Mycophenolate mofetil Accord: detailed information

Package leaflet: Information for the user

Mycophenolate Mofetil Accord 250 mg hard capsules

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any 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, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Mycophenolate Mofetil Accord is and what it is used for
What you need to know before taking Mycophenolate Mofetil Accord
How to take Mycophenolate Mofetil Accord
Possible side effects
How to store Mycophenolate Mofetil Accord
Contents of the pack and other information

1. What Micofenolato Mofetile Accord is and what it is used for

The full name of the medicine is Micofenolato Mofetile Accord 250 mg hard capsules.
Micofenolato Mofetile Accord 250 mg hard capsules belongs to a group of medicines called "immunosuppressants".
Micofenolato Mofetile Accord is used to prevent your body from rejecting a transplanted kidney, heart, or liver. Micofenolato Mofetile Accord must be given in combination with other medicines, such as ciclosporina and corticosteroids.

2. What you need to know before taking Mycophenolate Mofetil Accord

WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman of childbearing potential,
you must have a negative pregnancy test before starting treatment and must use the contraceptive method
recommended by your doctor.
Your doctor will explain and provide you with written information, particularly regarding the effects of mycophenolate on
unborn children. 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. See also further information in this section under "Warnings and precautions" and
"Pregnancy and breastfeeding".
Do not take Mycophenolate Mofetil Accord:

If you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6).
If you are a woman of childbearing potential and have not provided a negative pregnancy test before the first prescription, because mycophenolate causes birth defects and miscarriage.
If you are pregnant, planning pregnancy, or think you may be pregnant
If you are not using an effective contraceptive method (see Pregnancy, contraception and breastfeeding)
If you are breastfeeding.

Do not take this medicine if any of the above conditions apply to you. If you are unsure, consult your
doctor or pharmacist before taking Mycophenolate Mofetil.
Warnings and precautions
Contact your doctor immediately before starting treatment with Mycophenolate Mofetil Accord if:

you are over 65 years of age, as you may have a higher risk of developing adverse events such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients
you have signs of infection, such as fever or sore throat
you have any unexplained bruising or bleeding
you have ever had a gastrointestinal disorder, for example a stomach ulcer
you are planning a pregnancy or become pregnant while you or your partner are being treated with Mycophenolate Mofetil Accord.
you have an inherited enzyme deficiency, such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

If any of the above apply to you (or if you are in doubt), contact your doctor immediately before
taking Mycophenolate Mofetil Accord.
Effect of sunlight
Mycophenolate Mofetil Accord reduces the body's defences. As a result, there is an increased risk of
skin cancer. Limit your exposure to sunlight and ultraviolet rays. Do this by:

wearing protective clothing that covers the head, neck, arms, and legs, and by using sunscreen creams with a high protection factor.

Children
Do not administer this medicine to children under 2 years of age, because, based on limited safety and efficacy data in this age group, dose recommendations cannot be established.
Other medicines and Mycophenolate Mofetil Accord
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including those without a prescription, such as herbal remedies, because Mycophenolate Mofetil
Accord may affect how other medicines work, and other medicines may affect how Mycophenolate Mofetil Accord works.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before
starting Mycophenolate Mofetil Accord:

azathioprine or other medicines that suppress the immune system – administered after a transplant procedure
cholestyramine – used to treat high cholesterol levels
rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
antacids or proton pump inhibitors – used for stomach acid problems such as indigestion
phosphate binders – used in people with chronic kidney failure to reduce the amount of phosphate absorbed into the blood
antibiotics – used to treat bacterial infections
isavuconazole – used to treat fungal infections
telmisartan – used to treat high blood pressure

Vaccines
If you need to receive a vaccination (a live vaccine) during treatment with Mycophenolate Mofetil Accord,
consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you may receive.
You must not donate blood during treatment with Mycophenolate Mofetil and for at least 6 weeks after
stopping treatment. Men must not donate sperm during treatment with Mycophenolate
Mofetil and for at least 90 days after stopping treatment.
Mycofenolate Mofetil Accord with food and drinks:
Food and drink do not affect treatment with mycophenolate mofetil.
Pregnancy, contraception and breastfeeding:
Contraception in women taking Mycophenolate Mofetil
If you are a woman of childbearing potential, you must use an effective contraceptive method together with
Mycofenolate Mofetil. This includes:

