MYFORTIC 180 mg Enteric-Coated Tablet

Зміст інструкції

1. Myfortic 180 mg gastro-resistant tablets
   1. Cos’è Myfortic e a cosa serve
   2. Cosa deve sapere prima di prendere Myfortic
   3. How to take Myfortic
   4. Possible side effects
   5. How to store Myfortic
   6. Package contents and other information
2. Myfortic 360 mg gastro-resistant tablets
   1. What is Myfortic 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. Package contents and other information

Myfortic 180 mg gastro-resistant tablets

mycophenolic acid (as mycophenolate sodium)

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. Cos’è Myfortic e a cosa serve

Myfortic contains a substance called mycophenolic acid. It belongs to a group of medicines
called immunosuppressants.
Myfortic is used to prevent the immune system from rejecting a transplanted kidney. It is used in
combination with other medicines containing ciclosporin and corticosteroids.

2. Cosa deve sapere prima di prendere Myfortic

WARNING
Mycophenolate causes birth defects and miscarriages. If you are a woman of childbearing potential, you must provide a negative pregnancy test
before starting treatment and must follow the contraception advice provided
by your doctor.
Your doctor will talk to you and give you written information, particularly about the effects of mycophenolate on the unborn child.
Read the information carefully and follow the instructions.
If you do not fully understand the instructions, ask your doctor to explain them again before taking
mycophenolate. You can find more information in this section under “Warnings and precautions” and
“Pregnancy and breastfeeding”.

Do not take Myfortic:

• if you are allergic to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman of childbearing potential (who could become pregnant) and have not provided a negative pregnancy test before the first prescription, as mycophenolate causes birth defects and miscarriage
• if you are pregnant or planning a pregnancy or think you might be pregnant
• if you are not using effective contraception (see Contraception in women and men)
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

If this applies to you, tell your doctor before taking Myfortic .
Warnings and precautions
Talk to your doctor or pharmacist before taking Myfortic:

• if you have or have ever had severe digestive problems, such as a stomach ulcer.
• if you have a rare hereditary deficiency of the hypoxanthine-guanine-phosphoribosyl-transferase (HGPRT) enzyme, such as Lesch-Nyhan syndrome and Kelley-Seegmille syndrome.

You should also be informed that:

• Myfortic reduces the level of protection of the epidermis from the sun. This increases the risk of skin cancer. You must limit exposure to the sun and ultraviolet (UV) rays, protecting exposed areas as much as possible and regularly applying high-protection sunscreens. Ask your doctor for advice on how to protect yourself from the sun.
• If you have already had hepatitis B or C, Myfortic may increase the risk of these diseases by causing them to reappear. Your doctor may perform blood tests and check for symptoms of these diseases. If you develop any symptoms (yellowing of the eyes and skin, nausea, loss of appetite, dark urine), you should tell your doctor immediately.
• If you have a persistent cough or shortness of breath, especially when taking other immunosuppressants, you should tell your doctor immediately.
• Your doctor may ask to check the levels of antibodies in the blood during treatment with Myfortic, especially when infections recur, especially if you are also being treated with other immunosuppressants and will inform you if you can continue treatment with Myfortic.
• If you have signs of infection (such as fever or sore throat) or if you experience unexpected bruising or bleeding, you should tell your doctor immediately.
• Your doctor may ask to check the white blood cell counts during treatment with Myfortic and will inform you if you can continue treatment with Myfortic.
• The active ingredient, mycophenolic acid, is different from that of other medicines with a similar name such as mycophenolate mofetil. You should not switch from one medicine to another unless your doctor tells you to.
• The use of Myfortic during pregnancy can be harmful to the fetus (see also “Pregnancy and breastfeeding”) and may increase the risk of pregnancy loss (miscarriage).

Children and adolescents
Due to the lack of data, the use of Myfortic is not recommended in children and adolescents.

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

Other medicines and Myfortic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:

• other immunosuppressant medicines such as azathioprine or tacrolimus.
• medicines used to treat high cholesterol levels in the blood such as colestyramine.
• activated charcoal used to treat digestive problems such as diarrhea, stomach upset and flatulence.
• antacids containing magnesium and aluminum.
• medicines used to treat viral infections such as aciclovir or ganciclovir.

You should also tell your doctor if you are planning to have any vaccinations.
You should not donate blood during treatment with Myfortic and for at least 6 weeks after stopping
treatment. Men should not donate sperm 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 should choose whether to take the tablets with or without food and
then continue to take them every day in the same way. This way you are sure to absorb the same amount of
medicine each day.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you might be pregnant or are planning a
pregnancy, 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 alternative therapies you can take to prevent organ rejection
if:

• you are planning a pregnancy.
• you have missed or think you have missed a menstrual period or notice unusual vaginal bleeding or suspect you are pregnant.
• you have unprotected sexual intercourse without using an effective method of contraception. If you find out you are pregnant while taking mycophenolate, you should tell your doctor immediately. However, continue to take mycophenolate until you have seen your doctor.

Pregnancy
Mycophenolate causes a very high rate of miscarriages (50%) and serious birth defects (23 -
27%) in the unborn child. Birth defects that have been reported include abnormalities of the ears, the
eyes, the face (cleft lip/palate), the development of the fingers, the heart, the esophagus (the tube that
connects the throat to the stomach), the kidneys and the nervous system (for example spina bifida (where the bones of the
spine are not properly developed). One or more of these could affect your baby.
If you are a woman of childbearing potential, you must provide a negative pregnancy test before starting treatment and
must follow the contraception advice provided by your doctor. Your doctor may require more than one test to
ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Myfortic if you are breastfeeding. This is because small amounts of the medicine can pass into
breast milk.

Contraception in women taking Myfortic
If you are a woman of childbearing potential, you must use an effective method of contraception with Myfortic. This includes:

• Before starting treatment with Myfortic
• During all of the treatment period with Myfortic
• For 6 weeks after stopping treatment with Myfortic. Talk to your doctor about the most suitable method of contraception for you. Two methods of contraception are preferable as this will reduce the risk of an unwanted pregnancy. This will depend on your personal situation. Contact your doctor as soon as possible if you think the contraceptive methodmay not be effective and if you have forgotten to take your contraceptive pill.

If any of the following applies to you, you may consider yourself not fertile:

• You are postmenopausal, that is, you are at least 50 years old and your last menstrual period was more than a year ago (if your periods have stopped because you have received treatment for cancer, there is still a possibility that you may become pregnant)
• Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy)
• Your uterus has been surgically removed (hysterectomy)
• Your ovaries are no longer functioning (early ovarian failure confirmed by a gynecologist specialist)
• You were born with one of the rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis
• You are a child or adolescent who has not yet had her first menstrual period.

Contraception in men taking Myfortic
Available evidence does not indicate an increased risk of malformations or miscarriage if the father is taking
mycophenolate. However, a risk cannot be completely excluded. As a precaution, it is recommended
that you and your partner use effective contraception during treatment and for 90 days after
stopping Myfortic.
If you are planning to have a child, talk to your doctor about the potential risks.

Driving and using machines
Myfortic slightly impairs the ability to drive and operate machines.

Myfortic contains sodium
This medicine contains 13 mg of sodium (the main component of table salt) per tablet of
Myfortic 180 mg. This is equivalent to 0.65% of the recommended daily intake of salt with the diet
of an adult

Myfortic contains lactose
If you have been diagnosed with an intolerance to some sugars (including lactose, galactose or glucose),
contact your doctor before taking Myfortic.

3. How to take Myfortic

Always take Myfortic exactly as your doctor has instructed. Myfortic will only be prescribed by
doctors with experience in treating transplant patients. If you have any doubts, ask your doctor or pharmacist.

What dose to take
The recommended daily dose of Myfortic is 1440 mg (8 Myfortic 180 mg tablets). These are
taken in 2 separate doses of 720 mg each (4 Myfortic 180 mg tablets).
Take the tablets in the morning and evening.
The first dose of 720 mg will be administered within 72 hours of the transplant.

