Mycophenolate mofetil TilloMed: detailed information

Package leaflet: Information for the user

Mycophenolate Mofetil Tillomed 500 mg film-coated tablets

Equivalent 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before taking Micofenolato Mofetile Tillomed

WARNING
Micofenolato causes birth defects and miscarriages. If you are a woman who could become
pregnant, you must provide a negative pregnancy test before starting treatment and
follow the contraception advice given to you by your doctor.
Your doctor will speak with you and provide written information, particularly on the effects of
micofenolato 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 micofenolato. See also further information in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".
Do not take Micofenolato Mofetile if:

you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the ingredients of this medicine (listed in section 6);
you are a woman who could become pregnant and have not provided a negative pregnancy test before your first prescription, as micofenolato causes malformations and spontaneous abortions;
you are pregnant or planning a pregnancy, or think you may be pregnant;
you are not using effective contraception (see Pregnancy, contraception, breastfeeding);
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
Speak immediately with your doctor before taking Mycophenolate Mofetil:

if you are over 65 years of age, as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients;
if you have symptoms of infection such as fever or sore throat;
if you have unexpected bruising or bleeding;
if you have ever suffered from gastrointestinal disorders such as a stomach ulcer;
if you are planning a pregnancy or become pregnant while you or your partner are being treated with this medicine;
if you suffer from an inherited enzyme deficiency, such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or you are uncertain), consult your doctor immediately before taking Mycophenolate Mofetil.
Effect of sunlight
Mycophenolate Mofetil reduces your body's defenses. As a result, there is an increased risk of skin cancer. Limit your exposure to sunlight and UV rays. You can achieve this by:

wearing protective clothing covering your head, neck, arms, and legs;
using sunscreen with a high protection factor.

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

azathioprine or other medicines that suppress your immune system – prescribed after an organ transplant;
cholestyramine – 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 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) while taking Mycophenolate Mofetil Tillomed, inform your doctor or pharmacist first. Your doctor will advise you on which vaccine is appropriate for you.
You must not donate blood during treatment with Mycophenolate Mofetil Tillomed and for at least 6 weeks after treatment ends. Men must not donate sperm during treatment with this medicine and for at least 90 days after stopping treatment.
Taking Mycophenolate Mofetil Tillomed with food and drink
Food and drink do not affect treatment with this medicine.
Contraception
Contraception in women taking Mycophenolate Mofetil Tillomed
If you are a woman who could become pregnant, you must use an effective contraceptive method while taking Mycophenolate Mofetil Tillomed. This means:

before starting to take Mycophenolate Mofetil Tillomed;
during the entire treatment with Mycophenolate Mofetil Tillomed;
for 6 weeks after stopping Mycophenolate Mofetil Tillomed.

Talk to your doctor about the most suitable contraceptive method for you. This will depend on your individual situation. Two contraceptive methods are preferred, as this would reduce the risk of an unintended pregnancy.
Contact your doctor as soon as possible if you think contraception may not have been effective or if you missed taking your contraceptive pill.
You cannot become pregnant if any of the following conditions apply to you:

you are post-menopausal, 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 cancer treatment, there is still a possibility you could 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, confirmed by a specialist gynecologist);
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 started having menstrual cycles.

Contraception in men taking Mycophenolate Mofetil Tillomed
The dose normally used does not indicate an increased risk of birth defects or spontaneous abortion if the father takes mycophenolate. However, risks cannot be completely excluded. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for 90 days after stopping mycophenolate mofetil.
If you plan 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 to have a child, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks in case of pregnancy and alternative therapies you could use to prevent rejection of your transplanted organ if:

you plan to become pregnant;
you have missed or think you may have missed a menstrual period, or have unusual menstrual bleeding, or suspect you are pregnant;
you have sexual intercourse without using an effective contraceptive method.

If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue taking mycophenolate mofetil until you are seen by your doctor.
Pregnancy
Mycophenolate Mofetil causes a high frequency of miscarriage (50%) and serious birth defects (23–27%) in the newborn. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, esophagus (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 conditions.
If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and follow the contraception advice given to you by your doctor. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Mycophenolate Mofetil if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.
Driving and using machines
Mycophenolate Mofetil has a moderate effect on the ability to drive or use tools or machines. If you feel drowsy, dizzy, or confused, consult your doctor or nurse and do not drive or use tools or machinery until you feel better.

