Myfortic

Package leaflet: Information for the user

Myfortic 360 mg enteric-coated tablets
mycophenolic acid (as mycophenolate sodium)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Myfortic is and what it is 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 Myfortic is and what it is used for

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

2. Important information before taking Myfortic

WARNING
Mycophenolate may cause congenital malformations and miscarriage. Female patients who may become pregnant must
have a negative pregnancy test before starting treatment and must follow the contraception advice provided by their doctor.
The doctor will speak with the patient and provide written materials specifically addressing the effects of
mycophenolate on the unborn child. These materials should be carefully read and followed. If the information provided is not fully understood, the patient should ask the doctor for further explanation before taking mycophenolate. See also further information in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

When not to use Myfortic

• if the patient is allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient may become pregnant and has not had a negative pregnancy test result before first taking the medicine, because mycophenolate causes congenital malformations and miscarriage;
• if the patient is pregnant or plans to become pregnant, or thinks she may be pregnant;
• if the patient is not using effective contraception (see Contraception in women and men);
• if the patient is breastfeeding (see also section "Pregnancy and breastfeeding").

If any of the above apply, the patient must inform their doctor before taking Myfortic.

Warnings and precautions
Before starting Myfortic, discuss the following with your doctor or pharmacist:

• if the patient has or has ever had severe gastrointestinal disorders, such as peptic ulcer;
• if the patient has a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

The patient should be aware that:

• Myfortic weakens the body's natural defences against sunlight. Therefore, the risk of developing skin cancer is increased. Exposure to sunlight and ultraviolet (UV) radiation should be limited by wearing protective clothing and regularly applying sunscreen with a high sun protection factor. Advice on sun protection should be sought from the doctor.
• If the patient has previously had hepatitis B or C, Myfortic may increase the risk of reactivation of these diseases. The doctor may order blood tests and check for symptoms of these conditions. If any symptoms occur (yellowing of the skin or eyes, nausea, loss of appetite, dark urine), the patient must inform the doctor immediately.
• If the patient develops a persistent cough or shortness of breath, especially if taking other immunosuppressive medicines, the patient must inform the doctor immediately.
• The doctor may order blood tests to measure antibody levels during treatment with Myfortic, particularly in cases of recurrent infections, especially if the patient is also taking other immunosuppressive medicines. Based on test results, the doctor will decide whether treatment with Myfortic should continue.
• If the patient develops any signs of infection (such as fever or sore throat) or unexpected bruising or bleeding, the patient must contact the doctor immediately.
• During treatment with Myfortic, the doctor may order blood tests to monitor white blood cell counts and will inform the patient whether treatment can continue.
• The active substance, mycophenolic acid, is not the same as other substances with similar-sounding names, such as mycophenolate mofetil. These should not be used interchangeably without medical advice.
• Use of Myfortic during pregnancy may harm the unborn child (see also section "Pregnancy and breastfeeding") and increase the risk of pregnancy loss, including spontaneous abortion.

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

Elderly patients
Myfortic may be used in elderly patients (65 years of age or older) without the need to adjust the usual recommended dose.

Myfortic with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.
In particular, inform the doctor if the patient is taking any of the following medicines:

• another immunosuppressive medicine, such as azathioprine or tacrolimus;
• medicines used to treat high blood cholesterol levels, such as cholestyramine;
• activated charcoal, used to treat gastrointestinal disorders such as diarrhoea, stomach upset, and gas;
• antacids containing magnesium and aluminium, which neutralise stomach acid;
• medicines used to treat viral infections, such as acyclovir or ganciclovir.

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

Taking Myfortic with food and drink
Myfortic may be taken with or without food. The patient should choose one way and continue taking the medicine consistently in the same manner each day to ensure consistent absorption.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will discuss the risks associated with pregnancy and alternative methods to prevent organ rejection if:

• the patient plans to become pregnant;
• the patient has stopped menstruating or thinks she has stopped menstruating, or has irregular menstrual bleeding, or suspects she is pregnant;
• the patient has had sexual intercourse without using an effective method of contraception. If the patient becomes pregnant while taking mycophenolate, she must inform her doctor immediately. However, the patient should continue taking mycophenolate until speaking with her doctor.

Pregnancy
Mycophenolate causes frequent miscarriages (50%) and severe congenital malformations (23–27%) in unborn children. Reported congenital malformations include abnormalities of the ears, eyes, face (cleft lip/palate), fingers, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, or nervous system (e.g. spina bifida (a condition in which the spinal bones do not form properly)). One or more of these malformations may occur in the patient's child.
Female patients who may become pregnant must have a negative pregnancy test before starting treatment and must follow the contraception advice provided by their doctor. The doctor may request more than one test to confirm the patient is not pregnant before starting treatment.

Breastfeeding
Myfortic should not be taken if the patient is breastfeeding, as small amounts of the medicine may pass into breast milk.

Contraception in women taking Myfortic
If the patient is of childbearing age and may become pregnant, she must use an effective method of contraception during treatment with Myfortic. This applies to the following periods:

• before starting Myfortic;
• throughout the entire treatment period with Myfortic;
• for 6 weeks after stopping Myfortic.
  The patient should discuss the most appropriate method of contraception with her doctor. The choice will depend on the individual situation. It is best for the patient to use two methods of contraception, as this reduces the risk of unintended pregnancy. The patient should contact her doctor as soon as possible if she suspects contraception may not have been effective or if she missed taking a contraceptive pill.

A woman is considered unable to become pregnant if any of the following criteria apply:

• 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, pregnancy is still possible);
• she has undergone surgery to remove both fallopian tubes and both ovaries (bilateral salpingo-oophorectomy);
• she has undergone hysterectomy (surgical removal of the uterus);
• her ovaries have ceased functioning (premature ovarian failure, confirmed by a specialist gynaecologist);
• she was born with one of the following rare conditions leading to infertility: XY genotype, Turner syndrome, or uterine agenesis;
• she is 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 congenital malformations in children fathered by men taking mycophenolate. However, this risk cannot be completely ruled out. As a precautionary measure, it is recommended that the patient or his partner use effective contraception during treatment and for 90 days after stopping Myfortic.
Patients planning a pregnancy 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
This medicine contains 26 mg of sodium (the main component of table salt) in each Myfortic 360 mg tablet.
This corresponds to 1.3% of the maximum recommended daily dietary intake of sodium for adults.

Myfortic contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars (including lactose, galactose, or glucose), the patient should consult their doctor before taking this medicine.

3. How to take Myfortic

Myfortic must always be taken exactly as prescribed by the doctor. Myfortic should only be prescribed by physicians experienced in managing transplant patients. If in doubt, consult your doctor or pharmacist.

What dose to take
The recommended daily dose of Myfortic is 1440 mg (4 tablets of Myfortic 360 mg), taken as two separate doses of 720 mg each (2 tablets of Myfortic 360 mg).
The tablets should be taken in the morning and evening.
The first 720 mg dose 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 Myfortic 360 mg).

How to take Myfortic
Tablets must be swallowed whole with a glass of water.
Do not break or crush the tablets.
Do not take tablets that have been crushed or divided.
Treatment should continue as long as immunosuppression is needed to prevent the body from rejecting the transplanted organ.

Taking more Myfortic than prescribed
If you have taken more Myfortic tablets than prescribed or if someone else has taken the medicine, contact your doctor immediately or go to the nearest hospital. Medical assistance may be required. Take the tablets with you and show them to the doctor or hospital staff. If the patient no longer has the tablets, bring the empty packaging.

If you forget to take Myfortic
If the patient forgets to take Myfortic, they should take it as soon as possible unless it is almost time for the next dose. Then continue with the regular dosing schedule. Consult your doctor. Do not take a double dose to make up for a missed dose.

Stopping Myfortic treatment
Do not stop taking Myfortic unless instructed by your doctor. Stopping Myfortic may increase the risk of rejection of the transplanted kidney by the body.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Elderly patients may experience more adverse reactions due to weakened immune system function.
Immunosuppressive medicines, including Myfortic, weaken the patient's body's defence mechanisms by suppressing organ transplant rejection. As a result, the body cannot fight infections as effectively as normal. Therefore, when taking Myfortic, the patient is at increased risk of infections such as infections of the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.
The treating physician will order regular blood tests to monitor any changes in blood cell counts or blood levels of substances transported in the blood, such as glucose, fats, and cholesterol.

Adverse reactions that may be serious:

• signs of infection including fever, chills, excessive sweating, feeling tired, drowsiness, or lack of energy. When taking Myfortic, patients may be more susceptible than usual to viral, bacterial, or fungal infections. These infections may affect various body systems, most commonly the kidneys, bladder, and upper and/or lower respiratory tract;
• vomiting blood, black or bloody stools, stomach or intestinal ulcer;
• swollen lymph nodes, new skin growths or enlargement of existing skin lesions, or changes in existing moles. Since such events occur in patients taking immunosuppressive medicines, a very small number of patients treated with Myfortic may develop skin cancer or lymph node cancer. If any of the above symptoms occur, contact your doctor immediately.

Other adverse reactions, including:
Very common ( may occur in more than 1 in 10 patients )

• low white blood cell count
• low blood calcium levels (hypocalcaemia)
• low blood potassium levels (hypokalaemia)
• high blood uric acid levels (hyperuricaemia)
• high blood pressure (hypertension)
• anxiety
• diarrhoea
• joint pain (arthralgia)

Common ( may occur in less than 1 in 10 patients )

• low red blood cell count, which may cause fatigue, shortness of breath, and pallor (anaemia)
• low platelet count, which may cause unexpected bleeding and bruising (thrombocytopenia)
• high blood potassium levels (hyperkalaemia)
• low blood magnesium levels (hypomagnesaemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnoea)
• abdominal or stomach pain, inflammation of the stomach lining, bloating, constipation, indigestion, flatulence, loose stools, nausea, vomiting
• fatigue, fever
• abnormal kidney or liver function test results
• respiratory tract infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of hands, ankles, or feet (peripheral oedema)
• itching

Uncommon ( may occur in less than 1 in 100 patients )

• rapid heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• development of fluid-filled cysts (lymphocele)
• tremor, difficulty sleeping
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, bad breath, intestinal obstruction, lip ulceration, heartburn, discolouration of the tongue, dry mouth, gum inflammation, pancreatitis leading to severe upper abdominal pain, salivary duct blockage, inflammation of the inner lining of the abdominal cavity (peritonitis)
• bone, blood, and skin infections
• blood in urine, kidney damage, pain and difficulty urinating
• hair loss, skin bruising
• joint inflammation (arthritis), back pain, muscle cramps
• loss of appetite, increased blood lipid levels (hyperlipidaemia), increased blood glucose (diabetes), increased cholesterol (hypercholesterolaemia), or decreased blood phosphate levels (hypophosphataemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint and muscle pain), swelling of ankles and feet, pain, muscle stiffness, increased thirst, or weakness
• unusual dreams, false perceptions (hallucinations)
• inability to achieve or maintain an erection
• cough, breathing difficulties, pain on 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 low white blood cell count) (agranulocytosis)
• rash, itching, urticaria, shortness of breath or breathing difficulties, wheezing or cough, feeling faint, dizziness, changes in level of consciousness, hypotension with or without mild generalized itching, skin redness, and swelling of the face and/or throat (symptoms of severe allergic reaction)

Other adverse reactions reported with medicines similar to Myfortic
Additionally, the following adverse reactions have been reported in the group of medicines to which Myfortic belongs: colitis (inflammation of the large intestine), cytomegalovirus-induced inflammation of the stomach lining, intestinal wall perforation causing severe abdominal pain with possible bleeding, gastric or duodenal ulcers, low count of specific white blood cells or of all blood cells, severe infections such as endocarditis (infection of the heart and its valves) and meningitis (infection of the membranes covering the brain and spinal cord), shortness of breath, cough, which may be due to bronchiectasis (abnormal widening of the airway lumen), and other less common bacterial infections usually causing severe lung diseases (tuberculosis and infections caused by atypical mycobacteria Mycobacterium).
Patients should inform their doctor if they develop a persistent cough or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Myfortic

Keep this medicine 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 stated month.
There are no special requirements regarding the storage temperature of this medicine.
Store in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of having been opened.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Myfortic contains

• The active substance is mycophenolic acid (in the form of sodium mycophenolate). Each Myfortic tablet contains 360 mg of mycophenolic acid.
• Other ingredients are:
• Tablet core: maize starch, 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, oval tablets with the imprint "CT" on one side.
Myfortic 360 mg enteric-coated tablets are available in blister packs containing 50 or 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. 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 Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Vienna
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 medicinal product is authorised in the Member States of the European Economic Area under the name:
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, Sweden.
Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (https://www.gov.pl/web/urpl).