Skip to Content

MYFORTIC 360MG FILM-COATED GASTRO-RESISTANT TABLETS

Active substance(s): SODIUM MYCOPHENOLATE

View full screen / Print PDF » Download PDF ⇩
Transcript
1. WHAT MYFORTIC IS AND WHAT IT IS
USED FOR
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.
• 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.

What is in this leaflet
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

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
Do not take Myfortic:

if you are allergic (hypersensitive) to mycophenolic acid,
mycophenolate sodium, mycophenolate mofetil or any of
the other ingredients of this medicine (listed in section 6).
if you are breast-feeding (see also “Pregnancy and
breast-feeding”).
if you are a woman of child bearing potential and you
are not using highly effective contraception methods.
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:

• Myfortic 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 breast-feeding”) 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.

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

Paediatric population 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 a woman you should make sure that you are not
pregnant, by means of a negative pregnancy test, before
you start taking Myfortic. Because mycophenolic acid
may cause malformations in the foetus and miscarriage,
Myfortic should not be used during pregnancy unless
clearly necessary.

LFT MYFORTIC FCT 360MG GB

Production Site:
CTM:
Printing Colours:

Wehr
Glembotzki, Stefan
Black

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

2177399 R96 WEH
N/A
148 x 420 mm
2177399

Technical Colours:

Cutting
Dimensions

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

9 pt
News Gothic
Date: 13 Aug 2015



Comp. Description:

Braille:

Yes /
1415252



No /



Both

Driving and using machines

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

Myfortic contains lactose

Older people

P2

Live Text:
WO:

If you are a woman, your doctor should advise you about
contraception before you start taking Myfortic. You must use
contraception before and while taking it and for 6 weeks after
you have stopped taking it. Tell your doctor straight away if
you become pregnant during treatment with Myfortic.
It is not known whether Myfortic passes into breast milk.
Do not breast‑feed during treatment with Myfortic or for
6 weeks after you have stopped taking Myfortic.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
If you are a sexually active man it is recommended to use
condoms during treatment, and for a total of 13 weeks after
your last dose of Myfortic. In addition, your female partners
are recommended to use highly effective contraception
during your treatment and for a total of 13 weeks after the
last dose of Myfortic.

J.N.: 258505

N/A

! PLEASE TURN OVERPRINTING ON !
1 of 2

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. You should
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.
2177399 R96 WEH

4. POSSIBLE SIDE EFFECTS
Like all medicines, Myfortic 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:

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

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.

LFT MYFORTIC FCT 360MG GB

Wehr
Glembotzki, Stefan
Black

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

2177399 R96 WEH
N/A
148 x 420 mm
2177399

Technical Colours:

Cutting
Dimensions

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

9 pt
News Gothic
Date: 13 Aug 2015



Comp. Description:

Braille:

Yes /
1415252



No /



Both

Malta

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

5. HOW TO STORE MYFORTIC

Other side effects reported with medicines
similar to Myfortic

Production Site:
CTM:
Printing Colours:

Live Text:
WO:

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

J.N.: 258505

N/A

! PLEASE TURN OVERPRINTING ON !
2 of 2

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

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.
Do not store above 30°C.
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.

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

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

This leaflet was last revised in August 2015.

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

What Myfortic contains

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

2177399 R96 WEH

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