Micofit

Leaflet accompanying the packaging: patient information

Mycofit, 500 mg, film-coated tablets

Mycophenolate mofetil

You should read the contents of the leaflet before taking this medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Mycofit and what is it used for
• 2. Important information before taking Mycofit
• 3. How to take Mycofit
• 4. Possible side effects
• 5. How to store Mycofit
• 6. Contents of the packaging and other information

1. What is Mycofit and what is it used for

Mycofit contains mycophenolate mofetil. It belongs to a group of medicines called immunosuppressants.
Mycofit is used to prevent the rejection of a transplanted kidney, heart, or liver by the patient's body.
Mycophenolate mofetil tablets should be taken in combination with other medicines, such as cyclosporine and corticosteroids.

2. Important information before taking Mycofit

WARNING

Mycophenolate causes birth defects and miscarriages. If the patient is a woman of childbearing age who may become pregnant, she must have a negative pregnancy test before starting treatment and must follow the doctor's instructions for using contraception.
The doctor will discuss with the patient and provide her with written information, in particular about the effects of mycophenolate on unborn children. The patient should read this information carefully and follow the instructions.
If the instructions are not fully understood, the patient should consult a doctor to explain them again before taking mycophenolate. The patient should also read the further information provided in this section, in the "Warnings and precautions" and "Pregnancy and breastfeeding" sections.

When not to take Mycofit:

• if the patient is allergic to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6),
• if the patient may be pregnant and has not provided a negative pregnancy test result before receiving the first prescription, as mycophenolate causes birth defects and miscarriages.
• if the patient is pregnant or plans to become pregnant or suspects she may be pregnant.
• if the patient does not use effective methods of contraception (see: Pregnancy, contraception, and breastfeeding).
• if the patient is breastfeeding.

You should not take the medicine if any of the above situations apply to you.
In case of doubts, you should consult a doctor or pharmacist before taking Mycofit.

Warnings and precautions

Before starting Mycofit, you should immediately consult a doctor, pharmacist, or nurse:

• if the patient is over 65 years old, as they may be at increased risk of side effects, such as certain viral infections, gastrointestinal bleeding, and pulmonary edema, compared to younger patients,
• if the patient has symptoms of infection, such as fever or sore throat,
• if the patient has any unexpected bruising or bleeding,
• if the patient has ever had or currently has gastrointestinal problems, such as stomach ulcers,
• if the patient plans to become pregnant or has become pregnant while she or her partner is taking mycophenolate mofetil, or if the patient has a genetic deficiency of enzymes, such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above cases apply to you (or if you are not sure), you should consult a doctor before starting treatment with Mycofit.

Sun exposure

Mycofit weakens the body's defense system. As a result, there is an increased risk of skin cancer. You should limit exposure to sunlight and UV radiation. This can be achieved by:

• wearing protective clothing that covers the head, neck, arms, and legs
• using sunscreens with a high protection factor.

Children and adolescents

Children and adolescents aged 2 to 18 years
Mycofit tablets are used in children and adolescents (aged 2 to 18 years) to prevent the rejection of a transplanted kidney by the body.
Mycofit tablets should not be used in children and adolescents (aged 2 to 18 years) after a heart or liver transplant.
Mycofit tablets should not be used in children under 2 years of age, as there is limited data on safety and efficacy in this age group, and dosage recommendations cannot be established.

Other medicines and Mycofit

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken. This includes medicines obtained without a prescription, such as herbal medicines. This is because Mycofit may affect the action of some medicines. Also, some medicines may affect the action of Mycofit.
In particular, before starting Mycofit, you should inform your doctor or pharmacist if you are taking any of the following medicines:

• azathioprine or other medicines that suppress the immune system, given after a transplant,
• cholestyramine, used to treat high cholesterol levels
• rifampicin, an antibiotic used to prevent or treat infections, such as tuberculosis (TB),
• antacids or proton pump inhibitors, used to treat stomach acid problems, such as heartburn,

in case of problems with stomach acidity, such as heartburn,

• 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
• acyclovir, valacyclovir, or ganciclovir

Vaccinations

If you need to be vaccinated (with a live vaccine) while taking Mycofit, you should consult a doctor or pharmacist beforehand. The doctor will advise which vaccine to use.
You should not donate blood while taking mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men should not donate semen while taking mycophenolate mofetil and for at least 90 days after stopping treatment.

