ACIDO 180 mg Tabletki Powlekane

Treść ulotki

1. Mycophenolic Acid Accord 180 mg gastro-resistant tablets
   1. What is Acido micofenolico Accord and what is it used for
   2. What you need to know before you take Acido micofenolico Accord
   3. How to take Acido micofenolico Accord
   4. Possible side effects
   5. How to store Acido micofenolico Accord
   6. Package Contents and Other Information
2. Mycophenolic Acid Accord 360 mg gastro-resistant tablets
   1. What is Acido micofenolico Accord and what is it used for
   2. What you need to know before you take Acido micofenolico Accord
   3. How to take Acido micofenolico Accord
   4. Possible side effects
   5. How to store Acido micofenolico Accord
   6. Package contents and other information

Mycophenolic Acid Accord 180 mg gastro-resistant tablets

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Acido micofenolico Accord and what is it used for

Acido micofenolico Accord contains a substance called mycophenolic acid. It belongs to a
group of medicines called immunosuppressants.
Acido micofenolico Accord is used to prevent rejection of the transplanted kidney by the body's
immune system. It is used in combination with other medicines containing cyclosporine and corticosteroids.

2. What you need to know before you take Acido micofenolico Accord

WARNING
Mycophenolic acid causes congenital defects and miscarriage. If you are a woman who is able to become pregnant, you must
have a negative pregnancy test before starting treatment and follow your doctor's advice regarding contraception.
The doctor will talk to you and give you written information, especially about the effects of mycophenolic acid
on the unborn child. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking
mycophenolate. Also read the information within this paragraph under the headings “Warnings and precautions” and
“Pregnancy and breastfeeding”.

Do not take Acido micofenolico Accord

• 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 who is able to become pregnant and have not had a negative pregnancy test before your first prescription, as mycophenolate causes congenital defects and miscarriage.
• if you are pregnant, if you suspect you are pregnant or are planning to become pregnant.
• if you are not using an effective method of contraception (see “Contraception in women and men”).
• if you are breastfeeding (see also “Pregnancy, breastfeeding and fertility”).

If any of these conditions apply to you, tell your doctor before taking Acido micofenolico Accord.

Warnings and precautions
Tell your doctor, pharmacist or nurse before you take Acido micofenolico Accord:

• 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:

• Acido micofenolico Accord reduces the level of skin protection from the sun. This increases the risk of skin cancer. You should limit your exposure to the sun and ultraviolet (UV) rays, protecting the exposed skin 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 had hepatitis B or C, Acido micofenolico Accord may increase the risk of these diseases by causing them to reappear. The 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.
• The doctor may ask to check the levels of antibodies in your blood during treatment with Acido micofenolico Accord, especially when infections are recurrent, especially if you are also taking other immunosuppressants, and will tell you if you can continue treatment with Acido micofenolico Accord.
• 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.
• The doctor may ask to check the levels of white blood cells during treatment with Acido micofenolico Accord and will tell you if you can continue treatment with Acido micofenolico Accord.
• 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 Acido micofenolico Accord during pregnancy can be harmful to the fetus (see also “Pregnancy and breastfeeding”) and may increase the risk of pregnancy loss (miscarriage).

Other medicines and Acido micofenolico Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
In particular, you should 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 mycophenolic acid and for at least 6 weeks after
stopping treatment. Men should not donate sperm during treatment with mycophenolic acid and for at least 90 days after
stopping treatment.

Acido micofenolico Accord with food and drink and alcohol
Acido micofenolico Accord 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 ensures you absorb
the same amount of medicine each day.

Elderly patients
Elderly people (aged 65 years or older) can take Acido micofenolico Accord without
needing to adjust the usual recommended dose.

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

Pregnancy and breastfeeding and fertility
Contraception in women taking Acido micofenolico Accord
If you are a woman who is able to become pregnant, you must use an effective method of contraception with Acido
micofenolico Accord. This means:

• Before starting to take Acido micofenolico Accord
• During the entire treatment with Acido micofenolico Accord
• For 6 weeks after stopping treatment with Acido micofenolico Accord. Talk to your doctor about the most suitable method of contraception for you. This will depend on your individual situation. Two methods of contraception are preferable to reduce the risk of unwanted pregnancies. Contact your doctor as soon as possible if you think the contraceptive used maynot have been effectiveor if you have forgotten to take your contraceptive pill.

