TEMACCORD

Main information

  • Trade name:
  • TEMACCORD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TEMACCORD
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 172967
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

172967

TEMACCORD temozolomide 20 mg capsule bottle

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

19/07/2011

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. TEMACCORD

Product Type

Single Medicine Product

Effective date

12/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,Treatment of recurrence of

anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,Temozolomide is also indicated as a first-line treatment for patients with

advanced metastatic malignant melanoma.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type III

Coloured

24 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

20 Capsules

(S4) Prescription Only Medicine

15 Capsules

(S4) Prescription Only Medicine

5 Capsules

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Yellow/White hard capsule, size 5, printed in black ink with 'TMZ' on the cap

and '20' on the body.

Active Ingredients

Temozolomide

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 29.11.2017 at 04:51:49 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

TEMACCORD CMI

TEMACCORD

temozolomide Version 2.0

CONSUMER MEDICINE INFORMATION (CMI)

What is in this leaflet

This leaflet answers some common

questions about TEMACCORD.

It does not contain all of the

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking TEMACCORD

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, talk to

your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What TEMACCORD is

used for

TEMACCORD contains

temozolomide as the active

ingredient and belongs to a group

of medicines called cytotoxics or

chemotherapy medicines. It works

by killing cancer cells and stopping

cancer cells from growing and

multiplying.

TEMACCORD is used to treat:

patients with brain tumours

adult patients with advanced

metastatic malignant melanoma.

Ask your doctor if you have any

questions about why

TEMACCORD has been

prescribed for you.

Your doctor may have prescribed

TEMACCORD for another reason.

Use in children

TEMACCORD can be used to treat

children, 3 years of age and older,

with specific forms of brain cancer

(glioblastoma multiforme or

anaplastic astrocytoma, showing

recurrence or progression after

standard therapy).

TEMACCORD is available only with a

doctor's prescription.

Before you take

TEMACCORD

When you must not take it

Do not take TEMACCORD if you

are allergic to medicines

containing temozolomide,

dacarbazine

or any of the

ingredients listed at the end of

this leaflet.

Some of the symptoms of an

allergic reaction may include skin

rash, itching or hives, swelling of

the face, lips or tongue which may

cause difficulty in swallowing or

breathing, wheezing or shortness of

breath.

Do not take TEMACCORD if you

have very low levels of white

blood cells, red blood cells or

platelets.

Do not take TEMACCORD if you

are pregnant.

Do not take TEMACCORD if you

or your partner intend to

become pregnant.

TEMACCORD may cause birth

defects if either the male or female

is using TEMACCORD at the time of

conception or during pregnancy.

Therefore, female patients must

have a negative pregnancy test

before starting TEMACCORD. Both

male and female patients and their

partners should each use some kind

of birth control while taking

TEMACCORD. Male patients whose

partners are already pregnant

should use a condom to minimise

exposure of the unborn baby to

TEMACCORD in the sperm.

Do not take TEMACCORD if you

are breastfeeding.

Do not take TEMACCORD if the

expiry date (Exp.) printed on

the pack has passed.

Do not take TEMACCORD 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,

foods, dyes or preservatives.

Tell your doctor if you intend to

have children.

TEMACCORD may cause infertility in

men.

Tell your doctor if you have any

medical conditions, especially

the following:

liver or kidney problems

anaemia or blood clotting

problems.

Tell your doctor if you vomit

frequently.

Your doctor may give you medicine

to control the vomiting.

If you have not told your doctor

about any of the above, tell

them before you start taking

TEMACCORD.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including any that you buy

without a prescription from a

pharmacy, supermarket or

health food shop.

Some medicines may be affected by

TEMACCORD, or may affect how

well it works. These include other

medicine used to treat cancer or

nay other treatment that may affect

your immune system. You may

TEMACCORD CMI

need different amounts of your

medicine or you may need to use

different medicines. Your doctor

will advise you.

How to take

TEMACCORD

Follow all directions given to

you by your doctor carefully.

How much to take

Your doctor has worked out the

exact dose of TEMACCORD for you

according to your individual needs.

You may be given other medication

to take before or after TEMACCORD

to help stop nausea.

TEMACCORD in combination

treatment with radiation

(newly diagnosed patients):

If you are a patient with a newly

diagnosed brain tumour, your

doctor will start you on a dose of

TEMACCORD every day for 42 days

(up to 49 days) in combination with

radiation therapy. This is the first

part of the treatment ("concomitant

phase") in which you complete the

radiation therapy. Your treatment

will be interrupted for 4 weeks to

give your body a chance to recover.

