Marelim

Leaflet accompanying the packaging: information for the user

Marelim, 360 mg, gastro-resistant tablets

Myophenolic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Marelim and what is it used for

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

2. Important information before taking Marelim

WARNING
Mycophenolic acid can cause 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 this with the patient and provide written information, particularly about the effect of mycophenolic acid on the unborn child. The patient should read this information carefully and follow the instructions. If the information provided is not fully understood, the patient should ask the doctor to explain it again before taking mycophenolate. See also the further information in the "Warnings and precautions" and "Pregnancy and breastfeeding" sections.

When not to take Marelim

• 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 breastfeeding;
• if the patient has a severe impairment of renal function;
• if the patient is taking other immunosuppressive medicines;
• if the patient has a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

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

Warnings and precautions

Before starting Marelim, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient has or has had severe gastrointestinal disorders, such as stomach ulcers;
• 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:

• Marelim weakens the body's defense mechanisms, which can increase the risk of infections and cancer.
• The patient should limit their exposure to sunlight and UV radiation, wear protective clothing, and use sunscreen with a high sun protection factor. The patient should ask their doctor about sun protection.
• If the patient has had hepatitis B or C in the past, Marelim may increase the risk of these diseases coming back. The doctor may order blood tests to check for signs of these diseases. If the patient experiences any symptoms (yellowing of the skin and eyes, nausea, loss of appetite, dark urine), they 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 Marelim, especially if the patient has recurring infections. Based on the test results, the doctor will decide whether to continue treatment with Marelim.
• If the patient experiences any signs 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 will inform the patient whether they can continue taking Marelim.
• 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 Marelim during pregnancy can harm the fetus (see also the "Pregnancy and breastfeeding" section) and increase the risk of miscarriage.

Marelim and other medicines

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

• other immunosuppressive medicines, 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's cannot donate blood during treatment with mycophenolic acid and for at least 6 weeks after stopping treatment. Men cannot donate semen during treatment with mycophenolic acid and for at least 90 days after stopping treatment.

Marelim with food, drink, and alcohol

Marelim 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.

Elderly patients

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

Children and adolescents

The use of Marelim in children and adolescents is not recommended due to a lack of data.

Pregnancy, breastfeeding, and fertility

Contraception in women taking Marelim

Women who may become pregnant should use effective contraception when taking Marelim. This applies to:

• the period before starting Marelim;
• the entire duration of treatment with Marelim;
• 6 weeks after stopping Marelim.

The patient should discuss the choice of contraception with their doctor. The choice of contraception depends 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 method may have failed or if they have missed a contraceptive pill.
The patient is not able to become pregnant if any of the following points apply:

• the patient is post-menopausal, i.e., they are at least 50 years old and have not had a period for more than a year (if the patient has stopped having periods due to cancer treatment, they may still be able to become pregnant);
• the patient has had their fallopian tubes and ovaries removed (bilateral salpingo-oophorectomy);
• the patient has had their uterus removed (hysterectomy);
• the patient's ovaries have stopped working (premature ovarian failure, confirmed by a gynecologist);
• the patient has a rare congenital condition that makes it impossible for them to become pregnant, such as an XY genotype, Turner syndrome, or Mullerian agenesis;
• the patient is a child or adolescent who has not yet started their periods.

Contraception in men taking Marelim

Available data do not indicate an increased risk of miscarriage or birth defects in the child 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 at least 90 days after stopping Marelim.
If the patient plans to have a child, they should discuss the potential risk with their doctor.

Pregnancy and breastfeeding

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

• the patient plans to become pregnant;
• the patient has stopped having periods or thinks they have stopped having periods or has unusual menstrual bleeding or thinks they may be pregnant;
• the patient has had unprotected sex without using effective contraception. If the patient becomes pregnant while taking mycophenolate, they should tell their doctor immediately. However, they should continue taking Marelim until they have spoken to their doctor.

Pregnancy

Mycophenolate is a cause of very common miscarriages (50%) and severe birth defects (23-27%) in unborn babies. The reported birth defects have included ear, eye, face (cleft lip/palate), finger, heart, esophagus (the tube that connects the throat to the stomach), kidney, or nervous system defects (such as spina bifida). One or more of these defects may occur in the patient's child.
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 may ask the patient to have more than one pregnancy test to make sure they are not pregnant before starting treatment.

Breastfeeding

Do not take Marelim if the patient is breastfeeding. This is because a small amount of the medicine may pass into breast milk.

Driving and using machines

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

Marelim contains sodium

This medicine contains 1.21 mmol (27.9 mg) of sodium per tablet, which should be taken into consideration for patients on a controlled sodium diet.

3. How to take Marelim

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

What dose to take

The recommended daily dose of Marelim 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 renal impairment

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

How to take Marelim

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

If the patient takes more Marelim than they should

If the patient has taken more tablets than they should, 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 with them.

If the patient forgets to take Marelim

If the patient forgets to take Marelim, they should take it as soon as possible, unless it is nearly time for their next dose. In this case, they should skip the missed dose and continue with their regular dosing schedule. The patient should ask their doctor for advice. The patient should not take a double dose to make up for a forgotten dose.

Stopping treatment with Marelim

The patient should not stop taking Marelim unless their doctor tells them to. Stopping treatment with Marelim may increase the risk of the transplanted kidney being rejected by the body.
If the patient has any further questions about their treatment, they should ask their doctor, pharmacist, or nurse.

4. Possible side effects

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

Side effects that may be serious:

• signs of infection, including fever, chills, excessive sweating, fatigue, sleepiness, or lack of energy. If the patient is taking Marelim, they may be more likely to get infections. This can affect different 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 growing skin lesions or changes in existing moles. Because this occurs in patients taking immunosuppressive medicines, a small number of patients taking Marelim may develop skin or lymph node cancer.

If the patient experiences any of these symptoms after taking Marelim, they should contact their doctor immediately.

Other side effects, including:

Very common(affecting more than 1 in 10 people)

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

Common(affecting up to 1 in 10 people)

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

Uncommon(affecting up to 1 in 100 people)

• fast heartbeat or irregular heartbeat (tachycardia or extrasystoles), fluid in the lungs (pulmonary edema)
• growth of a cyst containing fluid (lymphocele)
• tremors, difficulty sleeping
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, bad breath, bowel obstruction, mouth ulcers, esophagitis, pancreatitis causing severe abdominal pain, salivary gland blockage, peritonitis
• 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 levels of lipids (hyperlipidemia), sugar (diabetes), or cholesterol (hypercholesterolemia) in the blood, or low levels of phosphates in the blood (hypophosphatemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of the ankles and feet, pain, shivering, increased thirst, or weakness
• abnormal dreams, hallucinations
• impotence
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease)

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

• rash
• fever, sore throat, frequent infections with possible signs of low white blood cell count in the blood (agranulocytosis).

Other side effects reported for medicines like Marelim

Additionally, the following side effects have been reported for the group of medicines that includes Marelim: colitis (inflammation of the large intestine), cytomegalovirus gastritis, perforation of the intestine, 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 infections of the heart and its valves and the membrane covering the brain and spinal cord, shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways are abnormally widened) and other less common bacterial infections that usually cause severe lung disease (tuberculosis and atypical mycobacterial infection). If the patient experiences persistent cough or shortness of breath, they should contact their doctor.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, with its registered office at:
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
By reporting side effects, more information can be gathered on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Marelim

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 stated.
There are no special storage instructions for this medicine.
Store in the original packaging to protect from light.
Do not use this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Marelim contains

• The active substance of Marelim is mycophenolic acid (in the form of mycophenolate sodium). Each tablet of Marelim contains 360 mg of mycophenolic acid.
• The other ingredients are:
• tablet core: microcrystalline cellulose, sodium croscarmellose, povidone K30, talc, colloidal anhydrous silica, magnesium stearate.
• coating: Acryl-Eze Pink 93O54222: methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide (E 171), triethyl citrate, colloidal anhydrous silica, sodium hydroxide, yellow iron oxide (E 172), red iron oxide (E 172), sodium lauryl sulfate
• ink Opacode Black S-1-17823: shellac, black iron oxide (E 172), propylene glycol, ammonia

What Marelim looks like and contents of the pack

Marelim is a peach-colored, oval, biconvex, gastro-resistant tablet with a black inscription M2 on one side and a smooth surface on the other side.
Marelim is available in packs of 50, 100, 120, or 250 tablets in blisters.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare Polska Sp.z o.o.,
Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009
Greece

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: June 2025