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Capecitabine MYX

 

 

capecitabine
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 Capecitabine MYX. It does not contain all the information that is known about Capecitabine MYX. 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 Capecitabine MYX is used for

Capecitabine MYX contains the active ingredient capecitabine.
Capecitabine MYX belongs to a group of medicines called anti- neoplastic agents. Within this group, Capecitabine MYX belongs to a class of medicines called fluoropyrimidine analogues.
Capecitabine MYX is used to treat cancer of the bowel and rectum (colorectal), breast and stomach and food pipe (oesophagus). It may be prescribed alone or in combination with other medicines used to treat cancer, such as chemotherapy medicines.
The medicine contained in Capecitabine MYX, is converted by the liver and cancer cells to another medicine called 5-fluorouracil (also called 5-FU).
It is 5-FU that acts to kill or stop the growth of cancer cells.
Your doctor may have prescribed Capecitabine MYX for another purpose.
Ask your doctor if you have any questions why Capecitabine MYX has been prescribed for you.
This medicine is available only with a doctor's prescription.
Capecitabine MYX is not addictive.

Before you take Capecitabine MYX

When you must not take it

Do not take Capecitabine MYX if:

1. you have had an allergy to

capecitabine or any of the ingredients listed at the end of this leaflet
5-fluorouracil (also called 5-FU), a medicine used to treat cancer
other fluoropyrimidine medicines
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty in breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching, hives on the skin

2. if you have severe kidney disease

3. If you have known dihydropyrimidine dehydrogenase (DPD) deficiency

4. you are taking a medicine containing sorivudine or brivudine

Taking sorivudine or brivudine at the same time as Capecitabine MYX is potentially fatal.

5. the package is torn or shows signs of tampering

6. the expiry date (EXP) printed on the pack has passed

If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking Capecitabine MYX, talk to your doctor.

Use in children

Do not give Capecitabine MYX to children.
Safety and effectiveness in persons less than 18 years of age have not been established.

Before you start to take it

Your doctor must know about all the following before you start to take Capecitabine MYX.
Tell your doctor if:

1. you are pregnant or plan to become pregnant.

Capecitabine MYX may be harmful to an unborn baby when taken by a pregnant woman. It is not recommended that you take Capecitabine MYX while you are pregnant. Additionally, if you are a woman, you should use effective contraception to avoid becoming pregnant while you are taking Capecitabine MYX.

2. you are breast-feeding or plan to breast-feed

It is not known whether Capecitabine MYX and 5-FU pass into breast milk. You doctor will discuss the risks and benefits of you taking Capecitabine MYX if you are breast-feeding.

3. you have any other health problems, especially the following:

heart disease
liver disease
kidney disease

4. you are dehydrated

Some signs and symptoms of dehydration include:
dry skin
dark coloured urine
thirst
weakness or fatigue
loss of appetite

5. you are allergic to any other medicines, foods, dyes or preservatives

If you have not told your doctor about any of the above, tell them before you start taking Capecitabine MYX.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought without a prescription from a pharmacy, supermarket or healthfood shop.
Some medicines may interfere with Capecitabine MYX. These medicines include:
Warfarin (Coumadin®, Marevan®), a medicine used to thin the blood phenytoin (Dilantin®), a medicine used to treat epilepsy and heart irregularities
leucovorin, also called folinic acid, a medicine used to treat folic acid deficient anaemias
antacids, medicines used to treat heart burn or indigestion
These medicines may be affected by Capecitabine MYX, or may affect how well Capecitabine MYX works. You may need to use different amounts of your medicines, or take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Capecitabine MYX.

