Mycophenolic acid Accord

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mycophenolic Acid Accord 180 mg gastro-resistant tablets

Generic Medicine
Please read this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Mycophenolic Acid Accord is and what it is used for
2. What you need to know before taking 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 Acido micofenolico Accord is and what it is used for

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

2. What you need to know before taking Mycophenolic Acid Accord

WARNING
Mycophenolic acid causes birth defects and miscarriage. If you are a woman of childbearing potential, you must
have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception.
Your doctor will discuss with you and provide written information, particularly about the effects of mycophenolic acid
on the unborn child. Read this 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 provided within this section under “Warnings and precautions” and
“Pregnancy and breastfeeding”.
Do not take Mycophenolic Acid 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 of childbearing potential and have not had a negative pregnancy test before the first prescription, as mycophenolate causes birth defects and miscarriage.
• if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• 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, inform your doctor and do not take Mycophenolic Acid Accord.
Warnings and precautions
Inform your doctor, pharmacist, or nurse before taking Mycophenolic Acid Accord:

• if you have or have ever had severe gastrointestinal disorders, such as gastric ulcer
• if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

You should also be aware that:

• Mycophenolic Acid Accord reduces the skin’s natural protection from sunlight. This increases the risk of skin cancer. You must limit exposure to sunlight and ultraviolet (UV) radiation by protecting exposed skin as much as possible and regularly applying high-protection sunscreen. Ask your doctor for advice on sun protection.
• If you have previously had hepatitis B or C, Mycophenolic Acid Accord may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these conditions. If you develop any symptoms (yellowing of eyes or skin, nausea, loss of appetite, dark urine), inform your doctor immediately.
• If you develop a persistent cough or shortness of breath, especially while taking other immunosuppressants, you must inform your doctor immediately.
• Your doctor may request periodic blood tests to monitor antibody levels during treatment with Mycophenolic Acid Accord, particularly if you experience recurrent infections, especially if you are also taking other immunosuppressants, and will inform you whether you can continue treatment.
• If you show signs of infection (such as fever or sore throat) or experience unexpected bruising or bleeding, inform your doctor immediately.
• Your doctor may request periodic monitoring of white blood cell counts during treatment with Mycophenolic Acid Accord and will inform you whether you can continue treatment.
• The active substance, mycophenolic acid, is different from that in other medicines with similar names, such as mycophenolate mofetil. Do not switch from one medicine to another unless instructed by your doctor.
• Use of Mycophenolic Acid Accord during pregnancy may harm the fetus (see also “Pregnancy and breastfeeding”) and may increase the risk of pregnancy loss (miscarriage).

Children and adolescents
Due to lack of data, use of Mycophenolic Acid Accord is not recommended in children and adolescents.
Elderly patients
Elderly people (aged 65 years or older) can take Mycophenolic Acid Accord without the need to adjust the usual recommended dose.
Other medicines and Mycophenolic Acid Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• other immunosuppressive medicines such as azathioprine or tacrolimus.
• medicines used to treat high cholesterol levels in the blood, such as colestyramine.
• activated charcoal used to treat gastrointestinal disorders such as diarrhoea, stomach upset, and bloating.
• antacids containing magnesium and aluminium.
• medicines used to treat viral infections such as aciclovir or ganciclovir.

You should also inform your doctor if you intend to receive any vaccination.
You must not donate blood during treatment with mycophenolic acid and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment with mycophenolic acid and for at least 90 days after stopping treatment.
Mycophenolic Acid Accord with food and drink and alcohol
Mycophenolic Acid Accord may be taken with or without food. You should choose whether to take the tablets with or without food and then continue taking them the same way every day. This ensures you absorb the same amount of medicine each day.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks associated with pregnancy and alternative treatments you may consider to prevent organ transplant rejection if:

• You are planning a pregnancy.
• You miss or think you may have missed a menstrual period, have unusual menstrual bleeding, or suspect you are pregnant.
• You have had sexual intercourse without using an effective method of contraception. If you become pregnant while taking mycophenolic acid, inform your doctor immediately. In any case, continue taking Mycophenolic Acid Accord until you have seen 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), fingers, heart, oesophagus (the tube connecting the throat and stomach), kidneys, and nervous system (e.g. spina bifida (where the bones of the spine are not fully developed)). The baby may have one or more of these defects.
If you are a woman of childbearing potential, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Mycophenolic Acid Accord if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Contraception in women taking Mycophenolic Acid Accord
If you are a woman of childbearing potential, you must use an effective method of contraception while taking Mycophenolic Acid Accord. This means:

• Before starting Mycophenolic Acid Accord
• Throughout the entire treatment period with Mycophenolic Acid Accord
• For 6 weeks after stopping treatment with Mycophenolic Acid Accord. Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your individual circumstances. Two contraceptive methods are preferred to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you forgot to take your contraceptive pill.

