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MYCOPHENOLATE MOFETIL 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): MYCOPHENOLATE MOFETIL

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Package leaflet: Information for the user

Mycophenolate mofetil
500 mg powder for
concentrate for solution
for infusion
mycophenolate mofetil

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Mycophenolate mofetil for infusion is and
what it is used for
2. What you need to know before you take
Mycophenolate mofetil for infusion
3. How to take Mycophenolate mofetil for infusion
4. Possible side effects
5. How to store Mycophenolate mofetil for infusion
6. Contents of the pack and other information
7. Making up the medicine

1. What Mycophenolate mofetil
for infusion is and what it is
used for
The full name of your medicine is Mycophenolate
mofetil 500 mg powder for concentrate for
solution for infusion
• In this leaflet the shorter name Mycophenolate
mofetil for infusion is used.
Mycophenolate mofetil for infusion contains
mycophenolate mofetil.
• This belongs to a group of medicines called
“immunosuppressants”.
Mycophenolate mofetil for infusion is used to
prevent your body rejecting a transplanted organ.
• A kidney or liver.
Mycophenolate mofetil for infusion should be
used together with other medicines:
• ciclosporin
• corticosteroids.

2. What you need to know before
you take Mycophenolate
mofetil for infusion
Do not have Mycophenolate mofetil for
infusion if:
• you are allergic (hypersensitive) to mycophenolate
mofetil, mycophenolic acid, polysorbate 80 or any
of the other ingredients of Mycophenolate mofetil
for infusion (listed in Section 6)
• you are pregnant or breast-feeding.
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or nurse before having Mycophenolate
mofetil for infusion.
Warnings and precautions
Talk to your doctor or nurse straight away before
having Mycophenolate mofetil for infusion if:
• you have a sign of infection such as a fever or
sore throat
• you have any unexpected bruising or bleeding
• you have ever had a problem with your
digestive system such as a stomach ulcer
• you are planning to become pregnant or if you
get pregnant while taking Mycophenolate
mofetil for infusion.
If any of the above apply to you (or you are not
sure), talk to your doctor or nurse straight away
before having Mycophenolate mofetil for infusion.
The effect of sunlight
Mycophenolate mofetil for infusion reduces your
body’s defences. As a result, there is an
increased risk of skin cancer. Limit the amount of
sunlight and UV light you get. Do this by:
• wearing protective clothing which also covers
your head, neck, arms and legs
• using a sunscreen with a high protection factor.
Other medicines and Mycophenolate mofetil
for infusion
Please tell your doctor or nurse if you are taking
or have recently taken, any other medicines. This
includes medicines obtained without a
prescription, including herbal medicines. This is
because Mycophenolate mofetil for infusion can
affect the way some other medicines work. Also
other medicines can affect the way
Mycophenolate mofetil for infusion works.
In particular, tell your doctor or nurse if you are
taking any of the following medicines before you
start Mycophenolate mofetil for infusion:
• azathioprine or other medicines which suppress
your immune system – given after a transplant
operation
• cholestyramine – used to treat high cholesterol
• rifampicin – an antibiotic used to prevent and
treat infections such as tuberculosis (TB)
• phosphate binders – used by people with
chronic kidney failure to reduce how much
phosphate gets absorbed into their blood.
Vaccines
If you need to have a vaccine (a live vaccine) while
having Mycophenolate mofetil for infusion, talk to
your doctor or pharmacist first. Your doctor will have
to advise you on what vaccines you can have.
Pregnancy, contraception and breast-feeding
Pregnancy
• If you are pregnant, do not take
Mycophenolate mofetil for infusion. This is
because Mycophenolate mofetil for infusion
may cause miscarriage or damage to your
unborn baby (affecting development of ears for
example).

• In certain situations, you and your doctor may
decide that the benefits of having
Mycophenolate mofetil for infusion for your
health are more important than the possible
risks to your unborn baby.
• If you plan to become pregnant, talk to your
doctor first. Your doctor will talk to you about
other medicines you can take to prevent
rejection of your transplant organ.
• If you think you may be pregnant tell your
doctor or nurse straight away.
• However, keep having Mycophenolate mofetil
for infusion until you see him or her.
If you are able to become pregnant, you must
have a pregnancy test before you start
Mycophenolate mofetil for infusion. You can only
start Mycophenolate mofetil for infusion if the test
is negative.
You are a woman who is not capable of
becoming pregnant if any of the following applies
to you:
• you are post-menopausal, i.e. at least 50 years
old and your last period was more than a year
ago (if your periods have stopped because you
have had treatment for cancer, then there is still
a chance you could become pregnant)
• your fallopian tubes and both ovaries have been
removed by surgery (bilateral
salpingo-oophorectomy)
• your womb (uterus) has been removed by
surgery (hysterectomy)
• your ovaries no longer work (premature ovarian
failure, which has been confirmed by a
specialist gynaecologist)
• you were born with one of the following rare
conditions that make pregnancy impossible: the
XY genotype, Turner’s syndrome or uterine
agenesis
• you are a child or teenager who has not started
having periods.
Contraception
You must always use an effective method of
contraception with Mycophenolate mofetil for
infusion. This includes:
• before you start having Mycophenolate mofetil
for infusion
• during your entire treatment with
Mycophenolate mofetil for infusion
• for 6 weeks after you stop having
Mycophenolate mofetil for infusion.
Talk to your doctor about the most suitable
contraception for you. This will depend on your
individual situation.
Breast-feeding
Do not have Mycophenolate mofetil for infusion if
you are breast-feeding. This is because small
amounts of the medicine can pass into the
mother’s milk.
Driving and using machines
Mycophenolate mofetil for infusion is not likely to
affect you being able to drive or use any tools or
machines.