If you have severe kidney problems
The daily dose should not exceed 1440 mg (8 Myfortic 180 mg tablets).

Taking Myfortic
Swallow the tablets whole with a glass of water.
The tablets should not be broken or crushed.
Do not take any broken or divided tablets.
Treatment will continue as long as immunosuppression is necessary to prevent rejection
of the transplanted organ.

If you take more Myfortic than you should
If you have taken more Myfortic than you were told to take or if someone else has taken your
tablets, contact your doctor and go to the hospital immediately. Medical treatment may be necessary.
Bring the tablets with you and show them to the doctor or hospital staff. If you have finished the
tablets, bring the empty package 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 to
take your next dose. In that case, take your next dose when it is scheduled to be taken. Ask
your doctor for advice. Do not take a double dose to make up for a missed dose.

If you stop taking Myfortic
Do not stop taking Myfortic unless your doctor tells you to. Stopping
treatment with Myfortic may increase the risk of rejection of the transplanted kidney.
If you have any doubts about 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 everyone will experience them.
Elderly patients may experience more side effects due to a reduced immune defense.
Immunosuppressants, including Myfortic, reduce your body's defense mechanisms to prevent it from
rejecting your transplanted organ. Consequently, your body will not be able to defend itself against
infections as it normally would. Therefore, if you are taking Myfortic, you may get more infections than
usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs, and the
urinary tract.
You will be regularly monitored by your doctor with blood tests to check for changes in the number of
blood cells or levels of substances carried in the blood, such as sugar, fats and cholesterol.

Some side effects can be serious:

• signs of infection including fever, chills, sweating, feeling tired, sleepy or lacking energy. If you are taking Myfortic you may have viral, bacterial and fungal infections more frequently than usual. These infections can affect different parts of the body but most commonly the kidneys, bladder, upper and/or lower airways.
• vomiting blood, black or bloody stools, stomach or intestinal ulcer.
• swelling of the glands, development of new skin formations, increase in the size of existing formations or changes in an existing formation. As can happen in patients treated with immunosuppressants, a very small number of patients treated with Myfortic have developed skin or lymph node tumors. If you have experienced any of the above side effects after taking Myfortic, contact your doctor immediately.

Other side effects may include:
Very common( affects more than 1 in 10 people)

• low levels of white blood cells.
• low levels of calcium in the blood (hypocalcemia)
• low levels of potassium in the blood (hypokalaemia)
• high levels of uric acid in the blood (hyperuricemia)
• high blood pressure (hypertension)
• anxiety
• diarrhoea
• joint pain (arthralgia)

Common( affects less than 1 in 10 people)

• low levels of red blood cells that can cause fatigue, shortness of breath and paleness (anaemia)
• low levels of platelets in the blood which can cause bleeding and unexpected bruising (thrombocytopenia)
• high levels of potassium in the blood (hyperkalaemia)
• low levels of magnesium in the blood (hypomagnesaemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnoea)
• pain in the abdomen or stomach, inflammation of the stomach wall, abdominal bloating, constipation, dyspepsia, flatulence, loose stools, nausea, vomiting
• fatigue, fever
• abnormal results of liver and kidney function tests
• respiratory infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of the hands, ankles or feet (peripheral oedema)
• itching

Uncommon( affects less than 1 in 100 people)

• fast (tachycardia) or irregular (ventricular extrasystoles) heartbeat, fluid in the lungs (pulmonary oedema)
• skin formation similar to a cyst containing fluid (lymphocele)
• tremor, difficulty sleeping
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, difficulty breathing, intestinal blockage (ileus), ulceration of the lips, heartburn, change in tongue colour, dry mouth, inflammation of the gums, inflammation of the pancreas causing severe pain in the upper abdomen (pancreatitis), blockage of the salivary glands, inflammation of the inner wall of the abdomen (peritonitis)
• infection of the bones, blood and skin
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, bruising
• inflammation of the joints (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolaemia) or decreased levels of phosphates in the blood (hypophosphataemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, stiffness, thirst or weakness
• abnormal dreams, feeling of disappointment
• inability to get or maintain an erection
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease).