You are considered a woman who is not able 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 over a year ago (if your menstrual cycle stopped due to cancer treatment, you may still be able to become pregnant).
• Both fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• The uterus has been surgically removed (hysterectomy).
• Your ovaries no longer function (premature ovarian failure, confirmed by a gynaecology specialist).
• 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 Mycophenolic Acid Accord
Available evidence does not indicate an increased risk of malformations 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 contraceptive methods during treatment and for 90 days after stopping therapy with Mycophenolic Acid Accord.
If you are planning a pregnancy, your doctor will explain the risks to you
Driving and using machines
Mycophenolic Acid Accord may have a moderate effect on the ability to drive vehicles or use machines.
Mycophenolic Acid Accord contains sodium
This medicine contains 13.9 mg of sodium (a key component of household/table salt) in each tablet. This corresponds to 0.7% of the maximum daily recommended intake of sodium for an adult.

3. How to take Mycophenolic Acid Accord

Take this medicine exactly as prescribed by your doctor.
Mycophenolic Acid Accord will only be prescribed by a doctor specialized in treating transplant patients.
If you have any doubts, consult your doctor, pharmacist, or nurse.

What dose to take
The recommended daily dose of Mycophenolic Acid Accord is 1440 mg (8 tablets of 180 mg). This is taken as two separate doses of 720 mg each (4 tablets of 180 mg).
Take the tablets in the morning and in the evening.
The first 720 mg dose will be administered within 72 hours after transplantation.

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

How to take Mycophenolic Acid Accord
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take broken or divided tablets.
Treatment will continue for as long as immunosuppression is needed to prevent your body from rejecting the transplanted organ.

If you take more Mycophenolic Acid Accord than you should
If you have taken more Mycophenolic Acid Accord than prescribed, 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 no tablets left, bring the empty packaging with you.

If you forget to take Mycophenolic Acid Accord
If you forget to take a dose of Mycophenolic Acid Accord, take it as soon as you remember, unless it is almost time for your next dose. In that case, take the 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 Accord
Do not stop taking Mycophenolic Acid Accord unless your doctor tells you to do so.
Stopping treatment with Mycophenolic Acid Accord may increase the risk of your body rejecting your transplanted kidney.

If you have any questions about the use of this medicine, ask your doctor, 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 reduced immune defences.
Immunosuppressants, including Mycophenolic acid Accord, reduce the defence mechanisms by which your body rejects the transplanted organ. As a result, your body will be less able to defend itself against infections than under normal conditions. Therefore, if you are taking Mycophenolic acid Accord, you may be more prone to infections than usual, such as infections of the brain, skin, mouth, stomach and intestine, lungs, and 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 your blood, such as sugar, fats, and cholesterol.

Some side effects can be serious:

• signs of infection including fever, chills, sweating, feeling tired, drowsy, or lacking energy. When taking Mycophenolic acid Accord, you may be more likely than normal to develop viral, bacterial, or fungal infections. These infections may affect various parts of the body, but the most commonly affected areas are the kidneys, bladder, and 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 size of existing growths, or changes in an existing growth. As may occur in patients receiving immunosuppressants, a very small number of patients treated with Mycophenolic acid Accord have developed skin cancer or lymph node tumours.

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

Other possible side effects include:

Very common (may affect more than 1 in 10 people)

• diarrhoea
• low levels of white blood cells
• low levels of calcium in the blood (hypocalcaemia)
• 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 may cause tiredness, shortness of breath, and paleness (anaemia)
• low levels of platelets in the blood which may lead to unexpected bleeding and bruising (thrombocytopenia)
• headache
• cough
• abdominal or stomach pain, inflammation of the inner lining of the stomach, abdominal swelling, constipation, indigestion, flatulence, soft stools, feeling unwell (nausea), malaise (vomiting)
• tiredness, fever
• abnormal results in 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 (dyspnoea)
• 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 heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• fluid-filled skin sac (cyst) containing lymph fluid (lymphocele)
• tremor, difficulty sleeping
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, bad breath, 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 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, skin bruising
• joint inflammation (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased levels of phosphate 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, feeling thirsty, or weakness
• strange dreams, belief that things are not real (illusions)
• inability to achieve or maintain an erection
• cough, breathing difficulty, painful breathing (possible symptoms of interstitial lung disease)

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

• fever, sore throat, frequent infections which may be symptoms of low white blood cell count (agranulocytosis)
• skin rash, itching, hives, shortness of breath or breathing difficulties, wheezing or cough, feeling of emptiness in the head, dizziness, changes in consciousness, hypotension, with or without mild generalized itching, skin redness, and swelling of the face/throat (symptoms of severe allergic reaction)

Other side effects reported with medicines similar to Mycophenolic acid Accord
Additional 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 stomach lining 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 blood cells, severe infections such as inflammation of the heart and its valves and of the membranes lining the brain and spinal cord, shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways of the lungs are abnormally widened) and other less common bacterial infections that usually lead to serious lung disorders (tuberculosis and atypical mycobacterial infections). Inform your doctor if you develop a persistent cough or shortness of breath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the 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 Mycophenolic acid Accord

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 packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido micofenolico Accord contains
The active substance is mycophenolic acid (as sodium mycophenolate).
Each tablet contains 180 mg of mycophenolic acid.
The other components 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)
Markings 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, round, yellowish-green, biconvex tablets with bevelled edges, marked with "M1" in black on one side and smooth on the other.
Acido micofenolico Accord 180 mg gastro-resistant tablet is available in blisters in pack sizes of 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,
The 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,
The Netherlands
STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

PATIENT INFORMATION LEAFLET

Mycophenolic Acid Accord 360 mg gastro-resistant tablets

Generic Medicine
Please read this entire 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

7. What Mycophenolic Acid Accord is and what it is used for
8. What you need to know before taking 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 Acido micofenolico Accord is and what it is used for

Acido micofenolico Accord contains a substance called mycophenolic acid. It belongs to a group of medicines known as 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 should know before taking Mycophenolic Acid Accord

WARNING
Mycophenolic acid causes birth defects and miscarriage. If you are a woman of childbearing potential, you must
have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception.
Your doctor will discuss with you and provide written information, particularly about the effects of mycophenolic acid
on the unborn child. Read this 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 provided in this section under “Warnings and precautions” and “Pregnancy and breastfeeding”.
Do not take Mycophenolic Acid 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 of childbearing potential and have not had a negative pregnancy test prior to the first prescription, as mycophenolate causes birth defects and miscarriage.
• if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• 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, inform your doctor before taking Mycophenolic Acid Accord.
Warnings and precautions
Inform your doctor, pharmacist, or nurse before taking Mycophenolic Acid Accord:

• if you have or have ever had severe gastrointestinal disorders, such as gastric ulcer.
• if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

You should also be aware that:

• Mycophenolic Acid Accord reduces the skin’s natural protection from sunlight. This increases the risk of skin cancer. You must limit exposure to sunlight and ultraviolet (UV) rays by protecting exposed skin areas as much as possible and regularly applying high-protection sunscreen. Ask your doctor for advice on how to protect yourself from the sun.
• If you have previously had hepatitis B or C, Mycophenolic Acid Accord may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these conditions. If you develop any symptoms (yellowing of eyes or skin, nausea, loss of appetite, dark urine), inform your doctor immediately.
• If you have a persistent cough or shortness of breath, especially while taking other immunosuppressants, you must inform your doctor immediately.
• Your doctor may request regular blood tests to monitor antibody levels during treatment with Mycophenolic Acid Accord, particularly if you experience recurrent infections, especially if you are also taking other immunosuppressants, and will inform you whether you can continue treatment with Mycophenolic Acid Accord.
• If you develop signs of infection (such as fever or sore throat) or experience unexpected bruising or bleeding, inform your doctor immediately.
• Your doctor may request regular monitoring of white blood cell counts during treatment with Mycophenolic Acid Accord and will inform you whether you can continue treatment.
• The active substance, mycophenolic acid, is different from that of other medicines with similar names, such as mycophenolate mofetil. Do not switch from one medicine to another unless instructed by your doctor.
• Use of Mycophenolic Acid Accord during pregnancy may harm the fetus (see also “Pregn游戏副本

3. How to take Mycophenolic Acid Accord

Take this medicine exactly as your doctor has told you.
Mycofenolic Acid Accord will only be prescribed by a doctor experienced in managing transplant patients.
If you have any doubts, consult your doctor, pharmacist, or nurse.

What dose to take
The recommended daily dose of Mycophenolic Acid Accord is 1440 mg (4 tablets of 360 mg). This is taken as two separate doses of 720 mg each (2 tablets of 360 mg).
Take the tablets in the morning and in the evening.
The first 720 mg dose will be administered within 72 hours after transplantation.

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

How to take Mycophenolic Acid Accord
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets. Do not take broken or divided tablets.
Treatment will continue as long as immunosuppression is needed to prevent your body from rejecting the transplanted organ.

If you take more Mycophenolic Acid Accord than you should
If you have taken more Mycophenolic Acid 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 no tablets left, bring the empty packaging with you.

If you forget to take Mycophenolic Acid Accord
If you forget to take Mycophenolic Acid Accord, take it as soon as you remember, unless it is almost time for your next dose. In that case, 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 Accord
Do not stop taking Mycophenolic Acid Accord unless your doctor tells you to.
Stopping treatment with Mycophenolic Acid Accord may increase the risk that your body rejects your transplanted kidney.

If you have any questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Elderly patients may experience more side effects due to reduced immune defences.
Immunosuppressants, including Mycophenolic Acid Accord, reduce the defence mechanisms your body uses to reject the transplanted organ. As a result, your body will not be able to defend itself from infections as effectively as under normal conditions. Therefore, if you are taking Mycophenolic Acid Accord, you may be more prone to infections than usual, such as infections of the brain, skin, mouth, stomach and intestine, lungs, and urinary tract. You will be regularly monitored by your doctor through blood tests to check for changes in the number of blood cells or 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, drowsiness, or lack of energy. While taking Mycophenolic Acid Accord, you may be more susceptible than normal to viral, bacterial, or fungal infections. These infections may affect various parts of the body, but the most commonly affected areas are the kidneys, bladder, and 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 size of existing growths, or changes in existing growths. As may occur in patients treated with immunosuppressants, a very small number of patients treated with Mycophenolic Acid Accord have developed skin cancer or lymph node tumours.

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

Other possible side effects include:

Very common (may affect more than 1 in 10 people)

• diarrhoea
• low levels of white blood cells
• low levels of calcium in the blood (hypocalcaemia)
• 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 may cause tiredness, shortness of breath, and paleness (anaemia)
• low levels of platelets in the blood, which may lead to unexpected bleeding and bruising (thrombocytopenia)
• headache
• cough
• abdominal or stomach pain, inflammation of the inner lining of the stomach, abdominal swelling, constipation, dyspepsia, flatulence, loose stools, feeling unwell (nausea), malaise (vomiting)
• fatigue, fever
• abnormal results in 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 (dyspnoea)
• 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 heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• skin cyst containing fluid (lymph) (lymphocele)
• tremor, difficulty sleeping
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, bad breath, 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 stomach (pancreatitis), blockage of the salivary glands, inflammation of the inner lining of the abdomen (peritonitis)
• bone, blood, and skin infections
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, skin bruising
• inflammation of the joints (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased levels of phosphates in the blood
• flu-like symptoms (such as fatigue, 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 achieve or maintain an erection
• cough, breathing difficulty, painful breathing (possible symptoms of interstitial lung disease).

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

• fever, sore throat, frequent infections, which may be symptoms of low white blood cell count (agranulocytosis)
• skin rash, itching, hives, breathlessness or difficulty breathing, wheezing or cough, feeling of emptiness in the head, dizziness, changes in consciousness, hypotension, with or without mild generalized itching, skin redness, and swelling of the face/throat (symptoms of severe allergic reaction)

Other side effects reported with medicines similar to Mycophenolic Acid Accord
Additional 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 stomach lining 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, severe infections such as inflammation of the heart and its valves and of 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 widened) and other less common bacterial infections that usually lead to serious lung disorders (tuberculosis and atypical mycobacterial infections). Inform your doctor if you develop a persistent cough or shortness of breath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the 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 Mycophenolic Acid Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the
last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via 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 Acido micofenolico Accord contains
The active substance is mycophenolic acid (as sodium mycophenolate).
Each tablet contains 360 mg of mycophenolic acid.
The other components 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)
Tablet marking: partially esterified shellac (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527)

Description of the appearance of Acido micofenolico Accord and the contents of the pack
Acido micofenolico Accord are enteric-coated, oblong, peach-coloured, biconvex tablets marked "M2" in black on one side and smooth on the other.
Acido micofenolico Accord 360 mg gastro-resistant 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,
The 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,
The Netherlands
STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece