MICOFENOLATO 500 mg Film-Coated Tablets

Зміст інструкції

1. Micofenolato Mofetile Tillomed 500 mg film-coated tablets
   1. What is Micofenolato Mofetile Tillomed and what it is used for
   2. What you need to know before taking Micofenolato Mofetile Tillomed
   3. How to take Micofenolato Mofetile Tillomed
   4. Possible side effects
   5. How to store Micofenolato Mofetile Tillomed
   6. Package contents and other information

Micofenolato Mofetile Tillomed 500 mg film-coated tablets

micofenolato mofetile

Generic medicine

because it contains important information for you.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What Micofenolato Mofetile Tillomed is and what it is used for
• 2. What you need to know before you take Micofenolato Mofetile Tillomed
• 3. How to take Micofenolato Mofetile Tillomed
• 4. Possible side effects
• 5. How to store Micofenolato Mofetile Tillomed 6 Contents of the pack and other information

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

Micofenolato Mofetile Tillomed 500 mg film-coated tablets contains micofenolate
mofetil. This belongs to a group of medicines called “immunosuppressants”.
Micofenolate mofetil is used to prevent your body from rejecting a transplanted kidney, heart or
liver. This medicine must be used in combination with other medicines, such as cyclosporines and
corticosteroids.

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

WARNING
Micofenolate causes birth defects and abortions. 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 talk to you and provide you with written information, particularly about the effects of
micofenolate on unborn children. 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 micofenolate. See also further information in this
paragraph below "Warnings and precautions" and "Pregnancy and breastfeeding"

Do not take Micofenolato mofetile if:

• If you are allergic (hypersensitive) to micofenolate mofetil, micophenolic acid or any of the components of this medicine.
• you are a woman who could be pregnant and have not provided a negative pregnancy test before your first prescription, as micofenolate causes malformations and spontaneous abortions,
• you are pregnant or planning a pregnancy, or think you might be pregnant,
• you are not using effective contraception,
• you are breastfeeding. Do not take this medicine if any of the above conditions apply to you. If you are unsure, ask your doctor or pharmacist before taking micofenolate mofetil.

Warnings and precautions
Talk to your doctor immediately before taking Micofenolato Mofetile:

• if you have symptoms of infection such as fever or sore throat,
• if you have any unexplained bruising or bleeding,
• if you have ever suffered from digestive disorders such as a stomach ulcer,
• if you are planning a pregnancy or if you become pregnant while taking this medicine. If any of the above conditions apply to you (or you are not sure), consult your doctor immediately before taking Micofenolato Mofetile.

The effect of sunlight
Micofenolato Mofetile reduces your body's defenses. Consequently, there is an increased
risk of skin cancer. Limit exposure to the sun and UV rays. You can achieve this
result as follows:

• wear protective clothing that also covers the head, neck, arms and legs,
• use a sunscreen with a high protection factor.

Other medicines and Micofenolato Mofetile
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Micofenolato Mofetile can affect how
other medicines work. Also, other medicines can affect how this
medicine works.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines before starting treatment with Micofenolato Mofetile:

• 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 acidity problems in the stomach such as indigestion.
• phosphate binders - used in patients with chronic kidney failure to reduce phosphate absorbed from the blood.

Vaccines
If you need to have a vaccination (a live vaccine) while taking Micofenolato
Mofetile Tillomed, tell your doctor or pharmacist first. Your doctor will advise you which
vaccine is suitable for you.
You must not donate bloodduring treatment with Micofenolato Mofetile Tillomed
and for at least another 6 weeks after the end of treatment. Men must not donate spermduring treatment with this medicine and for at least 90 days after the end of
treatment.

Taking Micofenolato Mofetile Tillomed with food and drink
Taking food and drink has no influence on treatment with this medicine.

Pregnancy, contraception and breastfeeding
Contraception in women taking Micofenolato Mofetile Tillomed
If you are a woman who could become pregnant, you must use an effective contraceptive
method with Micofenolato Mofetile Tillomed. This means:

• before starting to take Micofenolato Mofetile Tillomed
• during the entire treatment with Micofenolato Mofetile Tillomed
• for 6 weeks after you have stopped Micofenolato Mofetile Tillomed

Talk to your doctor about the most suitable contraceptive method for you. This will depend
on your individual situation. Two contraceptive methods are preferable as this
would reduce the risk of an unwanted pregnancy.

Contact your doctor as soon as possible if you think that contraception may not
have been effective or 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 post-menopausal, i.e. you are at least 50 years old and your last period was more than a year ago (if your menstrual cycle has stopped because you have had cancer treatment, then there is still a chance 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 insufficiency, which has been confirmed by a specialist 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 started to have menstrual cycles.

Contraception in men taking Micofenolato Mofetile Tillomed
The dose normally used does not indicate an increased risk of birth defects or miscarriage
if the father is taking micofenolate. However, the 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
micofenolate mofetil.
If you are planning to have a child, talk to your doctor about the potential risks.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. The
doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to
prevent rejection of your organ transplant if:

• you intend to become pregnant,
• you have not had or think you 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 micofenolate, you must inform
your doctor immediately. However, continue to take micofenolate mofetil until
you are seen.

Pregnancy
Micofenolate Mofetile causes a high rate of miscarriage(50%) and serious birth defects
(23-27%) in the unborn child. The birth defects that have been reported include abnormalities of the
ears, eyes, face (cleft lip / palate), development of the fingers, heart,
esophagus (tube connecting the throat to the stomach), kidneys and nervous system (for
example, 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 produce a negative pregnancy
test before starting treatment and follow the contraception advice given to you by your doctor. The doctor may require more than one test to ensure that you are not
pregnant before starting treatment.