Not known( frequency cannot be estimated from the available data)

• fever, sore throat, frequent infections (possible symptoms of a lack of white blood cells in the blood) (agranulocytosis)
• skin rash, itching, hives, shortness of breath or difficulty breathing, wheezing or coughing, dizziness, lightheadedness, changes in level of consciousness, low blood pressure, with or without mild general itching, redness of the skin and swelling of the face/throat (symptoms of a severe allergic reaction)

Other side effects reported with medicines similar to Myfortic
Further side effects have been reported with the group of medicines to which Myfortic belongs:
inflammation of the colon (large intestine), inflammation of the stomach walls caused by
cytomegalovirus, formation of a lesion in the intestinal wall causing severe abdominal pain
with possibility of bleeding, gastric or duodenal ulcer, low levels of white blood cells specifically
or of all blood cells, serious infections such as inflammation of the heart and heart valves and the
membranes lining the brain and spinal cord, shortness of breath, cough that may be caused by
bronchiectasis (a condition in which the airways of the lungs are abnormally dilated) and other
less common bacterial infections that usually cause severe lung disorders ( tuberculosis and infections

from atypical mycobacteria). Contact your doctor if you have a persistent cough or shortness of breath.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

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 packaging. The expiry date refers
to the last day of the month.
This medicine does not require any particular storage temperature.
Store Myfortic in the original packaging to protect the medicine from moisture.
Do not use Myfortic if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Myfortic contains

• The active ingredient is mycophenolic acid (as mycophenolate sodium). Each Myfortic tablet contains 180 mg of mycophenolic acid.
• The excipients are:
• Tablet core: corn starch, povidone, crospovidone, lactose, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132).

Description of Myfortic and package contents
Myfortic 180 mg gastroresistant tablets are yellowish-green in color, film-coated, round in shape and with “C” imprinted on one side.
Myfortic 180 mg gastroresistant tablets are available in blisters in packs containing 20, 50, 100 or 120 tablets or in multiple packs containing 5 packs of 50 tablets (250 tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy

Manufacturer
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D
Lendava, 9220
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following name:
Myfortic: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Hungary.

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency ( http://www.aifa.gov.it/ )

Myfortic 360 mg gastro-resistant tablets

mycophenolic acid (as mycophenolate sodium)

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

2. What is Myfortic and what it is used for

Myfortic contains a substance called mycophenolic acid. It belongs to a group of medicines
called immunosuppressants.
Myfortic is used to prevent the immune system from rejecting a transplanted kidney. It is used in
combination with other medicines containing ciclosporin and corticosteroids.

5. What you need to know before you take Myfortic

WARNING
Mycophenolate causes birth defects and miscarriages. If you are a woman of childbearing potential, you must provide a negative pregnancy test
before starting treatment and must follow the contraception advice provided
by your doctor.
Your doctor will talk to you and give you written information, especially about the effects of mycophenolate on the unborn child.
Read the information carefully and follow the instructions.
If you do not fully understand the instructions, ask your doctor to explain them again before taking
mycophenolate. You can find more information in this section under “Warnings and precautions” and
“Pregnancy and breastfeeding”.

Do not take Myfortic:

• if you are allergic to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman of childbearing potential (who could become pregnant) and have not provided a negative pregnancy test before the first prescription, as mycophenolate causes birth defects and miscarriage
• if you are pregnant or planning a pregnancy or think you might be pregnant
• if you are not using effective contraception (see Contraception in women and men)
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

If any of these apply to you, tell your doctor before taking Myfortic .
Warnings and precautions
Talk to your doctor or pharmacist before taking Myfortic:

• if you have or have ever had severe digestive problems, such as a stomach ulcer.
• if you have a rare hereditary deficiency of the hypoxanthine-guanine-phosphoribosyl-transferase (HGPRT) enzyme, such as Lesch-Nyhan syndrome and Kelley-Seegmille syndrome.

