CAPECITABINE

Main information

  • Trade name:
  • CAPECITABINE AN capecitabine 500 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CAPECITABINE AN capecitabine 500 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213037
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213037

CAPECITABINE AN capecitabine 500 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Juno Pharmaceuticals Pty Ltd

Postal Address

Level 2 6 Bond Street,South Yarra, VIC, 3141

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 AN capecitabine 500 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 DukeÆs 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

60 Tablets in blister pack

(S4) Prescription Only Medicine

120 Tablets in blister pack

(S4) Prescription Only Medicine

30 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. CAPECITABINE AN capecitabine 500 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Peach coloured, oblong shaped, biconvex, film-coated tablets, debossed

with 500 on one side and plain on other side.

Active Ingredients

Capecitabine

500 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 11:43:48 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

Capecitabine AN CMI v2.0

Capecitabine AN

Capecitabine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Capecitabine AN.

It does not contain all the available

information.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

risks

taking

Medicine

Name

against

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 AN

is used for

Capecitabine AN contains the

active ingredient capecitabine.

Capecitabine AN belongs to a

group of medicines called anti-

neoplastic agents. Within this

group, Capecitabine AN belongs to

a class of medicines called

fluoropyrimidine analogues.

Capecitabine AN 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 AN tablets,

capecitabine, 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 AN

for another purpose.

Ask your doctor if you have any

questions why Capecitabine AN

has been prescribed for you.

This medicine is available only

with a doctor's prescription.

Capecitabine AN is not addictive.

Before

you

take

Capecitabine AN

When you must not take it

Do not take Capecitabine AN 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 AN

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

AN, talk to your doctor

.

Use in children

Do not give Capecitabine

AN to children.

Safety and effectiveness in

persons less than 18 years of age

have not been established.

Before you start to take it

Tell your doctor if:

1. you are pregnant or plan to

become pregnant

Capecitabine AN may be harmful

to an unborn baby when taken by

a pregnant woman. It is not

recommended that you take

Capecitabine AN while you are

pregnant. Additionally, if you are a

woman, you should use effective

contraception to avoid becoming

pregnant while you are taking

Capecitabine AN.

Capecitabine AN CMI v2.0

2. you are breast-feeding or

plan to breast-feed

known

whether

Capecitabine AN and 5-FU pass

into breast milk. You doctor will

discuss the risks and benefits of

you taking Capecitabine AN 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 AN.

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 AN. 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

Capecitabine AN,

or may affect

how well Capecitabine AN works.

need

different

amounts of your medicines, or take

different medicines. Your doctor will

advise you.

Your doctor or pharmacist has more

information

medicines

careful

with

avoid

while

taking

Capecitabine AN

How

to

take

Capecitabine AN

How much to take

Take Capecitabine AN exactly

as your doctor has prescribed.

Capecitabine AN may be given with

without

chemotherapy.

Your

doctor

will

tell

many

Capecitabine

tablets

take

each day and how often to take

them. Your doctor will calculate the

dose

based

your

height

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 AN. Elderly patients

may need to receive less.

Use in elderly

The same dose is recommended

for elderly patients given

Capecitabine AN alone. A lower

dose may be given to elderly

patients taking Capecitabine AN

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 AN tablets

twice a day (morning and

evening).

Capecitabine

AN

tablets

should be taken with food. You

should

take

Capecitabine

AN

no later than 30 minutes after

food.

Take

Capecitabine

AN

tablets at about the same time

each day

Taking

your tablets at the same

time each day will have the best

effect.

will

also

help

remember

when

take

tablets.

When

taken

combination

with

chemotherapy,

your

doctor

will

advise

which

days

your

treatment cycle Capecitabine AN

should be taken.

If you are not sure when to take

Capecitabine

AN,

ask

your

doctor.

How long to take it

The duration of treatment with

Capecitabine AN varies,

depending on the nature of your

illness and your individual

response to the treatment.

Your Capecitabine AN 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.

most

cases,

your

treatment

cycle

will

consist

intermittent

Capecitabine

therapy,

where

you will take Capecitabine AN for

14 days. followed by a rest period

of 7 days. During the rest period,

you will not take any Capecitabine

Alternatively, your treatment cycle

may be continuous, which involves

21 days of Capecitabine AN

treatment and no rest period.

