Mifortic

Leaflet attached to the packaging: information for the user

Myfortic 360 mg enteric-coated tablets

mycophenolic acid (in the form of mycophenolate sodium)

You should carefully read the contents of the leaflet before taking the 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.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Myfortic and what is it used for

Myfortic contains the active substance mycophenolic acid. It belongs to a group of medicines called immunosuppressants.
Myfortic is used to prevent rejection of a transplanted kidney by suppressing the immune system. It is used in combination with cyclosporin and corticosteroids.

2. Important information before taking Myfortic

WARNING
Mycophenolate causes birth defects and miscarriage. Women who may become pregnant must have a negative pregnancy test before starting treatment and must follow the doctor's advice on contraception.
The doctor will discuss with the patient and provide written materials, particularly regarding the effect of mycophenolate on the unborn child. The patient should read these materials carefully and follow the instructions. If the information provided is not fully understood, the patient should ask their doctor to explain it again before taking mycophenolate. See also the further information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

When not to take Myfortic

• if the patient is allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or plans to become pregnant, as mycophenolate causes birth defects and miscarriage;
• if the patient is breastfeeding (see also "Pregnancy and breastfeeding");
• if the patient has a rare hereditary deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT, e.g., Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome).

If any of the above points apply to the patient, they should tell their doctor before taking Myfortic.

Warnings and precautions

Before starting treatment with Myfortic, the patient should discuss the following with their doctor or pharmacist:

• if the patient has or has had severe gastrointestinal disorders, such as stomach ulcers;
• if the patient has a rare hereditary deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT, e.g., Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome).

The patient should be aware that:

• Myfortic weakens the body's defense mechanisms, which can increase the risk of developing skin cancer. The patient should limit their exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and regularly using sunscreens with a high sun protection factor. The patient should consult their doctor about sun protection.
• If the patient has had hepatitis B or C in the past, Myfortic may increase the risk of these diseases coming back. The doctor may order blood tests and check for symptoms of these diseases. If any symptoms occur (yellowing of the skin and eyes, nausea, loss of appetite, dark urine), the patient should tell their doctor immediately.
• If the patient has a persistent cough or shortness of breath, especially if they are taking other immunosuppressive medicines, they should tell their doctor immediately.
• The doctor may order blood tests to check the levels of antibodies in the patient's blood during treatment with Myfortic, especially if the patient has recurring infections, especially if they are also taking other immunosuppressive medicines. Based on the test results, the doctor will decide whether to continue treatment with Myfortic.
• If the patient experiences any symptoms of infection (such as fever or sore throat) or unexpected bruising or bleeding, they should contact their doctor immediately.
• The doctor may order blood tests to check the patient's white blood cell count and inform them whether they can continue treatment with Myfortic.
• The active substance, mycophenolic acid, is not the same as other substances with similar names, such as mycophenolate mofetil. The patient should not take them interchangeably without their doctor's advice.
• Taking Myfortic during pregnancy may harm the fetus (see also "Pregnancy and breastfeeding") and increase the risk of miscarriage, including the risk of spontaneous abortion.

Children and adolescents

Due to the lack of data, Myfortic is not recommended for use in children and adolescents.

Elderly patients

In elderly patients (65 years or older), Myfortic can be used without the need to adjust the recommended dose.

Myfortic and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription.
In particular, the patient should inform their doctor about taking any of the following medicines:

• another immunosuppressive medicine, such as azathioprine or tacrolimus;
• medicines used to treat high cholesterol, such as cholestyramine;
• activated charcoal, used to treat gastrointestinal disorders, such as diarrhea, stomach upset, and gas;
• antacids containing magnesium and aluminum;
• medicines used to treat viral infections, such as acyclovir or ganciclovir.

The patient should also tell their doctor if they plan to receive any vaccinations.
Patient should not donate blood during treatment with Myfortic and for at least 6 weeks after stopping treatment.
Men should not donate semen during treatment with Myfortic and for at least 90 days after stopping treatment.

Taking Myfortic with food and drink

Myfortic can be taken with or without food. The patient should decide on one option and continue taking the medicine in the same way to ensure that it is absorbed at the same level every day.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine. The doctor will discuss with the patient the risks of pregnancy and other methods of preventing transplant rejection, if:

• the patient plans to become pregnant;
• the patient has stopped menstruating or thinks they have stopped menstruating or has unusual menstrual bleeding or thinks they may be pregnant;
• the patient has had unprotected sex. If the patient becomes pregnant while taking mycophenolate, they should tell their doctor immediately. However, they should continue taking mycophenolate until they have spoken to their doctor.