How to take Capecitabine MYX

How much to take

Take Capecitabine MYX exactly as your doctor has prescribed.
Capecitabine MYX may be given with or without chemotherapy. Your doctor will tell you how many Capecitabine MYX tablets to take each day and how often to take them. Your doctor will calculate the dose based on your height and weight.
Your doctor may want you to take a combination of 150 mg (light peach colour) and 500 mg (peach colour) tablets for each dose.
If a combination of tablets is prescribed, it is very important that you correctly identify the tablets.
Your doctor may vary your dose depending on the nature of your illness and your response to Capecitabine MYX. Elderly patients may need to receive less.

Use in Elderly

The same dose is recommended for elderly patients given Capecitabine MYX alone. A lower dose may be given to elderly patients taking Capecitabine MYX in combination with other medicines to treat cancer. Please follow your doctor's instructions carefully.

How to take it

Swallow the tablets whole with a glass of water.
Do not chew the tablets.

When to take it

Take Capecitabine MYX tablets twice a day (morning and evening).
Capecitabine MYX tablets should be taken with food. You should take Capecitabine MYX no later than 30 minutes after food. Take Capecitabine MYX tablets at about the same time each day
Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.
When taken in combination with chemotherapy, your doctor will advise which days of your treatment cycle Capecitabine MYX should be taken.
If you are not sure when to take Capecitabine MYX, ask your doctor.

How long to take it

The duration of treatment with Capecitabine MYX varies, depending on the nature of your illness and your individual response to the treatment.
Your Capecitabine MYX therapy is made up of a series of treatment cycles which usually lasts for 21 days. Your doctor will advise you how many cycles of treatment you will have and whether there are any rest days in the cycle.
In most cases, your treatment cycle will consist of intermittent Capecitabine MYX therapy, where you will take Capecitabine MYX for 14 days, followed by a rest period of 7 days. During the rest period, you will not take any Capecitabine MYX.
Alternatively, your treatment cycle may be continuous, which involves
21 days of Capecitabine MYX treatment and no rest period.
Continue taking Capecitabine MYX until your doctor tells you to stop.

If you forget to take it

Do not take an extra dose. Wait until the next dose and take your normal dose then.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Capecitabine MYX.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Capecitabine MYX

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Capecitabine MYX.
Tell your doctor if you become pregnant while taking Capecitabine MYX.
Tell your doctor immediately if you develop diarrhoea (more than 4 bowel movements each day).
Capecitabine MYX can sometimes cause diarrhoea in some people. Your doctor may stop your Capecitabine MYX treatment and treat your diarrhoea before starting you on Capecitabine MYX tablets again.
Tell your doctor immediately if you develop nausea (feeling like you want to vomit) and it has affected your appetite significantly.
Capecitabine MYX can cause nausea in some people. Your doctor may stop your Capecitabine MYX treatment and treat your nausea before starting you on Capecitabine MYX tablets again.
Tell your doctor immediately if you develop vomiting, and vomit more than once in a 24 hour period.
Capecitabine MYX can cause vomiting in some people. Your doctor may stop your Capecitabine MYX treatment and treat your vomiting before starting you on Capecitabine MYX tablets again.
Tell your doctor immediately if you develop redness or swelling of your hands and/or feet that affects your normal activities.
Capecitabine MYX can cause redness and swelling of hands and/or feet that can affect your normal activities. Your doctor may decide to treat this with other medicines, and/or stop your Capecitabine MYX treatment until the side effect settles.
Tell your doctor immediately if you develop pain, redness, swelling or sores in the mouth.
Capecitabine MYX can cause pain, redness, swelling or sores in the mouth in some people. Your doctor may treat this with other medicines, and/or may decide to stop your Capecitabine MYX treatment until the side effect settles.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Things you must not do

