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MYCOPHENOLATE MOFETIL 250 MG CAPSULES

Active substance(s): MYCOPHENOLATE MOFETIL

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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 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. See section 4.

600 mm

What is in this leaflet
1. What Mycophenolate Mofetil is and what
it is used for
2. What you need to know before you take
Mycophenolate Mofetil
3. How to take Mycophenolate Mofetil
4. Possible side effects
5. How to store Mycophenolate Mofetil
6. Contents of the pack and other
information

Kidney transplant
Adults
 The first dose is given within 3 days of the
transplant operation.
 The daily dose is 8 capsules (2 g of
medicine) taken as 2 separate doses.
 Take 4 capsules in the morning and then 4
capsules in the evening.

Vaccines
If you need to have a vaccine (a live vaccine)
while taking Mycophenolate Mofetil, 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 and for at least 6
weeks after stopping treatment. Men must not
donate semen during treatment with
Mycophenolate Mofetil and for at least 90
days after stopping treatment

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 the child's
height and weight (body surface areameasured as square meters or “m2”). The
recommended dose is 600 mg/m2 taken
twice a day.

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

Heart transplant

Pregnancy, contraception and breastfeeding
Contraception
in
women
Mycophenolate Mofetil

Adults
 The first dose is given within 5 days of the
transplant operation.
 The daily dose is 12 capsules (3 g of the
medicine) taken as 2 separate doses.
 Take 6 capsules in the morning and then 6
capsules in the evening.

taking

If you are a woman who could become
pregnant you must always use two effective
methods
of
contraception
with
1. What Mycophenolate Mofetil is and
Mycophenolate Mofetil. This includes:
what it is used for
 Before you start taking Mycophenolate
Mofetil
The full name of your medicine is

During your entire treatment with
Mycophenolate Mofetil 250 mg capsules.
Mycophenolate
Mofetil
 In this leaflet the shorter name

For
6
weeks
after you stop taking
Mycophenolate Mofetil is used.
Mycophenolate
Mofetil.
 This belongs to group of medicines called
“immunosuppresants”.
Talk to your doctor about the most suitable
contraception
for you. This will depend on
Mycophenolate Mofetil is used to prevent
your
individual
situation. Contact your
your body rejecting a transplanted organ
doctor as soon as possible, if you think your
 A kidney, heart or liver.
contraception may not have been effective
or if you have forgotten to take your
Mycophenolate mofetil should be used contraceptive pill.
together with other medicines:
 Ciclosporin and corticosteroids
You are a woman who is not capable of
becoming pregnant if any of the following
2. What you need to know before you
applies to you:
take Mycophenolate Mofetil
§ You are post-menopausal, i.e. at least 50
years old and your last period was more
WARNING
than a year ago (if your periods have
Mycophenolate causes birth defects and
stopped because you have had treatment
miscarriage. If you are a woman who could
for cancer, then there is still a chance you
become pregnant, you must provide a
could become pregnant)
negative pregnancy test before starting § Your fallopian tubes and both ovaries have
treatment and must follow the contraception
been removed by surgery (bilateral
advice given to you by your doctor.
salpingo-oophorectomy)
§ Your womb (uterus) has been removed by
Your doctor will speak to you and give you
surgery (hysterectomy)
written information, particularly on the effects § Your ovaries no longer work (premature
of mycophenolate on unborn babies. Read the
ovarian failure, which has been confirmed
information carefully and follow the
by a specialist gynaecologist)
instructions. If you do not fully understand § You were born with one of the following
these instructions, please ask your doctor to
rare conditions that make pregnancy
explain them again before you take
impossible: the XY genotype, Turner's
mycophenolate. See also further information
syndrome or uterine agenesis
in this section under “Warnings and § You are a child or teenager who has not
precautions” and “Pregnancy and breaststarted having periods.
feeding”.
Contraception
in
men
taking
Do not take Mycophenolate Mofetil:
Mycophenolate Mofetil
 If you are allergic (hypersensitive) to You must always use condoms during
mycophenolate mofetil, mycophenolic treatment and for 90 days after you stop taking
acid or any of the other ingredients in this Mycophenolate Mofetil.
medicine (listed in section 6).
If you are planning to have a child, your doctor
 If you are a woman who could be pregnant will talk to you about the risks and the
and you have not provided a negative alternative treatments you can take to prevent
pregnancy test before your first rejection of your transplant organ.
prescription, as mycophenolate causes
Pregnancy and breast-feeding
birth defects and miscarriage.
 If you are pregnant or planning to become
If you are pregnant or breast-feeding, think
pregnant or think you may be pregnant
you
may be pregnant or are planning to have a
 If you are not using effective
baby, ask your doctor or pharmacist for advice
contraception
(see
Pregnancy,
before taking this medicine. Your doctor will
contraception and breast-feeding)
talk to you about the risks in case of pregnancy
 If you are breast-feeding.
and the alternatives you can take to prevent
Do not take this medicine if any of the above rejection of your transplant organ if:
applies to you. If you are not sure, talk to your
doctor or pharmacist before taking
 You plan to become pregnant.
Mycophenolate Mofetil
 You miss or think you have missed a
period, or you have unusual menstrual
Warnings and precautions
bleeding, or suspect you are pregnant.
Talk to your doctor straight away before
 You have sex without using an effective
taking Mycophenolate Mofetil:
method of contraception.
 If you have a sign of infection such as a
If you do become pregnant during the
fever or sore throat
treatment with mycophenolate, you must
 If you have any unexpected bruising or
inform your doctor immediately.
bleeding
However, keep taking Mycophenolate
 If you have ever had a problem with your
Mofetil until you see him or her.
digestive system such as a stomach ulcer
 If you are planning to become pregnant or Pregnancy
if you get pregnant while taking Mycophenolate causes a very high frequency
Mycophenolate Mofetil.
of miscarriage (50%) and of severe birth
defects (23 - 27%) in the unborn baby. Birth
If any of above apply to you (or you are not defects which have been reported include
sure), talk to your doctor straight away before anomalies of ears, of eyes, of face (cleft
taking Mycophenolate Mofetil.
lip/palate), of development of fingers, of
heart, oesophagus (tube that connects the
The effect of sunlight
throat with the stomach), kidneys and nervous
Mycophenolate Mofetil reduces your body's system (for example spina bifida (where the
defences. As a result, there is an increased risk bones of the spine are not properly
of skin cancer. Limit the amount of sunlight developed)).Your baby may be affected by
and UV light you get. Do this by:
one or more of these.
 wearing protective clothing which also
covers your head, neck, arms and legs
If you are a woman who could become
 using a sunscreen with a high protection pregnant, you must provide a negative
pregnancy test before starting treatment and
factor.
must follow the contraception advice given to
Other medicines and Mycophenolate you by your doctor. Your doctor may request
more than one test to ensure you are not
Mofetil:
Please tell your doctor or pharmacist if you are pregnant before starting treatment.
taking or have recently taken, any other
medicines. This includes medicines obtained Breast-feeding
without a prescription, including herbal Do not take Mycophenolate Mofetil if you are
medicines. This is because Mycophenolate breast-feeding. This is because small amounts
Mofetil can affect the way some other of the medicine can pass into the mother's
medicines work. Also other medicines can milk.
affect the way Mycophenolate Mofetil works.
Driving and using machines:
In particular, tell your doctor or pharmacist if Mycophenolate Mofetil is not likely to affect
you are taking any of the following medicines you being able to drive or use any tools or
machines.
before you start Mycophenolate Mofetil:
 azathioprine or other medicines which
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)

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.

 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.

Children:
 There is no information for the use of
Mycophenolate Mofetil in children with a
heart transplant.
Liver transplant
Adults
 The first dose of oral Mycophenolate
Mofetil 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 12 capsules (3 g of the
medicine) taken as 2 separate doses.
 Take 6 capsules in the morning and then 6
capsules in the evening.
Children
 There is no information for the use of
Mycophenolate Mofetil in children with a
liver transplant.
Taking the medicine
Swallow your capsules whole with a glass of
water.
 Do not break or crush them.
 Do not take any capsules that have broken
open or split.

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
heartbeat, 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.
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 or pharmacist. 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

Take care not to let any powder from inside a
broken capsule get into your eyes or mouth.
 If this happens, rinse with plenty of plain
water.

600 mm

Package Leaflet: Information for the user

Take care not to let any powder from inside a
broken capsule get onto your skin.
 If this happens, wash the area thoroughly
with soap and water.
If you take more Mycophenolate Mofetil
than you should
If you take more Mycophenolate Mofetil 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
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 Mofetil
Do not stop taking Mycophenolate Mofetil
unless your doctor tells you to. If you stop
your treatment you may increase the chance of
rejection of your transplant organ.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

 Keep this medicine out of the sight and
reach of children.
 Do not use this capsule after the expiry
date stated on the carton (EXP). The
expiry date refers to the last day of that
month.
 This medicinal product does not require
any special storage conditions. Store
original package in order to protect from
moisture
 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 contains:
 The active substance is mycophenolate
mofetil.
Each capsule contains 250 mg mycophenolate
mofetil.
 The other ingredients are:
 Capsules: Pregelatinised starch,
Croscarmellose sodium, Povidone,
Magnesium strearate

4. Possible side effects

Like all medicines, Mycophenolate Mofetil
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 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.

3. How to take Mycophenolate Mofetil
Always take Mycophenolate Mofetil exactly
as your doctor has told you. You should check
with your doctor or pharmacist if you are not
sure.

What Mycophenolate Mofetil looks like
and contents of the pack:
 White to off white granular powder filled
in size “1” blue colored cap, brown
colored body hard gelatin capsule
imprinted with “266” on body with black
ink.
 The capsules are presented in blister pack
of 10 capsules and supplied in packs of
100 or 300 capsules per carton.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Ascend Laboratories (UK) Limited
5th Floor, 89 New Bond Street,
London, W1S 1DA
United Kingdom
Manufacturer
Wave Pharma Limited
4th floor, Cavendish House,
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW, United Kingdom
The leaflet was last revised in 04/2016

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.

How much to take
The amount you take depends on the type of

150 mm

PT 2406-02

150 mm

Product: Mycophenolate Mofetil 250 mg Capsules

Market: Ascend, UK

Size: 150 x 480 mm
Folding size : 150 x 30 mm

Itemcode: PT 2406-02

Superseed No: PT 2406-01

Mfg Location: Baddi

Pantone No.:

Version No: 02

Pantone 2945 C

Component: Insert
Change Part No: NA

Style: folded

Pack Size: NA
Substrate: ITC Bible Paper 40 ± 5 GSM (Front back printing)
Pharmacode: 2340

Barcode: - NA

Reason for Issue: Text change

Change Control No: NA

Date of Initiation: 21/01/2016

Final Approval of artwork:

Modification Date : 26-04-2016

Capsule shells: Gelatin, Titanium
dioxide (E171), Sodium lauryl
sulphate, Iron oxide red (E172), Iron
oxide yellow (E172, FD & C blue 2
(E132), shellac, black iron oxide
(E172), Potassium hydroxide.

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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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