You should also be informed that:

• Myfortic reduces the level of protection of the epidermis from the sun. This increases the risk of skin cancer. You should limit exposure to the sun and ultraviolet (UV) rays, protecting exposed areas as much as possible and regularly applying high-protection sunscreens. Ask your doctor for advice on how to protect yourself from the sun.
• If you have already had hepatitis B or C, Myfortic may increase the risk of these diseases by causing them to reappear. Your doctor may perform blood tests and check for symptoms of these diseases. If you experience any symptoms (yellowing of the eyes and skin, nausea, loss of appetite, dark urine), you should inform your doctor immediately.
• If you have a persistent cough or shortness of breath, especially when taking other immunosuppressants, you should tell your doctor immediately.
• Your doctor may ask to check the levels of antibodies in the blood during treatment with Myfortic, especially when infections recur, especially if you are also being treated with other immunosuppressants, and will inform you if you can continue treatment with Myfortic.
• If you have signs of infection (such as fever or sore throat) or if you experience unexpected bruising or bleeding, you should tell your doctor immediately.
• Your doctor may ask to check the levels of white blood cells during treatment with Myfortic and will inform you if you can continue treatment with Myfortic.
• The active ingredient, mycophenolic acid, is different from that of other medicines with a similar name, such as mycophenolate mofetil. Do not switch from one medicine to another unless your doctor tells you to.
• The use of Myfortic during pregnancy can be harmful to the fetus (see also “Pregnancy and breastfeeding”) and may increase the risk of pregnancy loss, miscarriage.

Children and adolescents
Due to the lack of data, the use of Myfortic in children and adolescents is not recommended.

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

Other medicines and Myfortic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:

• other immunosuppressant medicines such as azathioprine or tacrolimus.
• medicines used to treat high cholesterol levels in the blood such as colestyramine.
• activated charcoal used to treat digestive disorders such as diarrhea, stomach upset and bloating.
• antacids containing magnesium and aluminum.
• medicines used to treat viral infections such as acyclovir or ganciclovir.

You should also tell your doctor if you are planning to have any vaccinations.
You should not donate blood during treatment with Myfortic and for at least 6 weeks after stopping
treatment. Men should not donate sperm 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 should choose whether to take the tablets with or without food and
then continue to take them every day in the same way. This way you are sure to absorb every
day the same amount of medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you might be pregnant or are planning a
pregnancy, 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 alternative therapies that you can take to prevent rejection
of the transplanted organ if:

• you are planning a pregnancy.
• you have missed or think you have missed a menstrual period or notice unusual menstrual bleeding or suspect you are pregnant.
• you have unprotected sexual intercourse without using an effective method of contraception. If you find out you are pregnant while taking mycophenolate, tell your doctor immediately. However, continue to take mycophenolate until you have seen your doctor.

Pregnancy
Mycophenolate causes a very high rate of miscarriages (50%) and serious birth defects (23 -
27%) in the unborn child. Birth defects that have been reported include abnormalities of the ears, eyes,
face (cleft lip/palate), development of the fingers, heart, esophagus (the tube that
connects the throat to the stomach), kidneys and the nervous system (for example spina bifida (where the bones of the
spine are not properly developed). One or more of these could affect your baby.
If you are a woman of childbearing potential, you must provide a negative pregnancy test before starting treatment and
must follow the contraception advice provided by your doctor. Your doctor may require more than one test to
ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Myfortic if you are breastfeeding. This is because small amounts of medicine can pass into
breast milk.

Contraception in women taking Myfortic
If you are a woman of childbearing potential, you must use an effective method of contraception with Myfortic. This includes:

• Before starting treatment with Myfortic
• During all the time you take Myfortic
• For 6 weeks after stopping treatment with Myfortic. Talk to your doctor about the most suitable method of contraception for you. Two methods of contraception are preferable as this will reduce the risk of unwanted pregnancy. This will depend on your personal situation. Contact your doctor as soon as possible if you think the contraceptive methodmay not be effective and if you have forgotten to take your contraceptive pill.