Capecitabine AN CMI v2.0

Continue taking Capecitabine AN

until

your

doctor

tells

you

to

stop

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

Poisons

Information

Centre (telephone 13 11 26) or go

to

casualty

at

your

nearest

hospital, if you think that you or

anyone else may have taken too

much Medicine Name. Do this

even

if

there

are

no

signs

of

discomfort

or

poisoning.

You

may

need

urgent

medical

attention.

Keep

telephone

numbers of these places handy.

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

using

Capecitabine AN

Things you must do

Tell

all

doctors,

dentists

and

pharmacists

who

are

treating

you

that

you

are

taking

Capecitabine AN.

Tell your doctor if you become

pregnant

while

taking

Capecitabine AN.

Tell your doctor immediately if

you

develop

diarrhoea

(more

than 4 bowel movements each

day).

Capecitabine AN can sometimes

cause

diarrhoea in some people.

Your doctor may stop your

Capecitabine AN treatment and

treat your diarrhoea before starting

you on Capecitabine AN tablets

again.

Tell your doctor immediately if

you

develop

nausea

(feeling

like you want to vomit) and it

has

affected

your

appetite

significantly.

Capecitabine AN can cause

nausea in some people. Your

doctor may stop your

Capecitabine AN treatment and

treat your nausea before starting

you on Capecitabine AN tablets

again.

Tell your doctor immediately if

you develop vomiting, and

vomit more than once in a 24

hour period.

Capecitabine

cause

vomiting

some

people.

Your

doctor may stop your Capecitabine

treatment

treat

your

vomiting

before

starting

Capecitabine AN tablets again.

Tell your doctor immediately if

you develop redness or swelling

of your hands and/or

feet that affects your normal

activities

Capecitabine AN 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 AN treatment until

the side effect settles.

Tell your doctor immediately if

you develop pain, redness,

swelling or sores in the mouth.

Capecitabine AN 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 AN

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

AN 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 AN 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 AN affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

Capecitabine AN.

Capecitabine AN helps people

with bowel

cancer,

breast

cancer,

stomach

cancer

cancer of the oesophagus

(food

pipe), but it may have unwanted

side

effects.

medicines

have side effects.

Capecitabine AN CMI v2.0

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

• 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 AN

that you are likely to notice. Your

doctor

will

tell

more

about

them. Your doctor may also

recommend

that you change the

dose of Capecitabine AN that you

are taking if you experience any of

the above side effects.

Tell

your

doctor

immediately

and stop taking Capecitabine AN

if

you

notice

any

of

the

following:

• severe diarrhoea with more

than 4 bowel movements each

• 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,

breathlessness.

need

stop

taking

Capecitabine AN if you experience

the above side effects. Your doctor

will treat your side effects before

they start you on Capecitabine AN

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

lips,

eyes,

mouth,

nose

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

serious

side

effects.

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

AN in combination with a

chemotherapy medicine.

Please consult your doctor for

possible side effects that may be

caused by taking Capecitabine

AN with a chemotherapy

medicine.

Tell your doctor if you notice

anything 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 using

Capecitabine AN

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 AN 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 AN 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 the tablets or the tablets

have

passed

their

expiry

date,

ask your pharmacist what to do

with any tablets that are left over.

Product Description

Capecitabine AN is available in

two strengths, 150 mg and 500

Capecitabine AN CMI v2.0

Capecitabine

comes

blister

packs

following

pack sizes:

• 150 mg – 30, 60, 120 tablets

• 500 mg - 30, 60, 120 tablets

Not all pack sizes may be available.

What it looks like

Capecitabine AN 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

Tablets

500mg

peach

coloured,

oblong

shaped,

biconvex,

film-coated

tablets,

debossed

with

“500”

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

Amneal Pharma Australia

12 River St

South Yarra, VIC 3141

AUST R 213033 (150 mg)

AUST R 213037 (500 mg)

Date of Preparation

January 2015

.