Mycofit with food and drink

Taking food and drink does not affect treatment with Mycofit.

Pregnancy, breastfeeding, and fertility

Contraception in women taking Mycofit

If you are a woman of childbearing age who may become pregnant, you must use effective contraception while taking Mycofit. This applies to:

• the period before starting Mycofit;
• the entire treatment period with Mycofit;
• 6 weeks after stopping Mycofit. You should discuss the most suitable method of contraception with your doctor. The choice will depend on your individual situation. It is recommended that you use two methods of contraception, as this will reduce the risk of unintended pregnancy.

You should contact your doctor as soon as possible if you think your contraception may not be effective or if you have missed a contraceptive pill.

You are not able to become pregnant if you meet any of the following criteria:

• you are postmenopausal, i.e., you are over 50 years old and have not had a menstrual period for over a year (if your menstrual periods have stopped due to cancer treatment, you may still be able to become pregnant).
• you have had your fallopian tubes and both ovaries removed (bilateral salpingo-oophorectomy).
• you have had your uterus removed (hysterectomy).
• your ovaries have stopped functioning (premature ovarian failure confirmed by a gynecologist).
• you were born with one of the following rare conditions that make it impossible to become pregnant: XY genotype, Turner syndrome, or uterine agenesis.
• you are a child or adolescent who has not yet started menstruating.

Contraception in men taking Mycofit

Available data do not indicate an increased risk of miscarriage or birth defects in the child if the father is taking mycophenolate. However, this risk cannot be completely ruled out.
As a precaution, it is recommended that the patient or his partner use effective contraception during treatment and for 90 days after stopping Mycofit.
If you are planning to have a child, you should discuss the risks and other treatment options with your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should consult a doctor or pharmacist before taking this medicine. The doctor will inform you about the risks associated with pregnancy and other treatments that can be taken to prevent transplant rejection, if:

• you are planning to become pregnant.
• you have not had a menstrual period or have had unusual menstrual bleeding or suspect you may be pregnant.
• you have had unprotected sex.

You should immediately inform your doctor if you become pregnant while taking mycophenolate. However, you should continue taking Mycofit until you have consulted your doctor.

Pregnancy

Mycophenolate often causes miscarriages (50%) and severe birth defects in the unborn child (23-27%). The reported birth defects include ear, eye, facial (cleft lip/palate), finger, heart, esophagus (the tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida [abnormally formed spine]) abnormalities. The child may have one or more of these abnormalities.
If you are of childbearing age, you must have a negative pregnancy test before starting treatment and must follow the doctor's instructions for using contraception. The doctor may ask you to have more than one pregnancy test before starting treatment to make sure you are not pregnant.

Breastfeeding

You should not take Mycofit if you are breastfeeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines

Mycofit may have a moderate influence on the ability to drive and use machines. If you feel drowsy, numb, or confused, you should tell your doctor or nurse and not drive or use machines until you feel better.

Mycofit contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Mycofit

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist again.

What dose of Mycofit to take

The dose of Mycofit depends on the type of transplant you have had. The usual doses are presented below. Treatment will be continued for as long as you need to be protected from transplant rejection.

Kidney transplant

Adults

• The first dose of Mycofit is given within 3 days of the transplant operation
• The daily dose is 4 tablets (2 g of medicine) taken in two separate doses.
• You should take 2 tablets in the morning and 2 tablets in the evening.

Children (aged 2 to 18 years)

• The dose of Mycofit may vary depending on the size of the child.
• Your doctor will recommend the appropriate dose of Mycofit based on the child's height and weight

(body surface area measured in square meters or "m"). The recommended dose of Mycofit is 600 mg/m twice a day.

Heart transplant

Adults

• The first dose of Mycofit is given within 5 days of the transplant operation
• The daily dose is 6 tablets (3 g of medicine) taken in two separate doses.
• You should take 3 tablets in the morning and 3 tablets in the evening.

Children:

• There is no information on the use of Mycofit in children after a heart transplant.

