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MYFORTIC 360MG FILM-COATED GASTRO-RESISTANT TABLETS

Active substance(s): SODIUM MYCOPHENOLATE

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What is in this leaflet

Package leaflet:
Information for the user

Myfortic®
360 mg gastro-resistant tablets
Mycophenolic acid (as mycophenolate sodium)

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K
 eep 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.

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

1. What Myfortic is and what it is
used for
Myfortic contains a substance called
mycophenolic acid. This belongs to a group of
medicines called immunosuppressants.
Myfortic is used to stop the body’s immune
system from rejecting a kidney transplant. It is
used together with other medicines containing
ciclosporin and corticosteroids.

2. What you need to know before
you take Myfortic
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 and breastfeeding”.

Do not take Myfortic:

• if you are allergic to mycophenolic acid,
mycophenolate sodium, mycophenolate
mofetil 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 or planning to become
pregnant or think you may be pregnant
• if you are not using effective contraception
(see Contraception in women and men).
• if you are breast-feeding (see also “Pregnancy
and breast-feeding”).
If any of the above apply to you, tell your
doctor without taking Myfortic.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Myfortic:
• if you have or have ever had serious digestive
problems, such as stomach ulcer.
• if you have a rare hereditary enzyme
deficiency of hypoxanthine-guanine
phosphoribosyl-transferase (HGPRT) such as
Lesch‑Nyhan or Kelley-Seegmiller syndrome.

You should also be aware that:

• M
 yfortic lowers the skin´s level of protection
from the sun. This increases the risk of
skin cancer. You should limit your exposure
to sunlight and ultraviolet (UV) light by
covering exposed skin areas as much as
possible and regularly applying sunscreen
with a high protective factor. Ask your doctor
for advice on protection from the sun.
• if you already had hepatitis B or C, Myfortic
may increase the risk of these diseases
re-appearing. Your doctor may perform
blood analysis and check for symptoms
of these diseases. If you experience any
symptoms (yellow skin and eyes, nausea,
loss of appetite, dark urine) you should tell
your doctor immediately.
• if you get a persistent cough or become
breathless, especially when taking other
immunosuppressants, you should tell your
doctor straight away.
• your doctor may want to check your blood
level of antibodies during treatment with
Myfortic particularly when the infections
recur, especially if you are also taking other
immunosuppressants, and will tell you
whether you can continue taking Myfortic.
• if you get any signs of infection (such
as fever or a sore throat) or unexpected
bruising or bleeding you should tell your
doctor straight away.
• your doctor may want to check your white
blood cell count during treatment with
Myfortic, and will tell you whether you can
continue taking Myfortic.

• the active substance, mycophenolic acid,
is not the same as other similar-sounding
medicines such as mycophenolate mofetil.
You should not switch between medicines
unless your doctor tells you to.
• use of Myfortic in pregnancy may harm the
foetus (see also “Pregnancy and breastfeeding”) and increase the risk of pregnancy
loss (spontaneous abortion).

Other medicines and Myfortic

Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines, including medicines obtained
without a prescription.
In particular, you should talk to your doctor if
you are taking any of the following:
• other immunosuppressant medicines such
as azathioprine or tacrolimus.
• medicines used to treat high blood cholesterol
levels such as cholestyramine.
• activated charcoal used to treat digestive
problems such as diarrhoea, upset stomach,
and gas.
• antacids that contain magnesium and
aluminium.
• medicines used to treat viral infections such
as aciclovir or ganciclovir.
You should also tell your doctor if you plan to
have any vaccinations.
You must not donate blood during treatment
with Myfortic and for at least 6 weeks after
stopping treatment. Men must not donate
semen during treatment with Myfortic and for
at least 90 days after stopping treatment.

Myfortic with food and drink

Myfortic can be taken with or without food. You
need to choose whether to take your tablets
with or without food and then take them in
the same way each day. This is to make sure
that the same amount of your medication is
absorbed into your body each day.

Older people

Elderly people (age 65 years or older) can take
Myfortic without any need to adjust the usual
recommended dose.

Children and adolescents

The use of Myfortic in children and
adolescents is not recommended due to lack
of data.

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

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 salpingooophorectomy)
• 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 women taking Myfortic

You must always use condoms during treatment
and for at least 90 days after you stop taking
Myfortic.
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.

