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MYCOPHENOLATE MOFETIL SANDOZ 500MG FILM-COATED TABLETS

Active substance(s): MYCOPHENOLATE MOFETIL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mycophenolate mofetil Sandoz 500 mg
Film-coated Tablets
Mycophenolate mofetil

the following medicines before you start
Mycophenolate:

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 pharmacist.
• 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. See
section 4.

• 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)
• antacids or proton pump inhibitors – used for
acid problems in your stomach such as
indigestion
• 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
taking Mycophenolate, talk to your doctor or
pharmacist first. Your doctor will have to advise you
on what vaccines you can have.

What is in this leaflet
1. What Mycophenolate is and what it is used for
2. What you need to know before you take
Mycophenolate
3. How to take Mycophenolate
4. Possible side effects
5. How to store Mycophenolate
6. Contents of the pack and other information

1

You must not donate blood during treatment with
Mycophenolate and for at least 6 weeks after
stopping treatment. Men must not donate semen
during treatment with Mycophenolate and for at least
90 days after stopping treatment.

Mycophenolate with food and drink
Taking food and drink has no effect on your
treatment with Mycophenolate.

What Mycophenolate is and what
it is used for

Pregnancy, contraception and breast-feeding

Contraception in women taking Mycophenolate
If you are a woman who could become pregnant you
must always use two effective methods of
contraception with Mycophenolate. This includes:
• Before you start taking Mycophenolate
• During your entire treatment with Mycophenolate
• For 6 weeks after you stop taking Mycophenolate

Mycophenolate contains mycophenolate mofetil. This
belongs to a group of medicines called
“immunosuppressants”.
Mycophenolate tablets is used to prevent your body
rejecting a transplanted organ:
• A kidney, heart or liver.
Mycophenolate should be used together with other
medicines:
• Ciclosporin and corticosteroids.

2

Talk to your doctor about the most suitable
contraception for you. This will depend on your
individual situation. Contact your doctor as soon
as possible, if you think your contraception may
not have been effective or if you have forgotten
to take your contraceptive pill.

What you need to know before
you take Mycophenolate

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.

WARNING
Mycophenolate causes birth defects and miscarriage.
If you are a woman who could become pregnant, you
must provide a negative pregnancy test before
starting treatment and must follow the contraception
advice given to you by your doctor.

Your doctor will speak to you and give you written
information, particularly on the effects of
mycophenolate on unborn babies. Read the
information carefully and follow the instructions.

If you do not fully understand these instructions,
please ask your doctor to explain them again
before you take mycophenolate. See also further
information in this section under “Warnings and
precautions” and “Pregnancy and breast-feeding”.

Do not take Mycophenolate:
• If you are allergic (hypersensitive) to
mycophenolate mofetil, mycophenolic acid or
any of the other ingredients of this medicine
(listed in section 6).
• If you are a woman who could be pregnant
and you have not provided a negative pregnancy
test before your first prescription as
mycophenolate causes birth defects and
miscarriage.
• If you are pregnant or planning to become
pregnant or think you may be pregnant
• If you are not using effective contraception
(see Pregnancy, contraception and
breast-feeding).
• If you are breast-feeding.
Do not take this medicine if any of the above applies
to you. If you are not sure, talk to your doctor or
pharmacist before taking Mycophenolate.

Contraception in men taking Mycophenolate
You must always use condoms during treatment and
for 90 days after you stop taking Mycophenolate.
If you are planning to have a child, your doctor will
talk to you about the risks and the alternative
treatments you can take to prevent rejection of your
transplant organ.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine. Your doctor will talk to you about the risks
in case of pregnancy and the alternatives you can
take to prevent rejection of your transplant organ if:
• You plan to become pregnant.
• You miss or think you have missed a period, or
you have unusual menstrual bleeding, or suspect
you are pregnant.
• You have sex without using an effective method of
contraception.
If you do become pregnant during the treatment with
mycophenolate, you must inform your doctor
immediately. However, keep taking Mycophenolate
until you see him or her.

Warnings and precautions
Talk to your doctor straight away before taking
Mycophenolate:
• If you have a sign of infection such as a fever
or sore throat
• If you have any unexpected bruising or bleeding
• If you have ever had a problem with your
digestive system such as a stomach ulcer
• If you are planning to become pregnant, or if
you get pregnant while taking Mycophenolate.
If any of the above apply to you (or you are not sure),
talk to your doctor straight away before taking
Mycophenolate.

Pregnancy
Mycophenolate causes a very high frequency of
miscarriage (50%) and of severe birth defects (23-27
%) in the unborn baby. Birth defects which have
been reported include anomalies of ears, of eyes, of
face (cleft lip/palate), of development of fingers, of
heart, oesophagus (tube that connects the throat
with the stomach), kidneys and nervous system (for
example spina bifida (where the bones of the spine
are not properly developed)).Your baby may be
affected by one or more of these.

The effect of sunlight
Mycophenolate 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.

If you are a woman who could become pregnant, you
must provide a negative pregnancy test before
starting treatment and must follow the contraception
advice given to you by your doctor. Your doctor may
request more than one test to ensure you are not
pregnant before starting treatment.

Other medicines and Mycophenolate
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes medicines obtained without a
prescription, including herbal medicines. This is
because Mycophenolate can affect the way some
other medicines work. Also other medicines can
affect the way Mycophenolate works. In particular,
tell your doctor or pharmacist if you are taking any of

Breast-feeding
Do not take Mycophenolate if you are
breast-feeding. This is because small amounts of the
medicine can pass into the mother’s milk.

Please turn over

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Lymph and skin cancer
As can happen in patients taking this type of
medicine (immune-suppressants), a very small
number of mycophenolate mofetil patients have
developed cancer of the lymphoid tissues and skin.

Driving and using machines
Mycophenolate mofetil is not likely to affect you
being able to drive or use any tools or machines.

3

How to take Mycophenolate

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.

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.

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.

Other unwanted effects may include:
Skin problems such as:
• acne, cold sores, shingles, skin growth, hair
loss, rash, itching.

Urinary problems such as:
• kidney problems or the urgent need to pass
water (urine).

Kidney transplant

Adults
• The first dose is given within 3 days of the
transplant operation.
• The daily dose is 4 tablets (2 g of the medicine)
taken as 2 separate doses.
• Take 2 tablets in the morning and then 2 tablets in
the evening.
Children (aged 2 to 18 years)
• The dose given will vary depending on the size of
the child.
• Your doctor will decide the most appropriate dose
based on your child’s height and weight (body
surface area measured as square metres or
“m2”). The recommended dose is 600 mg/m2
taken twice a day.

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 dizzy, drowsy or numb,
• tremor, muscle spasms, convulsions,
• feeling anxious or depressed, changes in your
mood or thoughts.

Heart and blood vessel problems such as:
• change in blood pressure, unusual heartbeat,
widening of blood vessels.

Heart transplant

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.

Adults
• The first dose is given within 5 days of the
transplant operation.
• The daily dose is 6 tablets (3 g of the medicine)
taken as 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in
the evening.
Children
There is no information for the use of
mycophenolate mofetil in children with a heart
transplant.

Other problems such as:
• weight loss, gout, high blood sugar, bleeding,
bruising.

Liver transplant

Adults
• The first dose of oral mycophenolate mofetil
will be given to you at least 4 days after the
transplant operation and when you are able to
swallow oral medicines.
• The daily dose is 6 tablets (3 g of the medicine)
taken as 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in
the evening.
Children
There is no information for the use of Mycophenolate
in children with a liver transplant.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme (www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.

5

Taking the medicine
• Swallow your tablets whole with a glass of
water.
• Do not break or crush them.

Keep this medicine out of the sight and reach of
children.

Do not use this medicine after the expiry date which
is stated on the carton, blister or the label after EXP.
The expiry date refers to the last day of that month.

If you take more Mycophenolate than you should
If you take more of this medicine than you should,
talk to a doctor or go to a hospital straight away. Also
do this if someone else accidentaly takes your
medicine. Take the medicine pack with you.

This medicinal product does not require any
special storage conditions.

If you forget to take Mycophenolate
If you forget to take your medicine at any time, take it
as soon as you remember. Then continue to take it
at the usual times. Do not take a double dose to
make up for a forgotten dose.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6

If you stop taking Mycophenolate
Do not stop taking this medicine unless your
doctor tells you to. If you stop your treatment you
may increase the chance of rejection of your
transplanted organ.

Contents of the pack and
other information

What Mycophenolate contains
• The active substance is mycophenolate mofetil.
Each film-coated tablet contains 500 mg of
mycophenolate mofetil.
• The other ingredients are:
Core content:
Cellulose microcrystalline, povidone, talc,
magnesium stearate, croscarmellose sodium.
Coating content:
Hypromellose, hydroxypropylcellulose,
titanium dioxide (E171), macrogol (400), iron
oxide black (E172), iron oxide red (E172).

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

How to store Mycophenolate

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Talk to a doctor 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).

What Mycophenolate looks like and contents of
the pack
PVC/PE/PVdC/Al blister
Pack sizes: 50, 100, 120, 150, 180, 250
film-coated tablets.

HDPE bottle
Pack sizes: 50, 150 film-coated tablets.

Not all pack sizes may be marketed.

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.
Children may be more likely than adults to have
some side effects. These include diarrhoea,
infections, fewer white cells and fewer red cells in the
blood.

Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Lek Pharmaceuticals d.d., Verovśkova 57, 1526
Ljubljana, Slovenia or LEK S.A., ul. Podlipie 16, 95010 Stryków, Poland or LEK S.A., ul.
Domaniewska 50 C, 02-672 Warsaw, Poland or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Salutas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany or Lek Pharmaceuticals d.d, Trimlini 2D,
9220 Lendava, Slovenia.

Fighting infections
Mycophenolate mofetil 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.

This leaflet was last revised in 01/2016.

SZ00000LT000

Artwork Proof Box
Ref: V024: Safety update
Proof no.
010.0

Date prepared:
06/01/2016

Colours:
Black
Dimensions: 132 x 340 mm

Font size:
6.5pt
Fonts:
Helvetica

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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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