MYCOFIT

Package leaflet: Information for the patient

Mycofit, 500 mg, film-coated tablets
Mycophenolate mofetil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual only. Do not give it to others.
• This medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects worsens or if you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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 must be taken together with other medicines, such as cyclosporine and corticosteroids.

2. Important information before using 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 before starting treatment and must follow the doctor's instructions regarding contraception.
The doctor will speak with the patient and provide her with written information, particularly concerning the effects of mycophenolate on unborn children. Carefully read this information and follow the instructions.
If the instructions are not fully understood, consult the doctor to clarify them again before taking mycophenolate. Also, review the further information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".
When not to use 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, because 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 contraceptive methods (see: Contraception, pregnancy and breastfeeding),
• if the patient is breastfeeding.

Do not take this medicine if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before using Mycofit.
Warnings and precautions
Before starting Mycofit, immediately consult a doctor, pharmacist, or nurse:

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

If any of the above cases apply to the patient (or if the patient is uncertain), immediately speak with the 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. Limit exposure to sunlight and UV radiation by:

• wearing protective clothing covering the head, neck, arms, and legs,
• using high-protection sunscreen.

Children
In children, especially under 6 years of age, certain adverse reactions may be more likely than in adults. These include: diarrhea, vomiting, infections, reduced number of red blood cells, reduced number of white blood cells in the blood, and possibly lymphatic system or skin tumors.
Tablets are suitable only for children able to swallow solid medication without risk of choking. Therefore, the medicine should only be administered as directed by the doctor.
If in doubt about any issues related to treating a child, consult a doctor or pharmacist before using the medicine.
Other medicines and Mycofit
Inform the doctor or pharmacist about all medicines currently taken or recently taken, including over-the-counter medicines and herbal remedies. This is because Mycofit may affect the action of certain medicines, and some medicines may affect the action of Mycofit.
In particular, before starting Mycofit, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• azathioprine or other immunosuppressive medicines – administered 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 acidity 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.

Vaccinations
If vaccination (with a live vaccine) is required while taking Mycofit, consult the doctor or pharmacist first. The doctor should advise which vaccine to use.
Do not donate blood while taking mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with mycophenolate mofetil and for at least 90 days after stopping treatment.
Mycofit with food and drink
Food and drink do not affect treatment with Mycofit.
Pregnancy, breastfeeding, and fertility
Contraception in women taking Mycofit
If the patient is a woman of childbearing age who may become pregnant, she must use an effective method of contraception during treatment with Mycofit. This applies to the period:

• before starting Mycofit,
• throughout the entire Mycofit treatment period,
• for 6 weeks after stopping Mycofit.
  Discuss with the doctor the most appropriate contraceptive method. The choice will depend on the individual patient's situation. It is best for the patient to use two contraceptive methods, as this reduces the risk of unintended pregnancy. Contact the doctor immediately if the patient thinks contraception may not be effective or if she missed taking a contraceptive pill.

A woman is considered unable to become 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 stopped due to cancer treatment, pregnancy is still possible),
• she has undergone surgery to remove both fallopian tubes and both ovaries (bilateral adnexectomy),
• she has undergone hysterectomy (removal of the uterus),
• her ovaries have ceased functioning (premature ovarian failure confirmed by a specialist gynecologist),
• she was born with one of the following rare conditions that prevent pregnancy: XY genotype, Turner syndrome, or uterine agenesis,
• 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 congenital malformations in children fathered by men 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. When planning a pregnancy, discuss the risks and alternative treatment options with the doctor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will inform the patient about the risks associated with pregnancy and alternative treatments that can be used to prevent organ transplant rejection if:

• the patient plans pregnancy,
• the patient misses a menstrual period or experiences unusual bleeding, or suspects she is pregnant,
• the patient had intercourse without using effective contraception.

Inform the doctor immediately if the patient becomes pregnant during treatment with mycophenolate. However, continue taking Mycofit until contacting the doctor.
Pregnancy
Mycophenolate very frequently causes miscarriages (50%) and severe congenital malformations in the unborn child (23–27%). Reported birth defects include malformations of the ears, eyes, face (cleft lip/palate), developmental abnormalities of fingers, heart, esophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida [abnormally formed spinal bones]). The child may have one or more of these malformations.
If the patient is of childbearing age, she must provide a negative pregnancy test result before starting treatment and must follow the doctor's instructions regarding contraception. The doctor may request more than one test before starting treatment to confirm the patient is not pregnant.
Breastfeeding
Do not use Mycofit while breastfeeding, as small amounts of the medicine may pass into breast milk.
Driving and operating machinery
Mycofit has a moderate effect on the ability to drive vehicles and use tools or operate machinery. If the patient experiences drowsiness, dizziness, or confusion, inform the doctor or nurse and do not drive or use tools or operate machinery until well-being improves.
Mycofit contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Mycofit

