3
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan LA 50mg Prolonged-Release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release hard capsule contains 50 mg isosorbide
mononitrate.
Excipients: contains lactose monohydrate and sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard (prolonged-release capsule).
_Product imported from the UK:_
Size 3 hard gelatin opaque capsule. Brown capsule cap and flesh
coloured body,
containing white to beige odourless pellets.
4 CLINICAL PARTICULARS
As per PA2118/002/004
5 PHARMACOLOGICAL PROPERTIES
As per PA2118/002/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Hyprolose
Ethylcellulose
Talc
Macrogol 20,000
Sucrose
Corn starch
Gelatin
Titanium dioxide (E171)
Black iron oxide (E172)
Red iron oxide (E172)
Health Products Regulatory Authority
07 November 2018
CRN008KC3
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container
and outer packaging of the product on the market in the country of
origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled cartons containing 2 blister strips (14 capsules per
strip). Pack size of
28 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/078/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 26
th
September 2008
10 DATE OF REVISION OF THE TEXT
November 2018.