Breastfeeding
Do not take Micofenolato Mofetile if you are breastfeeding. This is because small amounts of
medicine can pass into breast milk.

Driving and using machinery
It is unlikely that Micofenolato Mofetile will affect your ability to drive or
use tools or machinery.

3. How to take Micofenolato Mofetile Tillomed

Always take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.

Amount to take
The amount you need to take depends on the type of transplant you have had. The recommended doses
are indicated below. Treatment will continue for as long as you need it to prevent
rejection of the transplanted organ.

Kidney transplant

Adults

• the first dose will be given within 3 days of the transplant surgery.
• The recommended daily dose is 4 tablets (2 g of medicine) divided into 2 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 to be administered will depend on the child's body surface area.
• The doctor will decide the appropriate dose based on your child's characteristics (weight and height, body surface area measured in square meters or m²). The recommended dose is 600 mg/m² administered twice a day.

Heart transplant

Adults

• The first dose is administered within 5 days of the transplant surgery.
• The daily dose is 6 tablets (3 g of medicine) taken in 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening.

Use in children
There is no information on the use of Micofenolato Mofetile Tillomed in children undergoing
heart transplantation.

Liver transplant

Adults

• The first dose of oral Micofenolato Mofetile will be given to you at least 4 days after the transplant and when you are able to swallow medicines orally.
• The daily dose is 6 tablets (3 g of medicine) taken in 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening.

Children
There is no information on the use of Micofenolato Mofetile in children with liver
transplantation.

How and route of administration

• Swallow the tablets whole with a glass of water.
• Do not break or crush to avoid inhalation or direct contact with the skin or mucous membranes with the powder. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.

If you take more Micofenolato Mofetile than you should
If you take more Micofenolato Mofetile than you should, talk to a doctor or go to the
hospital immediately. Do this even if someone else accidentally takes your medicine. Bring with
you the package of the medicine.

If you forget to take Micofenolato Mofetile
If you forget to take the medicine at any time, take it as soon as you
remember. Then continue to take it at the established intervals. Do not take a double dose to
make up for the missed dose.

If you stop taking Micofenolato Mofetile
Do not stop taking micofenolate mofetil unless your doctor tells you to
do so. If you stop treatment, it may increase the chance of rejection of your
transplanted organ.
If you have any questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctor immediately if you experience any of the following serious side effects, as you may need urgent medical treatment:

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

Common problems
Some of the most common problems are diarrhea, a lower number of white blood cells or red blood cells in the blood, infections and vomiting. Your doctor will regularly perform blood tests to check for any changes:

• in the number of blood cells.
• in the amount of sugar, fats or cholesterol in the blood. Children may be more likely than adults to experience some side effects. These include diarrhea, infections, fewer white blood cells and fewer red blood cells in the blood.

Fighting infections
Mycophenolate Mofetil reduces your body's defenses. This is to prevent you from rejecting the
transplant. As a result, your body will not be as able to fight infections. This
means you may get more infections than usual. This includes infections of the brain,
skin, mouth, stomach and intestines, lungs and urinary tract.

Cancer of the lymphatic system and skin
As can happen in patients taking this type of medicine
(immunosuppressants), a very small number of patients with Mycophenolate Mofetil have
developed cancer of the lymphoid tissues and skin.

General side effects
You may have general side effects that affect your body as a whole.
These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling
tired, difficulty sleeping, pains (such as stomach, chest, joints or muscles,
pain when urinating), headache, flu-like symptoms and swelling.

Other side effects may include:
Skin problemssuch as:

• acne, cold sores, shingles, skin growth, hair loss, skin rashes, itching.

Urinary problemssuch as:

• kidney problems or a sudden need to urinate.

Problems with the digestive system and mouthsuch as:

• swelling of the gums and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• intestinal problems including bleeding, liver problems,
• constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Problems with the nervous systemsuch as:

• feeling dizzy, sleepy or numb,
• tremor, muscle spasms, convulsions,
• feeling anxious or depressed, changes in your mood or thoughts.

Problems with the heart and blood vesselssuch as:

• change in blood pressure, unusual heartbeat, dilation of blood vessels.

Lung problemssuch 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,
• fluid in the lungs or inside the chest, sinusitis problems.

Other problemssuch as:

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

Reporting side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (Exp.). The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via domestic wastewater. Ask your
pharmacist how to dispose of medicines no longer needed. These measures will help to
protect the environment.

6. Package contents and other information

What Micofenolato Mofetile Tillomed 500 mg film-coated tablet contains

• The active ingredient is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients are: microcrystalline cellulose, povidone, sodium croscarmellose, talc, magnesium stearate. The tablet coating contains: hypromellose, 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 package contents
Micofenolato Mofetile Tillomed 500 mg film-coated tablets are violet in color,
capsule-shaped, smooth on both sides.
The tablets are available in PVC-aluminum blisters in packs of 50 and 150
film-coated tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Marketing Authorisation Holder
Tillomed Italia SRL
Viale Giulio Richard 1, 20143 Milan

Manufacturer:
Emcure Pharma UK Ltd
Basepoint Business Centre,
110 Butterfield, Great Marlings,
Luton, LU2 8DL
United Kingdom
Tillomed Laboratories Ltd
220 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom
Tillomed Pharma GmbH
Manhagener Allee 36
22926, Ahrensburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
United Kingdom Mycophenolate mofetil Tillomed 500 mg film-coated tablets
Germany Mycophenolate mofetil Tillomed 500 mg Filmtabletten
Spain MICOFENOLATO DE MOFETILO TILLOMED 500 MG
COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Italy Micofenolato Mofetile Tillomed
France Mycophenolate mofetil Tillomed 500 mg comprimés pelliculés