Patient Information Leaflet

Myfenax 500mg Film-Coated Tablets
micofenolato mofetilo

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

Myfenax is a medication used to suppress immune activity.

The active ingredient of this medication is mycophenolate mofetil.

Myfenax is used to prevent the body from rejecting a kidney, heart, or liver transplant. It is used in combination with other medications with a similar function (i.e. cyclosporine and corticosteroids).

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor.

Your doctor will explain and provide written information, particularly about the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not understand these instructions completely, please consult your doctor again before taking mycophenolate. See more information in this section, under the headings “Warnings and Precautions” and “Pregnancy, Contraception, and Breastfeeding”.

Do not take Myfenax,

• if you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the other components of this medication (listed in section6).
• if you are a woman who can become pregnant and have not obtained a negative pregnancy test result before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions,
• ifyou are pregnant or intend to become pregnant or believe you may be pregnant.
• if you are not using effective contraceptives (see Pregnancy, Contraception, and Breastfeeding).
• if you are breastfeeding.

Do not take this medication if you experience any of the above. If you are unsure, consult your doctor or pharmacist before taking Myfenax.

Warnings and Precautions

Consult your doctor before starting treatment with Myfenax:

• if you are over 65years old, as you may have a higher risk of developing adverse reactions such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients.
• if you experience any signs of infection (e.g., fever, sore throat), unexplained rashes, and/or bleeding.
• if you have or have had any gastrointestinal problems, e.g., stomach ulcers.
• if you are planning to become pregnant or have become pregnant while taking Myfenax.
• if you have a hereditary enzyme deficiency, such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

Myfenax reduces your body's defense mechanism. Therefore, there is a higher risk of developing skin cancer. Therefore, you must limit your exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and using a high-factor sunscreen.

Do not donate blood during treatment with Myfenax and for at least 6 weeks after completing treatment. Men should not donate semen during treatment with Myfenax and for at least 90 days after completing treatment.

Children and Adolescents

Myfenax is used in children and adolescents (2-18years old) to prevent rejection of a kidney transplant.

Myfenax should not be used in children and adolescents (2-18years old) for heart or liver transplants.

Myfenax should never be used in children under 2years old, as safety and efficacy data in this age group are limited, and recommendations for dosing cannot be made.

Other Medications and Myfenax

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If the answer to any of the following questions is affirmative, consult your doctor before starting to take Myfenax:

• Are you taking any medication that contains:

• azathioprine or another immunosuppressant (sometimes administered after a transplant operation),
• cholestyramine (used to treat patients with high blood cholesterol levels), rifampicin (antibiotic),
• antacids or proton pump inhibitors (used to treat stomach acid problems such as indigestion),

• phosphate binders (used in patients with chronic kidney disease to reduce phosphate absorption),
• antibiotics (used to treat bacterial infections),
• isavuconazole (used to treat fungal infections),
• telmisartan (used to treat high blood pressure)

• or any other medication (including over-the-counter medications) that your doctor does not know about?

• Do you need to receive a vaccine (live vaccine)? Your doctor will advise you on the most suitable vaccine for you.

Pregnancy, Contraception, and Breastfeeding

Contraception in Women Taking Myfenax

If you are a woman who can become pregnant, you must use an effective contraceptive method. This includes:

• Before starting to take Myfenax
• During treatment with Myfenax
• For at least 6weeks after stopping Myfenax

Consult your doctor to determine the most suitable contraceptive method for you. This will depend on your individual situation. It is recommended to use two contraceptive methods, as this will reduce the risk of unintended pregnancy.Consult your doctor as soon as possible if you believe your contraceptive method may not have been effective or if you have forgotten to take your contraceptive pill..

You cannot become pregnant, if your case is one of the following:

• You are postmenopausal, i.e., you are at least 50 years old and your last period occurred more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may become pregnant).
• Your fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (hysterectomy).
• Your ovaries do not function (premature ovarian failure, confirmed by a specialist gynecologist).
• You were born with one of the following rare diseases, which makes it impossible to become pregnant: XY genotype, Turner syndrome, or uterine agenesis.
• You are a girl or adolescent who has not yet started menstruating.

