MYCOPHENOLATE MOFETIL 250MG CAPSULES

Active substance: MYCOPHENOLATE MOFETIL

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Package leaflet: Information for
the user

Mycophenolate
Mofetil 250 mg
Capsules
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 further questions, please ask
your doctor,pharmacist 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Mycophenolate Mofetil Capsules is
and what it is used for
2. What you need to know before you take
Mycophenolate Mofetil Capsules
3. How to take Mycophenolate Mofetil
Capsules
4. Possible side effects
5. How to store Mycophenolate Mofetil
Capsules
6. Contents of the pack and other
information

1. What Mycophenolate Mofetil
Capsules is and what it is
used for
Immunosuppressant.
Mycophenolate Mofetil capsules are used to
prevent your body rejecting a transplanted
kidney, heart or liver.
Mycophenolate Mofetil capsules may be
used together with other medicines known
as ciclosporin and corticosteroids.

2. What you need to know
before you take
Mycophenolate Mofetil
Capsules
Do not take Mycophenolate Mofetil
Capsules:
• If you are allergic to Mycophenolate
Mofetil, Mycophenolic acid or any of the
other ingredients of this medicine (listed in
section 6).
• If you are breast-feeding.
Warnings and precautions
Talk to your doctor straight away before
taking Mycophenolate Mofetil 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.
If any of the above apply to you (or you are
not sure), talk to your doctor straight away
before taking Mycophenolate Mofetil.
The effect of sunlight
Mycophenolate Mofetil 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
Capsules:
Please tell your doctor or pharmacist 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 can affect the way some other
medicines work. Also other medicines can
affect the way Mycophenolate Mofetil works.
In particular, tell your doctor or pharmacist if
you are taking any of the following
medicines before you start Mycophenolate
Mofetil:
• 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
Mofetil, talk to your doctor or pharmacist
first. Your doctor will have to advise you on
what vaccines you can have.
Mycophenolate Mofetil Capsules with
food and drink
Taking food and drink has no influence on
your treatment with mycophenolate mofetil.
Pregnancy, contraception and
breast-feeding:
Pregnancy
• If you are pregnant, do not take
Mycophenolate Mofetil This is because
Mycophenolate Mofetil 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
taking Mycophenolate Mofetil 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 straight away.
However, keep taking Mycophenolate
Mofetil until you see him or her.
If you are able to become pregnant, you
must have a pregnancy test before you start
Mycophenolate Mofetil. You can only start
Mycophenolate Mofetil 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.
This includes:
• before you start taking Mycophenolate
Mofetil
• during your entire treatment with
Mycophenolate Mofetil
• for 6 weeks after you stop taking
Mycophenolate Mofetil.
Talk to your doctor about the most suitable
contraception for you. This will depend on
your individual situation.
Breast-feeding
Do not take Mycophenolate Mofetil 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
not likely to affect you being able to drive or
use any tools or machines.

3. How to take Mycophenolate
Mofetil Capsules
Always take this medicine exactly as your
doctor or pharmacist 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.
Kidney Transplant
Adults:
The first dose will be given within 72 hours
after the transplant operation. The
recommended daily dose is 8 capsules (2 g
of the active ingredient) taken as 2 separate
doses. This means taking 4 capsules in the
morning then 4 capsules 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 body
surface area (height and weight). The
recommended dose is 600 mg/m2 taken
twice a day.
Heart Transplant
Adults:
The first dose will be given within 5 days
following the transplant operation. The
recommended daily dose is 12 capsules (3 g
of the active ingredient) taken as 2 separate
doses. This means taking 6 capsules in the
morning then 6 capsules in the evening.

Children:
No data are available to recommend the use
of Mycophenolate Mofetil in children who
have received a heart transplant.

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

Liver Transplant
Adults:
The first dose of oral Mycophenolate Mofetil
Capsules will be given to you at least 4 days
after the transplant operation and when you
are able to swallow oral medications. The
recommended daily dose is 12 capsules (3 g
of the active ingredient) taken as 2 separate
doses. This means taking 6 capsules in the
morning then 6 capsules in the evening.
Children:
No data are available to recommend the use
of Mycophenolate Mofetil in children who
have received a liver transplant.

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

Method and Route of Administration
• Swallow your capsules whole with a glass
of water.
• Do not break or crush them and do not
take any capsules that have broken or split
open.
• Avoid contact with any powder that spills
out from damaged capsules.
• If a capsule breaks open accidentally,
wash any powder from your skin with soap
and water. If any powder gets into your
eyes or mouth, rinse thoroughly with plenty
of plain, fresh water.
• Treatment will continue for as long as you
need immunosuppression to prevent you
rejecting your transplanted organ.
If you take more Mycophenolate Mofetil
Capsules than you should
If you take more mycophenolate mofetil
capsules than you have been told to take, or
if someone else accidentally takes your
medicine, immediately see a doctor or go to
a hospital straight away.
If you forget to take Mycophenolate Mofetil
Capsules
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.
If you stop taking Mycophenolate Mofetil
Capsules
Stopping your treatment with
Mycophenolate Mofetil may increase the
chance of rejection of your transplanted
organ. Do not stop taking your medicine
unless your doctor tells you to.
If you have any further questions on the use
of this medicine, ask your doctor, pharmacist
or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can have
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).
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.
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.
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.
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.

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.
Lung problems such as:
• pneumonia, bronchitis
• shortness of breath, cough
• fluid on the lungs or inside the chest
• sinus problems.
Other problems such as:
• weight loss, gout, high blood sugar,
bleeding, bruising.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. By reporting side effects you can
help provide more information on the safety
of this medicine.
For UK - You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For Malta- ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt

5. How to store Mycophenolate
Mofetil Capsules
• 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 label or carton
after EXP. The expiry date refers to the last
day of that month.
• Store below 30oC.
• Do not use this medicine if you notice any
visible signs of deterioration.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
no longer use. These measures will help
protect the environment.

6. Contents of the pack and
other information
What Mycophenolate Mofetil Capsules
contains:
The active substance is Mycophenolate
Mofetil. Each capsule contains 250 mg of
Mycophenolate Mofetil.
The other ingredients are: cellulose
microcrystalline, hydroxy propyl cellulose,
povidone K 90, croscarmellose sodium, talc
& magnesium stearate.
Capsule Shell composition: Gelatin, sodium
lauryl sulfate, titanium dioxide (E171), iron
oxide red (E172), iron oxide yellow (E172),
FD & C Blue 2 (E132)
Black Ink composition: Shellac, Black iron
oxide.
What Mycophenolate Mofetil Capsules
looks like and content of the pack:
Mycophenolate Mofetil 250 mg capsules are
light blue/peach size ‘1’ hard gelatin
capsules with imprinting with ‘MMF’ on cap
and ‘250’ on body, containing white to off
white powder.
Mycophenolate Mofetil 250 mg Capsules
are available in blister in packs of 100 and
300’ capsules.
Not all pack sizes may be marketed.
Marketing authorization holder:
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
Manufacturer:
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
CEMELOG- BRS Limited
2040 Budaors, Vasut u.13.
Hungary
The leaflet was last revised in 02/2014.

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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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