IKOTAB nicorandil 10 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
20-05-2022
Summary of Product characteristics
(SPC)
20-05-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
nicorandil, Quantity: 10 mg
Available from:
Viatris Pty Ltd
INN (International Name):
Nicorandil
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: pregelatinised maize starch; croscarmellose sodium; mannitol; stearic acid
Administration route:
Oral
Units in package:
60, 20
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of chronic stable angina pectoris.
Product summary:
Visual Identification: Round, white tablets scored on one side and bearing the inscription '10' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-11-14
Patient Information leaflet
IKOTAB
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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 IKOTAB?
IKOTAB contains the active ingredient nicorandil. IKOTAB is used to
treat chronic stable angina pectoris (chest pain or discomfort
due to coronary heart disease). It works by widening blood vessels and
increases blood supply to heart muscle. For more
information, see Section 1. Why am I using IKOTAB? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IKOTAB?
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 IKOTAB? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IKOTAB 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 IKOTAB?
•
The standard adult dose of IKOTAB is 10 mg to 20 mg twice a day. A
lower starting dose may be needed in some patients. Your
doctor may have prescribed a different dose.
•
IKOTAB 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 IKOTAB? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IKOTAB?
THINGS YOU
SHOULD DO
•
Tell all the doctors, dentists and pharmacists who are treating you
that you are taking IKOTAB.
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist that you are taking
IKOTAB.
•
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 imme
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
IKOTAB
_nicorandil tablets _
1
NAME OF THE MEDICINE
Nicorandil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IKOTAB tablet contains either 10 mg or 20 mg nicorandil as the
active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
IKOTAB 10 mg tablets are round, white tablets, scored on one side and
bearing the inscription “10” on the
other side.
IKOTAB 20 mg tablets are round, white tablets, scored on one side and
bearing the inscription “20” on the
other side.
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.
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 phosphodiesterase 5 inhibitors
(e.g. sildenafil, tadalafil, vardenafil) is contraindicated (see
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