Contraception in Men Taking Myfenax

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for at least 90days after stopping Myfenax.

If you are planning to have a child, consult your doctor about the risks and alternative treatments.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will discuss the risks and alternative treatments with you if:

•You intend to become pregnant.

•You have missed or suspect a period or have unusual menstrual bleeding.

•You have had unprotected sex.

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking Myfenax until you see your doctor.

Pregnancy

Mycophenolate causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida, where the spine bones do not develop correctly) abnormalities. Your baby may be affected by one or more of these.

If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.

Breastfeeding

Do not take Myfenax if you are breastfeeding, as small amounts of the medication may pass into breast milk.

Driving and Using Machines

The influence of Myfenax on your ability to drive and use machines is moderate. If you feel drowsy, dizzy, or confused, speak with your doctor or nurse and do not drive or use tools or machines until you feel better.

Myfenax Contains Sodium

This medication contains less than 1mmol of sodium (23mg) pertablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your treatment will be started and monitored by a specialist doctor in transplants.

The usual way to take Myfenax is as follows:

Kidney Transplant

Adults

The first dose should be administered within the 72-hour period following the transplant surgery. The recommended daily dose is 4 tablets (2 g of active substance), administered in 2 separate doses. This means taking 2 tablets in the morning and other 2 tablets at night.

Children and adolescents (between 2 and 18 years)

The dose varies according to the child's height. The doctor will decide on the most suitable dose taking into account the body surface area (weight and height). The recommended dose is 600 mg/m2, administered twice a day.

Heart Transplant

Adults

The first dose should be administered within the 5-day period following the transplant surgery. The recommended daily dose is 6 tablets (3 g of active substance), administered in two separate doses. This means taking 3 tablets in the morning and other 3 tablets at night.

Children

There is no information on the use of Myfenax in children with heart transplants.

Liver Transplant

Adults:

The first oral dose of Myfenax should be administered at least 4 days after the transplant surgery and when able to swallow oral medications. The recommended daily dose is 6 tablets (3 g of active substance), administered in 2 separate doses. This means taking 3 tablets in the morning and other 3 tablets at night.

Children

There is no information on the use of Myfenax in children with liver transplants.

Form of use and route of administration

Swallow the tablets whole with a glass of water. You can take it with or without food. Do not break or crush them.

The treatment will continue as long as immunosuppression is needed to prevent rejection of the transplanted organ.

If you take more Myfenax than you should

It is essential not to take too many tablets. If you take more tablets than you have been told, or if you think a child has taken any, contact your doctor or the hospital's emergency department.

If you forget to take Myfenax

If you ever forget to take the medication, take it as soon as you remember and continue at your usual times.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Myfenax:

Do not stop taking Myfenax even if you feel better. It is essential to take the medication for the entire time your doctor has told you. Stopping treatment with Myfenax may increase the risk of organ rejection. Do not stop taking it unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Consult a doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:

• have a sign of infection, such as fever or sore throat.
• have a hematoma or unexpected bleeding.
• have a skin rash, facial swelling, lip, tongue, or throat swelling, with difficulty breathing; you may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).
• have black or bloody stools or vomit blood or dark particles similar to ground coffee. They may be signs of bleeding in the stomach or intestines.

The frequency of certain side effects depends on the transplanted organ, that is, some side effects may occur more or less frequently depending on whether this medicine is being taken to prevent your body from rejecting a transplanted heart or a transplanted kidney. For clarity, each side effect is always listed classified by its highest frequency.