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
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 presented below. Treatment will continue for as long as protection against organ rejection is required.
Kidney transplant
Adults:

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

Children:

• Tablets are suitable only for children who are able to swallow solid dosage forms without risk of choking. Therefore, the medicine should be administered strictly according to the doctor's instructions. In case of 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 recommend the appropriate dose based on the child's height and body weight (body surface area measured in square meters or "m²"). The recommended initial 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 transplantation surgery.
• The daily dose is 6 tablets (3 g of medicine) taken in two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:

• Tablets are suitable only for children who are able to swallow solid dosage forms without risk of choking. Therefore, the medicine should be administered strictly according to the doctor's instructions. In case of 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 recommend 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 transplantation and only when the patient is able to swallow the medicine.
• The daily dose is 6 tablets (3 g of medicine) taken in two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:

• Tablets are suitable only for children who are able to swallow solid dosage forms without risk of choking. Therefore, the medicine should be administered strictly according to the doctor's instructions. In case of 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 recommend 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:
Tablets should be swallowed whole with a glass of water. Do not break or crush the tablets.
Overdose of Mycofit
If more than the recommended dose of Mycofit has been taken, contact your doctor immediately or go to the hospital. The same applies if someone else accidentally takes the medicine. Bring the medicine packaging with you.
Missed dose of Mycofit
If a dose 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 the missed dose.
Stopping treatment with Mycofit
Do not stop treatment with Mycofit without consulting your doctor. Stopping treatment may increase the risk of transplant rejection.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, 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 observed disorders include: diarrhoea, 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 diarrhoea, infections, reduced number of white blood cells, and reduced number of red blood cells in the blood.
Fighting infections
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 that patients may be more susceptible than usual to infectious diseases. These include infections of the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.
Lymphoid tissue and skin tumours
In a very small number of patients treated with mycophenolate mofetil, lymphoid tissue and skin tumours have developed. This may occur in patients taking this type of medicine (immunosuppressive).
Generalised adverse reactions
Patients may experience generalised adverse reactions, including:

• severe hypersensitivity reactions (such as anaphylaxis, angioedema), fever, feeling tired, sleep disturbances, pain such as stomach pain, chest pain, joint or muscle pain, headache, flu-like symptoms, swelling.

Other possible adverse reactions may affect:
Skin disorders, such as

• acne, herpes simplex, shingles, skin hypertrophy, hair loss, rash, itching.

Urinary system disorders, such as

• presence of blood in the urine.

Gastrointestinal and oral disorders, such as

• swollen gums and mouth ulcers
• pancreatitis, colitis, or gastritis
• intestinal disorders, including bleeding
• liver disorders
• diarrhoea, constipation, nausea, indigestion, loss of appetite, bloating.

Nervous system disorders, such as

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

Cardiac and vascular disorders, such as

• changes in blood pressure, abnormal heart function, blood vessel dilation.

Lung disorders, such as

• pneumonia, bronchitis
• shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the bronchi are abnormally widened) or pulmonary fibrosis (scarring of the lungs). If a persistent cough or shortness of breath occurs, contact your doctor.
• 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: diarrhoea, 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 any not listed in this leaflet, tell your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, located at:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Mycofit

Do not store above 25°C. Keep in the original packaging to protect from light.
Store in a place inaccessible and not visible to children.
Do not use this medicinal product 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.
Any unused medicine should always be returned to the pharmacist. It may be retained only
if the doctor so advises.
Medicines must not be disposed of via the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Mycofit contains

• The active substance is 500 mg of mycophenolate mofetil
• The other components are:

Tablet core: microcrystalline cellulose, povidone, hydroxypropylcellulose, croscarmellose sodium, purified talc and magnesium stearate.
Coating composition: hypromellose 6 cPs, titanium dioxide (E171), macrogol 400, iron oxide red (E172), indigo carmine (E132), iron oxide black (E172), purified talc.

What Mycofit looks like and contents of the pack
Mycofit is purple, capsule-shaped, biconvex coated tablets, marked with "AHI" imprinted on one side and "500" on the other side.
Mycofit tablets are available in blisters containing 50, 150 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
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.
Lutomierska Street 50
95-200 Pabianice
Poland
LABORATORI FUNDACIÓDAU
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: