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MYCOPHENOLIC ACID 180 MG GASTRO-RESISTANT TABLETS

Active substance(s): MYCOPHENOLIC ACID

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Package leaflet: Information for the user

Mycophenolic acid
180 mg gastro-resistant
tablets
Mycophenolic acid

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 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 or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What Mycophenolic acid gastro-resistant
tablets is and what it is used for
2. What you need to know before you take
Mycophenolic acid gastro-resistant tablets
3. How to take Mycophenolic acid
gastro-resistant tablets
4. Possible side effects
5. How to store Mycophenolic acid
gastro-resistant tablets
6. Contents of the pack and other information

1. What Mycophenolic acid
gastro-resistant tablets is and
what it is used for
Mycophenolic acid gastro-resistant tablets
contains a substance called mycophenolic acid.
This belongs to a group of medicines called
immunosuppressants.
Mycophenolic acid gastro-resistant tablets 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 Mycophenolic acid
gastro-resistant tablets
Do not take Mycophenolic acid
gastro-resistant tablets
• 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 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 Mycophenolic acid gastro-resistant
tablets.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before
taking Mycophenolic acid gastro-resistant tablets:
• 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
• Mycophenolic acid gastro-resistant tablets
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 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 Mycophenolic
acid gastro-resistant tablets, and will tell you
whether you can continue taking Mycophenolic
acid gastro-resistant tablets.
• 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 Mycophenolic acid gastro-resistant
tablets in pregnancy may harm the foetus (see
also “Pregnancy and breast-feeding”) and
increase the risk of pregnancy loss.
Children and adolescents
The use of Mycophenolic acid gastro-resistant
tablets in children and adolescents is not
recommended due to lack of data.
Other medicines and Mycophenolic acid
gastro-resistant tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
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.

Mycophenolic acid gastro-resistant tablets
with food and drink and alcohol
Mycophenolic acid gastro-resistant tablets 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 amountof your
medication is absorbed into your body each day.
Elderly patients
Elderly people (age 65 years or older) can take
Mycophenolic acid gastro-resistant tablets
without any need to adjust the usual
recommended dose.
Pregnancy and breast-feeding and fertility
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
Mycophenolic acid gastro-resistant tablets.
Because mycophenolic acid may harm the foetus
and increase the risk of pregnancy loss,
Mycophenolic acid gastro-resistant tablets should
not be used during pregnancy unless clearly
necessary.
If you are a woman, your doctor should advise
you about contraception before you start taking
Mycophenolic acid gastro-resistant tablets. 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 Mycophenolic
acid gastro-resistant tablets.
It is not known whether Mycophenolic acid
gastro-resistant tablets passes into breast milk.
Do not breast-feed during treatment with
Mycophenolic acid gastro-resistant tablets or for
6 weeks after you have stopped taking
Mycophenolic acid gastro-resistant tablets.
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
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
Mycophenolic acid gastro-resistant tablets. 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 Mycophenolic acid gastro-resistant
tablets.
Driving and using machines
Mycophenolic acid gastro-resistant tablets has
not been shown to affect your ability to drive or
use machines.
Mycophenolic acid gastro-resistant tablets
contains sodium
This medicinal product contains 0.61 mmol (13.9
mg) sodium per tablet. To be taken into
consideration by patients on a controlled sodium
diet.

3. How to take Mycophenolic
acid gastro-resistant tablets
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist or
nurse has told you. Mycophenolic acid
gastro-resistant tablets will only be prescribed for
you by a doctor with experience in treating
transplant patients. Check with your doctor or
pharmacist or nurse if you are not sure.
How much to take
The recommended daily dose of Mycophenolic
acid gastro-resistant tablets is 1440 mg (8 tablets
of 180 mg). This is taken as 2 separate doses of
720 mg each (4 tablets of 180 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 (8 tablets of 180 mg).
Taking Mycophenolic acid gastro-resistant
tablets
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 Mycophenolic acid
gastro-resistant tablets than you should
If you take more Mycophenolic acid
gastro-resistant tablets 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 Mycophenolic acid
gastro-resistant tablets
If you forget to take Mycophenolic acid
gastro-resistant tablets, 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 Mycophenolic acid
gastro-resistant tablets
Do not stop taking Mycophenolic acid
gastro-resistant tablets unless your doctor tells
you to. Stopping Mycophenolic acid
gastro-resistant tablets 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 or
nurse.