You are a woman who is unable to become pregnant if any of the following conditions apply to you:

• You are postmenopausal, i.e. you are at least 50 years old and your last menstrual period was more than a year ago (if your menstrual cycle has stopped because you have undergone cancer treatment, 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 no longer function (premature ovarian failure, which has been confirmed by a gynecologist).
• 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 Acido micofenolico Accord
Available evidence does not indicate an increased risk of birth defects or miscarriage if the father
is taking mycophenolate. However, a risk cannot be completely ruled out. As a precaution, it is
recommended that you or your female partner use reliable methods of contraception during treatment
and for 90 days after stopping therapy with Acido micofenolico Accord.
If you are planning a pregnancy, your doctor will explain the risks

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine. The doctor will discuss with you
the risks in case of pregnancy and alternative treatments you can undergo to prevent rejection of the transplanted organ if:

• You are planning a pregnancy.
• You miss or think you have missed a menstrual period, if you have unusual menstrual bleeding or if you suspect you are pregnant.
• You have had unprotected sexual intercourse without using an effective method of contraception. If you become pregnant during treatment with mycophenolic acid, you should tell your doctor immediately. In any case, continue to take Acido micofenolico Accord until you see your doctor.

Pregnancy
Mycophenolic acid very frequently causes miscarriage (50%) and serious birth defects (23-27%) in the unborn child.
Reported birth defects include abnormalities of the ears, eyes, face
(cleft lip/palate), finger development, heart, esophagus (the tubular organ that connects the throat
and stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not
perfectly developed)). The baby may have one or more of these defects.
If you are a woman who is able to become pregnant, you must have a negative pregnancy test before
starting treatment and follow your doctor's advice regarding contraception. The doctor may
request more than one test to make sure you are not pregnant before starting treatment.

Breastfeeding
Do not take Acido micofenolico Accord if you are breastfeeding. Small amounts of medicine
can pass into breast milk.

Driving and using machines
Acido micofenolico Accord moderately impairs the ability to drive and operate machinery.

Acido micofenolico Accord contains sodium
This medicine contains 0.61 mmol (13.9 mg) of sodium per tablet. This should be taken into consideration
in patients on a low-sodium diet.

3. How to take Acido micofenolico Accord

Take this medicine following exactly the instructions of your doctor.
Acido micofenolico Accord will only be prescribed to you by a doctor specializing in the treatment of
transplant patients.
If you have any doubts, consult your doctor or pharmacist or nurse.

What dose to take
The recommended daily dose of Acido micofenolico Accord is 1440 mg (8 tablets of 180 mg). These
are taken in 2 separate doses of 720 mg each (4 tablets of 180 mg).
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 tablets of 180 mg).

Taking Acido micofenolico Accord
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take broken or split tablets.
Treatment will continue as long as immunosuppression is necessary to prevent your body from rejecting
the transplanted organ.

If you take more Acido micofenolico Accord than you should
If you have taken more Acido micofenolico Accord 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 your doctor or hospital staff. If you
have finished the tablets, bring the empty package with you.

If you forget to take Acido micofenolico Accord
If you forget to take Acido micofenolico Accord, take it as soon as you remember unless it is
almost time to take the next dose. At that point, take the next dose at the usual time. Ask
your doctor for advice. Do not take a double dose to make up for a missed dose.

