MYCOPHENOLATE MOFETIL 500MG TABLETS

Active substance: MYCOPHENOLATE MOFETIL

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Mycophenolate mofetil 500mg tablets
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
•  eep this leaflet. You may need to read it again.
K
• 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.

In particular, tell your doctor or pharmacist if you are taking any of
the following medicines before you start Mycophenolate mofetil
tablets:
• azathioprine or other medicines which suppress your immune

system – given after a transplant operation
• colestyramine – 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 tablets, 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 mofetil tablets are and
what they are used for
2 What you need to know before you take
Mycophenolate mofetil tablets
3 How to take Mycophenolate mofetil tablets
4 Possible side effects
5 How to store Mycophenolate mofetil tablets
6 Contents of the pack and other information

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

Pregnancy, contraception and breast-feeding

Pregnancy
If you are pregnant, do not take Mycophenolate mofetil tablets. This
is because Mycophenolate mofetil tablets may cause miscarriage
or damage to your unborn baby (affecting development of ears for
example).

1 What Mycophenolate mofetil tablets are and
what they are used for

•  f you plan to become pregnant, talk to your doctor first. Your
I
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 mofetil tablets for your health
are more important than the possible risks to your unborn baby.
•  f you think you may be pregnant tell your doctor straight
I
away.
• However, keep taking Mycophenolate mofetil tablets until you see

him or her.

Mycophenolate mofetil tablets contain mycophenolate mofetil.
• This belongs to a group of medicines called “immune
suppressants”.
Mycophenolate mofetil tablets are used to prevent your body
rejecting a transplanted organ.
• A kidney, heart or liver.

Mycophenolate mofetil is used together with other medicines:
• ciclosporin

• corticosteroids.


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

2 What you need to know before you take
Mycophenolate mofetil tablets

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,

and cannot become pregnant.

Do not take Mycophenolate mofetil tablets:

• 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 pregnant or breast-feeding.

Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Mycophenolate mofetil tablets.

Warnings and precautions:

Talk to your doctor straight away before taking Mycophenolate
mofetil 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 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 tablets.

Contraception
You must always use an effective method of contraception with
Mycophenolate mofetil tablets. This includes:
• Before you start taking Mycophenolate mofetil tablets

• During your entire treatment with Mycophenolate mofetil tablets

• For 6 weeks after you stop taking Mycophenolate mofetil tablets.


If any of the above apply to you (or you are not sure), talk to your
doctor straight away before taking Mycophenolate mofetil tablets.
The effect of sunlight
Mycophenolate mofetil tablets reduce 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.


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 tablets if you are breast-feeding.
This is because small amounts of the medicine can pass into the
mother’s milk.

Other medicines and Mycophenolate mofetil tablets:

Driving and using machines:

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This is because Mycophenolate
mofetil tablets can affect the way some other medicines work. Also
other medicines can affect the way Mycophenolate mofetil tablets
work.

Mycophenolate mofetil tablets are not likely to affect you being able
to drive or use any tools or machines.

continued top of next column
AAAE5252

continued over page

Mycophenolate Mofetil 500mg Tablets PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAE5252
5
06.11.12

originated by:
approved for print/date

15.03.13

160 x 270

revised by:
supplier:

DR
Intas

2.
3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

06.11.12

technically app. date:

08.11.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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.

3 How to take Mycophenolate mofetil tablets

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.
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 and adolescents (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.
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.

Children and adolescents
• There is no information for the use of Mycophenolate mofetil

tablets in children with a heart transplant.
Liver transplant
Adults
• The first dose of oral Mycophenolate mofetil 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.

Children and adolescents
• There is no information for the use of Mycophenolate mofetil

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


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, skin growth, 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 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 you get any side effects talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. However, do not
stop taking your medicine unless you have discussed this with your
doctor first.

5 How to store Mycophenolate mofetil tablets

If you take more Mycophenolate mofetil tablets than
you should:

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

If you take more Mycophenolate mofetil tablets than you should,
talk to 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.

Do not use this medicine after the expiry date which is stated on the
carton and blister after EXP. The expiry date refers to the last day of
that month.
Do not store above 25°C. Keep in outer carton in order to protect
from light.

If you forget to take Mycophenolate mofetil 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 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.

If you stop taking Mycophenolate mofetil tablets:

6 Contents of the pack and other information

Do not stop taking Mycophenolate mofetil tablets unless your
doctor tells you to. If you stop your treatment you may increase the
chance of rejection of your transplanted organ.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

What Mycophenolate mofetil tablets contain

• The active substance is mycophenolate mofetil. Each film-coated

tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients are:


Tablet core: Cellulose microcrystalline (E460), povidone,
hydroxypropyl cellulose, croscarmellose sodium, talc, magnesium
stearate.

Tablet coating: hypromellose (E464), titanium dioxide (E171),
macrogol, iron oxide red (E172), indigo carmine aluminium lake
(E132), iron oxide black (E172).

4 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).
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 tablets reduce 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.

What Mycophenolate mofetil tablets look like and
contents of the pack
Purple coloured capsule shaped, biconvex film coated tablet,
engraved ‘AHI’ on one side and ‘500’ on the other.
White opaque PVC/PVdC - Aluminium blister pack
Pack sizes: 50, 100 and 150 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegur 76 – 78, 220 Hafnarfjördur,
Iceland
Manufacturer
Actavis Nordic A/S, Ørnegårdsvej 16, 2820 Gentofte, Denmark
Actavis Group PTC ehf, Reykjavíkurvegur 76 – 78, 220 Hafnarfjördur,
Iceland
This leaflet was last revised in March 2013

If you would like a
leaflet with larger
text, please contact
01271 311257.

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AAAE5252

Actavis, Barnstaple, EX32 8NS, UK

Mycophenolate Mofetil 500mg Tablets PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAE5252
5
06.11.12

originated by:
approved for print/date

15.03.13

160 x 270

revised by:
supplier:

DR
Intas

2.
3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

06.11.12

technically app. date:

08.11.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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