If you are a woman who could become pregnant
you must always use two effective methods of
contraception with Myfortic. This includes:
• Before you start taking Myfortic
• During your entire treatment with Myfortic
• For 6 weeks after you stop taking Myfortic.
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

Contraception in men taking Myfortic

Driving and using machines

Myfortic has not been shown to affect your
ability to drive or use machines.
1602391 R96 WEH

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Telephone +353 (0)1 440 3222
novartis@perigord-as.com
www.perigord-as.com

Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15

LFT MYFORTIC FCT 360MG R96

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ACC:
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Myfortic contains lactose

If you have been told by a doctor that you have
an intolerance to some sugars (including lactose,
galactose, or glucose), talk to your doctor before
taking Myfortic.

3. How to take Myfortic
Always take Myfortic exactly as your doctor
has told you. Myfortic will only be prescribed
for you by a doctor with experience in treating
transplant patients. Check with your doctor or
pharmacist if you are not sure.

How much to take

The recommended daily dose of Myfortic is
1440 mg (4 tablets of Myfortic 360 mg). This
is taken as 2 separate doses of 720 mg each
(2 tablets of Myfortic 360 mg).
Take your tablets in the morning and in the
evening.
The first dose of 720 mg will be given within
72 hours after transplantation.

If you have severe kidney problems

Your daily dose should not be more than
1440 mg (4 tablets of Myfortic 360 mg).

Taking Myfortic

Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take any tablets that are broken or split.
Treatment will continue for as long as you
need immunosuppression to stop your body
rejecting your transplant.

If you take more Myfortic than you should
If you take more Myfortic than you should, or
if someone else has taken your tablets, talk

to a doctor or go to a hospital straight away.
Medical attention may be necessary. Take the
tablets with you and show them to your doctor
or to the hospital staff. If you have run out of
tablets, take the empty packaging with you.

If you forget to take Myfortic

If you forget to take Myfortic, take it as soon as
you remember unless it is almost time for your
next dose. Then take your next dose at the usual
time. Ask your doctor for advice. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Myfortic

Do not stop taking Myfortic unless your doctor
tells you to. Stopping Myfortic may increase
the chance of your body rejecting your kidney
transplant.
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.
Elderly patients may experience more side
effects due to a reduced immune defence.
Immunosuppressants, including Myfortic,
reduces your body´s own defence mechanisms
to stop you rejecting your transplanted organ.
Consequently your body will not be as good
as normal at fighting infections. So if you are
taking Myfortic, you may therefore catch more
infections than usual such as infections of the
brain, skin, mouth, stomach and intestines,
lungs and urinary tract.
Your doctor will perform regular blood tests to
monitor any changes in the number of your

blood cells or in the levels of substances carried
in your blood, such as sugar, fat and cholesterol.

Some effects could be serious:

• s igns of infection including fever, chills,
sweating, feeling tired, drowsy, or lack of
energy. If you are taking Myfortic you may
be more likely to get viral, bacterial and
fungal infections than usual. Such infections
could affect various parts of your body, but
the parts most commonly affected are the
kidneys, bladder, upper and/or lower airways.
• vomiting blood, black or bloody stools,
stomach or intestinal ulcer.
• swelling of your glands, development of
a new skin growth or enlargement of an
existing skin growth, or changes in an
existing mole. As can happen in patients
taking immunosuppressants, a very small
number of Myfortic patients have developed
cancer of the skin or lymph nodes.
If you experience any of the above after taking
Myfortic, talk to your doctor straight away.

Other side effects may include:

Very common (affecting more than 1 in 10
patients)
• low level of white blood cells
• low level of calcium in the blood
(hypocalcaemia)
• low level of potassium in the blood
(hypokalemia)
• high level of uric acid in the blood
(hyperuricemia)
• high blood pressure (hypertension)
• anxiety
• diarrhoea
• pain in joints (arthralgia)

Common (affecting less than 1 in 10 patients)
• low level of red blood cells which can result
in tiredness, breathlessness and looking pale
(anaemia)
• low level of blood platelets which can
result in unexpected bleeding and bruising
(thrombocytopenia)
• high level of potassium in the blood
(hyperkalemia)
• low level of magnesium in the blood
(hypomagnesemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnoea)
• abdominal or stomach pain, inflammation of
the lining of the stomach, abdominal bloating,
constipation, indigestion, wind (flatulence),
loose stools, feeling sick (nausea), being sick
(vomiting)
• tiredness, fever
• abnormal results of liver or kidney function
tests
• respiratory infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swollen hands, ankles or feet (oedema
peripheral)
• itching
Uncommon (affecting less than 1 in 100 patients)
• fast heart beat (tachycardia) or irregular
heart beat (ventricular extrasystoles), fluid in
the lungs (pulmonary oedema)

