TEMODAL®
Temozolomide
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Temodal. It does not contain all the information that is known about Temodal. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, 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:
1. 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.
2. 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.
3. you are breastfeeding.
4. 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:
1. you vomit frequently.
Your doctor may give you medicine to control the vomiting.
2. you are anaemic or have blood clotting problems.
3. you intend to have children.
TEMODAL 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.
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 immu