TEMODAL®
Temozolomide
What is in this leaflet
This leaflet answers some common questions about TEMODAL. It does not
contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking TEMODAL against the benefits this medicine is expected to have for
you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet. You may need to read it again.
What TEMODAL is used for
TEMODAL is used to treat patients with brain tumours. TEMODAL is also used
to treat adult patients with advanced metastatic malignant melanoma.
Your doctor, however, may prescribe TEMODAL for another purpose.
Ask your doctor if you have any questions about why TEMODAL has been
prescribed for you.
TEMODAL belongs to a group of medicines called cytotoxic or chemotherapy
medicines.
TEMODAL works by killing cancer cells and stopping cancer cells from
growing and multiplying.
This medicine is only available with a doctor's prescription.
Use in children
Temodal capsules are used to treat children 3 years and older, with
specific forms of brain tumour (glioblastoma multiforme or anaplastic
astrocytoma, showing recurrence or progression after standard therapy).
Before you take TEMODAL
When you must not take it
Do not take TEMODAL if:
- you are allergic to TEMODAL (temozolomide), dacarbazine (DTIC) or any of
the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may
include:- hives, itching or skin rash
- swelling of the face, lips or tongue. This may lead to difficulty
swallowing. - shortness of breath, wheezing, difficulty breathing or a tight feeling
in your chest.
- you or your partner are pregnant or intend to become pregnant.
TEMODAL may cause birth defects if either
the male or female is using TEMODAL at the time of conception or during
pregnancy. Therefore, female patients must have a negative pregnancy test
before starting TEMODAL. Both male and female patients and their partners
should each use some kind of birth control while taking TEMODAL. Male
patients whose partners are already pregnant should use a condom to minimise
exposure of the unborn baby to TEMODAL in the sperm. - you are breastfeeding.
- you have a very low level of white blood cells, red blood cells or
platelets.
Do not use TEMODAL after the expiry date printed on the bottle.
Do not use TEMODAL if the packaging shows signs of tampering.
Before you start to take it
You must tell your doctor if:
- you vomit frequently.
Your doctor may give you medicine to
control the vomiting. - you are anaemic or have blood clotting problems.
- you intend to have children.
TEMODAL may cause infertility in men. - you have liver or kidney problems.
- 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.
Some medicines may be affected by TEMODAL or may affect how well TEMODAL
works. These include other medicines used to treat cancer or any other
treatment that may lower your immune system. You may need different amounts of
your medicine or you may need to use different medicines. Your doctor will
advise you.
How to take TEMODAL
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
How much to take
Your doctor has worked out the exact dose of TEMODAL for you according to
your individual needs.
You may be given other medication to take before or after TEMODAL to help
stop nausea.
If you are taking TEMODAL 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 TEMODAL 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.
Then, you will start the next phase of treatment ("adjuvant phase") and
your TEMODAL 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
TEMODAL capsules once daily for the first five days ("dosing days") of each
cycle, followed by 23 days without TEMODAL; 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 TEMODAL.
Before each new treatment cycle begins, your blood will be tested to determine
if the TEMODAL dose needs to be adjusted.
If you are taking only TEMODAL (patients treated
for recurrent brain tumour):
Take the dose the doctor has prescribed once a day for five days.
Depending on your response to TEMODAL, 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 it
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.
All patients
TEMODAL comes in different strength capsules (shown on the outer label in
mg). Each strength has a different colour band. Depending on the dose of
TEMODAL 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
Swallow the capsules whole with a glass of water. Do not open or chew
the capsules.
When to take it
Take TEMODAL without food at least one hour before a meal.
It is good practice to take TEMODAL 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 - Australia, or 0800 764 766 - New Zealand) for advice, if you think
you or anyone else may have taken too much TEMODAL. Do this even if there are
no signs of discomfort or poisoning.
While you are taking TEMODAL
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are being treated with TEMODAL.
Tell your doctor if you feel sick or vomit while being treated with
TEMODAL.
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 TEMODAL.
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 TEMODAL.
If you or your partner becomes pregnant while you are being treated with
TEMODAL, 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 TEMODAL 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 TEMODAL.
Store TEMODAL 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 TEMODAL to anyone else, even if they have the same condition as
you.
Do not use TEMODAL 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 TEMODAL
affects you.
As with other medicines, TEMODAL may 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 TEMODAL.
Like other medicines that treat cancer, TEMODAL may have unwanted side
effects. Sometimes they may be serious, most of the time they are not. You may
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 sensation
- mouth ulcers
- coughing
- sleeplessness
These are the more common side effects of TEMODAL.
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.
These last two side effects of TEMODAL may take some time to occur.
Therefore, even after you have finished your treatment with TEMODAL, you
should tell your doctor immediately if you 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.
You may not experience any of them.
After using TEMODAL
Storage
Keep your TEMODAL capsules in the bottle until it is time to use them.
Keep TEMODAL in a cool dry place where the temperature stays below 30°C.
Do not leave it in the car or on window sills.
Keep it 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.
Disposal
Return any unused medicine to your pharmacist.
Product description
What it looks like
Before Mid 2007
TEMODAL Capsules are white capsules.
Each capsule has the word "TEMODAL" and two stripes printed on one part of
the capsule and "the strength" and two stripes on the other part. The printing
is green for the 5 mg capsule, brown for the 20 mg capsule, blue for the 100
mg capsule and black for the 250 mg capsule.
Each glass bottle contains 5 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
- silica
The capsule shells contain gelatin, titanium dioxide and sodium lauryl
sulfate.
TEMODAL does not contain sucrose, gluten, tartrazine or other azo dyes.
After Mid 2007
TEMODAL capsules have the word "TEMODAL" printed on one part of the capsule
and "the strength", two stripes and the Schering-Plough logo printed on the
other part. The colour of the printing is black.
TEMODAL 5 mg capsules are white and green.
TEMODAL 20 mg capsules are white and yellow.
TEMODAL 100 mg capsules are white and pink.
TEMODAL 250 mg capsules are white.
Each glass bottle contains 5 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:
- gelatin
- titanium dioxide
- sodium lauryl sulfate
- Indigo Carmine CI73015 (TEMODAL 5 mg)
- Iron Oxide Yellow CI77492 (TEMODAL 5 mg and 20 mg)
- Iron Oxide Red CI77491 (TEMODAL 100 mg)
TEMODAL does not contain sucrose, gluten, tartrazine or other azo dyes.