If any of the following conditions apply to you, you may consider yourself not fertile:

• You are postmenopausal, that is, you are at least 50 years old and your last menstrual period was more than a year ago (if your periods have stopped because you have received treatment for cancer, there is still a possibility that you may become pregnant)
• Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy)
• Your uterus has been surgically removed (hysterectomy)
• Your ovaries are no longer functioning (early ovarian failure confirmed by a gynecologist specialist)
• You were born with one of the rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis
• You are a child or adolescent who has not yet had their first menstrual period.

Contraception in men taking Myfortic
Available evidence does not indicate an increased risk of malformations or miscarriage if the father is taking
mycophenolate. However, a risk cannot be completely ruled out. As a precaution, it is recommended
that you and your partner use effective contraception during treatment and for 90 days after
stopping Myfortic.
If you are planning to have a child, talk to your doctor about the potential risks.

Driving and using machines
Myfortic slightly impairs the ability to drive and operate machines.

Myfortic contains sodium
This medicine contains 26 mg of sodium (the main component of table salt) per tablet of
Myfortic 360 mg. This is equivalent to 1.3% of the maximum recommended daily intake of
salt with the diet of an adult.

Myfortic contains lactose
If your doctor has diagnosed you with intolerance to certain sugars (including lactose, galactose or glucose),
contact him before taking Myfortic.

6. How to take Myfortic

Always take Myfortic exactly as your doctor has instructed. Myfortic will only be prescribed by
doctors with experience in treating transplant patients. If you have any doubts, ask your doctor or pharmacist.

What dose to take
The recommended daily dose of Myfortic is 1440 mg (4 Myfortic 360 mg tablets). These are
taken in 2 separate doses of 720 mg each (2 Myfortic 360 mg tablets).
Take the tablets in the morning and evening.
The first dose of 720 mg will be administered within 72 hours of the transplant.

If you have severe kidney problems
The daily dose should not exceed 1440 mg (4 Myfortic 360 mg tablets).

Taking Myfortic
Swallow the tablets whole with a glass of water.
The tablets should not be broken or crushed.
Do not take any broken or divided tablets.
Treatment will continue as long as immunosuppression is necessary to prevent rejection of the
transplanted organ.

If you take more Myfortic than you should
If you have taken more Myfortic than you were told to take or if someone else has taken your
tablets, contact your doctor and go to hospital immediately. Medical treatment may be necessary. Bring
the tablets with you and show them to the doctor or hospital staff. If you have finished the
tablets, bring 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 to
take your next dose. In that case, take your next dose when it is scheduled to be taken. Ask
your doctor for advice. Do not take a double dose to make up for a missed dose.

If you stop taking Myfortic
Do not stop taking Myfortic unless your doctor tells you to. Stopping
treatment with Myfortic may increase the risk of rejection of the transplanted kidney.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

7. 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 defense.
Immunosuppressants, including Myfortic, reduce the defense mechanisms of your body to prevent it from
rejecting your transplanted organ. Consequently, your body will not be able to defend itself against
infections as it normally would. Therefore, if you are taking Myfortic, you may get more infections than
usual such as infections of the brain, skin, mouth, stomach and intestines, lungs and the
urinary tract.
You will be regularly checked by your doctor with blood tests to monitor changes in the number of
blood cells or levels of substances carried in the blood, such as sugar, fats and cholesterol.

Some side effects can be serious:

• signs of infection including fever, chills, sweating, feeling tired, sleepy or lacking energy. If you are taking Myfortic you may have viral, bacterial and fungal infections more frequently than usual. These infections can affect different parts of the body but most commonly the kidneys, bladder, upper and/or lower airways.
• vomiting blood, black or bloody stools, stomach or intestinal ulcer.
• swelling of the glands, growth of new skin formations, increase in the size of existing formations or changes in an existing formation. As can happen in patients treated with immunosuppressants, a very small number of patients treated with Myfortic have developed skin or lymph node tumors. If you have experienced any of the above side effects after taking Myfortic, contact your doctor immediately.