Pregnancy
Mycophenolate is a cause of very frequent miscarriages (50%) and severe birth defects (23-27%) in unborn babies. The reported birth defects included ear, eye, facial (cleft lip/palate), finger, heart, esophagus (the tube connecting the throat to the stomach), kidney, or nervous system (e.g., spina bifida) abnormalities. One or more of these birth defects may occur in the patient's baby.
Women who can become pregnant must have a negative pregnancy test before starting treatment and must follow the doctor's advice on contraception. The doctor may ask the patient to have more than one pregnancy test to make sure they are not pregnant before starting treatment.
Breastfeeding
Myfortic should not be taken if the patient is breastfeeding. This is because a small amount of the medicine may pass into breast milk.

Contraception in women taking Myfortic

If the patient is of childbearing potential and may become pregnant, they must use effective contraception during treatment with Myfortic. This applies to:

• the period before starting Myfortic;
• the entire treatment period with Myfortic;
• 6 weeks after stopping Myfortic. The patient should discuss with their doctor the most suitable method of contraception. The choice will depend on the individual situation of the patient. It is recommended that the patient uses two methods of contraception, as this will reduce the risk of unintended pregnancy. The patient should contact their doctor as soon as possible if they think their contraception may not be working or if they have forgotten to take a contraceptive pill.

The patient is not able to become pregnant if any of the following apply:

• they are postmenopausal, i.e., they are over 50 years old and have not menstruated for more than a year (if menstruation has stopped due to cancer treatment, they may still be able to become pregnant);
• they have had their fallopian tubes and both ovaries removed (bilateral salpingo-oophorectomy);
• they have had their uterus removed (hysterectomy);
• their ovaries have stopped working (premature ovarian failure, confirmed by a gynecologist);
• they were born with one of the following rare genetic disorders that result in infertility: XY genotype, Turner syndrome, or uterine agenesis;
• they are a child or adolescent who has not yet started menstruating.

Contraception in men taking Myfortic

Available data do not indicate an increased risk of miscarriage or birth defects in the baby if the father is taking mycophenolate. However, this risk cannot be completely ruled out.
As a precaution, it is recommended that the patient or their partner uses effective contraception during treatment and for 90 days after stopping Myfortic.
If the patient plans to have a baby, they should discuss the risks with their doctor.

Driving and using machines

Myfortic has a minor influence on the ability to drive and use machines.

Myfortic contains sodium

The medicine contains 26 mg of sodium (the main component of common salt) in each 360 mg Myfortic tablet.
This is equivalent to 1.3% of the maximum recommended daily intake of sodium for adults.

Myfortic contains lactose

If the patient has been diagnosed with an intolerance to some sugars (e.g., lactose, galactose, or glucose), they should contact their doctor before taking the medicine.

3. How to take Myfortic

Myfortic should always be taken exactly as prescribed by the doctor. Myfortic should only be prescribed by doctors who have experience in treating patients who have had a transplant.
If the patient is unsure, they should ask their doctor or pharmacist.

What dose to take

The recommended daily dose of Myfortic is 1440 mg (4 tablets of 360 mg), taken as 2 separate doses of 720 mg each (2 tablets of 360 mg).
The tablets should be taken in the morning and evening.
The first dose of 720 mg should be taken within 72 hours after transplantation.

In case of severe kidney impairment

The daily dose should not exceed 1440 mg (4 tablets of 360 mg).

How to take Myfortic

The tablets should be swallowed whole, with a glass of water.
The tablets should not be broken or crushed.
Tablets that have been broken or crushed should not be taken.
Treatment should continue for as long as immunosuppression is needed to prevent rejection of the transplanted organ.

Overdose of Myfortic

If the patient has taken more tablets than prescribed or if someone else has taken the medicine, they should contact their doctor or go to the nearest hospital immediately. Medical attention may be necessary. The patient should take the tablets and show them to the doctor or hospital staff. If the patient no longer has the tablets, they should take the empty packaging.

Missing a dose of Myfortic

If the patient forgets to take a dose of Myfortic, they should take it as soon as possible, unless it is almost time for the next dose. Then, they should continue with their regular dosing schedule. The patient should consult their doctor. The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Myfortic

The patient should not stop taking Myfortic unless their doctor tells them to. Stopping treatment with Myfortic may increase the risk of rejection of the transplanted kidney.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Myfortic can cause side effects, although not everybody gets them.
In elderly patients, more side effects may occur due to weakened immune system function.
Immunosuppressive medicines, including Myfortic, weaken the body's defense mechanisms, which can increase the risk of infections, such as brain, skin, mouth, stomach, and intestinal infections, as well as urinary tract infections.
The doctor will order regular blood tests to monitor any changes in blood cell counts or levels of substances in the blood, such as sugar, fat, and cholesterol.

