IKOTAB

Main information

  • Trade name:
  • IKOTAB nicorandil 20 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IKOTAB nicorandil 20 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218689
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218689

IKOTAB nicorandil 20 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharma Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

14/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. IKOTAB nicorandil 20 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

14/11/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of chronic stable angina pectoris.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

12 Months

Store below 25

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. IKOTAB nicorandil 20 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Round, white tablets scored on one side and bearing the inscription '20' on

the other side.

Active Ingredients

Nicorandil

20 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:35:05 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

IKOTAB nicorandil 10 mg & 20 mg tablets – draft CMI

Page 1 of 4

Ikotab

nicorandil

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Ikotab. It does not

contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine.

You may need to read it again

What Ikotab is used for

Ikotab contains nicorandil as the

active ingredient and is used to

treat chronic stable angina pectoris

i.e. 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 it has been

prescribed for you.

Your doctor may have prescribed it

for another purpose.

This medicine is only available with

a doctor’s prescription.

It is not addictive.

Before you take it

When you must not take it

Do not take Ikotab if you have

ever had an allergic reaction to:

nicorandil, nicotinic acid or

nicotinamide

any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include shortness of breath,

wheezing or difficulty in breathing;

swelling of the face, lips, tongue or

any other parts of the body; rash,

itching or hives on the skin.

Do not take Ikotab if:

you have low blood pressure

(which could make you feel

faint, weak or dizzy, especially

when you stand up suddenly)

you suffer from any other type

of serious heart diseases

you have been prescribed a

type of medicine called a

phosphodiesterase 5 inhibitor.

These medicines are used to

treat impaired sexual function

e.g. sildenafil and tadalafil.

the blister strip in which the

tablets are stored has been

open for more than 30 days.

Do not give Ikotab to children.

There is no experience with its use

in children.

Do not take it after the expiry

date printed on the pack.

If you take it after the expiry date

has passed, it may not work as

well.

Do not take it if the packaging is

torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic

to any other medicines or any

foods, dyes or preservatives.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Your doctor will discuss the risks

and benefits of taking it if you are

pregnant.

Tell your doctor if you are breast

feeding or planning to breast feed.

It is not recommended for use

during breast feeding as it is not

known whether nicorandil passes

into breast milk.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney or liver disease

low blood pressure (which can

make you feel faint, weak or

dizzy, especially when you

stand up suddenly)

other types of serious heart

diseases

mouth, stomach or skin ulcers.

If you have not told your doctor

about any of the above, tell them

before you start to take Ikotab.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

any that you buy without a

prescription from your pharmacy,

supermarket or health food store.

IKOTAB nicorandil 10 mg & 20 mg tablets – draft CMI

Page 2 of 4

Some medicines may be affected

by Ikotab or may affect how well it

works. These include:

phosphodiesterase 5 inhibitors

e.g. sildenafil – medicines

often used to treat impaired

sexual function

vasodilators –used to widen

blood vessels

tricyclic antidepressants –

medicines often used to treat

depression

nitrates – medicines used to

treat angina

antihypertensive drugs

corticosteroids - e.g.

prednisone or cortisone.

Ikotab may also increase the

effects of alcohol.

You may need to use different

amounts of your medicine or take

different medicines. Your doctor

or pharmacist will advise you.

Your doctor or pharmacist has

more information on medicines to

be careful with or to avoid while

taking Ikotab.

How to take it

How much to take

Your doctor will tell you how much

Ikotab to take.

The usual adult dose is 10 to 20 mg

twice a day. A lower starting dose

(e.g. 5 mg twice a day) may be

needed in some patients.

When to take it

Take this medicine in the morning

and in the evening, at about the

same time each day either with or

without food.

Taking your tablets at the same

time each day will have the best

effect. It will also help you

remember when to take the

tablets.

If you are not sure when to take it,

ask your doctor or pharmacist.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

Do not stop taking Ikotab, or

change the dosage, without

checking with your doctor.

Your doctor may want you to

gradually change the amount you

are taking before stopping

completely.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed

and take the nest dose when you

are meant.

Do not take a double dose to

make up for the dose you have

missed.

If there is still a long time to go

before your next dose, take it as

soon as you remember, and then

go back to taking it as you would

normally.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your

doctor or the Poisons Information

Centre (telephone Australia 13 11

26) for advice, or go to Accident

and Emergency at your nearest

hospital, if you think you or

anyone else may have taken too

much Ikotab.

