Myfortic 360 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Myfortic 360 mg gastro-resistant tablets

mycophenolic acid (as mycophenolate sodium)

Read the entire leaflet carefully before you start taking 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Myfortic is and what it is used for
2. What you need to know 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 class of medicines 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 medicines containing cyclosporine and corticosteroids.

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

WARNING

Mycophenolate causes birth defects and miscarriages. If you are a woman who could become pregnant, you must have a negative pregnancy test result before starting treatment and must follow your doctor's advice regarding contraception.

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

If you do not fully understand these instructions, please consult your doctor again to have them explained 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 to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman who could become pregnant and have not obtained a negative result on a pregnancy test before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.
• if you are pregnant, planning to become pregnant, or think you might 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 conditions apply to you, inform your doctor and do not take Myfortic.

Warnings and precautions

Consult your doctor or pharmacist before taking Myfortic:

• if you have or have previously had serious gastrointestinal disorders, such as gastric ulcer.
• if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine-phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan or Kelley-Seegmiller syndromes.

You should also be aware that:

• Myfortic reduces your skin's natural protection against sunlight, increasing the risk of developing skin cancer. You should limit your exposure to sunlight and ultraviolet (UV) radiation by covering exposed skin areas as much as possible and frequently applying a sunscreen with a high sun protection factor. Consult your doctor on how to protect yourself from the sun.
• if you have previously had hepatitis B or C, Myfortic may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these conditions. If you experience any symptoms (yellowing of the skin or eyes, nausea, loss of appetite, dark urine), inform your doctor immediately.
• if you develop a persistent cough or shortness of breath, especially while taking other immunosuppressants, inform your doctor immediately.
• your doctor may wish to monitor your blood antibody levels during treatment with Myfortic, particularly if infection recurs, especially if you are also taking other immunosuppressants, and will advise you whether you can continue Myfortic treatment.
• if you experience any signs of infection (such as fever or sore throat) or unexpected bruising or bleeding, contact your doctor immediately.
• your doctor may wish to monitor your white blood cell count 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 interchange medications unless instructed by your doctor.
• 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 lack of data, the use of Myfortic is not recommended in children and adolescents.

Elderly patients

Elderly patients (aged 65 years and older) may take Myfortic without the need to adjust the normal recommended dose.

Other medicines and Myfortic

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

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

• other immunosuppressive medicines such as azathioprine or tacrolimus.
• medicines used to treat high blood cholesterol levels, such as colestyramine.
• activated charcoal used to treat gastrointestinal disorders such as diarrhoea, upset stomach, and gas.
• antacids containing magnesium and aluminium.
• medicines used to treat viral infections such as aciclovir or ganciclovir.

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

You 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. You should choose whether to take your tablets with or without food and then continue taking them the same way every day. This is to ensure that the same amount of medicine is absorbed into your body each day.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks and alternative treatments available to prevent organ transplant rejection if:

• you plan to become pregnant.
• you have missed a period or think you may have missed a period, have unusual menstrual bleeding, or suspect you may be pregnant.
• you have had sexual intercourse without using an effective contraceptive method.

If you become pregnant while taking mycophenolate, inform your doctor immediately. However, continue taking mycophenolate until you see your doctor.

Pregnancy

Mycophenolate causes a very high rate of spontaneous abortions (50%) and serious birth defects (23–27%). Reported malformations include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g. spina bifida, where the bones of the spine do not develop properly). Your baby may be affected by one or more of these.

If you are a woman of childbearing potential, you must have a negative pregnancy test before starting treatment and must follow your doctor’s contraceptive advice. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Breastfeeding

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

Contraception in women taking Myfortic

If you are a woman of childbearing potential, you must use an effective method of contraception with Myfortic. This includes:

• before starting Myfortic
• during the entire treatment with Myfortic
• up to 6 weeks after stopping Myfortic

Consult your doctor to determine the most appropriate contraceptive method for you, based on your personal circumstances. The use of two contraceptive methods is recommended, as this reduces 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 missed taking your contraceptive pill.

You are considered not susceptible to pregnancy if you meet any of the following criteria:

• you are postmenopausal, i.e., you are at least 50 years old and your last menstrual period occurred more than one 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 both ovaries surgically removed (bilateral salpingo-oophorectomy)
• you have had your uterus surgically removed (hysterectomy)
• your ovaries do not function (premature ovarian failure confirmed by a specialist gynaecologist)
• 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 yet 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 ruled out. As a precautionary measure, you or your female partner are advised to 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 possible risks.

Driving and use of machines

The influence of Myfortic on the ability to drive and use machines is negligible.

