ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle

Main information

  • Trade name:
  • ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179871
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179871

ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle

ARTG entry for

Medicine Registered

Sponsor

Orion Laboratories Pty Ltd T/A Perrigo Australia

Postal Address

25-29 Delawney Street,BALCATTA, WA, 6021

Australia

ARTG Start Date

27/03/2012

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. ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle

Product Type

Single Medicine Product

Effective date

24/10/2017

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Orion Temozolomide Capsules are indicated for the treatment of:,- patients with newly diagnosed glioblastoma multiforme concomitantly with

radiotherapy and then as adjuvant treatment. ,- recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. ,Orion

Temozolomide Capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type III

Coloured

36 Months

Store below 25

degrees Celsius

Not recorded

Keep Container

Tightly Closed/Airtight

Protect from Moisture

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

White opaque hard gelatine capsules, with two stripes in red ink on the cap

and with "T 180 mg" in red ink on the body.

Active Ingredients

Public Summary

Page 1 of

Produced at 22.05.2019 at 09:49:13 AEST

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

temozolomide

180 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 2 of

Produced at 22.05.2019 at 09:49:13 AEST

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

ORION TEMOZOLOMIDE CAPSULES

CONSUMER MEDICINE INFORMATION

PLEASE READ THIS INFORMATION CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE

(Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg and 250mg)

What is in this leaflet?

This leaflet answers some common

questions

about

Orion

Temozolomide

Capsules.

does

contain

available

information.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

benefits

risks.

Your

doctor

pharmacist

has weighed the benefits against

risks

taking

this

medicine.

If you have any concerns about

taking

this

medicine,

ask

your

doctor or pharmacist.

Keep

this

leaflet

with

the

medicine.

You may want to read it again.

What Orion Temozolomide

Capsules is used for

Orion

Temozolomide

Capsules

used

treat

patients

with

brain

tumours.

Orion

Temozolomide

Capsules is also used to treat adult

patients with advanced metastatic

malignant melanoma.

Your

doctor,

however,

prescribe

Orion

Temozolomide

Capsules for another purpose.

Ask your doctor if you have any

questions

about

why

Orion

Temozolomide

Capsules

has

been prescribed for you.

Orion

Temozolomide

Capsules

belongs to a group of medicines

called

cytotoxic

chemotherapy

medicines.

Orion

Temozolomide

Capsules

works by killing cancer cells from

growing and multiplying.

This medicine is only available with

a doctor’s prescription.

Use in children

Orion Temozolomide Capsules are

used to treat children 3 years and

older, with specific forms of brain

tumour (glioblastoma multiforme or

anaplastic

astrocytoma,

showing

recurrence

progression

after

standard therapy).

Before you take Orion

Temozolomide Capsules

When you must not take it

Do not take Orion Temozolomide

Capsules if:

1. you

are

allergic

to

temozolomide,

dacarbazine

(DTIC)

or

any

of

the

ingredients listed at the end

of this leaflet.

Symptoms

allergic

reaction may include:

- hives, itching or skin rash

- swelling of the face, lips or

tongue.

This

lead

difficulty swallowing.

- shortness of breath, difficulty

breathing,

wheezing,

tight feeling in your chest.

2. you

or

your

partner

are

pregnant or intend to become

pregnant.

Orion Temozolomide Capsules

may cause birth defects if either

male or female is using Orion

Temozolomide Capsules at the

time

conception

during

pregnancy.

Therefore,

female

patients must have a negative

pregnancy

test

before

starting

Orion Temozolomide Capsules.

Both male and female patients

and their partners should each

use some kind of birth control

while taking this medicine. Male

patients

whose

partners

already pregnant should use a

condom to minimise exposure of

unborn

baby

temozolomide in the sperm.

3. you are breastfeeding

4. you have a very low level of

white blood cells, red blood

cells or platelets.

Do not use Orion Temozolomide

Capsules

after

the

expiry

date

printed on the bottle.

Do not use Orion Temozolomide

Capsules if the packaging shows

signs of tampering.

Before you start to take it

You must tell your doctor if:

1. you vomit frequently

Your

doctor

give

medicine to control the vomiting.

2. you

are

anaemic

or

have

blood clotting problems.

3. you intend to have children.

Orion Temozolomide Capsules

may cause infertility in men.

4. you

have

liver

or

kidney

problems.

5. you have allergies to:

- any other medicines

- any other substances, such

as

foods,

preservatives

or

dyes

Taking other medicines

Tell your doctor if you are taking

any

other

medicines,

including

medicines that you buy without a

prescription

from

a

pharmacy,

supermarket

or

health

food

shop.

Orion Temozolomide (AUST R 179869, 179870, 179871, 179872, 179873, 179874) CMI

Page 1 of 4

Orion Temozolomide Capsules

CONSUMER MEDICINE INFORMATION

Some medicines may be affected

by Orion Temozolomide Capsules

affect

well

Orion

Temozolomide

Capsules

works.

These

include

other

medicines

used to treat cancer or any other

treatment

that

lower

your

immune

system.

need

different amounts of your medicine

or you may need to use different

medicines. Your doctor will advise

you.

How to take Orion

Temozolomide Capsules

Follow all directions given to you

by your doctor carefully.

They

differ

from

information contained in this leaflet.

How much to take

Your

doctor

worked

exact dose of Orion Temozolomide

Capsules for you according to your

individual needs.

You may be given other medication

take

before

after

Orion

Temozolomide

Capsules

help

stop nausea.

If

you

are

taking

Orion

Temozolomide

Capsules

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

Orion

Temozolomide

Capsules

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

interrupted for 4 weeks to give your

body a chance to recover.

Then, you will start the next phase

of treatment (“adjuvant phase”) and

your

Orion

Temozolomide

Capsules 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

Orion

Temozolomide

Capsules once daily for the first five

days (“dosing days”) of each cycle,

followed by 23 days without Orion

Temozolomide Capsules; this adds

treatment

cycle.

After day

28, the next cycle

will

begin, in which you will again take

this

medicine

once

daily

five

days followed by 23 days without

Orion

Temozolomide

Capsules.

Before each new treatment cycle

begins, your blood will be tested to

determine

Orion

Temozolomide

Capsules

dose

needs to be adjusted.

If

you

are

taking

only

Orion

Temozolomide

Capsules

(patients

treated

for

recurrent

brain tumour):

Take

the

dose

the

doctor

has

prescribed once a day for five

days.

Depending

your

response

Orion Temozolomide Capsules, a

new treatment cycle will begin each

28 days.

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 it

Each

time

start

treatment

cycle,

sure

understand

exactly

many

capsules of each strength you need

to take on each day of dosing.

All patients

Orion

Temozolomide

Capsules

come in different capsule strengths

(shown on the outer label in mg).

Each strength is a different colour.

Depending on the dose of Orion

Temozolomide Capsules that your

doctor prescribes, you may have to

take

several

capsules

each

dosing day of the treatment cycle

sure

understand

exactly

many

capsules

each

strength you need to take. Ask your

doctor or pharmacist to write down

number

each

strength

(include colour) that you need to

take on each dosing day.

Be sure you know exactly which

days are your dosing days.

sure

review

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.

Swallow the capsules whole with

a glass of water. Do not open or

chew the capsules.

When to take it

Take

Orion

Temozolomide

Capsules without food at

least

one hour before a meal.

It is good practice to take Orion

Temozolomide

Capsules

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 it

Your doctor will tell you when

your

treatment

should

be

stopped.

If you forget to take it

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

double

the

next

dose

unless your doctor tells you to

do so.

If

you

take

too

much

(overdose)

Immediately

telephone

your

doctor

or

Poisons

Information

Centre

(Phone

13

11

26

for

Australia

or

0800

764

766

for

New Zealand) for advice, if you

think

you

or

anyone

else

may

have

taken

to

much

Orion

Temozolomide Capsules. Do this

ORI02980F_CMI_02

Page 2 of 4

Orion Temozolomide Capsules

CONSUMER MEDICINE INFORMATION

even

if

there

are

no

signs

of

discomfort or poisoning.

While you are taking Orion

Temozolomide Capsules

Things you must do

Tell any of the doctors, dentists,

and

pharmacists

who

are

treating you that you are being

treated with Orion Temozolomide

Capsules.

Tell your doctor if you feel sick

or vomit while being treated with

Orion Temozolomide Capsules.

Your doctor may give you another

medicine to help stop this.

Tell your doctor if you become

unusually pale or tired, get blood

clotting

problems

or

frequent

infections

while

being

treated

with

Orion

Temozolomide

Capsules.

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

age.

Your

doctor

need to change your dose of Orion

Temozolomide Capsules.

If you or your partner becomes

pregnant

while

you

are

being

treated with Orion Temozolomide

Capsules, tell your doctor.

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 Orion Temozolomide

Capsules at the appropriate times

to get the best effects from your

treatment.

If you are about to be started on

any

new

medicine,

tell

your

doctor,

dentist

or

pharmacist

that you are being treated with

Orion Temozolomide Capsules.

Store

Orion

Temozolomide

Capsules

out

of

the

reach

of

children.

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 give Orion Temozolomide

Capsules to anyone else, even if

they have the same condition as

you.

Do not use Orion Temozolomide

Capsules

to

treat

any

other

complaints

unless

your

doctor

tells you to.

Things to be careful of

Be careful driving or operating

machinery, until you know how

Orion

Temozolomide

Capsules

affects you.

with

other

medicines,

Orion

Temozolomide

Capsules

make some people feel tired.

If this occurs do not drive.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel

well

while

you

are

taking

Orion Temozolomide Capsules.

Like

other

medicines

that

treat

cancer,

Orion

Temozolomide

Capsules may have unwanted side

effects.

Sometimes

they

serious, most of the time they are

not.

need

medical

attention if you get some of these

side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist 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 sensations

mouth ulcers

coughing

sleeplessness

These are the more common side

effects

Orion

Temozolomide

Capsules.

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

being

unusually pale or tired

This could be caused by a low

level of platelets or red blood

cells in the blood.

shivering

that

associated

with chills and fever

This

could

sign

infection caused by a low level

white

blood

cells

blood.

development of red or purple

spots under the skin

These may be serious side effects.

You may need medical attention.

These last two side effects of Orion

Temozolomide Capsules may take

some

time

occur.

Therefore,

even after you have finished your

treatment with Orion Temozolomide

Capsules,

should

tell

your

ORI02980F_CMI_02

Page 3 of 4

Orion Temozolomide Capsules

CONSUMER MEDICINE INFORMATION

doctor

immediately

notice

these side effects.

Other side effects not listed above

may also occur in some patients.

Tell

your

doctor

if

you

notice

anything else that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects.

experience

them.

After using Orion

Temozolomide Capsules

Keep your Orion Temozolomide

Capsules in a bottle until it is

time to use them.

Keep your Orion Temozolomide

Capsules

in

a

cool

dry

place

where

the

temperature

stays

below 25°C.

Do not leave it in the car or on

windowsills.

Keep

it

where

children

cannot

reach it.

A locked cupboard at least one and

half meters above ground is a good

place to store medicines.

Disposal

Return any unused medicine to

your pharmacist.

Product description

What it looks like

Orion

Temozolomide

5mg

Capsules: White opaque capsules,

with two stripes in green ink on the

cap and with “T 5mg” in green ink

on the body.

Orion

Temozolomide

20mg

Capsules: White opaque capsule,

with two stripes in orange ink on

with

“T

20mg”

orange ink on the body.

Orion

Temozolomide

100mg

Capsules: White opaque capsule,

with two stripes in pink ink on the

cap and with “T 100mg” in pink ink

on the body.

Orion

Temozolomide

140mg

Capsules: White opaque capsule,

with two stripes in blue ink on the

cap and with “T 140mg” in blue ink

on the body.

Orion

Temozolomide

180mg

Capsules: White opaque capsule,

with two stripes in red ink on the

cap and with “T 180mg” in red ink

on the body.

Orion

Temozolomide

250mg

Capsules: White opaque capsule,

with two stripes in black ink on the

cap and with “T 250mg” in black ink

on the body.

Each glass bottle contains 5 or 20

capsules.

Tell

your

pharmacist

if

you

notice

any

change

in

the

appearance of the capsule.

Ingredients

Active ingredient:

temozolomide

Inactive ingredients:

anhydrous lactose

sodium starch glycollate

stearic acid

tartaric acid

colloidal anhydrous silica

The capsule shells also contain the

following ingredients:

gelatine

titanium dioxide

TekPrint

SB-4020

Green

[ARTG

2652]

(Orion

Temozolomide 5mg Capsules)

TekPrint

SB-2008

Orange

[ARTG

107473]

(Orion

Temozolomide 20mg Capsules)

Pink

TekPrint

SW-1105

[ARTG

3325]

(Orion

Temozolomide

100mg Capsules)

TekPrint

SB-6018

Blue

[ARTG

2653]

(Orion

Temozolomide 140mg Capsules)

TekPrint

SW-1102

[ARTG

107015]

(Orion

180mg

Temozolomide Capsules)

OPACODE monogramming ink S-

S-1-277002 black [ARTG 107581]

(Orion

Temozolomide

250mg

Capsules)

Orion

Temozolomide

Capsules

does not contain sucrose, gluten,

tartrazine or other azo dyes.

Sponsor

Orion Laboratories Pty Ltd

25 – 29 Delawney Street

Balcatta WA 6021

Orion Temozolomide 5mg

Capsules: AUST R 179874

Orion Temozolomide 20mg

Capsules: AUST R 179872

Orion Temozolomide 100mg

Capsules: AUST R 179869

Orion Temozolomide 140mg

Capsules: AUST R 179870

Orion Temozolomide 180mg

Capsules: AUST R 179871

Orion Temozolomide 250mg

Capsules: AUST R 179873

This

leaflet

prepared

October 2011

Date

last

amendment:

June 2013

ACC03031P:2

ORI02980F_CMI_02

Page 4 of 4