IKOREL Nicorandil 10mg tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

nicorandil, Quantity: 10 mg

Saadav alates:

Sanofi-Aventis Australia Pty Ltd

Ravimvorm:

Tablet, uncoated

Koostis:

Excipient Ingredients: mannitol; maize starch; croscarmellose sodium; stearic acid

Manustamisviis:

Oral

Ühikuid pakis:

60 tablets, 20 tablets (physician sample)

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Ikorel is indicated for the treatment of chronic stable angina pectoris.

Toote kokkuvõte:

Visual Identification: Off-white, round tablets with facetted edge, scored on one side and with inscription IK10 on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

1996-10-09

Infovoldik

IKOREL
®
I
k
o
r
e
l
®
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

Toote omadused

ikorel-ccdsv10-piv16-18sep20
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – IKOREL
® (NICORANDIL)
1
NAME OF THE MEDICINE
Nicorandil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ikorel 10 mg tablet contains nicorandil 10 mg.
Each Ikorel 20 mg tablet contains nicorandil 20 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Uncoated tablet.
10 mg tablets: Off-white, round tablets with facetted edge, scored,
plain on one side and IK10
on the other.
20 mg tablets: Off-white, round tablets with facetted edge, scored,
plain on one side and IK20
on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorandil is indicated for the treatment of chronic stable angina
pectoris.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended therapeutic dose for nicorandil is 10 to 20 mg twice
daily. The usual starting
dose is 10 mg twice daily (preferably in the morning and in the
evening). A lower starting dose
of 5 mg twice daily may be used in patients who are prone to headache
or other adverse
reactions. Dosage should be titrated to the minimum effective dose.
ELDERLY
There are no dosage adjustments required for the elderly patients.
However, as with all other
medications, the lowest effective dose should be used.
ikorel-ccdsv10-piv16-18sep20
Page 2 of 13
CHILDREN
Not recommended for use in children as safety and efficacy have not
been established.
4.3
CONTRAINDICATIONS
•
known or idiosyncratic hypersensitivity to nicorandil, nicotinamide,
nicotinic acid or
any of the excipients in this product
•
cardiogenic shock
•
hypotension
•
in patients with severe hypotension or with a risk of developing
severe hypotension
including acute myocardial infarction with acute left ventricular
failure and low filling
pressures and hypovolaemia
•
in patients receiving any soluble guanylate cyclase stimulators (see
Section 4.5
Interactions with other medicines and other forms of interactions).
Due to the risk of severe hypotension, the concomitant use of
nicorandil and phos