Do not stop taking Capecitabine MYX or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give Capecitabine MYX to anyone else even if they have the same condition as you.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how Capecitabine MYX affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Capecitabine MYX.
Capecitabine MYX helps people with bowel cancer, breast cancer, stomach cancer and cancer of the oesophagus (food pipe), but it may have unwanted side effects. All medicines can have side effects.
Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
diarrhoea
vomiting
nausea (feeling like you want to vomit)
fatigue (tiredness), weakness or weariness
skin rashes, dry or itchy skin
abdominal (gut) pain
fever, or increased temperature sensitivity
constipation
headache
dizziness
loss of appetite, weight loss
hair loss
increased eye watering or irritation, conjunctivitis (itchy eyes and crusty eyelids)
taste disturbance
indigestion, wind
dry mouth, thirst
sore mouth, mouth ulcers, cold sores
nail disorders
sore throat, cough, nose bleeds
shortness of breath, difficulty in breathing, or tightening of the chest
redness or swelling of your hands and/or feet
tingling or numbness of the hands or feet
muscle and joint pain
dark coloured urine
difficulty sleeping
These are the more common side effects of Capecitabine MYX that you are likely to notice. Your doctor will tell you more about them. Your doctor may also recommend that you change the dose of Capecitabine MYX that you are taking if you experience any of the above side effects.
Tell your doctor immediately and stop taking Capecitabine MYX if you notice any of the following:
severe diarrhoea with more than 4 bowel movements each day
nausea that has reduced your appetite significantly
vomiting more than once in a 24 hour period
pain, redness and/or swelling of your hands and/or feet that has affected your normal activities (hand-foot- syndrome)
pain, redness, swelling or ulcers in the mouth (stomatitis)
passing little or no urine (this could be kidney disease) other symptoms include drowsiness, nausea, vomiting, and breathlessness.
You need to stop taking Capecitabine MYX if you experience the above side effects. Your doctor will treat your side effects before they start you on Capecitabine MYX again.
Tell your doctor immediately or go to your nearest Accident and Emergency centre if you notice any of the following:
chest pain
irregular heart beat
shortness of breath
confusion
poor balance or lack of coordination
numbness or weakness of arms or legs
signs of infection such as swelling, redness and increased temperature
signs of liver disease such as yellowing of the skin and eyes blood in the faeces
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell.
These are serious side effects. You may need urgent medical attention.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
These side effects may differ when taking Capecitabine MYX in combination with a chemotherapy medicine.
Please consult your doctor for possible side effects that may be caused by taking Capecitabine MYX with a chemotherapy medicine.
Tell your doctor if you notice else that is making you feel unwell, even if it is not on this list.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.

After taking Capecitabine MYX

Storage

Keep your tablets in their container until it is time to take them.
If you take the tablets out of their container they may not keep well.
Keep Capecitabine MYX in a cool dry place where the temperature stays below 25°C.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep Capecitabine MYX where young 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

If your doctor tells you to stop taking Capecitabine MYX, or the medication has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

Availability

Capecitabine MYX is available in two strengths, 150 mg and 500 mg.
Capecitabine MYX comes in blister packs in the following pack sizes*:
150 mg - 30, 60, 120 tablets
500 mg - 30, 60, 120 tablets
*Not all pack sizes are marketed.

What it looks like

Capecitabine MYX Tablets 150 mg are light peach coloured oblong shaped, biconvex, film-coated tablets, debossed with "150" on one side and plain on other side.
Capecitabine MYX Tablets 500 mg are peach coloured, oblong shaped, biconvex, film-coated tablets, debossed with "500" on one side and plain on other side.

Ingredients

Active ingredient:
Capecitabine
Inactive ingredients:
lactose anhydrous
cellulose microcrystalline
croscarmellose sodium
hypromellose
magnesium stearate
The tablets have a film-coating which contains:
hypromellose
purified talc
titanium dioxide
iron oxide yellow
iron oxide red

Supplier

Mayne Pharma International Pty Ltd
ABN 88 007 870 984
1538 Main North Road
Salisbury South SA 5106
Australian Registration Numbers
150 mg: AUST R 213041
500 mg: AUST R 213034
Date of preparation:
This leaflet was prepared in March 2015.
Version 1.0
MYX is a trade mark of Mayne Pharma International Pty Ltd.