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.
• 
Keep this leaflet. You may need to read it again.
•  you have any further questions, ask your doctor or pharmacist.
If
• his medicine has been prescribed for you only. Do not pass it on
T
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.

• olestyramine – used to treat high cholesterol
c
• 
rifampicin – an antibiotic used to prevent and treat infections such as
tuberculosis (TB)
• ntacids, or proton pump inhibitors – used for acid problems in your
a
stomach such as indigestion
• hosphate binders – used by people with chronic kidney failure to
p
reduce how much phosphate gets absorbed into their blood.

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:

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

Mycophenolate mofetil tablets contain mycophenolate mofetil.
• his belongs to a group of medicines called “immune-suppressants”.
T
Mycophenolate mofetil tablets are used to prevent your body rejecting
a transplanted organ.
•  kidney, heart or liver.
A
Mycophenolate mofetil is used together with other medicines:
• iclosporin
c
• orticosteroids.
c

2 What you need to know before you take
Mycophenolate mofetil tablets
Do not take Mycophenolate mofetil tablets:

•  you are allergic to mycophenolate mofetil, mycophenolic
if
acid or any of the other ingredients of this medicine (listed in section
6).
•  you are pregnant or breast-feeding.
if
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 before taking Mycophenolate mofetil tablets if:
• ou have a sign of infection such as a fever or sore throat
y
• ou have any unexpected bruising or bleeding
y
• ou have ever had a problem with your digestive system such as a
y
stomach ulcer
• ou are planning to become pregnant, or if you get pregnant while
y
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:
•  earing protective clothing which also covers your head, neck, arms
w
and legs
• sing a sunscreen with a high protection factor.
u

Other medicines and Mycophenolate mofetil tablets:

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.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines before you start Mycophenolate mofetil tablets:
• zathioprine or other medicines which suppress your immune system
a
– given after a transplant operation

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.
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).
• n certain situations, you and your doctor may decide that the benefits
I
of taking Mycophenolate tablets 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.
• owever, keep taking Mycophenolate mofetil tablets until you see
H
him or her.
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.
You are a woman who is not capable of becoming pregnant if any of the
following applies to you:
• ou are post-menopausal, i.e. at least 50 years old and your last period
Y
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).
• our fallopian tubes and both ovaries have been removed by surgery
Y
(bilateral salpingo oophorectomy).
• our womb (uterus) has been removed by surgery (hysterectomy).
Y
• our ovaries no longer work (premature ovarian failure, which has
Y
been confirmed by a specialist gynaecologist).
• ou were born with one of the following rare conditions that make
Y
pregnancy impossible: the XY genotype, Turner’s syndrome or uterine
agenesis.
• ou are a child or teenager who has not started having periods, and
Y
cannot become pregnant.
Contraception
You must always use an effective method of contraception with
Mycophenolate mofetil tablets. This includes:
• efore you start taking Mycophenolate mofetil tablets
B
•  uring your entire treatment with Mycophenolate mofetil tablets
D
• or 6 weeks after you stop taking Mycophenolate mofetil tablets.
F
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.

Driving and using machines:

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

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 recommended doses are shown below. Treatment will continue for
as long as you need to prevent you from rejecting your transplant organ.

continued top of next column
AAAH1432

continued over page

Mycophenolate Mofetil 500mg Tablets PIL - UK
item no: AAAH1432

dimensions: 160 x 270

print proof no: 2

pharmacode:

origination date: 13.08.14

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 20.08.14

Technical Approval

revised by: S.Anson

date sent: 13.08.14

supplier: Intas Pharma

technically app. date: 13.08.14

Non Printing Colours
1.
2.
3.

Kidney transplant
Adults
• he first dose is given within 3 days of the transplant operation.
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• he daily dose is 4 tablets (2 g of the medicine) taken as 2 separate
T
doses.
• ake 2 tablets in the morning and then 2 tablets in the evening.
T
Children and adolescents (aged 2 to 18 years)
• he dose given will vary depending on the size of the child.
T
• our doctor will decide the most appropriate dose based on your
Y
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
• he first dose is given within 5 days of the transplant operation.
T
• he daily dose is 6 tablets (3 g of the medicine) taken as 2 separate
T
doses.
• ake 3 tablets in the morning and then 3 tablets in the evening.
T
Children and adolescents
• here is no information for the use of Mycophenolate mofetil tablets in
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children with a heart transplant.
Liver transplant
Adults
• he first dose of oral Mycophenolate mofetil tablets will be given to
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you at least 4 days after the transplant operation and when you are
able to swallow oral medicines.
• he daily dose is 6 tablets (3 g of the medicine) taken as 2 separate
T
doses.
• ake 3 tablets in the morning and then 3 tablets in the evening.
T
Children and adolescents
• here is no information for the use of Mycophenolate mofetil tablets in
T
children with a liver transplant.
Taking the medicine
Swallow your tablets whole with a glass of water.
•  o not break or crush them.
D

If you take more Mycophenolate mofetil tablets than you
should:

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.

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.

If you stop taking Mycophenolate mofetil tablets:

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.

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:
• ou have a sign of infection such as a fever or sore throat
y
• ou have any unexpected bruising or bleeding
y
• ou have a rash, swelling of your face, lips, tongue or throat, with
y
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:
•  number of your blood cells
the
•  amount in your blood of things like sugar, fat or cholesterol.
the
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.
Lymph and skin cancer
As can happen in patients taking this type of medicine (immunesuppressants), a very small number of Mycophenolate mofetil patients
have developed cancer of the lymphoid tissues and skin.

Skin problems such as:
• cne, cold sores, shingles, skin growth, hair loss, rash,
a
itching.
Urinary problems such as:
• idney problems or the urgent need to pass water
k
(urine).
Digestive system and mouth problems such as:
• 
swelling of the gums and mouth ulcers
• 
inflammation of the pancreas, colon or stomach
• ut problems including bleeding, liver problems
g
• onstipation, feeling sick (nausea), indigestion,
c
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:
• hange in blood pressure, unusual heart beat, widening of blood
c
vessels.
Lung problems such as:
• neumonia, bronchitis
p
• 
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
•  on the lungs or inside the chest
fluid
• 
sinus problems.
Other problems such as:
•  eight loss, gout, high blood sugar, bleeding, bruising.
w
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. You can also
report side effects directly via the Yellow Card Scheme at: www.mhra.
gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Mycophenolate mofetil tablets
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 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.
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 Contents of the pack and other information
What Mycophenolate mofetil tablets contain

• he active substance is mycophenolate mofetil. Each film-coated
T
tablet contains 500 mg of mycophenolate mofetil.
• he other ingredients are:
T

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).

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, 18.0 mm in length, 9.0 mm in
width and 7.00 mm in thickness.
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 August 2014

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:

continued top of next column
AAAH1432

Actavis, Barnstaple, EX32 8NS, UK

Mycophenolate Mofetil 500mg Tablets PIL - UK
item no: AAAH1432

dimensions: 160 x 270

print proof no: 2

pharmacode:

origination date: 13.08.14

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 20.08.14

Technical Approval

revised by: S.Anson

date sent: 13.08.14

supplier: Intas Pharma

technically app. date: 13.08.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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