Product Information for the User

Myfortic 180 mgGastro-resistant Tablets

Mycophenolic Acid (as Mycophenolate Sodium)

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Product Information

1.What Myfortic is and for what it is used

2.What you need to know before starting to take Myfortic

3.How to take Myfortic

4.Possible adverse effects

5.Storage of Myfortic

6.Contents of the pack and additional information

Myfortic contains a substance called mycophenolic acid. It belongs to a class of medications known as immunosuppressants.

Myfortic is used to prevent your body's immune system from rejecting the transplanted kidney. It is used in combination with other medications that contain cyclosporin 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 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 to have them explained to you before taking mycophenolate. See more information below in this section, under the headings “Warnings and Precautions” and “Pregnancy and Breastfeeding”.

Do not take Myfortic:

• if you are allergic to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil, or any of the other components of this medication (listed in section 6).
• if you are a woman who can become pregnant and have not obtained a negative pregnancy test before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.
• if you are pregnant or intend to become pregnant or think you may be pregnant.
• if you are not using effective contraception (see “Contraception in Men and Women”),
• if you are breastfeeding (see also “Pregnancy and Breastfeeding”).

If any of the above cases apply to you, inform your doctor without taking Myfortic.

Warnings and Precautions

Consult your doctor or pharmacist before taking Myfortic:

• if you have or have had severe digestive disorders, such as gastric ulcers.
• if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

You should also be aware that:

• Myfortic reduces the level of protection of your skinfrom the sun, increasing the risk of skin cancer. You should limit your exposure to sunlight and ultraviolet (UV) rays by covering exposed skin areas as much as possible and applying sunscreen with a high protection factor frequently. Consult your doctor on how to protect yourself from the sun.
• if you have had hepatitis B or C, Myfortic may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and check for symptoms of these diseases. If you experience any symptoms (yellow skin and eyes, nausea, loss of appetite, dark urine), inform your doctor immediately.
• if you have persistent coughing or shortness of breath, especially when taking other immunosuppressants, inform your doctor immediately.
• your doctor may want to check your blood levels of antibodies during treatment with Myfortic, particularly when the infection recurs, especially if you are also taking other immunosuppressants and will inform you if you can continue taking Myfortic.
• if you experience any symptoms of infection (such as fever or throat inflammation) or unexpected bleeding or bruising, contact your doctor immediately.
• your doctor may want to check your white blood cell count in your blood during treatment with Myfortic and will inform you if you can continue taking Myfortic.
• the active ingredient, mycophenolic acid, is not the same as other medications that sound similar, such as mycophenolate mofetil. Do not exchange medications unless your doctor tells you to.
• the use of Myfortic during pregnancy may harm the fetus (see also “Pregnancy and Breastfeeding”) and increase the risk of fetal loss (spontaneous abortion).
• Children and Adolescents

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

Older Patients

Older patients (65 years of age or older) may take Myfortic without the need to adjust the recommended normal dose.

Other Medications and Myfortic

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Particularly, you should inform your doctor if you are taking any of the following medications:

• other immunosuppressants such as azathioprine or tacrolimus.
• medications used to treat high cholesterol levels in the blood, such as cholestyramine.
• activated charcoal used to treat digestive disorders, such as diarrhea, stomach upset, and gas.
• antacids containing magnesium and aluminum.
• medications used to treat viral infections, such as aciclovir or ganciclovir.

You should also inform your doctor if you plan to receive anyvaccines.

You should not donate blood during treatment with Myfortic and at least 6 weeks after completing treatment. Men should not donate semen during treatment with Myfortic and at least 90days after completing treatment.

Taking Myfortic with Food and Drinks

Myfortic can be taken with or without food. You should choose whether to take your tablets with or without food and take them in the same way every day. This is to ensure that the same amount of medication is absorbed by your body every day.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatment options with you that may prevent organ transplant rejection if:

If you become pregnant during treatment with mycophenolate, inform your doctor

immediately. However, continue taking mycophenolate 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 that have been reported are ear, eye, face (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (such as spina bifida) 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 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 Myfortic if you are breastfeeding. This is because small amounts of the

medication may pass into breast milk.

Contraception in Women Taking Myfortic

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

Consult your doctor to see which contraceptive method is most suitable 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 think your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You are considered not susceptible to becoming 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 that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis
• You are a girl or adolescent who has not started menstruating

Contraception in Men Taking Myfortic

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 90 days after stoppingMyfortic.

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

Driving and Using Machines

The influence of Myfortic on your ability to drive and use machines is small.

Myfortic contains sodium

This medication contains 13 mg of sodium(main component of table salt/for cooking)in each Myfortic 180 mg tablet. This is equivalent to 0.65% of the maximum daily sodium intake recommended for an adult.

Myfortic contains lactose

If your doctor has told you that you have an intolerance to certain sugars (including lactose, galactose, or glucose), consult them before taking Myfortic.

Follow exactly the administration instructions for Myfortic as indicated by your doctor. Myfortic can only be prescribed by a doctor with experience in treating transplant patients. If you have any doubts, consult your doctor or pharmacist before using this medication.

How much to take

The recommended daily dose of Myfortic is 1,440 mg (8 Myfortic 180 mg tablets). They should be taken in 2 separate doses of 720 mg each (4 Myfortic 180 mg tablets).

Take your tablets in the morning and at night.

The first dose of 720 mg will be administered within 72 hours after the transplant.

If you have severe kidney problems

Your daily dose should not exceed 1,440 mg (8 Myfortic 180 mg tablets).

Myfortic intake

Swallow the tablets whole with a glass of water.

Do not break, crush, or divide the tablets.

Do not take any broken or divided tablets.

Treatment should continue as long as immunosuppression is needed to prevent your body from rejecting your transplanted organ.

If you take more Myfortic than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the tablets with you and if you have finished them, bring the empty packaging.

If you forget to take Myfortic

If you forget to take a dose of Myfortic, take it as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at your regular time. Ask your doctor for advice. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Myfortic

Do not interrupt treatment with Myfortic unless your doctor tells you to. Stopping treatment with Myfortic may increase the risk of your body rejecting your transplanted kidney.

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

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

Older patients may experience more side effects because they have a reduced immune defense.

Immunosuppressants, including Myfortic, reduce the body's defense mechanisms, preventing the rejection of the transplanted organ. Consequently, the body will not be in normal conditions to fight infections. Therefore, if you are taking Myfortic, you may contract more infections than normal, such as brain, skin, mouth, stomach and intestinal, lung, and urinary tract infections.

Your doctor will perform regular blood tests to monitor any changes in the number of your blood cells or levels of substances transported in your blood, such as sugar, fat, and cholesterol.

Some side effects can be severe:

• symptoms of infection, including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. If you are taking Myfortic, you may contract more viral, bacterial, and fungal infections than normal, which can affect different systems of the body, with the kidneys, bladder, upper and lower respiratory tracts being the most commonly affected.
• blood in vomit, dark or bloody stools, gastric or intestinal ulcers.
• inflammation of your glands, development of a new skin thickening or growth of an existing one, or changes in an existing mole. As can occur in patients taking immunosuppressants, a very small number of patients treated with Myfortic have developed skin cancer or lymph node tumors.

If you experience any of the mentioned side effects after taking Myfortic, inform your doctor immediately.

Other side effects may include:

Very common(can affect more than1 in 10 patients)

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

Common(can affect up to1 in 10 patients)

• reduced red blood cell count, which can cause fatigue, shortness of breath, and pale appearance (anemia)
• reduced platelet count in the blood, which can cause bleeding and unexpected bruises (trombocytopenia)
• increased potassium levels in the blood (hyperkalemia)
• reduced magnesium levels in the blood (hypomagnesemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnea)
• abdominal or stomach pain, inflammation of the stomach walls, abdominal distension, constipation, indigestion, gas (flatulence), soft stools, nausea, vomiting
• fatigue, fever
• alteration in liver and kidney function test results
• respiratory tract infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of hands, ankles, or feet (peripheral edema)
• itching

Rare(can affect up to1 in 100 patients)

• rapid or irregular heartbeat (tachycardia or extrasystoles), fluid in the lungs (pulmonary edema)
• a sac-like thickening (quiste)containing fluid (linfa) (linfocele)
• tremor, insomnia
• conjunctivitis, blurred vision
• whistling or coughing
• eructation, bad breath, intestinal obstruction (ileus), labial ulcers, pyrosis, tongue discoloration, dry mouth, gum inflammation, pancreatitis, salivary gland obstruction, peritonitis
• bone, blood, and skin infections
• blood in urine, kidney alteration, pain and difficulty urinating
• hair loss, skin lesions
• arthritis, back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolemia), or decreased levels of phosphate in the blood (hypophosphatemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, rigor, feeling thirsty or weak
• nightmares, believing things that are not true (delirium)
• difficulty achieving or maintaining an erection
• cough, difficulty breathing, chest pain (possible symptoms of interstitial lung disease)

Unknown frequency(cannot be estimated from available data)

• fever, sore throat, frequent infections (possible symptoms of low white blood cell count in the blood) (agranulocytosis)
• skin rash, itching, urticaria, shortness of breath or difficulty breathing, wheezing or coughing, dizziness, drowsiness, changes in levels of consciousness, low blood pressure, with or without generalized mild itching, facial and throat redness and swelling (symptoms of a severe allergic reaction)

Other side effects reported with similar medications to Myfortic

Additional side effects have been reported with the group of medications to which Myfortic belongs: colon inflammation (large intestine), stomach wall inflammation caused by cytomegalovirus, development of a cavity in the intestinal wall, resulting in severe abdominal pain with possible bleeding, gastric or duodenal ulcers, reduced white blood cell count, specifically or of all blood cells, severe infections, such as heart and valve inflammation and meningeal inflammation, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the respiratory tract is abnormally dilated) and other less common bacterial infections that normally result in severe pulmonary alteration (tuberculosis and atypical mycobacterial infection). Consult your doctor if you develop persistent cough or shortness of breath.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directlythrough theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (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 packaging. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store Myfortic in the original packaging to protect it from moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Myfortic Composition

-The active ingredient is mycophenolic acid (as sodium mycophenolate). Each Myfortic tablet contains 180 mg of mycophenolic acid.

-The other components are:

-Tablet core: cornstarch, povidone, crospovidone, lactose, anhydrous colloidal silica, magnesium stearate.

-Tablet coating: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), indigotin (E 132).

Appearance of the product and contents of the package

Myfortic 180 mg gastro-resistant tablets are round, green lime-colored tablets, coated with a film, with the inscription “C” on one side.

Myfortic 180 mg gastro-resistant tablets are presented in blister packs containing 20, 50, 100, 120, or 250 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

Responsible Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Novartis Poland Sp. z o.o.

ul. Marynarska 15, 02-674 Warszawa

Poland

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Wien

Austria

Lek d.d., PE PROIZVODNJA LENDAVA

Trimlini 2D, Lendava, 9220

Slovenia

Novartis Pharmaceutical Manufacturing LLC

Verovskova Ulica 57

Ljubljana, 1000

Slovenia

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following 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.

Last review date of this leaflet:10/2024

Other sources of information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es./