CAPEX

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213039
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213039

CAPEX capecitabine 500 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

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. CAPEX capecitabine 500 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

22/07/2014

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

30 Tablets in blister pack

(S4) Prescription Only Medicine

120 Tablets in blister pack

(S4) Prescription Only Medicine

60 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. CAPEX 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 11:42:23 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

CAPEX

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2014-

Page: 1 of 5

Capex

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

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Capex

tablets.

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

weighed the risks of you taking

Capex tablets 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 Capex is used

for

Capex contains the active

ingredient capecitabine.

Capex belongs to a group of

medicines called anti-neoplastic

agents. Within this group, Capex

belongs to a class of medicines

called fluoropyrimidine

analogues.

Capex 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

Capex 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 Capex for

another purpose.

Ask your doctor if you have

any questions why Capex has

been prescribed for you.

This medicine is available only

with a doctor's prescription.

Capex is not addictive.

Before you take

Capex

When you must not take it

Do not take Capex 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

same

time

Capex

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 Capex, talk

to your doctor.

Use in children

Do not give Capex 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 Capex.

Tell your doctor if:

1. you are pregnant or plan to

become pregnant

CAPEX

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2014-

Page: 2 of 5

Capex may be harmful to an

unborn baby when taken by a

pregnant woman. It is not

recommended that you take

Capex while you are pregnant.

Additionally, if you are a woman,

you should use effective

contraception to avoid becoming

pregnant while you are taking

Capex.

2. you are breast-feeding or

plan to breast-feed

It is not known whether Capex

and 5-FU pass into breast milk.

You doctor will discuss the risks

and benefits of you taking Capex

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 Capex.

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 Capex. 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 by Capex, or may affect

how well Capex

works.

need

different

amounts

your

medicines,

take

different

medicines.

Your

doctor will advise you.

Your

doctor

pharmacist

more information on medicines

to be careful with or avoid while

taking Capex.

How to take

Capex

How much to take

Take Capex exactly as your

doctor has prescribed.

Capex may be given with or

without chemotherapy. Your

doctor will tell you how many

Capex 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

Capex. Elderly patients may

need to receive less.

Use in elderly

The same dose is recommended

for elderly patients given Capex

alone. A lower dose may be

given to elderly patients taking

Capex 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 Capex tablets twice a

day (morning and evening).

Capex tablets should be taken

with

food.

You

should

take

Capex no later than

30 minutes after food. Take

Capex 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 Capex should be

taken.

CAPEX

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2014-

Page: 3 of 5

If you are not sure when to

take Capex, ask your

doctor.

How long to take

Capex

The duration of treatment with

Capex varies, depending on the

nature of your illness and your

individual response to the

treatment.

Your Capex 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

Capex therapy, where you will

take Capex for 14 days,

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

Capex.

Do this even if there are no

signs

of

discomfort

or

poisoning.

need

urgent

medical

attention.

Keep telephone numbers for

these places handy.

If you are not sure what to do,

contact your doctor or

pharmacist.

like you want to vomit) and it

has

affected

your

appetite

significantly.

Capex can cause nausea in

some people. Your doctor may

stop your Capex treatment and

treat your nausea before

starting you on Capex tablets

again.

Tell your doctor immediately

if you develop vomiting, and

vomit more than once in a 24

hour period.

Capex can cause vomiting in

some people. Your doctor may

stop your Capex treatment and

treat your vomiting before

starting you on Capex tablets

again.

Tell your doctor immediately

followed by a rest period of 7

if you develop redness or

days. During the rest period, you

will not take any Capex.

Alternatively, your treatment

cycle may be continuous, which

involves 21 days of Capex

treatment and no rest period.

Continue taking Capex until

your doctor tells you to stop.

If you forget to take

Capex

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)

While you are taking

Capex

Things you must do

Tell

all

doctors,

dentists

and

pharmacists

who

are

treating

you that you are taking Capex.

Tell your doctor if you become

pregnant while taking Capex.

Tell your doctor immediately

if you develop diarrhoea (more

than 4 bowel movements each

day).

Capex can sometimes cause

diarrhoea in some people. Your

doctor may stop your Capex

treatment and treat your

diarrhoea before starting you on

Capex tablets again.

Tell your doctor immediately

if you develop nausea (feeling

swelling of your hands and/or

feet that affects your normal

activities

Capex 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

Capex treatment until the side

effect settles.

Tell your doctor immediately if

you develop pain, redness,

swelling or sores in the mouth.

Capex 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

Capex treatment until the side

effect settles.

Tell your doctor if, for any

reason, you have not taken

your medicine exactly as

prescribed.

CAPEX

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2014-

Page: 4 of 5

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 Capex 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 Capex 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

Capex affects you.

Side effects

Tell your doctor or pharmacist

as soon as possible if you do not

feel well while you are taking

Capex.

Capex 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

• 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 Capex that you

are likely to notice. Your doctor

will

tell

more

about

them.

Your doctor may also

recommend that you change the

dose of Capex that you are taking

experience

above side effects.

Tell

your

doctor

immediately

and stop taking Capex

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.

You need to stop taking Capex if

experience

above

side

effects.

Your

doctor

will

treat

your side effects before they

start you on Capex 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

CAPEX

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2014-

Page: 5 of 5

• 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.

need

urgent

medical

attention.

This is not a complete list of all

possible side effects. Others may

occur

in some

people

there

may be some side effects not yet

known.

These side effects may differ

when taking Capex in

combination with a

chemotherapy medicine.

Please consult your doctor for

possible side effects that may be

caused by taking Capex 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

Capex

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 Capex 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 Capex 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 Capex, or the medication

has passed its expiry date, ask

your pharmacist what to do

with

any

tablets

that

are

left

over.

Product description

Availability

Capex is available in two

strengths, 150 mg and 500 mg.

Capex

comes

blister

packs in the following pack

sizes:

• 150 mg – 30, 60, 120 tablets

• 500 mg - 30, 60, 120 tablets

What Capex looks like

Capex

Tablets 150 mg are light

peach coloured, oblong

shaped, biconvex, film-coated

tablets, debossed with “150” on

one side and plain on other side.

Capex 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:

• hypromellose

• purified talc

• titanium dioxide

• iron oxide yellow

• iron oxide red

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd.

15 Melliodora Crescent,

Greensborough, VIC 3088

Australia

Capex 150 mg:

AUST 213040

Capex 500 mg:

AUST 213039

Date of Approval

TGA approval: 03 July 2014