Mycofit

Patient Information Leaflet

Mycofit, 250 mg, hard capsules
Mycophenolate mofetil
Please read the entire leaflet before using this medicine, as it contains important information
for the patient

• Keep this leaflet, as you may need to read it again.
• Consult your doctor, pharmacist, or nurse if you need advice or additional information.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• This medicine may harm another person, even if their symptoms are similar.
• If any of the side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Mycofit is and what it is 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 Mycofit is and what it is 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 in adults and children to prevent the body from rejecting a transplanted kidney, heart, or liver.
Mycofit should be taken together with other medicines, such as cyclosporine and corticosteroids.

2. Important information before taking Mycofit

WARNING
Mycophenolate causes birth defects and miscarriages. 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 the treatment with you and provide written information, particularly about the effects of mycophenolate on unborn children. Read this information carefully and follow the instructions.
If you do not fully understand these instructions, speak to your doctor for clarification before taking mycophenolate. Also read the further information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

When not to use Mycofit

• 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 provided a negative pregnancy test result before the first prescription, because mycophenolate causes birth defects and miscarriages,
• during pregnancy, planning pregnancy, or suspected pregnancy,
• if you are not using effective contraception (see Contraception, pregnancy and breastfeeding),
• if you are breastfeeding.

Do not take this medicine if any of the above apply to you.
If in doubt, consult your doctor or pharmacist before taking Mycofit.

Warnings and precautions
Before starting Mycofit, consult your doctor immediately if:

• you are over 65 years old, as you may be at increased risk of certain side effects compared to younger patients, such as certain viral infections, gastrointestinal bleeding, or pulmonary edema,
• you have symptoms of infection, such as fever or sore throat,
• you have unexpected bruising or bleeding,
• you have had or currently have gastrointestinal problems, such as peptic ulcer disease,
• you are planning pregnancy or have become pregnant while you or your partner were taking Mycofit,
• you have a hereditary enzyme deficiency, such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

If any of the above apply to you (or if you are unsure), talk to your doctor before starting treatment with Mycofit.

Sunlight exposure
Mycofit weakens the body's immune 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 high-protection sunscreen.

Children
In children, especially those under 6 years of age, certain side effects may be more likely than in adults. These include diarrhea, vomiting, infections, reduced red blood cell count, reduced white blood cell count, and possibly lymphatic system or skin tumors.
The capsules are suitable only for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as directed by a doctor.
If you have any doubts about treating a child, consult your doctor or pharmacist before administering the medicine.

Mycofit and other medicines
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 remedies.
This is because Mycofit may affect the action of certain medicines. Likewise, some medicines may affect the action of Mycofit.
In particular, before starting Mycofit, inform your doctor or pharmacist if you are taking any of the following medicines:

• azathioprine or other immunosuppressive medicines used after transplantation,
• 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 for stomach acid 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,
• acyclovir, ganciclovir, or valganciclovir, used to treat and prevent viral infections.

Vaccinations
If you need to be vaccinated (with a live vaccine) while taking Mycofit, consult your doctor or pharmacist first.
Your doctor will advise which vaccine should be given.
You must not donate blood during treatment with Mycofit and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Mycofit and for at least 90 days after stopping treatment.

Mycofit with food and drink
Food and drink do not affect treatment with Mycofit.

Pregnancy, contraception, and breastfeeding

Contraception in women taking Mycofit
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with Mycofit. This applies to the periods:

• before starting Mycofit,
• throughout the entire treatment period with Mycofit,
• for 6 weeks after stopping Mycofit.

Discuss with your doctor the most appropriate method of contraception. The choice will depend on your individual situation. It is best to use two methods of contraception, as this reduces the risk of unintended pregnancy.
Contact your doctor as soon as possible if you think your contraception may not be effective or if you missed taking a contraceptive pill.

You are not considered capable of becoming pregnant if you meet any of the following criteria:

• You are postmenopausal, i.e., over 50 years old and have not menstruated for more than one year (if menstruation has stopped due to cancer treatment, pregnancy is still possible),
• You have undergone surgery to remove both fallopian tubes and both ovaries (bilateral salpingo-oophorectomy),
• You have undergone hysterectomy (removal of the uterus),
• Your ovaries have ceased functioning (premature ovarian failure confirmed by a specialist gynecologist),
• You were born with one of the following rare conditions resulting in infertility: 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 children fathered by men taking mycophenolate. However, this risk cannot be completely ruled out. As a precaution, it is recommended that you or your partner use effective contraception during treatment and for 90 days after stopping Mycofit.
If you are planning a pregnancy, discuss the risks with your doctor and the possibility of using alternative medicines to prevent organ rejection.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Your doctor will inform you about the risks associated with pregnancy and alternative treatments that may be used to prevent rejection of the transplanted organ if:

• you are planning pregnancy,
• you have missed a menstrual period or experienced unusual bleeding, or suspect you are pregnant,
• you had unprotected intercourse.
  Contact your doctor immediately if you become pregnant during treatment with mycophenolate. However, continue taking Mycofit until you speak with your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriages (50%) and severe birth defects in the unborn child (23–27%). Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), developmental defects of fingers, heart, esophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida – abnormal formation of the spinal bones). A child born to a woman treated with 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 your doctor's contraception advice. Your doctor may request more than one test before starting treatment to confirm you are not pregnant.

Breastfeeding
Do not take Mycofit while breastfeeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines
Mycofit has a moderate effect on the ability to drive and use tools or operate machinery. If you experience drowsiness, dizziness, or confusion, inform your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Mycofit contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

3. How to take Mycofit

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
What dose of the medicine should be taken
The dose of the medicine depends on the type of transplant the patient has received. The usual
doses are shown below. Treatment will continue as long as prevention of organ rejection is required.
Kidney transplant
Adults:

• The first dose of the medicine is administered within 3 days after the transplant procedure.
• The daily dose is 8 capsules (2 g of medicine) taken in two separate doses.
• Take 4 capsules in the morning and 4 capsules in the evening.

Children:

• Capsules are suitable only for children who are able to swallow solid medication without risk of choking. Therefore, the medicine should be administered only as directed by a doctor. If in doubt, consult your doctor or pharmacist before using the medicine.
• The dose may vary depending on the child's size.
• Your child's doctor will determine the appropriate dose based on the child's height and body weight (body surface area measured in square meters, "m²"). The recommended initial dose is 600 mg/m² twice daily. The recommended maintenance dose is 600 mg/m² twice daily (maximum total daily dose is 2 g). The dose should be individually adjusted based on the doctor's clinical assessment.

Heart transplant
Adults:

• The first dose of the medicine is administered within 5 days after the transplant procedure.
• The daily dose is 12 capsules (3 g of medicine) taken in two separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children:
Capsules are suitable only for children who are able to swallow solid medication without
risk of choking. Therefore, the medicine should be administered only as directed by a doctor.
If in doubt, consult your doctor or pharmacist before using the medicine.

• The dose may vary depending on the child's size.
• Your child's doctor will determine the appropriate dose based on the child's height and body weight (body surface area measured in square meters, "m²"). The recommended initial dose is 600 mg/m² twice daily. The dose should be individually adjusted based on the doctor's clinical assessment. If the medicine is well tolerated, the dose may be increased if necessary to 900 mg/m² twice daily (maximum total daily dose is 3 g). Liver transplant
• Adults: The first oral dose of Mycofit should be administered at least 4 days after the transplant procedure and once the patient is able to swallow medication.
• The daily dose is 12 capsules (3 g of medicine) taken in two separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children:
Capsules are suitable only for children who are able to swallow solid medication without
risk of choking. Therefore, the medicine should be administered only as directed by a doctor.
If in doubt, consult your doctor or pharmacist before using the medicine.

• The dose may vary depending on the child's size.
• Your child's doctor will determine the appropriate dose based on the child's height and body weight (body surface area measured in square meters, "m²"). The recommended initial dose is 600 mg/m² twice daily. The dose should be individually adjusted based on the doctor's clinical assessment. If the medicine is well tolerated, the dose may be increased if necessary to 900 mg/m² twice daily (maximum total daily dose is 3 g).