Liver transplant

Adults:

• The first dose of oral Mycofit should be given at least 4 days after the transplant and when the patient is able to swallow the medicine.
• The daily dose is 6 tablets (3 g of medicine) taken in two separate doses.
• You should take 3 tablets in the morning and 3 tablets in the evening.

Children:

• There is no information on the use of Mycofit in children after a liver transplant.

Method and route of administration:

Tablets should be swallowed whole with a glass of water. Tablets should not be broken or crushed.

Taking a higher dose of Mycofit than recommended

If you have taken more Mycofit tablets than recommended, or if someone else has taken them by mistake, you should immediately consult a doctor or go to the hospital. You should take the packaging of the medicine with you.

Missing a dose of Mycofit

If you miss a dose of Mycofit, you should take it as soon as you remember. Then, you should continue taking the medicine as usual. You should not take a double dose to make up for the missed dose.

Stopping treatment with Mycofit

You should not stop treatment with Mycofit without consulting your doctor. Stopping treatment may increase the risk of transplant rejection.
If you have any further doubts about taking this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Mycofit can cause side effects, although not everybody gets them.

You should immediately consult a doctor if you experience any of the following serious side effects - they may require urgent treatment:

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

Common disorders

The most common disorders include: diarrhea, decreased white or red blood cell count, infections, and vomiting. Your doctor will regularly order blood tests to check for any changes in:

• blood cell count or signs of infection

In children, certain side effects may occur more frequently than in adults. These include diarrhea, infections, decreased white blood cell count, and decreased red blood cell count.

Fighting infections

Mycofit weakens the body's defense system. This action prevents transplant rejection.
As a result, the body will not fight infections as effectively as usual. This means that patients may become infected more easily than usual. These infections include those of the brain, skin, mouth, stomach, intestines, lungs, and urinary tract.

Lymphoma and skin cancer

In a very small number of patients treated with Mycofit, lymphoma and skin cancer have developed, which can occur in patients taking this type of medicine (immunosuppressant).

Systemic side effects

You may experience systemic side effects. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, fatigue, sleep disturbances, pain (such as stomach, chest, joint, or muscle pain), headache, flu-like symptoms, swelling.
Other side effects may include:

• Skin disorders, such as
• acne, herpes, shingles, skin thickening, hair loss, rash, itching.

Urinary disorders, such as

• blood in the urine.

Gastrointestinal and mouth disorders, such as

• gum hypertrophy and mouth ulcers
• pancreatitis, colitis, or stomach inflammation
• gastrointestinal disorders, including bleeding
• liver disorders,
• diarrhea, constipation, nausea, indigestion, loss of appetite, bloating.

Nervous system disorders, such as

• dizziness, drowsiness, numbness,
• tremors, muscle spasms, seizures,
• anxiety or depression, thinking or mood disorders.

Heart and blood vessel disorders, such as:

• changes in blood pressure, abnormal heart function, vasodilation.

Lung disorders, such as:

• pneumonia, bronchitis
• shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the bronchi are abnormally enlarged) or pulmonary fibrosis (scarring of the lungs), if you experience persistent cough or shortness of breath, you should consult a doctor.
• fluid in the lungs or chest
• sinus problems.

Other disorders, such as:

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, with its seat at:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mycofit

Do not store above 25°C. Store in the original packaging to protect from light.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the words "Expiry date" (EXP). The expiry date refers to the last day of the month stated.
You should always return any leftover medicine to the pharmacist. You can only keep it if your doctor advises you to.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mycofit contains

• The active substance of Mycofit is 500 mg of mycophenolate mofetil
• The other ingredients of Mycofit are: Tablet core: microcrystalline cellulose, povidone, hydroxypropylcellulose, sodium croscarmellose, purified talc, and magnesium stearate. Film coating: hypromellose 6 cPs, titanium dioxide (E171), macrogol 400, red iron oxide (E172), indigo carmine (E132), and black iron oxide (E172), purified talc.

What Mycofit looks like and contents of the pack

Mycofit is a purple, capsule-shaped, biconvex film-coated tablet with "AHI" embossed on one side and "500" on the other side.
Mycofit tablets are available in blisters of 50, 150, and 250 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: + 48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare B.V
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona 08040
Spain
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia
32009 Schimatari
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: July 2025