If you stop taking Acido micofenolico Accord
Do not stop taking Acido micofenolico Accord unless you are told to do so by your doctor.
Stopping treatment with Acido micofenolico Accord may increase the risk that your body rejects
your transplanted kidney.
If you have any doubts about the use of this medicine, consult 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 defense.
Immunosuppressants, including Acido micofenolico Accord, reduce the defense mechanisms by which your
body rejects the organ that has been transplanted. Consequently, your body will not be able to defend itself
against infections as it normally would. Therefore, if you are taking Acido micofenolico Accord, you may get
more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, the
lung and the urinary tract. You will be regularly checked by your doctor with blood tests to monitor
changes in the number of your blood cells or the levels of substances transported in your 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 Acido micofenolico Accord you may be more likely than normal to contract viral, bacterial or fungal infections. These infections can involve different parts of the body but the parts most commonly affected are the kidneys, bladder, upper and/or lower respiratory tract.
• vomiting blood, black or bloody stools, stomach or intestinal ulcer.
• swelling of your glands, development of new skin growths, increase in the size of existing growths or changes to an existing growth. As can happen in patients treated with immunosuppressants, a very small number of patients treated with Acido micofenolico Accord have developed skin or lymph node tumors.

If you experience any of the above side effects after taking Acido micofenolico Accord, contact your doctor immediately.

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

• diarrhea
• 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)
• joint pain (arthralgia)
• anxiety

Common( may affect up to 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 lead to bleeding and unexpected bruising (thrombocytopenia)
• headache
• cough
• abdominal or stomach pain, inflammation of the inner lining of the stomach, abdominal bloating, constipation, dyspepsia, flatulence, loose stools, feeling unwell (nausea), discomfort (vomiting)
• tiredness, fever
• abnormal results of liver and kidney function tests
• respiratory infections
• high levels of potassium in the blood (hyperkalaemia)
• low levels of magnesium in the blood (hypomagnesaemia)
• dizziness
• low blood pressure (hypotension)
• shortness of breath (dyspnea)
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of the hands, ankles or feet (peripheral edema)
• itching.

Uncommon( may affect up to 1 in 100 people)

• fast or irregular heartbeat (tachycardia or ventricular extrasystoles), fluid in the lungs (pulmonary edema)
• skin formation similar to a sac (cyst) containing fluid (lymphocele)
• tremor, difficulty sleeping
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• burping, bad breath, blockage of the intestines (ileus), ulceration of the lips, heartburn, change in the color of the tongue, dry mouth, inflammation of the gums, inflammation of the pancreas causing severe pain in the upper part of the stomach (pancreatitis), blockage of the salivary glands, inflammation of the inner lining of the abdomen (peritonitis)
• infection of the bones, blood and skin
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, bruising of the skin
• inflammation of the joints (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolemia) or decreased levels of phosphates in the blood (hypophosphataemia)
• flu-like symptoms (such as tiredness, chills, sore throat, joint or muscle pain), swelling of the ankles and feet, pain, stiffness, thirst or weakness
• strange dreams, belief that things are not real (illusions)
• 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)

• skin rash
• fever, sore throat, frequent infections which are possible symptoms of a deficiency of white blood cells (agranulocytosis)

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

atypical). Tell your doctor if you develop a persistent cough or shortness of breath.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist or nurse. You can also report side effects directly
through
Website:
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 Acido micofenolico Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the medicines that you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What contains Acido micofenolico Accord
The active ingredient is mycophenolic acid (as sodium mycophenolate).
Each tablet contains 180 mg of mycophenolic acid.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30
(E1201), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b)
Tablet coating: methacrylic acid – ethyl acrylate copolymer (1:1), talc (E553b), titanium dioxide
(E171), triethyl citrate (E1505), anhydrous colloidal silica (E551), sodium bicarbonate (E500), yellow iron oxide
(E172), indigotine, aluminium lake (E132), Sodium lauryl sulfate (E487).
Impressions on the tablet: partially esterified shellac (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527)

Description of the appearance of Acido micofenolico Accord and contents of the pack
Acido micofenolico Accord are enteric-coated tablets, round in shape, greenish
yellow in colour, biconvex, with beveled edges imprinted with “M1” on one side in black and smooth on the other side.
Acido micofenolico Accord 180 mg gastroresistant tablet is available in blisters in packs containing
20, 50, 100, 120 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
STADA Arzneimittel AG
Stadastraße2-18
61118 Bad Vilbel
Germany
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

