APO-NICORANDIL nicorandil 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nicorandil, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Nicorandil

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: povidone; cetyl alcohol; croscarmellose sodium; sodium stearylfumarate; mannitol

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off-white round tablets scored on one side and engraved with 10 on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 15 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-10-03

Patient Information leaflet

APO-NICORANDIL TABLETS
1
APO-NICORANDIL TABLETS
_Contains the active ingredient nicorandil _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about nicorandil. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. YOU MAY WANT TO READ IT
AGAIN.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Nicorandil Tablets.
It contains the active ingredient
nicorandil, which belongs to a group
of medicines called "potassium
channel openers". This means it
increases the exit of potassium from
certain muscle cells, particularly
those found in arteries. This widens
the arteries and reduces the workload
required by the heart to pump the
blood.
In addition, nicorandil has a "nitrate"
property, which relaxes smooth
muscle in the blood vessels,
particularly in the veins.
Nicorandil is used to treat chronic
stable angina pectoris (chest pain). It
works by widening blood vessels and
increases blood supply to heart
muscle.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU. YOUR
DOCTOR MAY HAVE PRESCRIBED THIS
MEDICINE FOR ANOTHER REASON.
This medicine is available only with

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-NICORANDIL (NICORANDIL) TABLETS
1
NAME OF THE MEDICINE
Nicorandil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg of nicorandil, as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Nicorandil 10 mg: White to off-white round tablets scored on one side
and engraved with “10”
on the other side.
Nicorandil 20 mg: White to off-white round tablets scored on one side
and engraved with “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
APO-Nicorandil tablet is intended for oral administration.
DOSAGE
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).
2
Due
to
the
risk
of
severe
hypotension,
the
concomitant
use
of
nicorandil
and
phosphodiesterase 5 inhibitors (e.g. sild