3. How to take Mycophenolate Mofetil Tillomed

Always take this medicine exactly as instructed 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 recommended doses are indicated below. Treatment will continue for as long as needed to prevent rejection of the transplanted organ.
Kidney transplant
Adults

The first dose will be given within 3 days after the transplant surgery.
The recommended daily dose is 4 tablets (2 g of medicine), divided into two separate doses.
Take 2 tablets in the morning and 2 tablets in the evening.

Use in children (aged between 2 and 18 years):

The dose administered will depend on the child's body surface area.
Your doctor will determine the appropriate dose based on your child's characteristics (weight, height, 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 is administered within 5 days after the transplant surgery.
The daily dose is 6 tablets (3 g of medicine), taken in two separate doses.
Take 3 tablets in the morning and then 3 tablets in the evening.

Use in children
There is no information available on the use of Mycophenolate Mofetil Tillomed in children undergoing heart transplantation.
Liver transplant
Adults

The first dose of oral Mycophenolate Mofetil will be administered at least 4 days after transplantation and when you are able to swallow oral medication.
The daily dose is 6 tablets (3 g of medicine), taken in two separate doses.
Take 3 tablets in the morning and then 3 tablets in the evening.
Children
There is no information available on the use of Mycophenolate Mofetil in children with liver transplantation.

Method and route of administration

Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.

If you take more Mycophenolate Mofetil than you should
If you take more Mycophenolate Mofetil than prescribed, speak to a doctor or go to hospital immediately. Do this even if someone else accidentally takes your medicine. Take the medicine package with you.
If you forget to take Mycophenolate Mofetil
If you forget to take your medicine at any time, take it as soon as you remember. Then continue taking it at your regular intervals. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mycophenolate Mofetil
Do not stop taking mycophenolate mofetil unless your doctor tells you to. If you stop treatment, you may increase the risk of rejection of your transplanted organ.
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 everyone gets them.
Contact your doctor immediately if you experience any of the following serious side effects,
as you may need urgent medical treatment:

symptoms of infection such as fever or sore throat,
unexpected bruising or bleeding,
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 are diarrhoea, a lower number of white or red blood cells in the blood, infections and vomiting. Your doctor will regularly carry out blood tests to monitor for any changes:

in blood cell counts or signs of infection.

Children may be more likely than adults to experience certain side effects. These include diarrhoea, infections, lower white blood cell counts and lower red blood cell counts.
Fighting infections
Mycophenolate Mofetil reduces your body's defences. This is to prevent your body from rejecting the transplant. As a result, your body may be less able to fight infections. This means you may get more infections than usual. These include infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract.
Lymphatic system and skin cancer
As may occur in patients taking this type of medicine (immunosuppressants), a very small number of patients taking mycophenolate have developed cancer of the lymphoid tissues and of the skin.
General side effects
You may experience general side effects affecting your body as a whole. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling tired, difficulty sleeping, pain (such as stomach, chest, joint or muscle pain, pain when urinating), headache, flu-like symptoms and swelling.
Other possible 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,
feeling anxious or depressed, changes in mood or thoughts.

Heart and blood vessel problems such as:

changes in blood pressure, unusual 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 airways of the lungs are abnormally widened) or pulmonary fibrosis (scarring of the lungs). Talk to your doctor if you develop a persistent cough or shortness of breath,
sinus problems.

Other problems such as:

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

Reporting of side effects
If you experience any side effect, 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 the following website:
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 Mycophenolate Mofetil Tillomed

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.). The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Micofenolato Mofetile Tillomed 500 mg film-coated tablet contains

The active substance is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.
The other components are: microcrystalline cellulose, povidone, sodium croscarmellose, talc, magnesium stearate. The tablet coating contains: hypromellose, talc, titanium dioxide (E171), macrogol 400, red iron oxide (E172), black iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Micofenolato Mofetile Tillomed 500 mg and pack sizes

Micofenolato Mofetile Tillomed 500 mg film-coated tablets are purple, capsule-shaped, smooth on both sides.
The tablets are available in PVC-aluminium blisters in pack sizes of 50, 150 and 250 film-coated tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER

Marketing authorisation holder
Tillomed Italia S.r.l., Viale G. 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Mycophenolate mofetil Tillomed 500 mg Filmtabletten
Spain MICOFENOLATO DE MOFETILO TILLOMED 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Italy Micofenolato Mofetile Tillomed