Side effects that may be serious:

• symptoms of infection, including fever, chills, excessive sweating, feeling tired, sleepiness, or lack of energy. If the patient is taking Myfortic, they may be more susceptible to viral, bacterial, or fungal infections. This can affect various systems in the body, most commonly the kidneys, bladder, upper and/or lower respiratory tract;
• vomiting blood, black or bloody stools, stomach or intestinal ulcers;
• enlarged lymph nodes, new or enlarged growths on the skin or changes in existing moles. As this occurs in patients taking immunosuppressive medicines, a small number of patients treated with Myfortic may develop skin cancer or lymph node cancer. If any of these symptoms occur, the patient should contact their doctor immediately.

Other side effects, including:

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

• low white blood cell count
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• high uric acid levels in the blood (hyperuricemia)
• high blood pressure (hypertension)
• anxiety
• diarrhea
• joint pain (arthralgia)

Common( may affect up to 1 in 10 people)

• low red blood cell count, which can cause tiredness, shortness of breath, and pale skin (anemia)
• low platelet count, which can cause unexpected bleeding and bruising (thrombocytopenia)
• high potassium levels in the blood (hyperkalemia)
• low magnesium levels in the blood (hypomagnesemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnea)
• abdominal or stomach pain, gastritis, bloating, constipation, indigestion, gas, loose stools, nausea, vomiting
• fatigue, fever
• abnormal liver or kidney function test results
• respiratory tract infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of hands, ankles, or feet (peripheral edema)
• itching

Uncommon( may affect up to 1 in 100 people)

• fast heart rate (tachycardia) or irregular heartbeat (extrasystoles), fluid in the lungs (pulmonary edema)
• growth of a cyst containing fluid (lymphocele)
• tremors, sleep disturbances
• redness and swelling of the eyes (conjunctivitis), blurred vision
• snoring
• belching, bad breath, intestinal obstruction, mouth ulcers, esophagitis, dry mouth, gum inflammation, pancreatitis causing severe abdominal pain, closure of the salivary gland duct, peritonitis (inflammation of the lining of the abdominal cavity)
• bone, blood, or skin infections
• blood in the urine, kidney damage, pain, or difficulty urinating
• hair loss, skin discoloration
• arthritis, back pain, muscle cramps
• loss of appetite, high lipid levels (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolemia), or low phosphate levels in the blood (hypophosphatemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of the ankles and feet, pain, or stiffness of the muscles, increased thirst, or weakness
• abnormal dreams, hallucinations
• impotence
• cough, difficulty breathing, pain when breathing (possible symptoms of interstitial lung disease)

Frequency not known( frequency cannot be estimated from the available data)

• fever, sore throat, frequent infections (possible symptoms of agranulocytosis)
• rash, itching, hives, difficulty breathing or swallowing, wheezing or coughing, feeling faint, dizziness, changes in consciousness, low blood pressure with or without generalized itching, redness of the skin, and swelling of the face and/or throat (symptoms of a severe allergic reaction)

Other side effects reported for medicines like Myfortic

Additionally, the following side effects have been reported for the group of medicines to which Myfortic belongs: colitis (inflammation of the large intestine), cytomegalovirus gastritis, perforation of the intestinal wall, causing severe abdominal pain with possible bleeding, stomach or duodenal ulcers, low levels of certain white blood cells or all blood cells, severe infections, such as endocarditis (infection of the heart and its valves) and meningitis (inflammation of the membrane covering the brain and spinal cord), shortness of breath, cough, which may be caused by bronchiectasis (abnormal dilation of the airways) and other less common bacterial infections that usually cause severe lung disease (tuberculosis and atypical mycobacterial infection).
The patient should tell their doctor if they have a persistent cough or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (https://smz.ezdrowie.gov.pl)
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Myfortic

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Store in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Myfortic contains

• The active substance of Myfortic is mycophenolic acid (in the form of mycophenolate sodium). Each tablet contains 360 mg of mycophenolic acid.
• The other ingredients are:
• tablet core: cornstarch, povidone, crospovidone, lactose, colloidal anhydrous silica, magnesium stearate.
• tablet coating: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Myfortic looks like and contents of the pack

Myfortic 360 mg enteric-coated tablets are light orange-red, film-coated, and oval, with "CT" marked on one side.
Myfortic 360 mg enteric-coated tablets are available in packs containing 50, 100, 120, or 250 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Tel. +48 22 375 48 88

Manufacturer/Importer

Lek d.d.
PE PROIZVODNJA LENDAVA
Trimlini 2D, Lendava, 9220
Slovenia
Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Wien
Austria
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

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

Myfortic: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain.
Date of last revision of the leaflet:10/2024

Other sources of information

Detailed information on this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (https://www.gov.pl/web/urpl)