Do this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of overdose may

include feeling light-headed or

dizzy and a faster than normal

heart beat.

While you are taking it

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that 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.

Tell your doctor if you become

pregnant while you are taking this

medicine.

Things you must not do

Do not take more than the

recommended dose unless your

doctor tells you to.

Do not give this medicine to

anyone else, even if they have the

same condition as you.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not stop taking Ikotab, or

change the dosage, without

checking with your doctor.

Your doctor may want you to

gradually change the amount you

are taking before stopping

completely.

Things to be careful of

Be careful driving or operating

machinery until you know how

Ikotab affects you.

Ikotab may cause dizziness or light-

headedness in some people. Make

sure you know how you react to it

IKOTAB nicorandil 10 mg & 20 mg tablets – draft CMI

Page 3 of 4

before you drive a car, operate

machinery, or do anything else

that could be dangerous if you feel

dizzy. Do not drive if this occurs.

Dizziness and light headedness can

be made worse when this

medicine is taken with alcohol. It is

recommended that you do not

drink alcohol while taking Ikotab.

Be careful when getting up from a

sitting or lying position if you feel

light-headed, dizzy or faint.

It may help to get up slowly when

getting out of bed or standing up.

Side effects

Tell your doctor as soon as

possible if you do not feel well

while you are taking Ikotab.

All medicines can have side effects.

Sometimes they are serious, but

most of the time they are not. You

may need medical treatment if you

get some of the side effects.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

headache

The most common side effect of

Ikotab is headache. This usually

occurs in the first few days after

you start taking it and generally

does not last long.

dizziness and light-headedness,

especially when getting up from

a sitting or lying down position

tiredness, drowsiness

cough

nausea, vomiting, indigestion

diarrhoea

constipation

stomach ache

flushing, sweating

loss of appetite, weight loss

fever

leg, neck, back, chest or

muscular pain, pain in the arm or

general pain

trouble sleeping

nervousness

depression

itching

double vision

nose bleed.

These are mild side effects of Ikotab

and usually short-lived.

Tell your doctor immediately if you

notice any of the following:

high blood pressure

fast or irregular heart beat

swelling of the face, hands,

ankles or feet

difficulty in breathing or

shortness of breath

tingling or numbness of the

hands or feet

rash

ringing or other persistent noise

in the ears

persistent mouth ulcers or

genital, anal or skin ulcers.

Tell your doctor immediately or go

to Accident and Emergency at your

nearest hospital if you notice any

of the following symptoms:

allergic type reactions e.g. skin

rash, itching and difficulty

breathing, wheezing or coughing.

This is a serious side effect of

Ikotab. You may need urgent

medical attention. Serious side

effects are uncommon.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell, even if

you think the problems are not

connected with this medicine and

are not referred to in this leaflet.

Other side effects not listed above

may also occur in some people.

Do not be alarmed by this list of

possible side effects.

You may not experience any of

them.

After taking it

Storage

Store below 25

C in the original

package. Keep Ikotab tablets in the

blister strip until it is time to take

them.

If you take the tablets out of the

blister strip they may not keep as

well.

Discard 30 days after opening the

blister strip.

Ikotab tablets must be protected

from moisture.

Do not store it or any other

medicine in the bathroom, near a

sink or on a windowsill. Do not

leave it in the car.

Heat and damp can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Return any unused medicine to

your phamacist.

Product description

What it looks like

Ikotab tablets come in two

strengths, 10 mg and 20 mg.

10 mg: Round white tablets, scored

on one side and marked with ‘10’

on the other side. Blister packs of

IKOTAB nicorandil 10 mg & 20 mg tablets – draft CMI

Page 4 of 4

20 or 60 tablets. Each blister strip

also contains a desiccant.

20 mg: Round white tablets, scored

on one side and marked with ‘20’

on the other side. Blister packs of

20 or 60 tablets. Each blister strip

also contains a desiccant.

(Note: Not all pack sizes or

strengths may be marketed.)

Ingredients

Active Ingredient:

Each tablet contains either 10 mg

or 20 mg of nicorandil.

Inactive ingredients:

pregelatinised maize starch

croscarmellose sodium

stearic acid

mannitol.

Ikotab tablets do not contain

sucrose, lactose, gluten, tartrazine

or any other azo dyes.

Sponsor

Aspen Pharma Pty Ltd

34-36 Chandos Street

St Leonards NSW 2065

Australian Register Numbers:

10 mg tablets: AUST R 218690

20 mg tablets: AUST R 218689

This leaflet was prepared in

November 2014.