Mycophenolic Acid Accord 360 mg gastro-resistant tablets

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 7. What is Mycophenolic Acid Accord and what it is used for
• 8. What you need to know before you take Mycophenolic Acid Accord
• 9. How to take Mycophenolic Acid Accord
• 10. Possible side effects
• 11. How to store Mycophenolic Acid Accord
• 12. Contents of the pack and other information

1. What is Acido micofenolico Accord and what is it used for

Acido micofenolico Accord contains a substance called mycophenolic acid. It belongs to a
group of medicines called immunosuppressants.
Acido micofenolico Accord is used to prevent the rejection of a transplanted kidney by the body's
immune system. It is used in combination with other medicines containing ciclosporin and corticosteroids.

2. What you need to know before you take Acido micofenolico Accord

WARNING
Mycophenolic acid causes congenital defects and miscarriage. If you are a woman who can become pregnant, you must
have a negative pregnancy test result before starting treatment and follow your doctor's advice regarding
contraception.
The doctor will talk to you and give you written information, especially about the effects of mycophenolic acid
on the unborn child. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking
mycophenolate. Also read the information within this paragraph under "Warnings and precautions" and
"Pregnancy and breastfeeding".

Do not take Acido micofenolico Accord

• 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 who can become pregnant and have not had a negative pregnancy test before your first prescription, as mycophenolate causes congenital defects and miscarriage.
• if you are pregnant, if you suspect you are pregnant or are planning to become pregnant.
• if you are not using an effective method of contraception (see "Contraception in women and men”).
• if you are breastfeeding (see also “Pregnancy, breastfeeding and fertility”).

If any of these conditions apply to you, tell your doctor before taking Acido micofenolico Accord.

Warnings and precautions
Tell your doctor or pharmacist or nurse before you take Acido micofenolico Accord:

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

You should also be informed that:

• Acido micofenolico Accord reduces the level of skin protection from the sun. This increases the risk of skin cancer. You should limit exposure to the sun and ultraviolet (UV) rays, protecting the skin as much as possible and regularly applying high-protection sun creams. Ask your doctor for advice on how to protect yourself from the sun.
• If you have already had hepatitis B or C, Acido micofenolico Accord may increase the risk of these diseases by causing them to reappear. The 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.
• The doctor may ask to check the levels of antibodies in your blood during treatment with Acido micofenolico Accord, especially when infections are recurrent, especially if you are also taking other immunosuppressants, and will tell you if you can continue treatment with Acido micofenolico Accord.
• 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.
• The doctor may ask to check your white blood cell counts during treatment with Acido micofenolico Accord and will tell you if you can continue treatment with Acido micofenolico Accord.
• 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 Acido micofenolico Accord during pregnancy can be harmful to the fetus (see also “Pregnancy and breastfeeding”) and may increase the risk of pregnancy loss (miscarriage).

Other medicines and Acido micofenolico Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
In particular, you should 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 mycophenolic acid and for at least 6 weeks after
stopping treatment. Men should not donate sperm during treatment with mycophenolic acid and for at least 90 days after
stopping treatment.

Acido micofenolico Accord with food and drink and alcohol
Acido micofenolico Accord 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.

Elderly patients
Elderly people (aged 65 years or older) can take Acido micofenolico Accord without
needing to adjust the usual recommended dose.

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

Pregnancy and breastfeeding and fertility
Contraception in women taking Acido micofenolico Accord
If you are a woman who can become pregnant, you must use an effective method of contraception with Acido
micofenolico Accord. This means:

• Before starting to take Acido micofenolico Accord
• During the entire treatment with Acido micofenolico Accord
• For 6 weeks after stopping treatment with Acido micofenolico Accord. Talk to your doctor about the most suitable method of contraception for you. This will depend on your individual situation. Two methods of contraception are preferable to reduce the risk of unwanted pregnancies. Contact your doctor as soon as possible if you think the contraceptive used maynot have been effectiveor if you have forgotten to take your contraceptive pill.

