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 or sachet pack until it is time to use them.
Keep TEMODAL in a cool dry place where the temperature stays below 25°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
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 140 mg capsules are white and blue.#
TEMODAL 180 mg capsules are white and orange*
TEMODAL 250 mg capsules are white.
Glass Bottles: Each glass bottle contains 5 capsules.
Sachets: Each sachet contains 1 capsule. There are 5 sachets in a pack.
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 and 140 mg)
Iron Oxide Yellow CI77492 (TEMODAL 5 mg, 20 mg and 180 mg)
Iron Oxide Red CI77491 (TEMODAL 100 mg and 180 mg)
TEMODAL does not contain sucrose, gluten, tartrazine or other azo dyes.
Supplier
In Australia:
Merck Sharp & Dohme (Australia) Pty Limited
54-68 Ferndell Street
South Granville NSW 2142
Australia
In New Zealand:
Merck Sharp & Dohme (New Zealand) Ltd
P O Box 99 851
Newmarket
Auckland 1149
New Zealand
Australian Registration Number
TEMODAL 5 mg: AUST R 68723, AUST R 164210
TEMODAL 20 mg: AUST R 68722, AUST R 164211
TEMODAL 100 mg: AUST R 68721, AUST R 164212
TEMODAL 140 mg AUST R 142240, AUST R 164213#
TEMODAL 180 mg AUST R 142241, AUST R 164215 *
TEMODAL 250 mg: AUST R 68720, AUST R 164216
Date of preparation
24 August 2011
*The 180 mg capsules are not marketed in Australia and New Zealand.
#The 140 mg capsules are not marketed in New Zealand
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