Myfortic contains sodium

This medicine contains 26 mg of sodium (the main component of table/cooking salt) in each 360 mg Myfortic tablet. This corresponds to 1.3% of the maximum daily intake of sodium recommended for an adult.

Myfortic contains lactose

If your doctor has informed you of an intolerance to certain sugars (including lactose, galactose, or glucose), consult him before taking Myfortic.

3. How to take Myfortic

Follow exactly the dosing instructions for Myfortic given by your doctor. Myfortic can only be prescribed by a physician experienced in managing transplant patients. If you have any doubts, consult your doctor or pharmacist before using this medicine.

What dose to take

The recommended daily dose of Myfortic is 1,440 mg (4 tablets of Myfortic 360 mg). This should be taken as two separate doses of 720 mg each (2 tablets of Myfortic 360 mg).

Take your tablets in the morning and in the evening.

The first 720 mg dose will be administered within 72 hours after transplantation.

If you have severe kidney problems

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

How to take 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 be continued 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, contact a doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine 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 that case, take your next dose at the usual time. Seek advice from your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Myfortic

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

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

4. Possible adverse effects

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

Elderly patients may experience more adverse effects because they have a weakened immune system.

Immunosuppressants, including Myfortic, reduce your body's natural defences, preventing rejection of your transplanted organ. As a result, your body will be less able than normal to fight infections. Therefore, if you are taking Myfortic, you may get more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.

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

Some effects may be serious:

• symptoms of infection including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. If you are taking Myfortic, you may get more viral, bacterial, and fungal infections than usual, which can affect different systems in the body, with the kidneys, bladder, and upper and/or lower respiratory tract being the most commonly affected.
• blood in vomit, dark or bloody stools, gastric or intestinal ulcer.
• swelling of your glands, development of a new skin thickening or growth of an existing one, or changes in an existing mole. As may 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 effects listed above 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 levels in the blood (hypocalcemia)
• reduced potassium levels in the blood (hypokalaemia)
• increased uric acid levels in the blood (hyperuricaemia)
• high blood pressure (hypertension)
• anxiety
• diarrhoea
• joint pain (arthralgia)

Common (may affect up to 1 in 10 patients)

• reduced red blood cell count which may result in tiredness, shortness of breath, and pale appearance (anaemia)
• reduced platelet count in the blood which may result in unexpected bleeding and bruising (thrombocytopenia)
• increased potassium levels in the blood (hyperkalaemia)
• reduced magnesium levels in the blood (hypomagnesaemia)
• dizziness
• headache
• cough
• low blood pressure (hypotension)
• shortness of breath (dyspnoea)
• abdominal or stomach pain, inflammation of the stomach walls, abdominal distension, constipation, indigestion, gas (flatulence), soft stools, feeling unwell (nausea), dizziness (vomiting)
• fatigue, fever
• changes in liver and kidney function test results
• respiratory tract infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swollen hands, ankles or feet (peripheral oedema)
• itching

Uncommon (may affect up to 1 in 100 patients)

• rapid heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• a fluid-filled sac-like swelling (cyst) containing lymph (lymphocele)
• tremor, insomnia
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, bad breath, intestinal obstruction (ileus), cold sores, heartburn, discolouration of the tongue, dry mouth, gum inflammation, inflammation of the pancreas leading to severe upper stomach pain (pancreatitis), blockage of the salivary glands, inflammation of the inner abdominal walls (peritonitis)
• bone, blood, and skin infections
• blood in urine, kidney problems, pain and difficulty passing urine
• hair loss, skin lesions
• joint inflammation (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased blood phosphate levels (hypophosphataemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, rigors, feeling thirsty or weak
• nightmares, believing things that are not true (delusions)
• inability to achieve or maintain an erection
• cough, difficulty breathing, pain when breathing (possible symptoms of interstitial lung disease)

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

• fever, sore throat, frequent infections (possible symptoms of low white blood cell count) (agranulocytosis)
• skin rash, itching, hives, shortness of breath or difficulty breathing, wheezing or cough, dizziness, drowsiness, changes in level of consciousness, hypotension, with or without mild generalised itching, skin redness, 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: inflammation of the colon (large intestine), inflammation of the stomach wall 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 reduced counts of all blood cells, serious infections such as inflammation of the heart and its valves and of the membrane covering the brain and spinal cord, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways of the lungs are abnormally widened), and other less common bacterial infections that typically result in severe lung problems (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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide 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 expiry date stated on the packaging. The expiry 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 tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Myfortic

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

Appearance of the product and contents of the pack

Myfortic 360 mg gastro-resistant tablets are oval-shaped, pale orange-red, film-coated tablets, marked 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

Manufacturer responsible

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 under 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.

Date of the most recent review of this leaflet: 10/2024

Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es./