Other side effects

Very common (may affect more than 1 in 10 people)

• bacterial, viral, and/or fungal infections
• severe infection that can affect the entire body
• decrease in the number of white blood cells, platelets, or red blood cells, which can result in a higher risk of infections, hematomas, bleeding, difficulty breathing, and weakness
• bleeding under the skin

• increase in the number of white blood cells
• excess acid in the body
• high levels of cholesterol and/or lipids in the blood
• high blood sugar levels
• high levels of potassium in the blood, low levels of potassium, magnesium, calcium, and/or phosphate in the blood
• high levels of uric acid in the blood, gout
• feeling of unease, abnormalities in thought, perception, and levels of consciousness, depression, feeling of anxiety, difficulty sleeping
• increased muscle tension, spasms, drowsiness, feeling of dizziness, headache, tingling, pins and needles, or numbness
• rapid heart rate,
• low/high blood pressure, dilation of blood vessels
• fluid accumulation in the lungs, difficulty breathing, cough
• swollen abdomen
• vomiting, stomach pain, diarrhea, nausea
• constipation, indigestion, gas (flatulence)
• loss of appetite
• changes in various analytical parameters
• inflammation of the liver, yellowing of the skin and the white of the eyes
• skin growth, skin rash, acne
• muscle weakness
• joint pain
• kidney problems
• blood in the urine
• fever, feeling of cold, pain, feeling of fatigue and weakness
• fluid retention in the body
• part of an internal organ or tissue that protrudes through a weak point in the abdominal muscles
• muscle pain, neck, and back pain

Frequent (may affect up to 1 in 10people)

• skin cancer, non-cancerous skin growth
• abnormal and excessive growth of a tissue
• decrease in the number of all blood cells
• benign enlargement of lymph nodes, inflammatory changes in the skin (pseudolymphoma)
• weight loss
• abnormal thinking
• seizures
• alteration of the sense of taste
• blood clot that forms inside a vein
• inflammation of the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs
• intestinal obstruction
• inflammation of the colon that causes abdominal pain or diarrhea (sometimes caused by cytomegalovirus), mouth and/or stomach and/or duodenum ulcers, inflammation of the stomach, esophagus, and/or mouth and lips
• belching
• hair loss
• general feeling of illness
• overgrowth of gum tissue
• inflammation of the pancreas, which causes intense pain in the abdomen and back

Rare (may affect up to 1 in 100 people)

• protozoal infections
• growth of lymphatic tissue, including malignant tumors

• insufficient production of red blood cells
• serious bone marrow diseases, accumulation of lymphatic fluid in the body
• difficulty breathing, cough, which may be due to bronchiectasias (a condition in which the respiratory pathways are abnormally dilated) or pulmonary fibrosis (pulmonary scarring). Consult your doctor if you develop persistent cough or difficulty breathing.
• decrease in the amount of antibodies in the blood
• intense reduction in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)

Frequency not known (cannot be estimated from available data)

• alterations of the inner wall of the small intestine (intestinal atrophy)
• severe inflammation of the membrane that covers the brain and spinal cord
• severe inflammation of the heart and its valves
• bacterial infections that usually cause severe respiratory disease (tuberculosis, atypical mycobacterial infection)
• serious kidney disease (BK virus-associated nephropathy)
• serious central nervous system disease (progressive multifocal leukoencephalopathy associated with JC virus)
• decrease in the number of certain white blood cells (neutropenia)
• change in the shape of certain white blood cells

Do not stop taking the medicine unless you have previously discussed it with your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Myfenax:

• The active ingredient is mycophenolate mofetil 500mg.

Each tablet contains 500mg of mycophenolate mofetil.

• The other components are:

Tablet core

Microcrystalline cellulose

Povidone K-30

Magnesium stearate

Sodium croscarmellose

Tablet coating

Hydroxypropyl methylcellulose (HPMC 2910)

Titanium dioxide (E171)

Macrogol (PEG400)

Talc

Lacquer of aluminium carmine (E132)

Iron oxide black (E172)

Iron oxide red (E172)

Appearance of the product and contents of the package

Coated tablets:

Coated tablet, pale purple, oval, engraved with "M500" on one side and smooth on the other side.

Myfenax 500mg coated tablets are available in PVC/PVdC-aluminium blister packs in pack sizes of 50, 100, 150, 50x1or 100 x 1 tablets and in multiple packs with 150(3packs of 50)tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturers:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042

Hungary

Teva Operations Poland Sp. Z.o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet: {month/YYYY}

For more detailed information about this medicine, please visit the website of the European Medicines Agencyhttp://www.ema.europa.eu.