Ikorel

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Nicorandil 10mg

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Alþjóðlegt nafn):

Nicorandil 10 mg

Skammtar:

10 mg

Lyfjaform:

Tablet

Samsetning:

Active: Nicorandil 10mg Excipient: Croscarmellose sodium Maize starch Mannitol Stearic acid

Einingar í pakka:

Blister pack, PA/Al/PVC laminate with an aluminium foil coated with a heat sealing varnish, 60 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Chugai Pharmaceutical Co Ltd

Ábendingar:

Nicorandil is indicated for the symptomatic treatment of stable angina pectoris that is inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, PA/Al/PVC laminate with an aluminium foil coated with a heat sealing varnish - 60 tablets - 18 months from date of manufacture stored at or below 25°C 30 days opened, Not Specified

Leyfisdagur:

1991-08-08

Upplýsingar fylgiseðill

Ikorel
®
1
IKOREL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IKOREL?
Ikorel contains the active ingredient nicorandil. Ikorel is used to
treat some forms of angina pectoris (chest pain). It works by
widening blood vessels and increases blood supply to heart muscle. For
more information, see Section 1. Why am I using Ikorel?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IKOREL?
Do not use if you have ever had an allergic reaction to nicorandil or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Ikorel?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ikorel and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE IKOREL?
•
The standard adult dose of Ikorel is 10 mg to 20 mg twice a day. A
lower starting dose (e.g. 5 mg twice a day) may be needed
in some patients. Your doctor may have prescribed a different dose
•
Ikorel is swallowed whole with a full glass of water, in the morning
and evening, with or without food.
•
More instructions can be found in Section 4. How do I use Ikorel? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IKOREL?
THINGS YOU
SHOULD DO
•
Tell all the doctors, dentists and pharmacists who are treating you
that you are taking Ikorel
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist that you are
taking Ikorel
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are
taking this medicine
•
If you become pregnant while you are taking this medicine, tell your
doctor or pharmacist
immediately
THINGS YOU

Vara einkenni

ikorel-ccdsv10-dsv14-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
IKOREL
Ikorel 10 mg and 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg nicorandil.
Each 20 mg tablet contains 20 mg nicorandil
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
10 mg tablets: Off-white round tablets, scored, plain on one side, and
IK10 on the other.
20 mg tablets: Off-white round tablets, scored, plain on one side, and
IK20 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorandil is indicated for the symptomatic treatment of stable angina
pectoris that is
inadequately controlled or have a contraindication or intolerance to
first-line anti-anginal
therapies.
4.2
DOSE AND METHOD OF ADMINISTRATION
The usual therapeutic range is 10 to 20 mg twice daily.
The usual starting dose is 10 mg twice daily, in the morning and in
the evening preferably, and
should be titrated upwards in accordance with patients' needs,
response and tolerance up to 40mg
twice daily, if necessary. An even lower starting dose of 5 mg twice
daily may be used in patients
particularly prone to headache.
ikorel-ccdsv10-dsv14-20jun22
Page 2
ELDERLY
There are no special dosage requirements for elderly patients, but as
with all medicines the lowest
effective dose should be used. Nicorandil should be administered with
care, using low starting
dosages, in the elderly.
PAEDIATRIC POPULATION
Nicorandil is not recommended in paediatric patients since its safety
and effectiveness have not
been established in this age group.
DIABETES, RENAL OR HEPATIC DYSFUNCTION
Nicorandil should be used with caution in patients with serious
hepatic dysfunction.
4.3
CONTRAINDICATIONS
•
in patients with known or idiosyncratic hypersensitivity to
nicorandil, nicotinamide,
nicotinic acid or any of the excipients listed in Section 6.1
•
in patients with severe hypotension or with a risk of developing
severe hypotension
including shock (including cardiogenic shock) or left ventricular
failure with low filling
pressure