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 CellCept?
CellCept contains the active ingredient mycophenolate mofetil. CellCept is used to
prevent the rejection of a transplanted organ.
2. What should I know before I take CellCept?
Do not use if you have ever had an allergic reaction to mycophenolate mofetil or any
of the ingredients listed at the end of the CMI. Do not use if you are pregnant or
breast feeding, or if you are a woman who could become pregnant and you are not using
two reliable forms of contraception.
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 take CellCept? in the full CMI.
3. What if I am taking other medicines?
4. How do I take CellCept?
Your doctor will tell you how many CellCept capsules or tablets, or how much CellCept
suspension, to take each day.
Your doctor will work out how much CellCept infusion will be given to you.
5. What should I know while taking CellCept?
|
Things you should do
|
Tell any doctor, surgeon, anaesthetist, dentist or pharmacist that is treating you
that you are using CellCept.
Wear protective clothing and broad-spectrum sunscreen when outdoors.
|
|
Things you should not do
|
Do not stop using this medicine without first checking with your doctor.
Do not take any other medicines - whether they require a prescription or not - without
first telling your doctor or consulting with a pharmacist.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how CellCept affects you,
or if you experience somnolence (drowsiness) (drowsiness), confusion, dizziness, tremor
or hypotension (low blood pressure).
|
|
Drinking alcohol
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n/a
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Looking after your medicine
|
Keep CellCept capsules and tablets in a cool dry place where the temperature stays
below 25°C.
Keep CellCept suspension in a cool dry place where the temperature stays below 30°C.
It may be stored in a refrigerator but should not be frozen.
|
6. Are there any side effects?
More common side effects include diarrhoea, constipation, nausea, vomiting, indigestion,
pain in the stomach, chest or back, headache, and urinary infection. Less common but
possibly serious side effects include infections, bruising, anaemia, swelling of the
hands, ankles or lymph nodes (glands), hypersensitivity (skin rash, itching, swelling
of the face, lips, throat, or tongue), breathing difficulties, pain in the chest,
and chronic cough with blood.
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.
Active ingredient:
Mycophenolate mofetil
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking CellCept. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking CellCept.
Where to find information in this leaflet:
1. Why am I taking CellCept?
CellCept contains the active ingredient mycophenolate mofetil.
CellCept belongs to a group of medicines called immunosuppressants. Immunosuppressants
are used to prevent the rejection of a transplanted organ and work by stopping your
immune system from reacting to the transplanted organ.
There are many different types of medicines used to prevent rejection of a transplanted
organ.
CellCept may be taken together with other medicines known as cyclosporin and corticosteroids.
2. What should I know before I take CellCept?
Warnings
Do not take CellCept if:
you are allergic to mycophenolate mofetil, or any of the ingredients listed at the
end of this leaflet. Some of the 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.
CellCept IV solution should not be given if you have an allergy to polysorbate 80.
you are pregnant
CellCept is harmful to an unborn baby when taken by a pregnant woman.
There have been cases of miscarriage and severe birth defects reported when patients
have taken CellCept during pregnancy.
You must tell your doctor if you are pregnant or plan to become pregnant.
you are breast feeding
CellCept may pass into human breast milk and could cause serious side effects in your
baby if you breastfeed.
you are a woman who could become pregnant and you are not using two reliable forms
of contraception
You must use two reliable forms of contraception at the same time before beginning
CellCept therapy, during therapy, and for at least six weeks after stopping CellCept,
unless you are not sexually active.
the package is torn or shows signs of tampering
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 whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
are a sexually active man
you are recommended to use condoms during treatment and for 90 days after stopping
treatment, even if you have had a vasectomy.
your female partner(s) are recommended to use reliable contraception while you are
being treated with CellCept and for 90 days after you have stopped receiving CellCept
you should not donate semen while you are being treated with CellCept and for 90 days
after you have stopped receiving CellCept
have any other health problems, especially the following:
a history of sun spots or skin cancers
a history of low blood counts of neutrophils (a type of white blood cell)
a history of serious stomach or bowel problems (such as ulceration or bleeding)
rare diseases due to a deficiency of the HGPRT enzyme such as Lesch-Nyhan or Kelley-Seegmiller
syndrome
kidney disease
phenylketonuria. You may not be able to take CellCept oral suspension as it is a source
of phenylalanine.
have allergies to any other medicines, foods, preservatives or dyes.