You will then start the next phase

of treatment ("adjuvant phase")

and your TEMACCORD dose will

change. In this phase, there are up

to 6 treatment cycles. Each

treatment cycle lasts 28 days. You

will take your new dose of

TEMACCORD capsules once daily for

the first five days ("dosing days") of

each cycle, followed by 23 days

without TEMACCORD; this adds up

to a 28 day treatment cycle. After

day 28, the next cycle will begin, in

which you will again take this

medicine once daily for five days

followed by 23 days without

TEMACCORD.

Before each new treatment cycle

begins, your blood will be tested to

determine if the TEMACCORD dose

needs to be adjusted.

Taking TEMACCORD alone

(patients treated for recurrent

brain tumour):

Take the dose the doctor has

prescribed once a day for five

days.

Depending on your response to

TEMACCORD, a new treatment

cycle will begin each 28 days. You

will then take this medicine again

once daily for five days.

Before each new treatment cycle,

your blood will be tested to see if

the dose needs to be changed.

How to take TEMACCORD

Swallow the capsules whole

with a glass of water. Do not

open or chew the capsules.

Each time you start a new

treatment cycle, be sure you

understand exactly how many

capsules of each strength you need

to take on each day of dosing.

TEMACCORD comes in different

strength capsules (shown on the

outer label in mg). Each strength is

a different colour. Depending on

the dose of TEMACCORD that your

doctor prescribes, you may have to

take several capsules on each

dosing day of the treatment cycle

Be sure you understand exactly

how many capsules you need to

take of each strength.

Ask your doctor or pharmacist to

write down the number of each

strength (include colour) that you

need to take on each dosing day.

Be sure you know exactly

which days are your dosing

days.

Be sure you review the dose

with your health care provider

each time you start a new

cycle.

Sometimes the dose or the mix of

capsules you need to take will be

different from the last cycle.

Once you take the medicine

home, if you are confused or

unsure about how to take your

dose, call for re-instruction

before beginning the treatment

cycle.

Errors in how you take this

medicine may have serious health

consequences.

When to take TEMACCORD

Take TEMACCORD without food

at least one hour before a meal.

It is good practice to take it at

about the same time each day.

If vomiting occurs after you take

your capsules, do not take another

dose that day.

How long to take TEMACCORD

for

Keep taking TEMACCORD

exactly as your doctor

recommends.

Your doctor will tell you when your

treatment should be stopped.

If you forget to take

TEMACCORD

If you miss a dose, take the

missed dose as soon as possible

during the same day. If a full

day has gone by, check with

your doctor.

Do not take a double dose to

make up for the dose you

missed unless your doctor tells

you to

If you take too much

TEMACCORD (overdose)

Immediately telephone your

doctor, or the Poisons

Information Centre (telephone

13 11 26), or go to Accident

and Emergency at the nearest

hospital, if you think you or

anyone else may have taken

too much TEMACCORD. Do this

even if there are no signs of

discomfort or poisoning.

While you are taking

TEMACCORD

Things you must do

Tell all the doctors, dentists

and pharmacists who are

TEMACCORD CMI

treating you that you are taking

TEMACCORD.

Tell your doctor if you feel sick

or vomit while being treated

with TEMACCORD.

Your doctor may give you another

medicine to help with this.

Tell your doctor if you become

unusually pale or tired, get

blood clotting problems or

frequent infections while being

treated with TEMACCORD.

These could be caused by a low

level of red blood cells, platelets or

white blood cells in the blood. This

is more common in patients over 70

years of age. Your doctor may need

to change your dose of

TEMACCORD.

Tell your doctor immediately if

you or your partner becomes

pregnant while taking

TEMACCORD.

Be sure to keep all your

doctor's appointments so your

progress can be checked.

Your doctor may need to do some

blood and other tests from time to

time to check on your progress and

detect any unwanted side effects.

Keep follow-up appointments

with your doctor.

It is important to have your follow-

up doses of TEMACCORD at the

appropriate times to get the best

effects from your treatment.

Things you must not do

Do not open the capsules. If a

capsule is damaged, avoid

contact with your skin, eyes

and nose. Avoid inhaling the

powder. If you touch the

powder or get some in your

eyes or nose, wash the area

with water.

Do not use TEMACCORD to

treat any other conditions

unless your doctor tells you to.

Do not give TEMACCORD to

anyone else, even if they have

the same condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

TEMACCORD affects you.

TEMACCORD may cause

drowsiness, in some people. If this

occurs, do not drive, operate

machinery or do anything else that

could be dangerous.

