Micofit

Leaflet accompanying the packaging: patient information

Mycofit, 250 mg, hard capsules

Mycophenolate mofetil

Before taking the medicine, you should read the contents of the leaflet, 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, pharmacist, or nurse if you need advice or further information.
• 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 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 pack and other information

1. What is Mycofit and what is it used for

The full name of the medicine is Mycofit, 250 mg, hard capsules.
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 capsules should be used 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 provide a negative pregnancy test result before starting treatment and follow the doctor's instructions for contraception.
The doctor will discuss the therapy with the patient and provide written information, particularly regarding the effects of mycophenolate on unborn children. You should read this information carefully and follow the instructions.
If the patient does not fully understand these instructions, they should consult their doctor to explain them again before taking mycophenolate. You should also read the additional information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

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),

or

• if the patient is a woman who can become pregnant and has not provided a pregnancy test result excluding pregnancy before the first prescription of the medicine, because mycophenolate causes birth defects and miscarriages,
• in case of pregnancy, planned pregnancy, or suspected pregnancy.
• in case of not using effective contraception (see Pregnancy, contraception, and breastfeeding).
• if the patient is breastfeeding.

You should not take this medicine if any of the above conditions apply to you.
In case of doubt, you should consult your doctor or pharmacist before taking Mycofit.

Warnings and precautions

Before starting Mycofit, you should immediately consult your doctor 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
• there are symptoms of infection, such as fever or sore throat
• there are any unexpected bruises or bleeding
• there have been or are gastrointestinal problems, such as stomach ulcers
• the patient is planning to become pregnant or has become pregnant while taking Mycofit
• the patient has a hereditary deficiency of enzymes, such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or if you are unsure), you should consult your doctor before taking 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

This medicine should not be given to children under 2 years of age, as there is limited data on safety and efficacy in this age group, and dosage recommendations cannot be made.

Mycofit and other medicines

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
• 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, ganciclovir, or valganciclovir, used to treat or prevent viral infections.

Vaccinations

If you need to be vaccinated (with a live vaccine) while taking Mycofit, you should consult your doctor or pharmacist first.
Your doctor will advise which vaccine to use.
You should not donate blood during treatment with Mycofit and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Mycofit 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, contraception, and breastfeeding

Contraception in women taking Mycofit

If the patient is a woman of childbearing age who may become pregnant, she must use effective contraception during treatment with Mycofit. This applies to:

• before starting Mycofit
• during the entire treatment period with Mycofit
• for 6 weeks after stopping Mycofit

You should discuss with your doctor the most suitable method of contraception.
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.

A woman is not capable of becoming pregnant if she meets any of the following criteria:

• •She is postmenopausal, i.e., over 50 years old and has not menstruated for over a year (if menstruation has stopped due to cancer treatment, she may still be able to become pregnant).
• •She has had her fallopian tubes and both ovaries removed (bilateral salpingo-oophorectomy).
• •She has had her uterus removed (hysterectomy)
• •Her ovaries have stopped working (premature ovarian failure confirmed by a gynecologist)
• •She was born with one of the following rare conditions that result in infertility: XY genotype, Turner syndrome, or Mayer-Rokitansky-Küster-Hauser syndrome
• •She is 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 a child, you should discuss the risk and the possibility of using other medicines to prevent transplant rejection with your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a child, you should consult your doctor or pharmacist before taking this medicine.
Your 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 think you may be pregnant.
• you have had unprotected sex. You should inform your doctor immediately if you become pregnant while taking mycophenolate. However, you should continue to take Mycofit until you have consulted your doctor.

Pregnancy

Mycophenolate causes very frequent miscarriages (50%) and severe birth defects (23-27%) in unborn children.
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) abnormalities.
A child of a mother taking mycophenolate may have one or more of these abnormalities.
If you are of childbearing age, you must provide a negative pregnancy test result before starting treatment and follow the doctor's instructions for contraception. Your doctor may ask you to perform more than one pregnancy test before starting treatment to ensure 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 operate machinery until you feel better.

Mycofit contains sodium

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

3. How to take Mycofit

This medicine should always be taken exactly as your doctor has instructed.
In case of doubt, you should consult your doctor or pharmacist.

What dose to take

The dose of Mycofit depends on the type of transplant you have had.
The usual doses are shown below. Treatment will be continued for as long as you need to prevent rejection of the transplanted organ.

Kidney transplant

Adults:
The first dose is given within 3 days after the transplant operation. The daily dose is 8 capsules (2 g of medicine) taken in two divided doses. You should take 4 capsules in the morning and 4 capsules in the evening.
Children (aged 2 to 18 years):
The dose may vary depending on the size of the child. Your doctor will provide information on the appropriate dose based on the child's height and weight (body surface area in square meters or "m"). The recommended dose is 600 mg/m twice daily.

Heart transplant

Adults:
The first dose is given within 5 days after the transplant operation. The daily dose is 12 capsules (3 g of medicine) taken in two divided doses. You should take 6 capsules in the morning and 6 capsules in the evening.
Children:
There is no information on the use of Mycofit in children after a heart transplant.

Liver transplant

Adults:
The first oral dose of Mycofit will be given at least 4 days after the transplant operation and when you are able to take oral medicines. The recommended daily dose is 12 capsules (3 g of medicine) taken in two divided doses. This means you should take 6 capsules in the morning and 6 capsules in the evening.
Children:
There is no information on the use of Mycofit in children after a liver transplant.

Method and route of administration

• Capsules should be swallowed whole with a glass of water.
• They should not be broken, crushed, or taken as broken, opened, or divided capsules.
• Caution should be exercised to avoid contact between the powder from a damaged capsule and the mouth or throat. If this happens, you should rinse with a large amount of clean water.
• Caution should be exercised to avoid contact between the powder from a damaged capsule and the skin. If this happens, you should wash the skin thoroughly with soap and water.

Taking a higher dose of Mycofit than recommended

If you have taken more Mycofit than you should, you should immediately consult your doctor or go to the hospital. You should do the same if someone else has taken your medicine by mistake. You should take the medicine packaging with you.

Missing a dose of Mycofit

If you miss a dose, you should take it as soon as you remember, and then continue to take your medicine as usual. You should not take a double dose to make up for a 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 doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should immediately consult your 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 or 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 brain, skin, mouth, stomach, intestine, lung, and urinary tract infections.

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 or 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, gastritis
• gastrointestinal disorders, including bleeding
• liver disorders
• diarrhea, constipation, nausea, heartburn, 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, rapid heartbeat, vasodilation

• Lung disorders, such as pneumonia, bronchitis
• cough, which may be associated with bronchiectasis (a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lungs). You should tell your doctor if you develop a persistent cough or shortness of breath
• 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, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, with its seat at:
Jerozolimskie Avenue 181C
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mycofit

Store in a temperature below 30°C.
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.
Do not use this medicine if visible signs of deterioration are evident.
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 pack and other information

What Mycofit contains

• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
• The other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, povidone K-90, sodium croscarmellose, talc, and magnesium stearate.
• Capsule contents: gelatin, sodium lauryl sulfate, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), indigo carmine (FD & C Blue 2) (E132).
• Printing ink: shellac, iron oxide black (E172)

What Mycofit looks like and contents of the pack

Mycofit, 250 mg, are light blue to peach-colored, size "1", hard, gelatin capsules, with "MMF" embossed on the cap and "250" on the body, containing a white to off-white powder.
Mycofit, 250 mg, are available in blisters of 100 and 300 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
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.
Lutomierska 50 Street
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009
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