Skip to Content

UK Edition. Click here for US version.

MYCOPHENOLATE MOFETIL 500MG TABLETS

Active substance(s): MYCOPHENOLATE MOFETIL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

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.
• 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.
• I f 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.

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
1 What Mycophenolate mofetil

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

In particular, tell your doctor or pharmacist if
you are taking any of the following medicines
before you start taking Mycophenolate
mofetil tablets:
• azathioprine or other medicines which
suppress your immune system – given after
a transplant operation.
• aciclovir – used for treatment and
prevention (in immunosuppressed
individuals) of viral infections, such as
cold sores, genital herpes, shingles and
chickenpox
• 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
• medicines that interfere with liver circulation
• ganciclovir (used for treatment and
prevention of CMV (cytomegalovirus)
infections), especially if you also have kidney
problems
• norfloxicin and metronidazole in
combination.
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.
You must not donate blood during treatment
with Mycophenolate mofetil tablets and for at
least 6 weeks after stopping treatment. Men
must not donate semen during treatment
with Mycophenolate mofetil tablets and for at
least 90 days after stopping treatment.

Mycophenolate mofetil tablets with
food and drink:

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

Mycophenolate mofetil is used together with
other medicines:
• ciclosporin and corticosteroids.

2 What you need to know before

you take Mycophenolate mofetil
tablets
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, contraception and breastfeeding”.

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 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, 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 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:
• 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
• you have a rare hereditary deficiency
of the enzyme hypoxanthine-guanine
phosphoribosyl-transferase (HGPRT) such as
Lesch-Nyhan or Kelley-Seegmiller syndrome,
as Mycophenolate mofetil tablets should be
avoided.
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.

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 taking
Mycophenolate mofetil tablets can affect the
way some other medicines work. Also other
medicines can affect the way Mycophenolate
mofetil tablets work.

Pregnancy, contraception and
breast-feeding
Contraception in women taking
Mycophenolate mofetil tablets

If you are a woman who could become
pregnant you must always use two
effective methods 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.
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.
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 in men taking
Mycophenolate mofetil tablets

You must always use condoms during
treatment and for 90 days after you stop
taking Mycophenolate mofetil tablets. 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 mofetil tablets
until you see him or her.
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.

continued top of next column

continued over page

AAAI9151

Mycophenolate Mofetil 500mg Tablets PIL - UK
item no: AAAI9151

dimensions: 170x550

print proof no: 2

pharmacode:

origination date: 12.04.16

min pt size: 9pt

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

originated by: DR
approved for print/date

colours/plates:

revision date: 20.04.16

Technical Approval

revised by: DR

date sent: 12.04.16

supplier: IL/Intas Pharmaceuticals, Ltd.

technically app. date: 18.04.16

Non Printing Colours
1.
2.
3.

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.
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.

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 (immunosuppressants), 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.

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.
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.
Mycophenolate mofetil tablets are not
recommended for kidney transplant patients
under 2 years of age.
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.

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, taste disturbance and
mouth ulcers
• inflammation of the food pipe, pancreas,
colon or stomach
• gut problems including bleeding and ulcers,
liver problems
• constipation, feeling sick (nausea),
indigestion, loss of appetite, flatulence and
burping/belching.
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, 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.

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.

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.
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

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 and blister after
EXP. The expiry date refers to the last day of
that month.

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.

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.

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.

6 Contents of the pack and other

information

What Mycophenolate mofetil tablets
contain

If you stop taking Mycophenolate
mofetil tablets:

• 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).

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 P
 ossible 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 of substances in your blood
such as sugar, fat, electrolytes, enzymes or
cholesterol.

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,
Reykjavikurvegi 76 – 78,
220 Hafnarfjördur, Iceland
Manufacturer
Actavis Group PTC ehf,
Reykjavikurvegur 76 – 78,
220 Hafnarfjördur, Iceland
This leaflet was last revised in May 2016

Children and adolescents
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.
Elderly patients
Elderly patients (≥65 years) may generally
be at an increased risk of side effects.
Elderly patients receiving Mycophenolate
mofetil tablets in combination with other
immunosuppressive medicines, may also
be at a greater risk for certain infections, as
well as gut bleeding and fluid on the lungs
compared to younger patients.

continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

AAAI9151

Mycophenolate Mofetil 500mg Tablets PIL - UK
item no: AAAI9151

dimensions: 170x550

print proof no: 2

pharmacode:

origination date: 12.04.16

min pt size: 9pt

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

originated by: DR
approved for print/date

colours/plates:

revision date: 20.04.16

Technical Approval

revised by: DR

date sent: 12.04.16

supplier: IL/Intas Pharmaceuticals, Ltd.

technically app. date: 18.04.16

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.

Hide