Elantan LA 25 mg Prolonged Release Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ISOSORBIDE MONONITRATE

Available from:

Imbat Limited

ATC code:

C01DA; C01DA14

INN (International Name):

ISOSORBIDE MONONITRATE

Dosage:

25

Pharmaceutical form:

Prolonged-release capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Organic nitrates; isosorbide mononitrate

Authorization status:

Authorised

Authorization date:

2009-03-13

Patient Information leaflet

_Page 1 of 2 _
ELANTAN
® LA
25MG PROLONGED RELEASE CAPSULES, HARD
(isosorbide mononitrate)
PATIENT INFORMATION LEAFLET
Your medicine is available using the above name but will be
referred to as Elantan LA 25 throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
ƒ
Keep this leaflet. You may need to read it again.
ƒ
If you have any further questions, ask your doctor or
pharmacist.
ƒ
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 LA 25 is for
2.
Before you take Elantan LA 25
3.
How to take Elantan LA 25
4.
Possible side effects
5.
How to store Elantan LA 25
6.
Further information.
1.
WHAT ELANTAN LA 25 IS FOR
Elantan LA 25 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 25 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 LA 25
DO NOT TAKE ELANTAN LA 25 IF:
ƒ
You are allergic to isosorbide mononitrate, other nitrates or
any of the other ingredients of Elantan LA 25 (see section 6)
ƒ
You suffer from anaemia
ƒ
You have had a heart attack (myocardial infarction)
ƒ
You have had a brain haemorrhage (bleeding)
ƒ
You have had a head injury (trauma)
ƒ
You have a low blood volume (hypovolaemia)
ƒ
You have very low blood pressure
ƒ
You are suffering from “shock” as the blood has stopped
circulating properly around your body (circulatory failure)
ƒ
You take sildenafil tadalfil or vardenafil (medicines to treat
erectile dysfunction and/or pulmonary hypertension) or any
other phosphodiesterase inhibitor.
ƒ
You have an eye disease called glaucoma
ƒ
You have been diagnosed with any o

Summary of Product characteristics

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1151/078/002
Case No: 2069197
The Irish Medicines Board in exercise of the powers conferred on it by
the above mentioned Regulations hereby grants to
IMBAT LIMITED
UNIT L2
,
NORTH RING BUSINESS PARK
,
SANTRY
,
DUBLIN 9
an authorisation, subject to the provisions of the said Regulations,
in respect of the product
ELANTAN LA 25, 25 --UNKNOWN--
The particulars of which are set out in Part I and Part II of the
attached Schedule. The authorisation is also subject to the general
conditions as
may be specified in the said Regulations as listed on the reverse of
this document.
This authorisation, unless previously revoked, shall continue in force
from
26/08/2009
.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan LA 25 mg Prolonged Release Capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release hard capsule contains 25 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.
Product imported from th