Other side effects can include:
Very common( affects more than 1 in 10 people)

• low levels of white blood cells.
• low levels of calcium in the blood (hypocalcemia)
• low levels of potassium in the blood (hypokalaemia)
• high levels of uric acid in the blood (hyperuricemia)
• high blood pressure (hypertension)
• anxiety
• diarrhoea
• joint pain (arthralgia)

Common( affects less than 1 in 10 people)

• low levels of red blood cells which can cause tiredness, shortness of breath and paleness (anaemia)
• low levels of platelets in the blood which can cause bleeding and unexpected bruising (thrombocytopenia)
• high levels of potassium in the blood (hyperkalaemia)
• low levels of magnesium in the blood (hypomagnesaemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnoea)
• pain in the abdomen or stomach, inflammation of the stomach wall, abdominal bloating, constipation, dyspepsia, flatulence, loose stools, nausea, vomiting
• tiredness, fever
• abnormal results of liver and kidney function tests
• respiratory infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of the hands, ankles or feet (peripheral oedema)
• itching

Uncommon( affects less than 1 in 100 people)

• fast (tachycardia) or irregular (ventricular extrasystoles) heartbeat, fluid in the lungs (pulmonary oedema)
• skin formation similar to a cyst containing fluid (lymphocele)
• tremor, difficulty falling asleep
• itching, redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• burping, difficulty breathing, intestinal blockage (ileus), ulceration of the lips, heartburn, change in tongue colour, dry mouth, inflammation of the gums, inflammation of the pancreas causing severe pain in the upper abdomen (pancreatitis), blockage of the salivary glands, inflammation of the inner wall of the abdomen (peritonitis)
• infection of the bones, blood and skin
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, bruising
• inflammation of the joints (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolaemia) or decreased levels of phosphates in the blood (hypophosphataemia)
• flu-like symptoms (such as tiredness, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, stiffness thirst or weakness
• abnormal dreams, feeling of disappointment
• inability to get or maintain an erection
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease)

Not known( frequency cannot be estimated from the available data)

• fever, sore throat, frequent infections (possible symptoms of lack of white blood cells in the blood) (agranulocytosis)
• skin rash, itching, hives, shortness of breath or difficulty breathing, wheezing or coughing, dizziness, lightheadedness, changes in level of consciousness, low blood pressure, with or without mild general itching, redness of the skin and swelling of the face/throat (symptoms of a severe allergic reaction)

Other side effects reported with medicines similar to Myfortic
Further side effects have been reported with the group of medicines to which Myfortic belongs:
inflammation of the colon (large intestine), inflammation of the stomach walls caused by
cytomegalovirus, formation of a lesion in the intestinal wall causing severe abdominal pain
with possibility of bleeding, gastric or duodenal ulcer, low levels of white blood cells specifically
or of all blood cells, serious infections such as inflammation of the heart and heart valves and the
membranes lining the brain and spinal cord (shortness of breath, cough that may be caused by
bronchiectasis (a condition in which the airways of the lungs are abnormally dilated) and other
less common bacterial infections that usually cause serious lung disorders ( tuberculosis and infections

from atypical mycobacteria). Contact your doctor if you have a persistent cough or shortness of breath.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

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 packaging. The expiry date refers
to the last day of the month.
This medicine does not require any particular storage temperature.
Store Myfortic in the original package to protect the medicine from moisture.
Do not use Myfortic if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Myfortic contains

• The active ingredient is mycophenolic acid (as mycophenolate sodium). Each Myfortic tablet contains 360 mg of mycophenolic acid.
• The excipients are:
• Tablet core: corn starch, povidone, crospovidone, lactose, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Myfortic and package contents
Myfortic 360 mg gastroresistant tablets are pale orange-red in color, film-coated, oval in shape and with “CT” imprinted on one side.
Myfortic 360 mg gastroresistant tablets are available in blisters in packs containing 50, 100, 120 or
250 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy

Manufacturer
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D
Lendava, 9220
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following name:
Myfortic:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden, Hungary.

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (http://www.aifa.gov.it/)