Side effects

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are

taking TEMACCORD.

Like all other medicines,

TEMACCORD may have unwanted

side effects in some people.

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:

nausea, vomiting, feeling unwell

tiredness, sleepiness

constipation

headache

loss of appetite or weight

diarrhoea

fever or high temperature

rash, hair loss, itching

dizziness, weakness

general body pain

stomach pain, indigestion

different taste sensation

mouth ulcers

coughing

sleeplessness.

These are the more common side

effects of TEMACCORD.

Tell your doctor as soon as

possible if you notice any of the

following:

shortness of breath

tingling or numbness in hands or

feet

bruising, bleeding or being

unusually pale or tired

This could be caused by a low

level of platelets or red blood cells

in the blood.

shivering that is associated with

chills and fever

This could be sign of an infection

caused by a low level of white

blood cells in the blood.

development of red or purple

spots under the skin

These may be serious side effects.

You may need medical attention.

Shivering associated with chills and

fever or the development of red or

purple spots under the skin may

take some time to occur.

Therefore, even after you have

finished your treatment with

TEMACCORD, you should tell

your doctor immediately if you

notice these side effects.

Tell your doctor if you notice

anything that is making you

feel unwell.

Other side effects not listed above

may also occur in some patients.

Do not be alarmed by this list of

possible side effects.

You may not experience any of

them.

After taking

TEMACCORD

Storage

Keep TEMACCORD 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.

Keep your capsules in the

bottle until it is time to take

them.

Keep your capsules in a cool

dry place where the

temperature stays below 25

C.

TEMACCORD CMI

Do not store TEMACCORD or

any other medicine in the

bathroom or near a sink.

Do not leave TEMACCORD in

the car or on window sills.

Heat and dampness can destroy

some medicines.

Disposal

Return any unused medicine to

your pharmacist.

Product description

What it looks like

TEMACCORD comes in 6 strengths

of capsules:

TEMACCORD 5 mg – green and

white capsule printed with “TMZ”

and “5” in black

TEMACCORD 20 mg – yellow and

white capsule printed with “TMZ”

and “20” in black

TEMACCORD 100 mg– pink and

white capsule printed with “TMZ”

and “100” in black

TEMACCORD 140 mg – blue and

white capsule printed with “TMZ”

and “140” in black

TEMACCORD 180 mg– maroon

and white capsule printed with

“TMZ” and “180” in black

TEMACCORD 250 mg– white

capsule printed with “TMZ” and

“250” in black.

Bottle Pack: Each bottle contains 5

capsules or 15 capsules or 20

capsules.

Sachet Pack: Each sachet contains

1 capsule. There are 5 sachets or

20 sachets in a pack.

Ingredients

The active ingredient in

TEMACCORD is temozolomide:

each TEMACCORD 5mg capsule

contains 5 mg of temozolomide

each TEMACCORD 20 mg capsule

contains 20 mg of temozolomide

each TEMACCORD 100 mg

capsule contains 100 mg of

temozolomide

each TEMACCORD 140 mg

capsule contains 140 mg of

temozolomide

each TEMACCORD 180 mg

capsule contains 180 mg of

temozolomide

each TEMACCORD 250 mg

capsule contains 250 mg of

temozolomide.

The capsules also contain:

lactose anhydrous

silica-colloidal anhydrous

sodium starch glycollate

tartaric acid

stearic acid.

The capsule shells contain

gelatin

water

titanium dioxide

indigo carmine CI73015 (5 mg,

140 mg capsules only)

iron oxide yellow CI77492 (5 mg,

20 mg, 180 mg capsules only)

iron oxide red (100 mg, 180 mg

capsules only)

sodium lauryl sulfate (250 mg

TekPrint SW-9008 black ink,

(ARTG 2328).

TEMACCORD does not contain

sucrose, gluten, tartrazine or other

azo dyes.

Sponsor

Accord Healthcare Pty Ltd

Unit 702/23,

Queens Road,

Melbourne, Victoria, 3004

Australia

Australian registration numbers:

TEMACCORD 5 mg –

AUST R 172980, AUST R 206030.

TEMACCORD 20 mg-

AUST R 172967, AUST R 206031.

TEMACCORD 100 mg –

AUST R 172976, AUST R 206032.

TEMACCORD 140 mg –

AUST R 172974, AUST R 206033.

TEMACCORD 180 mg –

AUST R 172977, AUST R 206034.

TEMACCORD 250 mg-

AUST R 172978, AUST R 206035.

This leaflet was revised in May

2013.