You should not donate blood while you are being treated with CellCept and for at least
6 weeks after you stop receiving CellCept.
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. If you are a woman of child bearing potential, you must have two negative pregnancy
tests 8-10 days apart just prior to starting treatment with CellCept.
Repeat pregnancy tests will be performed during routine follow-up visits with your
doctor.
Talk to your doctor if you are breast feeding or intend to breast feed.
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 CellCept and affect how it works. These include:
azathioprine, tacrolimus and sirolimus – medicines used to suppress the immune system
which can be used to prevent organ rejection after a transplant
acyclovir, ganciclovir, valaciclovir or valganciclovir used to treat certain viral
infections
isavuconazole - used to treat fungal infections
antacids - used to treat heartburn and indigestion
cholestyramine - used to treat high cholesterol
ciprofloxacin, amoxicillin plus clavulanic acid, norfloxacin plus metronidazole and
rifampicin - used to treat infections
iron supplements - used to treat low iron levels in the blood
certain vaccines, (especially live vaccines) - medicines that work by causing your
body to produce its own protection against an infectious disease
proton-pump inhibitors such as lansoprazole and pantoprazole - used to treat indigestion
and stomach ulcers
calcium-free phosphate binders (such as sevelamer) - used to treat high phosphate
levels in the blood
These medicines may be affected by CellCept or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CellCept.
4. How do I take CellCept?
CellCept infusion is only given in a hospital setting, by specially trained doctors
or nurses.
How much to take
Take CellCept exactly as your doctor has prescribed.
Your doctor will tell you how many CellCept capsules or tablets or how much CellCept
suspension to take each day.
Your doctor will work out how much CellCept infusion will be given to you.
CellCept Capsules and Tablets
The dose to prevent organ rejection is usually 1 g to 1.5 g in the morning and 1 g
to 1.5 g at night (2 g to 3 g per day) depending on which organ has been transplanted.
CellCept Suspension
Adult
The dose to prevent organ rejection is usually 2 g or 3 g per day depending on which
organ has been transplanted. This should be taken as 5 mL or 7.5 mL in the morning
and 5 mL or 7.5 mL at night using the oral dispenser provided.
Children
For renal transplant only.
For children 2 to 18 years of age, the dose to prevent organ rejection is dependent
on the child’s height and weight. The maximum dose is usually 1 g in the morning and
1 g at night (2 g daily).
CellCept Infusion
The dose to prevent organ rejection is usually 2 g to 3 g per day depending on which
organ has been transplanted.
Your doctor may adjust your dose depending on your response.
How to take it
CellCept Capsules and Tablets
Swallow the capsules or tablets whole with a full glass of water.
Do not crush tablets or open or crush capsules. If a capsule breaks open accidentally,
wash any powder off your skin with soap and water.
CellCept Suspension
Shake the suspension well before you measure out your dose. Shaking the bottle will
make sure that you get the correct dose.
Just before the suspension was given to you, water was added to the powder in the
bottle. The bottle will only be about three-quarters full when you receive it.
After the addition of water, the amount of suspension that can be withdrawn from the
bottle is 165 mL. However, each bottle will contain a little more than 165 mL to allow
for the small amount of suspension that cannot be withdrawn from the bottle with the
oral dispenser.
After each dose of the suspension have a glass of water.
If you accidentally spill the suspension on yourself, wash off any liquid thoroughly
with soap and water.
Taking the medicine
You need to use the dispenser and bottle adapter supplied with the medicine to measure
the dose. Take care not to let the made-up medicine get into your eyes. If this happens,
rinse your eyes with plain water. Take care not to let the made-up medicine get onto
your skin. If this happens, wash the area thoroughly with soap and water.