3. How to take Mycophenolate
mofetil for infusion
Mycophenolate mofetil for infusion is usually
given by a doctor or nurse in hospital. It is given
as a slow drip (infusion) into a vein.
How much to take
The amount you take depends on the type of
transplant you have had. The usual doses are
shown below. Treatment will continue for as long
as you need to prevent you from rejecting your
transplant organ.
Kidney transplant
Adults
• The first dose is given within 24 hours of the
transplant operation.
• The daily dose is 2 g of the medicine taken as
2 separate doses.
• This will be given as 1 g in the morning and
then 1 g in the evening.
Liver transplant
Adults
• The first dose is given to you as soon as
possible after the transplant operation.
• You will have the medicine for at least 4 days.
• The daily dose is 2 g of the medicine taken as
2 separate doses.
• This will be given as 1 g in the morning and
then 1 g in the evening.
• When you are able to swallow, you will be
given this medicine by mouth.
Making up the medicine
The medicine comes as a powder. This needs
mixing with glucose before using. Your doctor or
nurse will make up the medicine and give it to
you. They will follow the instructions under
Section 7 “Making up the medicine”.
If you have more Mycophenolate mofetil for
infusion than you should
If you think that you have had too much medicine,
talk to your doctor or nurse straight away.
If you forget to take Mycophenolate mofetil
for infusion
If a dose of Mycophenolate mofetil for infusion is
missed, this will be given to you as soon as
possible. Your treatment will then continue at the
normal times.
If you stop taking Mycophenolate mofetil for
infusion
Do not stop having Mycophenolate mofetil for
infusion unless your doctor tells you to. If you
stop your treatment you may increase the chance
of rejection of your transplant organ.
If you have any further questions on the use of
this product, ask your doctor or nurse.

4. Possible side effects
Like all medicines, Mycophenolate mofetil for
infusion can cause side effects, although not
everybody gets them.
Talk to a doctor or nurse straight away if you
notice any of the following serious side
effects – you may need urgent medical
treatment:

• you have a sign of infection such as a fever or
sore throat
• you have any unexpected bruising or bleeding
• you have a rash, swelling of your face, lips,
tongue or throat, with difficulty breathing - you
may be having a serious allergic reaction to the
medicine (such as anaphylaxis, angioeodema).
Usual problems
Some of the more usual problems are diarrhoea,
fewer white cells or red cells in your blood,
infection and vomiting. Your doctor will do regular
blood tests to check for any changes in:
• the number of your blood cells
• the amount in your blood of things like sugar, fat
or cholesterol.
Fighting infections
Mycophenolate mofetil for infusion reduces your
body’s defences. This is to stop you rejecting
your transplant. As a result, your body will not be
as good as normal at fighting infections. This
means you may catch more infections than usual.
This includes infections of the brain, skin, mouth,
stomach and gut, lungs and urinary system.
Lymph and skin cancer
As can happen in patients having this type of
medicine (immune-suppressants), a very small
number of Mycophenolate mofetil for infusion
patients have developed cancer of the lymphoid
tissues and skin.
General unwanted effects
You may get general side effects affecting your
body as a whole. These include serious allergic
reactions (such as anaphylaxis, angioeodema),
fever, feeling very tired, difficulty sleeping, pains
(such as stomach, chest, joint or muscle, pain on
passing urine), headache, flu symptoms and
swelling.
Other unwanted effects may include:
Skin problems such as:
• acne, cold sores, shingles, hair loss, rash, itching.
Urinary problems such as:
• kidney problems or the urgent need to pass
water (urine).
Digestive system and mouth problems such as:
• swelling of the gums and mouth ulcers
• inflammation of the pancreas, colon or stomach
• gut problems including bleeding, liver problems
• constipation, feeling sick (nausea), indigestion,
loss of appetite, flatulence.
Nervous system problems such as:
• feeling drowsy or numb
• tremor, muscle spasms, convulsions
• feeling depressed, changes in your mood or
thoughts.
Heart and blood vessel problems such as:
• change in blood pressure, blood clots, unusual
heartbeat
• pain, redness and swelling of the blood vessels
where you had the infusion.
Lung problems such as:
• pneumonia, bronchitis
• shortness of breath, cough which can be due to
bronchiectasis (a condition in which the lung
airways are abnormally dilated) or pulmonary
fibrosis (scarring of the lung). Talk to your doctor if
you develop a persistent cough or breathlessness
• fluid on the lungs or inside the chest
• sinus problems.
Other problems such as:
• weight loss, high blood sugar, bleeding, bruising.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the the national
reporting system (see contact details below).
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website:www.medicinesauthority.gov.mt/adrportal

5. How to store Mycophenolate
mofetil for infusion
• Keep out of the sight and reach of children.
• Do not use after the expiry date stated on the
carton and vial label (EXP).
• Powder for concentrate for solution for infusion:
do not store above 30°C.
• Reconstitution and dilution: After reconstitution
and dilution, chemical and physical in-use
stability of solution for infusion has been
demonstrated for 24 hours at 20 to 30 °C. From
a microbiological point of view, the product
should be used immediately. If not used
immediately, in-use storage times and
conditions prior to use are the responsibility of
the user.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and
other information
What Mycophenolate mofetil for infusion
contains
• The active substance is mycophenolate mofetil.
• The other ingredients are: polysorbate 80, citric
acid, hydrochloric acid, sodium chloride and
sodium hydroxide (for pH-adjustment).
What Mycophenolate mofetil for infusion
looks like and contents of the pack
• Mycophenolate mofetil for infusion is provided
in a 20 ml type I clear glass vial with a grey butyl
rubber stopper and aluminium flip off seal.
• It is available in packs of either 4 vials or 1 vial.

7. Making up the medicine
Method and route of administration
Mycophenolate mofetil for infusion does not
contain an antibacterial preservative; therefore,
reconstitution and dilution of the product must be
performed under aseptic conditions.
The content of Mycophenolate mofetil for infusion
vials must be reconstituted with 14 ml of glucose
intravenous infusion 5 % each. A further dilution
with glucose intravenous infusion 5 % is required
to a final concentration of 6 mg/ml. This means
that to prepare a 1 g dose of mycophenolate
mofetil the content of 2 reconstituted vials
(approx. 2 x 15 ml) must be further diluted into
140 ml glucose intravenous infusion 5 % solution.
If the infusion solution is not prepared
immediately prior to administration, the
commencement of administration of the infusion
solution should be within 24 hours from
reconstitution and dilution of the medicinal
product.
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 on
your skin.
• If this happens, wash the area thoroughly with
soap and water.
Mycophenolate mofetil for infusion must be given
as intravenous (IV) infusion. The infusion flow
rate should be controlled to equate a 2 hour
period of administration.
Mycophenolate mofetil for infusion IV solution
should never be administered by rapid or bolus
intravenous injection.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited
Ground Floor, Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Wessling Hungary Kft.
Fòti ùt 56., Budapest, 1047,
Hungary
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Country
Austria

Proposed Name
Mycophenolatmofetil Accord
500 mg Pulver zur Herstellung
eines
Infusionslösungskonzentrats
Belgium
Mycophenolate mofetil Accord
Healthcare 500 mg poeder
voor concentraat voor
oplossing voor infusie / poudre
pour solution à diluer pour
perfusion / Pulver für ein
Konzentrat zur Herstellung
einer Infusionslösung
Germany
Mycophenolatmofetil Accord
500 mg Pulver zur Herstellung
eines
Infusionslösungskonzentrats
Denmark
Mycophenolatmofetil Accord
500 mg pulver til koncentrat til
infusionsvæske, opløsning
Spain
Micofenolato de mofetilo
Accord 500 mg polvo para
concentrado para solución
para perfusión EFG
France
Mycophénolate mofétil Accord
500 mg poudre pour solution à
diluer pour perfusion
Hungary
Mikofenolát-mofetil Accord
500 mg por oldatos infúzióhoz
való koncentrátumhoz
Malta
Mycophenolate mofetil 500 mg
Powder for concentrate for
solution for infusion
The Netherlands Mycofenolaat mofetil Accord
500 mg poeder voor
concentraat voor oplossing
voor infusie
Norway
Mykofenolatmofetil Accord
Poland
Mykofenolan mofetylu Accord
Portugal
Micofenolato de mofetil Accord
500 mg pó para concentrado
para solução para perfusão
Sweden
Mykofenolatmofetil Accord
500 mg pulver till koncentrat till
infusionsvätska, lösning
United Kingdom Mycophenolate mofetil 500 mg
Powder for concentrate for
solution for infusion
This leaflet was last revised in 02/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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