MYCOPHENOLATE MOFETIL 250MG CAPSULES

Active substance: MYCOPHENOLATE MOFETIL

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Mycophenolate-250mg

Market

UK / Malta

Language

English

Size

170 x 550 mm PIL

Min. Font Size

10

Version No.

5 (Page 1 of 2) (IB008 & 61 (3))

Date

21_02_13 (MMF 250mg(UK-Malta)NEW-PIL)

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.
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, pharmacist or nurse before
taking Mycophenolate Mofetil Capsules
You should inform your doctor immediately if:
• you experience any evidence of infection
(e.g. fever, sore throat), unexpected
bruising and/or bleeding.
• you have or ever have had any problems
with your digestive system, e.g., stomach
ulcers.
• you are planning to become pregnant or if
you get pregnant while taking
Mycophenolate Mofetil
• you have rare hereditary deficiency of
hypoxanthine-guanine
phosphoribosyl-transferase (HGPRT)
such as Lesch-Nyhan and
Kelley-Seegmiller syndrome.
Mycophenolate Mofetil reduces your body's
defense mechanism. Because of this, there
is an increased risk of skin cancer. Therefore
you should limit your exposure to sunlight
and UV light by wearing appropriate
protective clothing and using a sunscreen
with a high protection factor.
Other medicines and Mycophenolate
Mofetil Capsules:
Tell your doctor or pharmacist if you are
taking, have recently taken or might take, any
other medicines.
Talk to your doctor before you start to take
Mycophenolate Mofetil Capsules if:
• you are taking any medicines containing:
azathioprine or other immunosuppressive
agents (which are sometimes given to
patients after a transplant operation),
cholestyramine (used to treat patients
with high blood cholesterol), antacids or
proton pump inhibitors (used for acid
problems in your stomach such as
indigestion), rifampicin (antibiotic),
phosphate binders (used in patients with
chronic renal failure to reduce the
absorption of phosphate), ciprofloxacin
and amoxicillin plus clavulanic acid
(antibiotic to treat infections ).
• Live vaccines should be avoided. Your
doctor will have to advise you what is
indicated for you.
Mycophenolate Mofetil Capsules with
food and drink
Taking food and drink has no influence on
your treatment with mycophenolate mofetil.

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.
Use of Mycophenolate Mofetil during
pregnancy may cause miscarriage or
damage to your unborn baby (abnormal
development of ears for example).
If you plan to become pregnant, discuss with
your doctor alternative medicines to best
prevent rejection of your transplanted organ.
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 become pregnant while taking
Mycophenolate Mofetil, do not stop taking it,
but tell your doctor about your pregnancy as
soon as possible
Do not take Mycophenolate Mofetil if you are:
• Breast-feeding
• Pregnant (unless your doctor clearly tells
you)
Tell your doctor straight away if:
• You think you may be pregnant
• You are breast-feeding
• You plan to start a family in the near future
You must always use an effective method of
birth control:
• Before you start taking Mycophenolate
Mofetil
• During your entire treatment with
Mycophenolate Mofetil
• For 6 weeks after you stop taking
Mycophenolate Mofetil
You should talk to your doctor about the
most suitable methods for birth control for
you based on your individual situation.
Women who are capable of becoming
pregnant must have a negative pregnancy
test BEFORE starting treatment with
Mycophenolate Mofetil.
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 (bilateral
salpingo-oophorectomy).
• Your uterus has been surgically removed
(hysterectomy).
• You have premature failure of the
ovaries, confirmed by a specialist
gynaecologist.
• You have been diagnosed with one of the
following rare conditions that some
patients are born with that make
pregnancy impossible: the XY genotype,
Turner’s syndrome or uterine agenesis.
• You are a child/teenager who has not
started having periods, and cannot
become pregnant
Driving and using machines:
Mycophenolate Mofetil has not been shown
to impair your ability to drive or operate
machinery.

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.
The
recommended
dose
of
Mycophenolate Mofetil Capsules is as
follows:
Kidney Transplant
Adults:
The first dose will be given within 72 hours
after the transplant operation. The
recommended daily dose is 8 capsules (2g 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.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Mycophenolate-250mg

Market

UK / Malta

Language

English

Size

170 x 550 mm PIL

Min. Font Size

10

Version No.

5 (Page 2 of 2) (IB008 & 61 (3))

Date

21_02_13 (MMF 250mg(UK-Malta)NEW-PIL)

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.
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.
Some of the more usual problems are
diarrhoea, fewer white cells and/or red cells
in your blood, infection and vomiting. Your
doctor will do regular blood tests to monitor
any changes in the number of your blood
cells or changes in the levels of any of the
substances carried in your blood, e.g. sugar,
fat, cholesterol. Children may be more likely
than adults to have side effects such as
diarrhoea, infections, fewer white cells and
fewer red cells in the blood.
Mycophenolate mofetil reduces your body’s
own defense mechanisms to stop you
rejecting your transplanted kidney, heart or
liver. Consequently your body will not be as
good as normal at fighting infections. So if
you are taking Mycophenolate mofetil you
may therefore catch more infections than
usual, such as infections of the brain, skin,
mouth, stomach and intestines, lungs and
urinary tract. As can happen in patients
taking this type of medicine, a very small
number of Mycophenolate mofetil patients
have developed cancer of the lymphoid
tissues and skin.
General unwanted effects affecting your
body
as
a
whole
could
include
hypersensitivity (such as anaphylaxis,
angioedema), fever, lethargy, difficulty in
sleeping, pains (such as abdominal, chest,
joint/muscle, pain on passing urine),
headache, flu symptoms and swelling.
Other unwanted effects may include:
Disorders of the skin such as acne, cold
sores, shingles, skin growth, hair loss, rash,
itching.
Urinary disorders such as kidney problems
or the urgent need to pass urine.
Disorders of the digestive system and
mouth such as constipation, nausea,
indigestion, pancreas inflammation, intestinal
disorders including bleeding, inflammation of
the stomach, liver problems, inflammation of
the colon, loss of appetite, flatulence,
swelling of the gums and mouth ulcers.
Disorders of the nerves and senses such
as convulsions, tremor, dizziness, depression,
drowsiness, numbness, muscle spasms,
anxiety, changes in thinking or mood.
Metabolic, blood and vascular disorders
such as reduced formation of red blood cells,
weight loss, gout, high blood sugar, bleeding,
clots and bruises, change in blood pressure,
abnormal heart beat and dilation of blood
vessels may be seen.

Disorders of the lungs such as pneumonia,
bronchitis, shortness of breath, cough, fluid
on the lungs/chest cavity, sinus problems.
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 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 02/2013.

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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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