XELABINE

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213045
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213045

XELABINE capecitabine 500 mg film-coated 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

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. XELABINE 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 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

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

30 Tablets in blister pack

(S4) Prescription Only Medicine

60 Tablets in blister pack

(S4) Prescription Only Medicine

120 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. XELABINE 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 11:38:23 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

XELABINE

CONSUMER MEDICINE INFORMATION

Version: 3.0

-2016- Page: 1 of 5

Xelabine

(Capecitabine film-coated Tablets 150 mg and 500 mg)

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Xelabine tablets.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

Xelabine

tablets

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 Xelabine is used

for

Xelabine contains the active

ingredient capecitabine.

Xelabine belongs to a group of

medicines called anti-neoplastic

agents. Within this group,

Xelabine belongs to a class of

medicines called

fluoropyrimidine analogues.

Xelabine 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

Xelabine 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 Xelabine for another

purpose.

Ask your doctor if you have any

questions why Xelabine has

been prescribed for you.

This medicine is available only

with a doctor's prescription.

Xelabine is not addictive.

Before you take

Xelabine

When you must not take it

Do not take Xelabine 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 Xelabine 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 Xelabine, talk

to your doctor.

Use in children

Do not give Xelabine to

children.

Safety and effectiveness in

persons less than 18 years of

age have not been established.

Before you start to take it

XELABINE

CONSUMER MEDICINE INFORMATION

Version: 3.0

-2016- Page: 2 of 5

Your doctor must know about all

the following before you start to

take Xelabine.

Tell your doctor if:

1. you are pregnant or plan to

become pregnant

Xelabine may be harmful to an

unborn baby when taken by a

pregnant woman. It is not

recommended that you take

Xelabine while you are pregnant.

Additionally, if you are a woman,

you should use effective

contraception to avoid becoming

pregnant while you are taking

Xelabine.

2. you are breast-feeding or

plan to breast-feed

It is not known whether Xelabine

and 5-FU pass into breast milk.

You doctor will discuss the risks

benefits

taking

Xelabine

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

Xelabine.

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 Xelabine. 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

affected

Xelabine,

affect how well Xelabine 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 Xelabine.

How to take Xelabine

How much to take

Take Xelabine exactly as your

doctor has prescribed.

Xelabine may be given with or

without chemotherapy. Your

doctor will tell you how many

Xelabine 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 Xelabine. Elderly patients

may need to receive less.

Use in elderly

The same dose is recommended

for elderly patients given

Xelabine alone. A lower dose

may be given to elderly patients

taking Xelabine 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 Xelabine tablets twice a

day (morning and evening).

Xelabine tablets should be

taken with food. You should

take Xelabine no later than 30

minutes after food.

XELABINE

CONSUMER MEDICINE INFORMATION

Version: 3.0

-2016- Page: 3 of 5

Take Xelabine 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 in combination with

chemotherapy, your doctor will

advise

which

days

your

treatment cycle Xelabine should

be taken.

If you are not sure when to take

Xelabine, ask your doctor.

How long to take

Xelabine

The duration of treatment with

Xelabine varies, depending on

the nature of your illness and

your individual response to the

treatment.

Your Xelabine 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

Xelabine therapy, where you will

take Xelabine for 14 days,

followed by a rest period of 7

days. During the rest period, you

will not take any Xelabine.

Alternatively, your treatment

cycle may be continuous, which

involves 21 days of Xelabine

treatment and no rest period.

Continue taking Xelabine until

your doctor tells you to stop.

If you forget to take Xelabine

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;

New

Zealand

telephone

0800

764

766)

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

Xelabine.

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

Xelabine

Things you must do

Tell

all

doctors,

dentists

and

pharmacists

who

are

treating

you

that

you

are

taking

Xelabine.

Tell your doctor if you become

pregnant while taking Xelabine.

Tell your doctor immediately if

you

develop

diarrhoea

(more

than 4 bowel movements each

day).

Xelabine can sometimes cause

diarrhoea in some people. Your

doctor may stop your Xelabine

treatment and treat your

diarrhoea before starting you

on Xelabine tablets again.

Tell your doctor immediately if

you

develop

nausea

(feeling

like you want to vomit) and it

has

affected

your

appetite

significantly.

Xelabine can cause nausea in

some people. Your doctor may

stop your Xelabine treatment

and treat your nausea before

starting you on Xelabine tablets

again.

Tell your doctor immediately if

you develop vomiting, and

vomit more than once in a 24

hour period.

Xelabine can cause vomiting in

some people. Your doctor may

stop your Xelabine treatment

and treat your vomiting before

starting you on Xelabine tablets

again.

Tell your doctor immediately if

you develop redness or

swelling of your hands and/or

feet that affects your normal

activities

Xelabine 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

XELABINE

CONSUMER MEDICINE INFORMATION

Version: 3.0

-2016- Page: 4 of 5

Xelabine treatment until the side

effect settles.

Tell your doctor immediately if

you develop pain, redness,

swelling or sores in the mouth.

Xelabine 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 Xelabine 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 Xelabine 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 Xelabine 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

Xelabine affects you.

Side effects

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are

taking Xelabine.

Xelabine

helps

people

with

bowel

cancer,

breast

cancer,

stomach cancer and cancer of

the oesophagus (food pipe), but

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) 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)

• 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

more

common

side effects of Xelabine that you

are likely to notice. Your doctor

will tell you more about them.

Your

doctor

also

recommend

that

change

the dose of Xelabine that you

are taking if you experience any

of the above side effects.

Tell

your

doctor

immediately

and stop taking Xelabine 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

XELABINE

CONSUMER MEDICINE INFORMATION

Version: 3.0

-2016- Page: 5 of 5

symptoms include drowsiness,

nausea, vomiting,

breathlessness.

You need to stop taking Xelabine

if you experience the above side

effects.

Your

doctor

will

treat

your

side

effects

before

they

start you on Xelabine 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

• one or a combination of the

following: confusion,

disorientation or memory loss,

changes in the way you move,

walk or talk, decreased strength

or progressive weakness in your

body, blurred or loss of vision.

• 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

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 Xelabine in

combination with a

chemotherapy medicine.

Please consult your doctor for

possible side effects that may

be caused by taking Xelabine

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 taking Xelabine

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 Xelabine 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 Xelabine where young

children cannot reach it.

A locked cupboard at least one-

a-half

metres

above

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking

Xelabine,

or

the

medication

has

passed

its

expiry

date,

ask

your

pharmacist

what

to

do

with

any tablets that are left over.

Product description

Availability

Xelabine is available in two

strengths, 150 mg and 500 mg.

Xelabine comes in blister packs

in the following pack sizes:

• 150 mg – 30, 60, 120 tablets

• 500 mg - 30, 60, 120 tablets

What Xelabine looks like

Xelabine

Tablets

light

peach

coloured,

oblong

shaped,

biconvex,

film-coated

tablets, debossed with “150” on

side

plain

other

side.

Xelabine Tablets 500mg 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:

XELABINE

CONSUMER MEDICINE INFORMATION

Version: 3.0

-2016- Page: 6 of 5

• hypromellose

• purified talc

• titanium dioxide

• iron oxide yellow

• iron oxide red

Name

and

Address

of

the

Sponsor

Aspen Pharma Pty Ltd

34-36 Chandos Street,

ST LEONARDS, NSW, 2065

Australia

Xelabine 150 mg:

AUST R 213042

Xelabine 500 mg:

AUST R 213045

Date of Preparation

September 2017