Method and route of administration

• Swallow the capsules whole with a glass of water.
• Do not break, crush, or take broken, opened, or divided capsules.
• Take care to avoid contact of the powder from a damaged capsule with the skin or oral cavity. If contact occurs, rinse thoroughly with large amounts of clean water.
• Take care to avoid contact of the powder from a damaged capsule with the skin. If contact occurs, wash the skin thoroughly with soap and water.

Taking more Mycofit than recommended
If more Mycofit than recommended has been taken, contact your doctor immediately or go directly
to hospital. The same applies if someone else accidentally takes the medicine. Bring the medicine
packaging with you.
Missing a dose of Mycofit
If a dose of Mycofit is missed, take it as soon as you remember, then continue taking the medicine
as usual. Do not take a double dose to make up for a missed dose.
Stopping treatment with Mycofit
Do not stop treatment with Mycofit without consulting your doctor.
Stopping treatment may increase the risk of rejection of the transplanted organ.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Seek immediate medical advice if any of the following serious adverse reactions occur – they may require urgent treatment:

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

Common disorders
The most frequently reported disorders include: diarrhea, decreased number of white or red blood cells in the blood, infections, and vomiting. Your doctor will regularly order blood tests to monitor for any changes in:

• blood cell counts or signs of infection

In children, certain adverse reactions may occur more frequently than in adults. These include diarrhea, infections, reduced number of white blood cells, and reduced number of red blood cells in the blood.
Infection control
Mycofit weakens the body's immune system. This effect helps prevent transplant rejection. However, as a result, the body will not fight infections as effectively as usual. This means patients may be more susceptible to infectious diseases than normal. These include infections of the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.
Lymphoid tissue and skin tumors
A very small number of patients treated with Mycofit have developed lymphoid tissue and skin tumors, which may occur in patients receiving this type of medicine (immunosuppressive).
Systemic adverse reactions
Patients may experience systemic adverse reactions, including:
severe hypersensitivity reactions (such as anaphylaxis, angioedema), fever, fatigue, sleep disturbances, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and edema.
Other possible adverse reactions may include:
Skin disorders, such as:

• acne, herpes, shingles, skin overgrowth, hair loss, rash, itching.

Urinary system disorders, such as:

• presence of blood in urine.

Gastrointestinal and oral disorders, such as:

• swollen gums and oral ulcers,
• pancreatitis, colitis, or gastritis,
• gastrointestinal disorders including bleeding,
• liver disorders,
• diarrhea, constipation, nausea, indigestion, loss of appetite, bloating.

Nervous system disorders, such as:

• dizziness, drowsiness, numbness,
• tremor, muscle cramps, seizures,
• anxiety or depression, disturbances in thinking or mood.

Cardiac and vascular disorders, such as:

• changes in blood pressure, increased heart rate, blood vessel dilation.

Lung disorders, such as:

• pneumonia, bronchitis,
• shortness of breath, cough, which may be related to bronchiectasis (a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lungs). You should inform your doctor if a persistent cough or shortness of breath develops.
• fluid in the lungs or chest cavity,
• sinus problems.

Other disorders, such as:

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

Additional adverse reactions occurring in children and adolescents
In children, especially those under 6 years of age, the risk of certain adverse reactions is higher than in adults. These include: diarrhea, vomiting, infections, reduced number of red and white blood cells in the blood, as well as lymphoma or skin cancer.
Reporting adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, located at:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mycofit

Store below 30°C.
Keep out of the 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 stated month.
Do not use this medicine if there are visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. 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.
• Other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, povidone K-90, sodium croscarmellose, talc and magnesium stearate.
• Capsule shell composition: gelatin, sodium lauryl sulfate, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), indigotine (FD & C Blue 2) (E132).
• Printing ink composition: shellac, iron oxide black (E 172).

What Mycofit looks like and contents of the pack
Mycofit 250 mg capsules are light blue to peach-coloured, size "1", hard gelatin capsules, containing white to off-white powder, with "MMF" imprinted on the cap and "250" on the body.
Mycofit 250 mg is available in blister packs containing 100 and 300 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: + 48 22 577 28 00

Manufacturer/Importer
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009
Greece

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