Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use COTELLIC? in the full CMI.
COTELLIC is taken once daily for 21 days followed by a 7 day treatment break (no medicine) in a 28 day cycle. Start your next COTELLIC treatment cycle after the 7 day treatment break.
More instructions can be found in Section 4. How do I use COTELLIC? in the full CMI.
Things you should do
|
Remind any doctor (including a surgeon or anaesthetist), dentist or pharmacist you
visit that you are using COTELLIC.
Tell your doctor straight away if you become pregnant or have changes to your vision
while taking COTELLIC.
Check your skin and tell your doctor right away about any changes. Avoid going out
in the sun.
Avoid drinking grapefruit juice.
Tell your doctor if you feel your medicine is not helping your condition.
|
---|---|
Things you should not do
|
Do not stop taking COTELLIC or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
|
Driving or using machines
|
Be careful driving or operating machinery until you know how COTELLIC affects you.
If COTELLIC affects your vision, consult your doctor before driving or operating machinery.
COTELLIC may affect your vision.
|
Looking after your medicine
|
Keep your tablets in the blister pack until it is time to take them.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
Do not store COTELLIC in the bathroom or near a sink. Do not leave it on a window
sill or in the car.
|
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI
Warnings
Do not use COTELLIC if:
1. You are allergic to cobimetinib (the active ingredient), or any of the ingredients listed at the end of this leaflet.
2. The package is torn or shows signs of tampering
3. The expiry date (EXP) printed on the pack has passed.
Check with your doctor if you:
1. You have any eye problems
2. You have any heart problems
3. You have any liver problems
4. You have any medical conditions that increase your risk of bleeding
5. You have any muscle problems
6. You have any problems with your kidneys
7. You have allergies to any other medicines, foods, preservatives or dyes
Pregnancy and breastfeeding
How to use COTELLIC
When to use COTELLIC
If you vomit after taking COTELLIC
If you forget to use COTELLIC
If you use too much COTELLIC
(by calling 13 11 26), or
Things you should do
Call your doctor straight away if you:
Things you should not do
Driving or using machines
Looking after your medicine
Getting rid of any unwanted medicine
Less serious side effects
Less serious side effects
|
What to do
|
---|---|
fever
chills
Signs and symptoms of low iron in your blood (anaemia):
tiredness
headaches
being short of breath when exercising
dizziness
looking pale
Signs and symptoms of dehydration:
dry or sticky mouth
low or no urine output
urine looks dark yellow
no tears
sunken eyes
Signs and symptoms of skin problems:
sunburn or sun sensitivity
rashes
spots
itching
dry or scaly skin
hardened or thickened areas of the skin
painful red lumps or warts
Signs and symptoms of respiratory problems:
coughing
Signs and symptoms of gastro-intestinal problems:
diarrhoea
nausea
vomiting
Some side effects can only be found when your doctor performs tests from time to time
to check your progress, for example:
increased levels of liver enzymes or sugars in the blood
decreased levels of sodium or phosphate in the blood
increased levels of blood creatine phosphokinase, a marker of tissue damage
increased blood pressure (hypertension)
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Serious side effects
|
What to do
|
---|---|
Signs and symptoms of severe skin problems:
a rash that covers a large area of your body
blisters
peeling skin
Signs and symptoms of muscle damage:
muscle aches
muscle spasms and weakness
dark, reddish urine
Signs and symptoms of a serious bleeding problem:
red or black stools that look like tar
blood in your urine or stools
unusual vaginal bleeding
headaches, dizziness, or feeling weak
Signs and symptoms of an allergic reaction:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Signs and symptoms of heart problems:
persistent coughing or wheezing
shortness of breath
difficulty breathing
tiredness
increased heart rate
swelling of your ankles and feet
Signs and symptoms of severe eye or vision problems:
blurred vision, loss of vision or other vision changes
changes in colour
seeing a blurred outline around objects
eye pain, swelling or redness
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Reporting side effects
What COTELLIC contains
Active ingredient
(main ingredient)
|
cobimetinib
(as a hemifumarate salt) |
---|---|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose (460)
croscarmellose sodium
magnesium stearate
polyvinyl alcohol
titanium dioxide (171)
macrogol 3350
purified talc
|
Potential allergens
|
lactose monohydrate
|