MYFORTIC 360 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Myfortic 360 mggastro-resistant tablets

mycophenolic acid (as sodium mycophenolate)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Myfortic is and what it is used for
2. What you need to know before you take Myfortic
3. How to take Myfortic
4. Possible side effects
5. Storing 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 called immunosuppressants.

Myfortic is used to prevent your body's immune system from rejecting your transplanted kidney. It is used together with other medicines that contain ciclosporin and corticosteroids.

2. What you need to know before you take Myfortic

WARNING

Mycophenolate causes birth defects and miscarriages. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the advice on contraception given by your doctor.

Your doctor will explain and give you written information, in particular 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 so that they can explain them to you before you take mycophenolate. See more information below in this section, under the headings “Warnings and precautions” and “Pregnancy and breast-feeding”.

Do not take Myfortic:

• if you are allergic to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman who can become pregnant and have not had a negative pregnancy test before the first prescription, since mycophenolate can cause birth defects and miscarriages.
• if you are pregnant or plan 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 breast-feeding (see also “Pregnancy and breast-feeding”).

If any of the above applies to you, tell your doctor before taking Myfortic.

Warnings and precautions

Consult your doctor or pharmacist before taking Myfortic:

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

You should also be aware that:

• Myfortic reduces the level of protection of your skin from 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 a 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 these diseases coming back. Your doctor may perform blood tests and check for symptoms of these diseases. If you experience any symptoms (yellowing of the skin and eyes, nausea, loss of appetite, dark urine), tell your doctor immediately.
• if you have a persistent cough or shortness of breath, especially when taking other immunosuppressants, tell your doctor immediately.
• your doctor may want to check your blood antibody levels during treatment with Myfortic, especially when the infection recurs, especially if you are also taking other immunosuppressants, and will discuss with you whether you can continue treatment with Myfortic.
• if you experience any symptoms of infection (such as fever or throat inflammation) or an unexpected bruise or bleeding, 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 whether you can continue taking Myfortic.
• the active substance, mycophenolic acid, is not the same as other medicines that sound similar, such as mycophenolate mofetil. Do not switch medicines unless your doctor tells you to.
• taking Myfortic during pregnancy may harm the unborn baby (see also “Pregnancy and breast-feeding”) and increase the risk of miscarriage.

Children and adolescents

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

Elderly patients

Elderly patients (65 years of age and older) can take Myfortic without the need to adjust the normal recommended dose.

Other medicines and Myfortic

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, you should tell your doctor if you are taking any of the following medicines:

• other immunosuppressant medicines such as azathioprine or tacrolimus.
• medicines used to treat high cholesterol levels in the blood, such as colestyramine.
• activated charcoal used to treat digestive disorders, such as diarrhea, upset stomach, and gas.
• antacids that contain magnesium and aluminum.
• medicines used to treat viral infections such as aciclovir or ganciclovir.

You should also tell your doctor if you are planning to receive any vaccine.

Do 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 drinks

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss the risks and alternative treatments that you can take to prevent organ rejection if:

• You plan to become pregnant.
• You have missed a period or have unusual menstrual bleeding or suspect you may be pregnant.
• You have had unprotected sex.

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

Pregnancy

Mycophenolate causes a very high frequency of miscarriages (50%) and severe damage to the unborn baby (23-27%). The reported malformations include ear, eye, facial (cleft lip and palate), finger, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (such as spina bifida, where the bones of the spine do not develop properly) 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 must follow the advice on contraception given by your doctor. Your doctor may request more than one pregnancy test to ensure you are not pregnant before starting treatment.

Breast-feeding

Do not take Myfortic if you are breast-feeding. This is because small amounts of the medicine may pass into breast milk.

Contraception in women taking Myfortic

If you are a woman who can become pregnant, you must use a reliable method of contraception with Myfortic. This includes:

• Before starting to take Myfortic
• During treatment with Myfortic
• For 6 weeks after stopping Myfortic

Consult your doctor to determine the most suitable contraceptive method for you. This will depend on your personal 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 to be at risk of becoming pregnant if you are:

• Post-menopausal, i.e., you are at least 50 years old and your last period was more than a year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant)
• You have had both fallopian tubes and ovaries removed by surgery (bilateral salpingo-oophorectomy)
• You have had your uterus removed by surgery (hysterectomy)
• Your ovaries do not work (premature ovarian failure confirmed by a specialist gynecologist)
• You were born with one of the following rare conditions 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

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precaution, it is recommended that you or your female partner use a reliable method of contraception during treatment and for 90 days after stopping Myfortic.

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

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 (a major component of cooking/table salt) in each Myfortic 360 mg tablet. This is equivalent to 1.3% of the maximum recommended daily intake of sodium for an adult.

Myfortic contains lactose

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

3. How to take Myfortic

Follow exactly the instructions for taking Myfortic given by your doctor. Myfortic can only be prescribed by a doctor with experience in treating transplant patients. If you are unsure, consult your doctor or pharmacist before using this medicine.

How much to take

The recommended daily dose of Myfortic is 1,440 mg (4 tablets of Myfortic 360 mg). These should be taken in 2 divided doses of 720 mg each (2 tablets of Myfortic 360 mg).

Take your tablets in the morning and in the evening.

The first dose of 720 mg should be given within 72 hours after transplantation.

If you have severe kidney problems

Your daily dose should not be more than 1,440 mg (4 tablets of Myfortic 360 mg).

Taking Myfortic

Swallow the tablets whole with a glass of water.

Do not break or crush 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 kidney.

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, telephone: 91 562 04 20, stating the medicine and the amount taken. Bring the tablets with you, and if they are finished, bring the empty pack.

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 the usual time. Ask your doctor for advice. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Myfortic

Do not stop 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Elderly patients may experience more adverse effects due to their reduced immune defense.

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

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

Some effects can be serious:

• infection symptoms including fever, chills, sweating, feeling of tiredness, drowsiness, or lack of energy. If you are taking Myfortic, you may contract more viral, bacterial, and fungal infections than usual, which can affect different systems of the body, with the most commonly affected being the kidneys, bladder, upper and/or lower respiratory tract.
• blood in vomit, dark or bloody stools, gastric or intestinal ulcer.
• 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 nodes.

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

Other adverse effects may include:

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

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

Common(may affect up to 1 in 10 patients)

• reduced red blood cell count that can result in tiredness, shortness of breath, and pale appearance (anemia)
• reduced platelet count in the blood that can result in bleeding and unexpected bruising (thrombocytopenia)
• increased potassium level in the blood (hyperkalemia)
• reduced magnesium level 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, feeling of nausea (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

Uncommon(may affect up to 1 in 100 patients)

• rapid heartbeats (tachycardia) or irregular heartbeats (ventricular extrasystoles), fluid in the lungs (pulmonary edema)
• a thickening that looks like a sac (cyst) containing fluid (lymph) (lymphocele)
• tremor, insomnia
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, bad breath, intestinal obstruction (ileus), lip ulcers, heartburn, discoloration of the tongue, dry mouth, gum inflammation, inflammation of the pancreas leading to severe pain in the upper stomach (pancreatitis), obstruction of the salivary glands, inflammation of the inner walls of the abdomen (peritonitis)
• bone, blood, and skin infections
• blood in urine, kidney alteration, pain and difficulty urinating
• hair loss, skin wounds
• joint inflammation (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, rigors, feeling of thirst or weakness
• nightmares, believing in things that are not true (delirium)
• inability to have or maintain an erection
• cough, difficulty breathing, pain when breathing (possible symptoms of interstitial lung disease)

Frequency not known(cannot be estimated from available data)

• fever, sore throat, frequent infections (possible symptoms of lack of white blood cells in the blood) (agranulocytosis)
• skin rash, itching, hives, shortness of breath or difficulty breathing, wheezing or cough, dizziness, fainting, changes in levels of consciousness, hypotension, with or without generalized mild itching, redness of the skin and swelling of the face and throat (symptoms of a severe allergic reaction)

Other adverse effects reported with medicines similar to Myfortic

Additional adverse effects have been reported with the group of medicines 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 or all blood cells, severe infections, such as heart and valve inflammation and inflammation of the membrane covering the brain and spinal cord, shortness of breath, cough, which may be due to bronchiectasis (a situation in which the pulmonary airways are abnormally dilated) and other less common bacterial infections that usually result in severe lung alteration (tuberculosis and atypical mycobacterial infection). Consult your doctor if you develop a persistent cough or shortness of breath.

Reporting of adverse effects

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

5. Storage of Myfortic

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

Do not use this medicine if you notice that the packaging is damaged or shows signs of having been tampered with.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Myfortic

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

Appearance of the product and package contents

Myfortic 360 mg gastro-resistant tablets are oval, pale orange-red, film-coated tablets with the inscription "CT" on one side.

Myfortic 360 mg gastro-resistant tablets are available in blister packs containing 50, 100, 120, or 250 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

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 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, Sweden.

Date of last revision of this leaflet:10/2024

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es./