Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using CAPRELSA?
CAPRELSA contains the active ingredient vandetanib. CAPRELSA is used to treat a type
cancer (tumour) in the thyroid gland (found in the throat near the windpipe) called
medullary thyroid cancer. It is generally used when the cancer has spread to other
parts of the body (metastatic). For more information, see Section
1. Why am I using CAPRELSA? in the full CMI.
2. What should I know before I use CAPRELSA?
Do not use if you have ever had an allergic reaction to vandetanib or any of the ingredients
listed at the end of the CMI.
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 CAPRELSA? in the full CMI.
3. What if I am taking other medicines?
4. How do I use CAPRELSA?
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet. More instructions can be found
in Section
4. How do I use CAPRELSA? in the full CMI.
5. What should I know while using CAPRELSA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using CAPRESLA
If you are about to be start on any new medicine, remind your doctor and pharmacist
that you are taking CAPRELSA.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
CAPRELSA may increase your chance of getting sunburnt. Be sure to avoid exposure to
the sun.
Keep all of your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not stop using this medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
Do not take CAPRELSA if you have a heart disorder that you were born with called 'congenital
long QT syndrome'.
Do not give this medicine to a child (under 18 years).
Do not give your medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how CAPRELSA
affects you.
This medicine may cause tiredness, weakness and blurred vision in some people. If
you have any of these symptoms, do not drive or operate machinery.
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Looking after your medicine
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Store it in a cool dry place where the temperature stays below 30°C.
Keep it where children cannot reach it.
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6. Are there any side effects?
Serious side effects may include severe diarrhoea; severe skin reactions which may
include redness or swelling of your face, hands, or soles of your feet, itching or
blisters. For more serious side effects, see Section
6. Are there any side effects? in the full CMI.
Common side effects may include mild diarrhoea; nausea; vomiting, loss of appetite
(anorexia), weight loss, dehydration, skin rash/acne including hand and foot rash,
skin sensitivity to sunlight; symptoms of sunburn (redness, itching, swelling or blistering),
tiredness; fatigue. For more common side effects, including what to do if you have
any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
vandetanib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using CAPRELSA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using CAPRELSA.
Where to find information in this leaflet:
1. Why am I using CAPRELSA?
CAPRELSA contains the active ingredient vandetanib. CAPRELSA belongs to a group of medicines called antineoplastics.
CAPRELSA is used to treat a type of cancer (tumour) in the thyroid gland (found in
the throat near the windpipe) called medullary thyroid cancer. It is generally used when the cancer has spread to other parts of the body (metastatic).
CAPRELSA works by slowing down the growth of new blood vessels in tumours (cancers).
This cuts off the supply of food and oxygen to the tumour. CAPRELSA may also act directly
on cancer cells to kill them or slow down their growth.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
2. What should I know before I use CAPRELSA?
Warnings
Do not use CAPRELSA if:
you are allergic to vandetanib, or any of the ingredients listed at the end of this
leaflet. Symptoms of an allergic reaction may include:
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
Always check the ingredients to make sure you can use this medicine.
you have a heart disorder that you were born with called 'congenital long QT syndrome'.
This is seen on an ECG (electrocardiogram)
CAPRELSA is not likely to affect your ability to drive or use machines. However, if
you feel weak or tired or your vision is blurred whilst taking this medicine, take
care when you are driving or using tools or machines.
CAPRELSA may increase your chance of getting sunburnt. You should take special care
to protect yourself from the sun.
Do not give this medicine to a child (under 18 years).
Safety and effectiveness in children has not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have any other medical conditions:
Heart or blood pressure problems
Kidney problems
Liver problems
an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood
vessel wall.
Plan to have any surgery before starting or during treatment. CAPRELSA may affect
the healing of any wounds. Your doctor will advise you when to stop taking CAPRELSA
before surgery and when you may start taking CAPRELSA again after surgery.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
CAPRELSA may harm an unborn child. If you are pregnant, you should not take CAPRELSA.
Women at risk of becoming pregnant must use effective contraception when they are
taking CAPRELSA and for at least four months after the last dose of CAPRELSA. Your
doctor can discuss with you the risks and benefits involved.
If you are a fertile man, you must use effective contraception during treatment with
CAPRELSA and for at least four months after your last dose of CAPRELSA.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
For the safety of your baby, you should discontinue breast-feeding during treatment
with CAPRELSA. Your doctor can discuss with you the risks and benefits involved.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with CAPRELSA and affect how it works, and some medicines
may be affected by CAPRELSA. These medicines include:
medicines used to treat infections such as itraconazole, ketoconazole, ritonavir,
clarithromycin and rifampicin
medicines used to control seizures such as carbamazepine and phenobarbital
ondansetron - a medicine used to treat nausea and vomiting
medicines used to treat mental illness such as haloperidol and chlorpromazine
vitamin K antagonists and dabigatran often referred to as 'blood thinners'
cyclosporin and tacrolimus - medicines used to treat transplant rejection
digoxin - a medicine used to treat heart problems
metformin - a medicine used to control your blood sugar
medicines used to treat heartburn such as cisapride and proton pump inhibitors
You may need different amounts of your medicines, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CAPRELSA.
4. How do I use CAPRELSA?
How much to take
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
The usual dose is 300 mg once a day (as three 100 mg tablets).
If you have kidney problems, your doctor may start you on a lower dose (200 mg once
a day).
Your doctor may also reduce your dose down to 200 mg or 100 mg a day if you have certain
side effects. .
Follow the instructions provided and use CAPRELSA until your doctor tells you to stop.
How to take CAPRELSA
Swallow the tablets whole. If you have trouble swallowing the tablet, you can mix
it with water as follows:
Take half a glass (50 mL) of still (non-carbonated) water only. Do not use any other
liquid.
Put the tablet into the water.
Stir the tablet until it has dispersed into the water. This may take about 10 minutes.
Then drink it straight away.
To make sure there is no medicine left, rinse the empty glass very well with another
half a glass of water and drink it.
When to take CAPRELSA
CAPRELSA should be used at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
If you forget to use CAPRELSA
If it is less than 12 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much CAPRELSA
If you think that you have used too much CAPRELSA, you may need urgent medical attention.
Symptoms of an overdose may include an increase in frequency or severity of some of
the side effects listed below such as rash, diarrhoea, high blood pressure (you may
have headaches, dizziness, nose bleeds etc.) and effects to your heart (including
racing heart, and possible loss of consciousness).
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using CAPRELSA?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking CAPRELSA.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
Call your doctor straight away if you:
become pregnant while taking this medicine.
Women at risk of becoming pregnant must use effective contraception when they are
taking CAPRELSA and for at least four months after the last dose of CAPRELSA.
Be sure to avoid exposure to the sun. Always protect yourself when you go outside
by using sun block and wearing sun-protective clothing which covers as much skin as
possible. Some people who are taking CAPRELSA become more sensitive to the sun. This
can cause sunburn.
Keep all of your doctor's appointments so that your progress can be checked. Your
doctor may do some tests (e.g. ECG heart test, blood tests, urine tests) from time
to time to make sure the medicine is working and to prevent unwanted side effects.
Remind any doctor, dentist or pharmacist you visit that you are using CAPRELSA.
Things you should not do
Do not stop using this medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
Do not take CAPRELSA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CAPRELSA
affects you.
This medicine may cause tiredness, feeling weak and blurred vision in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place where the temperature stays below 30°C away from moisture,
heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Gastrointestinal or gut related:
Mild or moderate diarrhoea; nausea; vomiting; loss of appetite (anorexia); weight
loss; dehydration
Abdominal pain
Skin related:
Skin rash/acne including hand and foot rash
Dry or itching skin, small raised acne-like bumps usually on the face, scalp, chest
and upper back
Skin sensitivity to sunlight; symptoms of sunburn (redness, itching, swelling or blistering)
that may occur more quickly than normal
Impaired wound healing
Muscle related:
Muscle weakness/loss of energy
Head related:
Headache; nose bleeds
Blurred vision including halos; dry eye; irritation of the inner eyelid or surface
of the eye; other issues with your eye sight
Bleeding related:
Blood in the urine
Other:
Tiredness; fatigue; trouble sleeping
Dry mouth; irritation or ulcers of the lining of the mouth, lips or tongue; changes
in taste of food
Unusual hair loss or thinning; nail problems
Depression
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Gastrointestinal or gut related:
Severe diarrhoea
Skin related:
Severe skin reactions affecting large areas of your body and may include redness or
swelling of your face, hands, or soles of your feet, itching, blisters and bleeding
of the lips, nose, eyes, mouth or genitals, peeling of your skin, muscle or joint
aches
Allergic reaction related:
Breathlessness/chest tightness
Shortness of breath and swelling of the feet or ankles
Heart or blood vessel related:
Changes in heart rhythm, fainting or dizziness
Stroke which may include symptoms such as loss of vision in one eye, double vision,
dizziness/spinning sensation; weakness in one side of the body, or in the arms or
legs; slurred speech and/or loss of co-ordination
Symptoms of enlargement and weakening of a blood vessel wall (aneurysm) or a tear
in a blood vessel wall (arterial dissections) which may include a sudden and extremely
severe headache, neck pain, blurry or double vision, sensitivity to light, drooping
eyelid, eye pain, pulsing sound in the ear
Other:
Cough
Fever
Sudden onset of cramping pain in lower back and/or side, groin or abdomen
Seizures, headache, confusion/difficulty concentrating
Renal (Kidney) failure
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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.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some side effects for example, thyroid function, liver function, and changes in your
blood, urine or heart rhythm may only be found when your doctor does tests from time
to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What CAPRELSA contains
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Active ingredient
(main ingredient)
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vandetanib (100 mg)
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Other ingredients
(inactive ingredients)
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Calcium hydrogen phosphate dihydrate (E341)
Microcrystalline cellulose (E460)
Crospovidone
Povidone
Magnesium stearate
Hypromellose (E464)
Macrogol 300
Titanium dioxide (E171)
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Potential allergens
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None.
This medicine does not contain lactose, sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What CAPRELSA looks like
CAPRELSA 100 mg is a white biconvex-shaped tablet with "Z100" imprinted on one side
and plain on the other (AUST R 192496).
CAPRELSA comes in a blister pack of 30 tablets.
Who distributes CAPRELSA
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park
NSW 2113
This leaflet was prepared in October 2023.
caprelsa-ccdsv5-cmiv6-18oct23