1. Shake the closed bottle well for about 5 seconds before each use.
2. Take off the child-resistant bottle cap.
3. Take the dispenser and push the plunger completely down toward the tip of the dispenser.
4. Then put the tip of the dispenser firmly into the opening of the bottle adapter.
5. Turn the whole thing upside down (bottle and dispenser).
6. Pull the plunger down slowly. Keep pulling it out until the desired amount of medicine
is in the dispenser.
7. Turn the whole thing back around the right way. Holding onto the body of the dispenser,
carefully pull the dispenser out of the bottle adapter. The bottle adapter should
stay in the bottle.
8. Put the end of the dispenser directly into your mouth and swallow the medicine. Do
not mix the medicine with any other liquid when you swallow it.
9. Close bottle with child-resistant cap after each use.
10. Immediately after administration disassemble the dispenser, rinse under running tap
water and air dry prior to next use.
CellCept Infusion
CellCept is added to an infusion bag and given as a ‘drip’ into a vein, usually over
a period of two or more hours
It is only given in a hospital setting and doses are usually approximately 12 hours
apart.
If contact with the infusion solution occurs, wash off any liquid thoroughly with
soap and water.
When to take CellCept
It is best to take doses of CellCept capsules, tablets or suspension approximately
12 hours apart. .
Taking CellCept at the same time each day will have the best effect. It will also
help you remember when to take it.
How long to take CellCept
CellCept should be taken every day. It is important to keep taking CellCept to ensure
your new transplant keeps working properly.
Continue taking CellCept for as long as your doctor tells you.
If you are receiving CellCept infusion, your doctor will most likely change this medication
to CellCept capsules, tablets or suspension once you are able to take these.
If you forget to take CellCept tablets, capsules or suspension
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember and then go
back to taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist. If you have trouble
remembering to take your medicine, ask your pharmacist for some hints.
If you take too much CellCept
If you think that you have taken too much CellCept, you may need urgent medical attention.
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 taking CellCept?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking CellCept.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
CellCept.
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.
Tell your doctor if you become pregnant while taking CellCept. If you are a woman
of child bearing potential, you must use two reliable forms of contraception at the
same time before beginning CellCept therapy, during therapy and for at least six weeks
after stopping CellCept, unless you are not sexually active.
If you are a sexually active male, you are recommended to use condoms during treatment
and for 90 days after stopping treatment, even if you have had a vasectomy. Your female
partner(s) are recommended to use reliable contraception while you are being treated
with CellCept and for 90 days after you have stopped receiving CellCept.
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 your medicine is not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked. Your doctor will need to give you regular blood tests.
Wear protective clothing and broad-spectrum sunscreen when outdoors. Medicines that
prevent the rejection of transplanted organs can increase the risk of skin cancers.
Things you should not do
Do not stop taking CellCept or change the dose without first checking with your doctor.
Do not use CellCept 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.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not crush CellCept tablets or open CellCept capsules.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful driving or operating machinery until you know how CellCept affects you
or if you experience somnolence (drowsiness), confusion, dizziness, tremor or hypotension
(low blood pressure).
CellCept may affect your ability to drive a car or operate machinery.
Looking after your medicine
Do not store CellCept or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
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.
CellCept Capsules and Tablets
Keep your capsules or tablets in the blister pack until it is time to take them. If
you take the capsules or tablets out of the blister pack they may not keep well.
Keep CellCept capsules and tablets in a cool dry place where the temperature stays
below 25°C.
CellCept Suspension
Discard the suspension after 60 days. The suspension only lasts for 60 days once water
has been added. After this time it may not work as well.
Keep CellCept suspension in a cool dry place where the temperature stays below 30°C.
It may be stored in a refrigerator but should not be frozen.
CellCept Infusion
The infusion will be stored by the hospital pharmacy or on the ward until it is time
to use it.
When to discard your medicine
If your doctor tells you to stop taking CellCept, or the expiry date has passed, 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.
To stop you rejecting your organ, transplant medications reduce your body’s own defence
mechanisms. This means your body will not be as good at fighting infection. People
receiving CellCept therefore develop more infections than usual and this could increase
the severity of the infections.
Patients who receive immunosuppressant medicines may also have a small increase in
their risk of developing some types of cancer. You should discuss this with your doctor.
If you are over 65 years of age you may have an increased chance of side effects occurring
due to immunosuppression.
Less serious side effects
Serious side effects
The above list includes serious side effects. You may need urgent medical attention.
Serious side effects are rare.
This is not a complete list of all possible side effects. Other side effects may occur
in some people and there may be some others that are not yet known.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
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.
CellCept Capsules
CellCept 250 mg capsules come in packs of 100 capsules.
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Active ingredient
(main ingredient)
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Mycophenolate mofetil
|
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Other ingredients
(inactive ingredients)
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Pregelatinised maize starch
Croscarmellose sodium
Povidone
Magnesium stearate
The capsule shell contains:
Gelatine
Sodium lauryl sulfate
Shellac
Potassium hydroxide
Silicon dioxide
The dyes in the capsule shell are:
Indigo carmine (132)
Iron oxide red (172)
Titanium dioxide (171)
Iron oxide yellow (172)
Iron oxide black (172)
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Potential allergens
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CellCept capsules are gluten and lactose free.
|
CellCept capsules are oblong, blue on one end and brown on the other, printed with
black ink ‘CellCept 250’ on the cap and ‘Roche’ on the body.
AUST R 67313
CellCept Tablets
CellCept 500 mg tablets come in packs of 50 tablets.
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Active ingredient
(main ingredient)
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Mycophenolate mofetil
|
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Other ingredients
(inactive ingredients)
|
Microcrystalline cellulose (460)
Croscarmellose sodium
Povidone
Magnesium stearate (470)
Talc (553)
The proprietary ingredient Opadry Lavender Y-5R-10272-A (includes 464, 171, 132 and
172).
|
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Potential allergens
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CellCept tablets are gluten and lactose free.
|
CellCept tablets are lavender coloured and capsule shaped, engraved with ‘CellCept
500’ on one side and ‘Roche’ on the other.
AUST R 82372
CellCept Suspension
CellCept 200 mg/mL suspension comes in a 225 mL bottle with an adapter and two oral
dispensers.
CellCept suspension contains 1 g of mycophenolate mofetil per 5 mL as the active ingredient
when reconstituted.
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Active ingredient
(main ingredient)
|
Mycophenolate mofetil
|
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Other ingredients
(inactive ingredients)
|
Sorbitol (420)
Silicon dioxide (551)
Sodium citrate (331)
Soybean lecithin
Mixed fruit flavor
Xanthan gum (415)
Aspartame (951)
Methyl hydroxybenzoate (218)
Citric acid anhydrous (330)
|
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Potential allergens
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Contains aspartame (a source of phenylalanine), sorbitol, soya bean products and hydroxybenzoates.
Maximum recommended daily dose of CellCept (3 g) contains 5.99 g sorbitol. Products
containing sorbitol may have a laxative effect or cause diarrhoea.
|
CellCept suspension is a white to off-white powder.
AUST R 72582
CellCept Infusion
CellCept 500 mg infusion comes in packs of 4 vials.
CellCept infusion contains 500 mg of mycophenolate mofetil as the hydrochloride salt.
CellCept vials will be kept in the hospital pharmacy or on the ward.
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Active ingredient
(main ingredient)
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Mycophenolate mofetil
|
|
Other ingredients
(inactive ingredients)
|
Polysorbate 80
Citric acid (330)
Sodium chloride
|
|
Potential allergens
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N/a
|
CellCept infusion is a sterile white to off-white powder in a clear glass vial. It
will be made up into an infusion bag before being given to you. The solution in the
infusion bag should be clear to slightly yellow.
AUST R 68233
Who distributes CellCept
CellCept is distributed in Australia by:
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney NSW 2000
AUSTRALIA
Medical enquiries: 1800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information.
This leaflet was prepared in June 2023.