• a
 growth that looks like a sac (cyst) containing
fluid (lymph) (lymphocele)
• trembling, difficulty in sleeping
• redness and swelling of eyes (conjunctivitis),
blurred vision
• wheezing
• belching, bad breath, bowel blockage (ileus),
lip ulcers, heartburn, tongue discolouration,
dry mouth, inflammation of the gums,
inflammation of the pancreas leading to
severe upper stomach pain (pancreatitis),
blockage of the salivary glands, inflammation
of the inner lining of the abdomen (peritonitis)
• infection of the bones, blood and the skin
• blood in urine, damage to the kidney, pain
and difficulty passing urine
• hair loss, skin bruising
• inflammation of the joints (arthritis), back
pain, muscle cramps
• loss of appetite, increased level of lipids
(hyperlipidemia), sugar (diabetes), cholesterol
(hypercholesterolemia), or decreased level of
phosphate in the blood (hypophosphatemia)
• signs of flu (such as tiredness, chills, sore
throat, aching joints or muscles), swelling of
ankles and feet, pain, rigors, feeling thirsty
or weak
• strange dreams, believing things that aren´t
true (delusions)
• inability to get or keep an erection
• cough, difficulty breathing, painful breathing
(possible symptoms of interstitial lung disease)
Not known (frequency cannot be estimated
from the available data)
• rash

Telephone +353 (0)1 440 3222
novartis@perigord-as.com
www.perigord-as.com

Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15

LFT MYFORTIC FCT 360MG R96

Production Site:
ACC:
Printing Colours:

Wehr
Schumann, Anita
Black

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1602391 R96 WEH
N/A
148 x 594 mm
000000

Technical Colours:

Cutting
Dimensions

Min. Font Size Text:
Font Type:
Proof No.: 2

9 pt
News Gothic
Date: 18 May 2017

Live Text:
WO:

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Both

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• fever, sore throat, frequent infections (possible
symptoms of lack of white cells in the blood)
(agranulocytosis)

Other side effects reported with medicines
similar to Myfortic
Additional side effects have been reported with
the group of medicines that Myfortic belongs to:
inflammation of the colon (large intestine),
inflammation of the stomach lining caused by
cytomegalovirus, development of a hole in the
intestinal wall, resulting in severe abdominal
pain with possible bleeding, stomach or
duodenal ulcers, a low level of specific white
blood cells or of all blood cells, serious infections
such as inflammation of the heart and its valves
and of the membrane that covers the brain and
spinal cord, shortness of breath, cough, which
can be due to bronchiectasis (a condition in
which the lung airways are abnormally dilated)
and other less common bacterial infections
usually resulting in a serious lung disorder
(tuberculosis and atypical mycobacterial infection).
Talk to your doctor if you develop a persistent
cough or breathlessness.

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 (see
details below). By reporting side effects you can
help provide more information on the safety of
this medicine.

United
Yellow Card Scheme
Kingdom Website: www.mhra.gov.uk/yellowcard
Malta

ADR Reporting
Website:
www.medicinesauthority.gov.mt/
adrportal

5. How to store Myfortic
Keep this medicine out of the sight and reach
of children.
Do not use Myfortic after the expiry date which
is stated on the carton. The expiry date refers
to the last day of that month.
This medicine does not require any special
temperature storage conditions.
Store Myfortic in the original package in order
to protect it from moisture.
Do not use Myfortic if you notice that the pack
is damaged or shows signs of tampering.
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 Myfortic contains

• T
 he active substance is mycophenolic acid (as
mycophenolate sodium). Each tablet of Myfortic
contains 360 mg of mycophenolic acid.
• The other ingredients are:
• Tablet core: maize starch, povidone,
crospovidone, lactose anhydrous, colloidal
anhydrous silica, magnesium stearate.

• T
 ablet coating: hypromellose phthalate,
titanium dioxide (E 171), iron oxide
yellow (E 172), iron oxide red (E 172).

What Myfortic looks like and contents of
the pack

Myfortic 360 mg gastro-resistant tablets are
pale orange red, film-coated and ovaloid, with
“CT” on one side.
Myfortic 360 mg gastro-resistant tablets are
available in blister packs containing 50, 100,
120 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR.

Manufacturer

Novartis Pharma GmbH
Roonstrasse 25
D‑90429 Nürnberg
Germany

This medicinal product is authorised in
the Member States of the EEA under the
following name:
Myfortic

This leaflet was last revised in
May 2017.

1602391 R96 WEH

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