Ikorel 20 mg Tablets

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Nicorandil

Հասանելի է:

PCO Manufacturing Ltd.

ATC կոդը:

C01DX; C01DX16

INN (Միջազգային անվանումը):

Nicorandil

Դոզան:

20 milligram(s)

Դեղագործական ձեւ:

Tablet

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Թերապեւտիկ տարածք:

Other vasodilators used in cardiac diseases; nicorandil

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2003-11-18

Տեղեկատվական թերթիկ

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
IKOREL
® 10 MG TABLETS
IKOREL
® 20 MG TABLETS
nicorandil
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 Ikorel is and what it is used for
2.
What you need to know before you take Ikorel
3.
How to take Ikorel
4.
Possible side effects
5.
How to store Ikorel
6.
Contents of the pack and other information
1.
WHAT IKOREL IS AND WHAT IT IS USED FOR
Ikorel contains the active substance ‘nicorandil’. This belongs to
a
group of medicines called ‘potassium channel activators’.
Ikorel is used to prevent or reduce painful, signs (angina pectoris)
of
your heart disease. It is used in adults who cannot take heart
medicines called ‘beta-blockers’ or ‘calcium antagonists’.
Ikorel works by increasing the blood flow through the blood vessels
of the heart. It improves the blood and oxygen supply of your heart
muscle and reduces its workload.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IKOREL
DO NOT TAKE IKOREL IF:

you are allergic to nicorandil or any of the other ingredients of
this medicine (listed in section 6).

you have severe low blood pressure (‘hypotension’).

you have heart problems such as cardiogenic shock, or left
ventricular failure with low filling pressure or cardiac
decompensation.

you are taking medicines to treat erectile dysfunction (such as
sildenafil, tadalafil, vardenafil) or medicines to treat ‘pulmonary
hypertension’ (such as riociguat). Your blood pressure may be
affected if these medicines are t

Ապրանքի հատկությունները

Health Products Regulatory Authority
28 September 2018
CRN008LWR
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ikorel 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg nicorandil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the Netherlands and the United Kingdom_
Round, white tablets with ‘IK20’ on one side and a breakline on
the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4 CLINICAL PARTICULARS
As per PA0540/102/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/102/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Corn starch
Croscarmellose sodium
Stearic acid
Mannitol (E421)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
28 September 2018
CRN008LWR
Page 2 of 2
The shelf life expiry date for this product shall be the date shown on
the container
and outer package of the product on the market in the country of
origin.
After opening
Each blister strip should be used within 30 days of opening at below
mentioned
storage conditions.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Store in the original packaging in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Ikorel Tablets are presented in soft tempered aluminium foil/PVC
blister strips of 10
tablets, in which each tablet is linked to a silica gel capsule
dessicant.
Blister pack containing 30 or 60 tablets, in outer cardboard carton.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/103/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authoris