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MYCOPHENOLATE MOFETIL 500 MG FILM-COATED TABLETS

Active substance(s): MYCOPHENOLATE MOFETIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MYCOPHENOLATE MOFETIL
500 mg FILM-COATED TABLETS
(mycophenolate mofetil)

Vaccines:
• If you need to have a vaccine (a live vaccine) while taking
Mycophenolate Tablets, talk to your doctor or pharmacist
first. Your doctor will have to advise you on what vaccines
you can have.
Taking Mycophenolate Tablets with food and drink:
Taking food and drink has no effect on your treatment
with Mycophenolate Tablets.

Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Pregnancy, contraception and breast-feeding

In this leaflet:
1. What Mycophenolate Tablets are and what they are
used for.
2. Before you take Mycophenolate Tablets.
3. How to take Mycophenolate Tablets.
4. Possible side effects.
5. How to store Mycophenolate Tablets.
6. Further information.
1. WHAT MYCOPHENOLATE TABLETS ARE AND WHAT
THEY ARE USED FOR
The full name of your medicine is Mycophenolate mofetil
500 mg film-coated tablets:
• In this leaflet the shorter name Mycophenolate Tablets
is used.
Mycophenolate Tablets contain mycophenolate mofetil:
• This belongs to a group of medicines called 'immunesuppressants'.
Mycophenolate Tablets are used to prevent your body
rejecting a transplanted organ:
• A kidney, heart or liver.
Mycophenolate Tablets are used together with other
medicines:
• ciclosporin
• corticosteroids.
2. BEFORE YOU TAKE MYCOPHENOLATE TABLETS

Take special care with Mycophenolate Tablets
Talk to your doctor straight away before taking
Mycophenolate Tablets 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 any problems with your digestive
system such as a stomach ulcer
• you are planning to become pregnant or if you get
pregnant while taking Mycophenolate Tablets.
If any of the above apply to you (or you are not sure) talk
to your doctor straight away before taking Mycophenolate
Tablets.
The effect of sunlight
Mycophenolate Tablets 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.
Taking other medicines
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 Tablets
can affect the way some other medicines work. Also other
medicines can affect the way Mycophenolate Tablets
works.
In particular, tell your doctor or pharmacist if you are
taking any of the following Medicines before you start
Mycophenolate Tablets:
• azathioprine or other medicines which may 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.

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.

Heart transplant
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.

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

Children:
• There is no information for the use of Mycophenolate
Tablets in children with a heart transplant.

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.

Liver transplant
Adults:
• The first dose of oral Mycophenolate Tablets 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.

If you are able to become pregnant, you must have a
pregnancy test before you start Mycophenolate Tablets.
You can only start Mycophenolate Tablets if the test is
negative.

Children:
• There is no information for the use of Mycophenolate
Tablets in children with a liver transplant.

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
you r 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,
Turners syndrome or uterine agenesis.
• You are a child or teenager who has not started having
periods.

Taking the medicine:
• Swallow your tablets whole with a glass of water.
• Do not break or crush them.
If you take more Mycophenolate Tablets than you should
If you take more Mycophenolate Tablets than you shoud
talk to or a doctor or go to a hospital straight away. Also do
this if someone else accidentally takes your medicine.
Take the medicine pack with you.
If you forget to take Mycophenolate Tablets
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 missed dose.
If you stop taking Mycophenolate Tablets
Do not stop taking Mycophenolate Tablets unless your
doctor tells you to. If you stop your treatment you may
increase the chance of rejection of your transplanted
organ.

Contraception
You must always use an effective method of contraception
with Mycophenolate Tablets. This includes:
• before you start taking Mycophenolate Tablets
• during your entire treatment with Mycophenolate
Tablets
• for 6 weeks after you stop taking Mycophenolate Tablets.
Talk to your doctor about the most suitable contraception
for you. This will depend on your individual situation.

If you have any further questions on the use of this
product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mycophenolate Tablets can cause side
effects, although not everybody gets them.

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

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).

Driving and using machines
Mycophenolate Tablets is not likely to affect you being
able to drive or use any tools or machines.
3. HOW TO TAKE MYCOPHENOLATE TABLETS
Always take Mycophenolate Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

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.

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 you r transplant organ.
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.

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

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 heart beat, 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.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist. However, do not stop taking your medicine
unless you have discussed this with your doctor first.
5. HOW TO STORE MYCOPHENOLATE TABLETS
Keep out of reach and sight of children. Do not store
above 30°C. Keep in outer carton to protect from light.
Do not use Mycophenolate Tablets after the expiry date
which is stated on the carton after 'EXP'.
The expiry date refers to the last day of that month.
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. FURTHER INFORMATION
What Mycophenolate Tablets contains
Each tablet contains 500 mg of Mycophenolate mofetil
(the active ingredient, which makes the tablets work).
The other ingredients are: microcrystalline cellulose,
povidone, croscarmellose sodium, magnesium stearate.
The tablet coating contains: hypromellose, hydroxypropyl
cellulose, titanium dioxide (E171), macrogol, indigo
carmine aluminium lake (E132) and red iron oxide (E172).
What Mycophenolate Tablets look like and contents of
the pack
Mycophenolate Tablets are lavender coloured, capsule
shaped, film-coated tablets marked with 'RDY' on one side
and '585' on the other side. They are available in packs of
50, 100 or 150 tablets.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, HU17 0LD.
Distributed by Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Fighting infections
Mycophenolate Tablets 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 Tablets patients have developed cancer of
the lymphoid tissues and skin.
This leaflet was last revised in 09/2012

created 25-FEB-2013

Job No. 37007376v1

modified DD-MMM-20YY

product category MYCOPHENOLATE MOFETIL
market UK 2013
packing site Dr. Reddy's
product Mycophenolate Mofetil 500mg Tab x50
component type Leaflet

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artwork code 10004878
superseded code 10002865

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dimensions 180 mm x 400 mm
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Do not take Mycophenolate Tablets if:
• you are allergic (hypersensitive) to mycophenolate
mofetil, mycophenolic acid or any of the other
ingredients of Mycophenolate Tablets (listed in
Section 6)
• you are pregnant or 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 Tablets.

Pregnancy
If you are pregnant, do not take Mycophenolate Tablets.
This is because Mycophenolate Tablets may cause
miscarriage or damage to your unborn baby (affecting
development of ears for example):
• 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.
* In certain situations, you and your doctor may decide
that the benefits of taking Mycophenolate Tablets for
your health are more important than the possible risks
to your unborn baby.
• If you think you may be pregnant tell your doctor
straight away.
* However, keep taking Mycophenolate Tablets until you
see him or her.

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.

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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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