Before starting Mycophenolate Mofetil
Throughout the entire treatment with Mycophenolate Mofetil
For 6 weeks after stopping Mycophenolate Mofetil
Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your individual situation. Using two contraceptive methods is preferable to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraception may not have been effective or if you have missed taking your contraceptive pill.

You cannot become pregnant if any of the following conditions apply:

You are post-menopausal, i.e. you are at least 50 years old and your last menstrual period was over a year ago (if your menstrual periods have stopped due to cancer treatment, you may still be able to become pregnant)
Your Fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy)
Your womb (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 started menstruating.

Contraception in men being treated with Mycophenolate Mofetil
Although available clinical data do not indicate an increased risk of birth defects or miscarriage if the
father is taking mycophenolate, the risk cannot be completely ruled out. As a precaution, you or your partner are advised to use a reliable contraceptive method during treatment and for 90
days after stopping Mycophenolate Mofetil.
If you are planning to have a child, talk to your doctor about potential risks and alternative therapies.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a
pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will explain the
risks during pregnancy and the alternative treatments available 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 pregnancy.
You have sexual intercourse without using effective contraceptive methods. If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue taking Mycophenolate Mofetil until your doctor advises otherwise.

Pregnancy
Mycophenolate causes a very high rate of miscarriage (50%) and severe 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 to the stomach), kidneys, and nervous system (e.g. spina bifida (where the bones of the spine are not properly developed)). Your baby may be affected by one or more of these.
If you are a woman of childbearing potential, you must have a negative pregnancy test before starting
treatment and must follow your doctor's advice on contraception. Your doctor may require more
than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Mycophenolate Mofetil Accord if you are breastfeeding. This is because small amounts of the medicine
can pass into breast milk.
Driving and using machines
Mycofenolate Mofetil Accord has a moderate effect on the ability to drive vehicles or operate tools or
machinery. If you feel drowsy, dizzy, or confused, contact your doctor or nurse and do not drive
or operate tools or machinery until you feel better.
Mycophenolate mofetil capsules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially "sodium-free".

3. How to take Micofenolato Mofetile Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The dose you take depends on the type of transplant you have received. The usual doses are described below. Treatment will continue for as long as necessary to prevent rejection of the transplanted organ.
Kidney transplant
Adults:

The first dose is administered within 3 days after transplantation surgery.
The daily dose is 8 capsules (2 g of medicine), divided into two separate doses.
Take 4 capsules in the morning and 4 capsules in the evening.

Children (aged between 2 and 18 years):

The dose to be administered will depend on the child's body surface area.
Your doctor will determine the most appropriate dosage based on your child’s height and weight (body surface area), measured in square meters or “m²”. The recommended dose is 600 mg/m² twice daily.

Heart transplant
Adults:

The first dose is administered within the first 5 days after transplantation surgery.
The daily dose is 12 capsules (3 g of medicine), taken in two separate doses.
Take 6 capsules in the morning and 6 capsules in the evening.

Children:

There is no available information regarding the use of mycophenolate mofetil in children undergoing heart transplantation.

Liver transplant
Adults:

The first oral dose of Micofenolato Mofetile Accord will be administered at least 4 days after transplantation and when you are able to take oral medication.
The daily dose is 12 capsules (3 g of medicine), taken in two separate doses.
Take 6 capsules in the morning and 6 capsules in the evening.

Children:

There is no available information regarding the use of mycophenolate mofetil in children with liver transplantation.

Dosage and method of administration

Swallow the capsules with a glass of water.
Do not break or crush the capsules, and do not take capsules that are broken or opened.
Take care to avoid contact between the powder leaking from damaged capsules and your eyes or mouth.
If this occurs, rinse thoroughly with running water.
Take care to avoid contact between the powder leaking from damaged capsules and your skin. If this occurs, wash the area thoroughly with soap and water.

If you take more Micofenolato Mofetile Accord than you should
If you take more Micofenolato Mofetile Accord than prescribed, inform a doctor or go to hospital immediately. Do the same if someone else accidentally takes your medicine. Take the medicine pack with you.
If you forget to take Micofenolato Mofetile Accord
If you forget to take your medicine at any time, take it as soon as you remember, then continue your treatment at the usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Micofenolato Mofetile Accord
Do not stop taking Micofenolato Mofetile Accord unless instructed by your doctor. Stopping treatment may increase the risk of rejection of the transplanted organ.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following serious side effects – you may need urgent
medical treatment:

you have signs of infection, such as fever or sore throat
you have any unexpected bruising or bleeding
you have a rash, swelling of the face, lips, tongue or throat, with difficulty breathing
- you may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema)

Common problems
Some of the more common problems include diarrhoea, lower numbers of white or red blood cells in the
blood, infections, and vomiting. Your doctor will carry out regular blood tests to monitor for any
changes:

in blood cell counts or signs of infection.

The likelihood of certain side effects is higher in children than in adults. These include diarrhoea,
infections, lower numbers of white blood cells, and lower numbers of red blood cells in the blood.
Fighting infections
Mycophenolate Mofetil Accord reduces your body’s defences. This is done to prevent transplant rejection. As a
result, your body will not be able to fight infections as effectively as usual. This means you may get more
infections than normal. These include infections affecting the brain, skin, mouth, stomach and intestines, lungs,
and urinary tract.
Tumours of lymphoid tissue and skin
As can occur in patients taking this type of medicine (immunosuppressants), a very small number of patients
treated with Mycophenolate Mofetil Accord have developed tumours of the lymphoid tissue and skin.
General side effects
You may experience general side effects affecting the whole body. These include severe allergic reactions
(such as anaphylaxis, angioedema), fever, extreme tiredness, sleep difficulties, pain (such as stomach, chest,
joint or muscle pain), headache, flu-like symptoms, and swelling.
Other side effects may include:
Skin problems such as:

acne, cold sores, shingles, skin overgrowth, hair loss, rashes, itching

Urinary problems such as:

blood in the urine

Digestive and mouth problems such as:

swollen gums and mouth ulcers,
inflammation of the pancreas, colon or stomach,
gastrointestinal disorders, including bleeding,
liver disorders,
diarrhoea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence

Nervous system problems such as:

dizziness, drowsiness or numbness,
tremor, muscle spasms, seizures,
feelings of anxiety or depression, mood or thought changes

Heart and blood vessel problems, such as:

changes in blood pressure, rapid heartbeat, blood vessel dilation

Lung problems such as:

pneumonia, bronchitis,
shortness of breath, cough, which may be due to bronchiectasis (a condition in which the lung airways are abnormally widened) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop a persistent cough or shortness of breath.
fluid in the lungs or chest,
sinus problems.

Other problems such as:

weight loss, gout, high blood sugar levels, bleeding, bruising.

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor or nurse.
web: 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 Mycophenolate Mofetil Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton after "Exp.". The expiry date refers to the last day of that month.
Store below 30°C.
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Micofenolato Mofetile Accord contains:
The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
The excipients are: microcrystalline cellulose, hydroxypropylcellulose, povidone K 90, sodium croscarmellose,
talc and magnesium stearate.
Capsule shell composition: gelatin, sodium lauryl sulfate, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), indigo carmine (E132).
Black ink composition: Shellac, Black iron oxide.

Description of the appearance of Micofenolato Mofetile Accord and contents of the pack:
Micofenolato Mofetile Accord 250 mg capsules are hard gelatin capsules, blue/peach in colour, size '1', with 'MMF' printed on the cap and '250' on the body, containing white to off-white powder.
Micofenolato Mofetile Accord is available in blisters in pack sizes of 100 and 300 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

Manufacturer:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009,
Greece