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 Mycophenolic
acid gastro-resistant tablets, 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 Mycophenolic acid
gastro-resistant tablets, 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 Mycophenolic acid
gastro-resistant tablets you may be more likely
to get an infection 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 Mycophenolic acid
gastro-resistant tablets patients have developed
cancer of the skin or lymph nodes.
If you experience any of the above after taking
Mycophenolic acid gastro-resistant tablets, talk to
your doctor straight away.
Other side effects may include:
Very common (may affect more than 1 in 10
people)
• diarrhoea
• low level of white blood cells.
Common (may affect up to 1 in 10 people)
• low level of red blood cells which can result in
tiredness, breathlessness and looking pale
(anaemia)
• unexpected bleeding and bruising (possible
signs of a low level of blood platelets)
• headache
• 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.
Uncommon (may affect up to 1 in 100 people)
• fast or irregular heart beat, fluid in the lungs
• a growth that looks like a sac (cyst) containing
fluid (lymph)
• trembling, difficulty in sleeping
• itching, redness and swelling of eyes, blurred
vision
• wheezing
• belching, bad breath, bowel blockage, lip ulcers,
heartburn, tongue discolouration, dry mouth,
inflammation of the gums, inflammation of the
pancreas leading to severe upper stomach
pain, blockage of the salivary glands,
inflammation of the inner lining of the abdomen
• 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, back pain, muscle
cramps
• loss of appetite, increased level of lipids, sugar,
cholesterol, or decreased level of phosphate in
the blood
• signs of flu (such as tiredness, chills, sore
throat, aching joints or muscles), swelling of
ankles and feet, feeling thirsty or weak
• strange dreams, believing things that aren´t true
(delusions)
• inability to get or keep an erection.
Not known (frequency cannot be estimated from
the available data)
• rash
• 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
Other side effects reported with medicines
similar to Mycophenolic acid gastro-resistant
tablets
Additional side effects have been reported with
the group of medicines that Mycophenolic acid
gastro-resistant tablets 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, and other less
common bacterial infections usually resulting in a
serious lung disorder (tuberculosis and atypical
mycobacterial infection).
Reporting of side effects
If you get any side effects, talk to your doctor or
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, 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 Mycophenolic
acid gastro-resistant tablets
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. The expiry date
refers to the last day of that month.
This medicinal product does not require any
special temperature storage conditions.
Store in the original package in order to protect
from light.
Do not use this medicine if you notice description
of the visible signs of deterioration.
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 Mycophenolic acid gastro-resistant
tablets contains
• The active substance is mycophenolic acid (as
mycophenolate sodium).
Each tablet contains 180 mg of mycophenolic
acid.
The other ingredients are:
Tablet core: Cellulose Microcrystalline (E460),
Croscarmellose sodium (E468), Povidone K30
(E1201), Talc (E553b), silica colloidal anhydrous
(E551), Magnesium stearate (E470b).
Tablet Coating:
Methacrylic acid - ethyl acrylate copolymer (1:1),
talc (E553b), titanium dioxide (E171), triethyl
citrate (E1505), silica colloidal anhydrous (E551),
sodium hydrogen carbonate (E500), iron oxide
yellow (E172), indigo carmine aluminium lake
(E132), sodium laurilsulfate (E487).
Tablet Imprinting:
Shellac glaze, partially esterified (E904), iron
oxide black (E172), propylene glycol (E1520),
ammonia (E527).
What Mycophenolic acid gastro-resistant
tablets looks like and contents of the pack
Mycophenolic acid 180 mg gastro-resistant
tablets are Lime Green colored, round shaped,
biconvex bevelled edged enteric-coated tablets
imprinted with M1 on one side with black ink and
plain on the other side
The tablets are available in blister packs
containing 20, 50, 100, 120 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate, Birzebbugia
BBG 3000
Malta
This leaflet was last revised in 01/2015.

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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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