You are a woman who is unable to become pregnant if any of the following conditions apply to you:

• You are postmenopausal, i.e. you are at least 50 years old and your last menstrual period was more than a year ago (if your menstrual cycle has stopped because you have undergone cancer treatment, 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 no longer function (premature ovarian failure, which has been confirmed by a gynecologist).
• You were born with one of the following 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 Acido micofenolico Accord
Available evidence does not indicate an increased risk of birth defects or miscarriage if the father
takes mycophenolate. However, a risk cannot be completely ruled out. As a precaution, it is
recommended that you or your female partner use reliable methods of contraception during treatment
and for 90 days after stopping therapy with Acido micofenolico Accord.
If you are planning a pregnancy, your doctor will explain the risks and alternative treatments you can undergo
to prevent rejection of the transplanted organ.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine. The doctor will discuss with you the
risks in case of pregnancy and alternative treatments you can undergo to prevent rejection of the transplanted organ if:

• You are planning a pregnancy.
• You miss or think you have missed a menstrual period, if you have unusual menstrual bleeding or if you suspect a pregnancy.
• You have had unprotected sex without using an effective method of contraception. If you become pregnant during treatment with mycophenolic acid, you should tell your doctor immediately. In any case, continue to take Acido micofenolico Accord until you see your doctor.

Pregnancy
Mycophenolic acid very frequently causes miscarriage (50%) and serious birth defects (23-27%) in the unborn child.
Reported birth defects include abnormalities of the ears, eyes, face
(cleft lip/palate), finger development, heart, esophagus (the tubular organ that connects the throat
and stomach), kidneys and nervous system (e.g. spina bifida (where the bones of the spine are not
perfectly developed)). The baby may have one or more of these defects.
If you are a woman who can become pregnant, you must have a negative pregnancy test result before
starting treatment and follow your doctor's advice regarding contraception. The doctor may
require more than one test to make sure you are not pregnant before starting treatment.

Breastfeeding
Do not take Acido micofenolico Accord if you are breastfeeding. Small amounts of medicine
can pass into breast milk.

Driving and using machines
Acido micofenolico Accord moderately impairs the ability to drive and operate machines.

Acido micofenolico Accord contains sodium
This medicine contains 1.21 mmol (27.9 mg) of sodium per tablet. This should be taken into consideration
in patients on a low-sodium diet.

3. How to take Acido micofenolico Accord

Take this medicine following exactly the instructions of your doctor.
Acido micofenolico Accord will only be prescribed to you by a doctor specializing in the treatment of
transplant patients.
If you have any doubts, consult your doctor or pharmacist or nurse.

What dose to take
The recommended daily dose of Acido micofenolico Accord is 1440 mg (4 tablets of 360 mg). These
are taken in 2 separate doses of 720 mg each (2 tablets of 360 mg).
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 tablets of 360 mg).

Taking Acido micofenolico Accord
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets. Do not take broken or split tablets.
Treatment will continue as long as immunosuppression is necessary to prevent your body from rejecting
the transplanted organ.

If you take more Acido micofenolico Accord than you should
If you have taken more Acido micofenolico Accord 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 your doctor or hospital staff. If you have
finished the tablets, bring the empty package with you.

If you forget to take Acido micofenolico Accord
If you forget to take Acido micofenolico Accord, take it as soon as you remember unless it is
almost time to take the next dose. At that point, take the next dose at the usual time. Ask
your doctor for advice. Do not take a double dose to make up for a missed dose.

If you stop taking Acido micofenolico Accord
Do not stop taking Acido micofenolico Accord unless you have been told to do so by your doctor.
Stopping treatment with Acido micofenolico Accord may increase the risk that your body rejects
your transplanted kidney.
If you have any doubts about using this medicine, consult 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 defense.
Immunosuppressants, including Mycophenolic Acid Accord, reduce the defense mechanisms by which your
body rejects the organ that has been transplanted. Consequently, your body will not be able to defend itself
against infections as it normally would. Therefore, if you are taking Mycophenolic Acid Accord, 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
cells in your blood or the levels of substances carried in your 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 Mycophenolic Acid Accord you may be more prone to contracting viral, bacterial or fungal infections than normal. Such infections can involve different parts of the body but the most commonly affected parts are the kidneys, bladder, upper and/or lower respiratory tract.
• vomiting blood, black or bloody stools, stomach or intestinal ulcer.
• swelling of your glands, development of new skin growths, increase in the size of existing growths or changes to an existing growth. As can happen in patients treated with immunosuppressants, a very small number of patients treated with Mycophenolic Acid Accord have developed skin or lymph node tumors.

If you experience any of the above side effects after taking Mycophenolic Acid Accord, contact your doctor immediately.

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

• diarrhea
• 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 (hyperuricaemia)
• high blood pressure (hypertension)
• joint pain (arthralgia)
• anxiety

Common( may affect up to 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 lead to bleeding and unexpected bruising (thrombocytopenia)
• headache
• cough
• abdominal or stomach pain, inflammation of the inner lining of the stomach, abdominal bloating, constipation, dyspepsia, flatulence, loose stools, feeling unwell (nausea), discomfort (vomiting)
• tiredness, fever
• abnormal results of liver and kidney function tests
• respiratory infections
• high levels of potassium in the blood (hyperkalaemia)
• low levels of magnesium in the blood (hypomagnesaemia)
• dizziness
• low blood pressure (hypotension)
• shortness of breath (dyspnea)
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of the hands, ankles or feet (peripheral oedema)
• itching.

Uncommon( may affect up to 1 in 100 people)

• fast (tachycardia) or irregular (ventricular extrasystoles) heartbeat, fluid in the lungs (pulmonary oedema)
• skin formation similar to a sac (cyst) containing fluid (lymphocele)
• tremor, difficulty falling asleep
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• burping, bad breath, blockage of the intestine (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 lining of the abdomen (peritonitis)
• infection of the bones, blood and skin
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, bruising of the skin
• 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
• flu-like symptoms (such as tiredness, chills, sore throat, joint or muscle pain), swelling of the ankles and feet, pain, stiffness, thirst or weakness
• strange dreams, belief that things are not real (illusions)
• 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)

• skin rash
• fever, sore throat, frequent infections which are possible symptoms of a deficiency of white blood cells in the blood (agranulocytosis).

Other side effects reported with medicines similar to Mycophenolic Acid Accord
Further side effects have been reported with the group of medicines to which Mycophenolic Acid Accord belongs: inflammation of the colon (large intestine), inflammation of the inner walls of the stomach caused by cytomegalovirus, formation of a lesion in the intestinal wall causing severe abdominal pain with possible bleeding, gastric or duodenal ulcer, low levels of specific white blood cells or of all other blood cells, serious infections such as inflammation of the heart and its valves and the membranes lining the brain and spinal cord, shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways in the lungs are abnormally dilated) and other less common bacterial infections that usually lead to serious lung disorders (tuberculosis and mycobacterial infections). Tell your doctor if you develop 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 or nurse. You can also report side effects directly through
Website:
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 Acido micofenolico Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after Expiry. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What contains Acido micofenolico Accord
The active ingredient is mycophenolic acid (as sodium mycophenolate).
Each tablet contains 360 mg of mycophenolic acid.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30
(E1201), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b)
Tablet coating: methacrylic acid – ethyl acrylate copolymer (1:1), talc (E553b), titanium dioxide
(E171), triethyl citrate (E1505), anhydrous colloidal silica (E551), sodium bicarbonate (E500), yellow iron oxide
(E172), red iron oxide (E172), Sodium lauryl sulfate (E487).
Impressions on the tablet: partially esterified shellac (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527).

Description of the appearance of Acido micofenolico Accord and package contents
Acido micofenolico Accord are enteric-coated tablets, oblong in shape, peach-colored,
biconvex, imprinted with “M2” on one side in black and smooth on the other side.
Acido micofenolico Accord 360 mg gastroresistant tablet is available in blisters in packs containing
50, 100, 120 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
STADA Arzneimittel AG
Stadastraße2-18
61118 Bad Vilbel
Germany
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece