Mycophenolate mofetil Tillymed Italia: detailed information

Package leaflet: Information for the patient

Mycophenolate Mofetil Tillomed Italia 250 mg capsules

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 or pharmacist.
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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Micofenolato Mofetile Tillomed Italia is and what it is used for

Micofenolato Mofetile Tillomed Italia belongs to a group of medicines called
"immunosuppressants".
Micofenolato Mofetile Tillomed Italia is used to prevent your body from rejecting a transplanted kidney, heart, or liver.
Micofenolato Mofetile Tillomed Italia must be used in combination with other medicines such as cyclosporine and corticosteroids.

2. What you should know before taking Mycophenolate Mofetil Tillomed Italia

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 follow your doctor's advice regarding contraception.
Your doctor will discuss this with you and provide written information, particularly about the effects of mycophenolate 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 Mycophenolate Mofetil Tillomed Italia:

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 had a negative pregnancy test prior to starting treatment, 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 Pregnancy, contraception and breastfeeding),
if you are breastfeeding. Do not take this medicine if any of the above conditions apply to you. If you have any doubts, speak with your doctor or pharmacist before using Mycophenolate Mofetil Tillomed Italia.

Warnings and precautions
Contact your doctor immediately before taking Mycophenolate Mofetil Tillomed Italia:

if you are over 65 years of age, as you may have an increased risk of adverse events such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients,
if you experience signs of infection such as fever or sore throat,
if you experience unexpected bruising or bleeding,
if you have ever had gastrointestinal disorders, for example gastric ulcer,
if you are planning a pregnancy or become pregnant while you or your partner are being treated with Mycophenolate Mofetil Tillomed Italia,
if you suffer from an inherited enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or if you have any doubts), contact your doctor immediately before taking Mycophenolate Mofetil Tillomed Italia.
Effect of sunlight
Mycophenolate Mofetil Tillomed Italia weakens the body's defences, increasing the risk of skin cancer. Limit your exposure to sunlight and ultraviolet (UV) radiation by:

wearing protective clothing covering your head, neck, arms, and legs,
using high-protection-factor sunscreen creams.

Children
Do not administer this medicine to children under 2 years of age, as due to limited safety and efficacy data in this age group, dosage recommendations cannot be established.
Other medicines and Mycophenolate Mofetil Tillomed Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, such as herbal medicines. This is because Mycophenolate Mofetil Tillomed Italia may affect the action of other medicines, and other medicines may also affect the action of Mycophenolate Mofetil Tillomed Italia.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before taking Mycophenolate Mofetil Tillomed Italia:

azathioprine or other immunosuppressive medicines prescribed after an organ transplant,
colestyramine – used to treat high cholesterol,
rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB),
antacids or proton pump inhibitors – used for stomach acidity problems such as indigestion,
phosphate binders – used in patients with chronic kidney failure to reduce phosphate absorption 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 are due to receive a vaccination (live vaccine) during treatment with Mycophenolate Mofetil Tillomed Italia, inform your doctor or pharmacist first. Your doctor will advise you which vaccine is appropriate for you.
You must not donate blood during treatment with Mycophenolate Mofetil Tillomed Italia and for at least six weeks after stopping treatment. Men must not donate sperm during treatment with Mycophenolate Mofetil Tillomed Italia and for at least 90 days after stopping treatment.
Mycophenolate Mofetil Tillomed Italia with food and drink
Eating and drinking do not affect treatment with Mycophenolate Mofetil Tillomed Italia.
Contraception
Contraception in women taking Mycophenolate Mofetil Tillomed Italia
If you are a woman of childbearing potential, you must use an effective method of contraception while taking Mycophenolate Mofetil Tillomed Italia. This means:

before starting Mycophenolate Mofetil Tillomed Italia,
throughout the entire treatment period with Mycophenolate Mofetil Tillomed Italia,
for 6 weeks after stopping treatment with Mycophenolate Mofetil Tillomed Italia. Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your individual situation. Using two methods of contraception is preferable 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 have missed taking your oral contraceptive pill.

You cannot 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 one year ago (if your menstrual cycle has stopped due to anti-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 gynaecological specialist),
you were born with one of the following rare conditions making 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 Mycophenolate Mofetil Tillomed Italia
Although available clinical data do not indicate an increased risk of birth defects or miscarriage when the father takes mycophenolate, this risk cannot be completely ruled out. As a precaution, you and your partner are therefore advised to use a reliable method of contraception during treatment and for 90 days after stopping therapy with Mycophenolate Mofetil Tillomed Italia.
If you are planning a pregnancy, talk to your doctor about potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks associated with pregnancy and 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, experience unusual menstrual bleeding, or suspect you may be pregnant,
you have had sexual intercourse without using an effective method of contraception.

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. In any case, continue taking Mycophenolate Mofetil Tillomed Italia until you have consulted your doctor.
Pregnancy
Mycophenolate very frequently causes 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), finger development, 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 formed]). 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 Mycophenolate Mofetil Tillomed Italia if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines
Mycophenolate Mofetil may have a moderate effect on the ability to drive vehicles or use tools or machines. 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.

3. How to take Mycophenolate Mofetil Tillomed Italia

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The dose you should take depends on the type of transplant you have received. The usual doses
are indicated below. Treatment will continue for as long as necessary to prevent rejection
of the transplanted organ.
Kidney transplant
Adults

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

Heart transplant
Adults

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

Children

There is no information available on the use of Mycophenolate Mofetil Tillomed Italia in children receiving a heart transplant.

Liver transplant
Adults

The first oral dose of Mycophenolate Mofetil Tillomed Italia 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), divided into two separate doses.
Take 6 capsules in the morning and 6 capsules in the evening.

Children

There is no information available on the use of Mycophenolate Mofetil Tillomed Italia in children receiving a liver transplant.

How to take the medicine
Swallow the capsules whole with a glass of water.

Do not break or crush the capsules. Do not take any capsule that is 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 plenty of running water.

Take care to avoid contact between the powder leaking from damaged capsules and the
skin.

If this occurs, wash the affected area thoroughly with water and soap.

If you take more Mycophenolate Mofetil Tillomed Italia than you should
If you take more Mycophenolate Mofetil Tillomed Italia than you should, contact a doctor or
go to the hospital immediately. Do the same if someone else accidentally takes the medicine. Bring the medicine packaging with you.
If you forget to take Mycophenolate Mofetil Tillomed Italia
If you forget to take the medicine, take it as soon as you remember, then continue taking it as usual. Do not take a double dose to make up for the forgotten dose.
If you stop taking Mycophenolate Mofetil Tillomed Italia
Do not stop taking Mycophenolate Mofetil Tillomed Italia unless your doctor tells you to. If you stop treatment, the risk of rejection of your transplanted organ may increase.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

signs of infection such as fever or sore throat,
unexplained bruising or bleeding,
rash, swelling of the face, lips, tongue or throat, with difficulty breathing; this may be a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems
Some of the more common side effects include diarrhea, reduced 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.

Children may be more likely than adults to develop certain side effects. These include diarrhea, infections, and reduced white and red blood cells in the blood.
Fighting infections
Micofenolato Mofetile Tillomed Italia reduces the body's natural defences to prevent transplant rejection. As a result, the body may not be able to fight infections effectively as it normally would. This means you may be more prone to infections. These infections may affect the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.
Lymphatic system and skin tumours
As with other medicines of this type (immunosuppressants), a very small number of patients taking mycophenolate have developed tumours of the lymphatic system and skin.
General side effects
You may experience side effects affecting the body in general. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling tired, sleep disturbances, pain (in the stomach, chest, muscles or joints, or when urinating), headache, flu-like symptoms and swelling.
Other possible side effects may include:
Skin disorders such as:

acne, cold sores, shingles, skin thickening, hair loss, rash and itching

Urinary system disorders such as:

blood in the urine

Digestive and mouth disorders such as:

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

Nervous system disorders such as:

dizziness, drowsiness or paraesthesia,
tremors, muscle spasms, seizures,
feelings of anxiety or depression, changes in mood and thinking.

Heart and blood vessel disorders such as:

changes in blood pressure, irregular heartbeat, blood vessel dilation.

Lung disorders such as:

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

Other problems such as:

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micofenolato Mofetile Tillomed Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (EXP.) and on the blister. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original packaging to protect the medicine from moisture.
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 Micofenolato Mofetile Tillomed Italia contains

The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
The other components are:

Capsule contents
Pregelatinized starch
Sodium croscarmellose
Povidone (K90)
Magnesium stearate

Capsule shell
Gelatin
Indigo carmine (E132)
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)

Printing ink
Shellac
Black iron oxide (E172)
Potassium hydroxide

Description of the appearance of Micofenolato Mofetile Tillomed Italia and package contents
Micofenolato Mofetile Tillomed Italia capsules are hard gelatin capsules of size “1”, with an opaque blue cap and an opaque brown body, printed in black with “EM” on the cap and “250” on the body, filled with granular powder ranging from white to off-white.
Micofenolato Mofetile Tillomed Italia 250 mg capsules are supplied in unit-dose divisible blisters made of white opaque PVC/aluminum, in pack sizes of 100 x 1 or 300 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale Richard 1, Tower A
20143, Milan
Italy

Manufacturer
SGS Pharma Magyarorszag Kft.
Derkovits Gyula Utca 53,
Budapest XIX, 1193, Hungary
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This leaflet was last updated in 02/2025