CAPECITABINE

Main information

  • Trade name:
  • CAPECITABINE MYX capecitabine 150 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CAPECITABINE MYX capecitabine 150 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213041
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213041

CAPECITABINE MYX capecitabine 150 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

22/07/2014

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. CAPECITABINE MYX capecitabine 150 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

15/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Colon Cancer:,Capecitabine is indicated for the adjuvant treatment of patients with Duke's stage C and highrisk stage B, colon cancer, either as

monotherapy or in combination with oxaliplatin.,Colorectal Cancer:,Capecitabine is indicated for the treatment of patients with advanced or metastatic

colorectal cancer.,Oesophagogastric Cancer:,Capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in

combination with a platinum-based regimen.,Breast Cancer:,Capecitabine is indicated for the treatment of patients with locally advanced or metastatic

breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are

clinically contraindicated.,Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast

cancer after failure of prior anthracycline containing chemotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

120 Tablets in blister pack

(S4) Prescription Only Medicine

60 Tablets in blister pack

(S4) Prescription Only Medicine

30 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. CAPECITABINE MYX capecitabine 150 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light peach coloured, oblong shaped, biconvex, film-coated tablets,

debossed with 150 on one side and plain on other side.

Active Ingredients

Capecitabine

150 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 11:40:34 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

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CAPECITABINE MYX

capecitabine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Capecitabine MYX.

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 Capecitabine

MYX 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 Capecitabine

MYX is used for

Capecitabine MYX contains the

active ingredient capecitabine.

Capecitabine MYX belongs to a

group of medicines called anti-

neoplastic agents. Within this group,

Capecitabine MYX belongs to a class

of medicines called fluoropyrimidine

analogues.

Capecitabine MYX is used to treat

cancer of the bowel and rectum

(colorectal), breast and stomach and

food pipe (oesophagus). It may be

prescribed alone or in combination

with other medicines used to treat

cancer, such as chemotherapy

medicines.

The medicine contained in

Capecitabine MYX, is converted by

the liver and cancer cells to another

medicine called 5-fluorouracil (also

called 5-FU).

It is 5-FU that acts to kill or stop the

growth of cancer cells.

Your doctor may have prescribed

Capecitabine MYX for another

purpose.

Ask your doctor if you have any

questions why Capecitabine MYX

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

Capecitabine MYX is not addictive.

Before you take

Capecitabine MYX

When you must not take it

Do not take Capecitabine MYX if:

1.

you have had an allergy to

capecitabine or any of the

ingredients listed at the end of

this leaflet

5-fluorouracil (also called 5-

FU), a medicine used to treat

cancer

other fluoropyrimidine

medicines

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty in

breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching, hives on the skin

2.

if you have severe kidney

disease

3.

If you have known

dihydropyrimidine

dehydrogenase (DPD)

deficiency

4.

you are taking a medicine

containing sorivudine or

brivudine

Taking sorivudine or brivudine at the

same time as Capecitabine MYX is

potentially fatal.

5.

the package is torn or shows

signs of tampering

6.

the expiry date (EXP) printed

on the pack has passed

If you take this medicine after the

expiry date has passed, it may not

work as well.

If you are not sure if you should be

taking Capecitabine MYX, talk to

your doctor.

Use in children

Do not give Capecitabine MYX to

children.

Safety and effectiveness in persons

less than 18 years of age have not

been established.

Before you start to take it

Your doctor must know about all the

following before you start to take

Capecitabine MYX.

Tell your doctor if:

1.

you are pregnant or plan to

become pregnant.

Capecitabine MYX may be harmful

to an unborn baby when taken by a

pregnant woman. It is not

recommended that you take

Capecitabine MYX while you are

pregnant. Additionally, if you are a

woman, you should use effective

contraception to avoid becoming

pregnant while you are taking

Capecitabine MYX.

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2.

you are breast-feeding or plan

to breast-feed

It is not known whether Capecitabine

MYX and 5-FU pass into breast

milk. You doctor will discuss the

risks and benefits of you taking

Capecitabine MYX if you are breast-

feeding.

3.

you have any other health

problems, especially the

following:

heart disease

liver disease

kidney disease

4.

you are dehydrated

Some signs and symptoms of

dehydration include:

dry skin

dark coloured urine

thirst

weakness or fatigue

loss of appetite

5.

you are allergic to any other

medicines, foods, dyes or

preservatives

If you have not told your doctor

about any of the above, tell them

before you start taking

Capecitabine MYX.

Taking other medicines

Tell your doctor if you are taking

any other medicines including any

that you have bought without a

prescription from a pharmacy,

supermarket or healthfood shop.

Some medicines may interfere with

Capecitabine MYX. These medicines

include:

Warfarin (Coumadin

Marevan

), a medicine used to

thin the blood phenytoin

(Dilantin

), a medicine used to

treat epilepsy and heart

irregularities

leucovorin, also called folinic

acid, a medicine used to treat

folic acid deficient anaemias

antacids, medicines used to treat

heart burn or indigestion

These medicines may be affected by

Capecitabine MYX, or may affect

how well Capecitabine MYX works.

You may need to use different

amounts of your medicines, or take

different medicines. Your doctor will

advise you.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

Capecitabine MYX.

How to take

Capecitabine MYX

How much to take

Take Capecitabine MYX exactly as

your doctor has prescribed.

Capecitabine MYX may be given

with or without chemotherapy. Your

doctor will tell you how many

Capecitabine MYX tablets to take

each day and how often to take them.

Your doctor will calculate the dose

based on your height and weight.

Your doctor may want you to take a

combination of 150 mg (light peach

colour) and 500 mg (peach colour)

tablets for each dose.

If a combination of tablets is

prescribed, it is very important

that you correctly identify the

tablets.

Your doctor may vary your dose

depending on the nature of your

illness and your response to

Capecitabine MYX. Elderly patients

may need to receive less.

Use in Elderly

The same dose is recommended for

elderly patients given Capecitabine

MYX alone. A lower dose may be

given to elderly patients taking

Capecitabine MYX in combination

with other medicines to treat cancer.

Please follow your doctor's

instructions carefully.

How to take it

Swallow the tablets whole with a

glass of water.

Do not chew the tablets.

When to take it

Take Capecitabine MYX tablets

twice a day (morning and evening).

Capecitabine MYX tablets should

be taken with food. You should

take Capecitabine MYX no later

than 30 minutes after food. Take

Capecitabine MYX tablets at about

the same time each day

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.

When taken in combination with

chemotherapy, your doctor will

advise which days of your treatment

cycle Capecitabine MYX should be

taken.

If you are not sure when to take

Capecitabine MYX, ask your

doctor.

How long to take it

The duration of treatment with

Capecitabine MYX varies, depending

on the nature of your illness and your

individual response to the treatment.

Your Capecitabine MYX therapy is

made up of a series of treatment

cycles which usually lasts for 21

days. Your doctor will advise you

how many cycles of treatment you

will have and whether there are any

rest days in the cycle.

In most cases, your treatment cycle

will consist of intermittent

Capecitabine MYX therapy, where

you will take Capecitabine MYX for

14 days, followed by a rest period of

7 days. During the rest period, you

will not take any Capecitabine MYX.

Alternatively, your treatment cycle

may be continuous, which involves

21 days of Capecitabine MYX

treatment and no rest period.

Continue taking Capecitabine

MYX until your doctor tells you to

stop.

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If you forget to take it

Do not take an extra dose. Wait

until the next dose and take your

normal dose then.

Do not try to make up for the dose

that you missed by taking more

than one dose at a time.

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

(Australia telephone 13 11 26) for

advice or go to Accident and

Emergency at your nearest

hospital if you think that you or

anyone else may have taken too

much Capecitabine MYX.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Keep telephone numbers for these

places handy.

If you are not sure what to do,

contact your doctor or pharmacist.

While you are taking

Capecitabine MYX

Things you must do

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking Capecitabine

MYX.

Tell your doctor if you become

pregnant while taking

Capecitabine MYX.

Tell your doctor immediately if

you develop diarrhoea (more than

4 bowel movements each day).

Capecitabine MYX can sometimes

cause diarrhoea in some people. Your

doctor may stop your Capecitabine

MYX treatment and treat your

diarrhoea before starting you on

Capecitabine MYX tablets again.

Tell your doctor immediately if

you develop nausea (feeling like

you want to vomit) and it has

affected your appetite significantly.

Capecitabine MYX can cause nausea

in some people. Your doctor may

stop your Capecitabine MYX

treatment and treat your nausea

before starting you on Capecitabine

MYX tablets again.

Tell your doctor immediately if

you develop vomiting, and vomit

more than once in a 24 hour

period.

Capecitabine MYX can cause

vomiting in some people. Your

doctor may stop your Capecitabine

MYX treatment and treat your

vomiting before starting you on

Capecitabine MYX tablets again.

Tell your doctor immediately if

you develop redness or swelling of

your hands and/or feet that affects

your normal activities.

Capecitabine MYX can cause

redness and swelling of hands and/or

feet that can affect your normal

activities. Your doctor may decide to

treat this with other medicines,

and/or stop your Capecitabine MYX

treatment until the side effect settles.

Tell your doctor immediately if

you develop pain, redness, swelling

or sores in the mouth.

Capecitabine MYX can cause pain,

redness, swelling or sores in the

mouth in some people. Your doctor

may treat this with other medicines,

and/or may decide to stop your

Capecitabine MYX treatment until

the side effect settles.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Tell your doctor if you feel the

tablets are not helping your

condition.

Be sure to keep all of your

appointments with your doctor so

that your progress can be checked.

Things you must not do

Do not stop taking Capecitabine

MYX or change the dose without

first checking with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

Do not give Capecitabine MYX to

anyone else even if they have the

same condition as you.

Do not take any other medicines

whether they require a

prescription or not without first

telling your doctor or consulting

with a pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

Capecitabine MYX affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Capecitabine MYX.

Capecitabine MYX helps people with

bowel cancer, breast cancer, stomach

cancer and cancer of the oesophagus

(food pipe), but it may have

unwanted side effects. All medicines

can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

diarrhoea

vomiting

nausea (feeling like you want to

vomit)

fatigue (tiredness), weakness or

weariness

skin rashes, dry or itchy skin

V 0.1

abdominal (gut) pain

fever, or increased temperature

sensitivity

constipation

headache

dizziness

loss of appetite, weight loss

hair loss

increased eye watering or

irritation, conjunctivitis (itchy

eyes and crusty eyelids)

taste disturbance

indigestion, wind

dry mouth, thirst

sore mouth, mouth ulcers, cold

sores

nail disorders

sore throat, cough, nose bleeds

shortness of breath, difficulty in

breathing, or tightening of the

chest

redness or swelling of your hands

and/or feet

tingling or numbness of the hands

or feet

muscle and joint pain

dark coloured urine

difficulty sleeping

These are the more common side

effects of Capecitabine MYX that

you are likely to notice. Your doctor

will tell you more about them. Your

doctor may also recommend that you

change the dose of Capecitabine

MYX that you are taking if you

experience any of the above side

effects.

Tell your doctor immediately and

stop taking Capecitabine MYX if

you notice any of the following:

severe diarrhoea with more than 4

bowel movements each day

nausea that has reduced your

appetite significantly

vomiting more than once in a 24

hour period

pain, redness and/or swelling of

your hands and/or feet that has

affected your normal activities

(hand-foot- syndrome)

pain, redness, swelling or ulcers

in the mouth (stomatitis)

passing little or no urine (this

could be kidney disease) other

symptoms include drowsiness,

nausea, vomiting, and

breathlessness.

You need to stop taking Capecitabine

MYX if you experience the above

side effects. Your doctor will treat

your side effects before they start you

on Capecitabine MYX again.

Tell your doctor immediately or go

to your nearest Accident and

Emergency centre if you notice any

of the following:

chest pain

irregular heart beat

shortness of breath

confusion

poor balance or lack of

coordination

numbness or weakness of arms or

legs

signs of infection such as

swelling, redness and increased

temperature

signs of liver disease such as

yellowing of the skin and eyes

blood in the faeces

severe blisters and bleeding in the

lips, eyes, mouth, nose and

genitals

severe skin reaction which starts

with painful red areas, then large

blisters and ends with peeling of

layers of skin. This is

accompanied by fever and chills,

aching muscles and generally

feeling unwell.

These are serious side effects. You

may need urgent medical attention.

This is not a complete list of all

possible side effects. Others may

occur in some people and there may

be some side effects not yet known.

These side effects may differ when

taking Capecitabine MYX in

combination with a chemotherapy

medicine.

Please consult your doctor for

possible side effects that may be

caused by taking Capecitabine MYX

with a chemotherapy medicine.

Tell your doctor if you notice else

that is making you feel unwell,

even if it is not on this list.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After taking

Capecitabine MYX

Storage

Keep your tablets in their

container until it is time to take

them.

If you take the tablets out of their

container they may not keep well.

Keep Capecitabine MYX in a cool

dry place where the temperature

stays below 25°C.

Do not store it, or any other

medicine, in a bathroom or near a

sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep Capecitabine MYX where

young 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

If your doctor tells you to stop

taking Capecitabine MYX, or the

medication has passed its expiry

date, ask your pharmacist what to

do with any tablets that are left

over.

V 0.1

Product description

Availability

Capecitabine MYX is available in

two strengths, 150 mg and 500 mg.

Capecitabine MYX comes in blister

packs in the following pack sizes*:

150 mg - 30, 60, 120 tablets

500 mg - 30, 60, 120 tablets

*Not all pack sizes are marketed.

What it looks like

Capecitabine MYX Tablets 150 mg

are light peach coloured oblong

shaped, biconvex, film-coated

tablets, debossed with "150" on one

side and plain on other side.

Capecitabine MYX Tablets 500 mg

are peach coloured, oblong shaped,

biconvex, film-coated tablets,

debossed with "500" on one side and

plain on other side.

Ingredients

Active ingredient:

Capecitabine

Inactive ingredients:

lactose anhydrous

cellulose microcrystalline

croscarmellose sodium

hypromellose

magnesium stearate

The tablets have a film-coating

which contains:

hypromellose

purified talc

titanium dioxide

iron oxide yellow

iron oxide red

Supplier

Accord Healthcare Pty Ltd.

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australian Registration Numbers

150 mg: AUST R 213041

500 mg: AUST R 213034

Date of preparation:

This leaflet was prepared on 13 April

2017.