Ikorel 10mg tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Nicorandil

Tilgængelig fra:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-kode:

C01DX; C01DX16

INN (International Name):

Nicorandil

Dosering:

10 milligram(s)

Lægemiddelform:

Tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other vasodilators used in cardiac diseases; nicorandil

Autorisation status:

Marketed

Autorisation dato:

1997-10-17

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
IKOREL 10MG TABLETS
IKOREL 20MG 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 taken with Ik

Produktets egenskaber

Health Products Regulatory Authority
16 March 2021
CRN009WXD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ikorel 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg nicorandil.
Excipient(s) with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per dosage
unit, that is to say essentially ‘sodium-free’.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Off-white, round tablets with facetted edge, scored on one side and
with inscription “IK10” on the other side. The tablet can be
divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ikorel is indicated in adults for the symptomatic treatment of
patients with stable angina pectoris who are inadequately
controlled or have a contraindication or intolerance to first-line
antianginal therapies (such as beta-blockers and/or calcium
antagonists_)_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual therapeutic range is 10mg to 20mg twice daily. The usual
starting dose is 10mg twice daily (bid), in the morning and
in the evening preferably. It is recommended that the dose be titrated
upwards in accordance with patients' needs, response
and tolerance up to a maximum of 40mg twice daily, if necessary. A
lower starting dose of 5mg twice daily may be used in
patients particularly prone to headache.
_Elderly_
There are no special dose requirements for elderly patients, but as
with all medicines, use of the lowest effective dose is
recommended.
_Patients with liver and/or renal impairment_
There are no special dosage requirements for patients with hepatic
and/or renal impairment.
_Paediatric population_
Ikorel is not recommended in paediatric patients since its safety and
efficacy have not been established in this patient group.
Method of administration
Ikorel is administered by oral route.
The tablets are to be swallowed in the morning and in the evening as a
whole with some liquid.
Administration is independent from food intake