Marelim

Package Leaflet: Information for the User

Marelim, 180 mg, Gastro-Resistant Tablets

Myophenolic Acid

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, Pharmacist, or Nurse.
• 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, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Marelim Is and What It Is Used For
• 2. What You Need to Know Before You Take 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 Marelim Is and What It Is 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. It Works by Reducing the Activity of the Body's Immune System. It Is Used in Combination with Other Medicines Containing Cyclosporin and Corticosteroids.

2. What You Need to Know Before You Take 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 Advice on Contraception Given by Their Doctor.
The Doctor Will Discuss 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 Advice Given. If the Patient Does Not Understand the Advice, They Should Ask Their Doctor to Explain It Again Before Taking Mycophenolic Acid. See Also the Further Information in This Section Under "Warnings and Precautions" and "Pregnancy and Breast-Feeding".

When You Should Not Take Marelim

• If You Are Allergic to Mycophenolic Acid, Mycophenolate Sodium, 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 Dose of Marelim, Because Mycophenolic Acid Can Cause Birth Defects and Miscarriage;

If Any of the Above Applies to You, Tell Your Doctor Before Taking Marelim.

Warnings and Precautions

Before You Start Taking Marelim, Talk to Your Doctor, Pharmacist, or Nurse If:

• You Have Ever Had Severe Stomach Problems, Such as a Stomach Ulcer;
• You Have a Rare Hereditary Deficiency of the Enzyme Hypoxanthine-Guanine Phosphoribosyltransferase (HGPRT), Such as Lesch-Nyhan Syndrome or Kelley-Seegmiller Syndrome.

You Should Know That:

• Marelim Weakens Your Body's Defense System, Which Can Increase the Risk of Skin Cancer. You Should Limit Your Exposure to the Sun and Ultraviolet (UV) Radiation, Wear Protective Clothing, and Use Sunscreens with a High Sun Protection Factor. Ask Your Doctor About Sun Protection Measures.
• If You Have Had Hepatitis B or C in the Past, Marelim May Increase the Risk of These Diseases Coming Back. Your Doctor May Ask You to Have Blood Tests to Check for Signs of These Diseases. If You Get 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 If You Are Taking Other Immunosuppressive Medicines, Tell Your Doctor Immediately.
• Your Doctor May Ask You to Have Blood Tests to Check the Levels of Antibodies in Your Blood While You Are Taking Marelim, Especially If You Have Repeat Infections, Especially If You Are Taking Other Immunosuppressive Medicines. Based on the Results of These Tests, Your Doctor Will Decide Whether You Should Continue to Take Marelim.
• If You Get Any Symptoms of Infection (Such as Fever or Sore Throat) or Unexplained Bruising or Bleeding, Tell Your Doctor Immediately.
• Your Doctor May Ask You to Have Blood Tests to Check the Number of White Blood Cells and Will Tell You Whether You Can Continue to Take Marelim.
• The Active Substance, Mycophenolic Acid, Is Not the Same as Other Medicines with Similar-Sounding Names, Such as Mycophenolate Mofetil. Do Not Take Them Interchangeably Without Your Doctor's Advice.
• Taking Marelim During Pregnancy Can Harm the Unborn Baby (See Also Section "Pregnancy and Breast-Feeding") and Increase the Risk of Miscarriage.

Marelim and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, Including Those You Have Bought Without a Prescription.
In Particular, Tell Your Doctor If You Are Taking Any of the Following Medicines:

• Another Immunosuppressive Medicine, Such as Azathioprine or Tacrolimus;
• Medicines Used to Treat High Cholesterol, Such as Cholestyramine;
• Activated Charcoal, Used to Treat Stomach Problems, Such as Diarrhea, Stomach Upset, and Gas;
• Antacids Containing Magnesium and Aluminum;
• Medicines Used to Treat Viral Infections, Such as Acyclovir or Ganciclovir.

You Should Also Tell Your Doctor If You Plan to Receive Any Vaccinations.
Patient Should Not Donate Blood During Treatment with Mycophenolic Acid and for at Least 6 Weeks After Stopping Treatment. Men Should Not Donate Sperm 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. You Should Choose One Option and Stick to It to Ensure That the Medicine Is Absorbed at the Same Rate Every Day.

Elderly Patients

In Elderly Patients (65 Years or Older), Marelim Can Be Used Without the Need to Adjust the Dose.

Children and Adolescents

Marelim Should Not Be Used in Children and Adolescents Due to a Lack of Data.

Pregnancy, Breast-Feeding, and Fertility

Contraception in Women Taking Marelim

Women Who Can Become Pregnant Must Use Effective Contraception When Taking Marelim. This Applies to:

• Before Starting Treatment with Marelim;
• During Treatment with Marelim;
• For 6 Weeks After Stopping Treatment with Marelim.

You Should Discuss with Your Doctor the Best Method of Contraception for You. The Choice of Contraception Will Depend on Your Individual Situation. It Is Recommended That You Use Two Methods of Contraception to Reduce the Risk of Unplanned Pregnancy. You Should Contact Your Doctor as Soon as Possible If You Think That Your Contraception Method May Have Failed or If You Have Forgotten to Take a Contraceptive Pill.
A Woman Is Considered Unable to Become Pregnant If Any of the Following Applies:

• She Is Post-Menopausal, i.e., She Is 50 Years or Older and Has Not Had a Period for More Than a Year (If the Woman Has Stopped Having Periods Due to Cancer Treatment, There Is Still a Possibility of Becoming Pregnant);
• She Has Had Both Ovaries and Fallopian Tubes Removed (Bilateral Salpingo-Oophorectomy);
• She Has Had Her Uterus Removed (Hysterectomy);
• Her Ovaries Do Not Work (Premature Ovarian Failure, Confirmed by a Gynecologist);
• She Has a Rare Congenital Condition That Makes Pregnancy Impossible, Such as a XY Genotype, Turner Syndrome, or Mayer-Rokitansky-Küster-Hauser Syndrome;
• She Is a Child or Adolescent Who Has Not Yet Started Having Periods.

Contraception in Men Taking Marelim

Available Data Do Not Indicate an Increased Risk of Miscarriage or Birth Defects in the Baby If the Father Is Taking Mycophenolic Acid. However, This Risk Cannot Be Completely Ruled Out.
As a Precaution, It Is Recommended That the Patient or His Partner Use Effective Contraception During Treatment and for at Least 90 Days After Stopping Treatment with Marelim.
If the Patient Plans to Have a Child, He Should Discuss the Potential Risk with His Doctor.

Pregnancy and Breast-Feeding

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant, or Plan to Become Pregnant, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine. Your Doctor Will Discuss with You the Risks and Benefits of Taking Marelim During Pregnancy and Alternative Methods of Preventing Rejection of the Transplanted Organ, If:

• You Plan to Become Pregnant;
• You Have Missed a Period or Think You May Be Pregnant or Have Unusual Menstrual Bleeding;
• You Have Had Unprotected Sex.

Pregnancy

Mycophenolic Acid Can Cause Serious Birth Defects and Miscarriage (50%) and Serious Birth Defects (23-27%) in the Unborn Baby.
Reported Birth Defects Include Abnormalities of the Ears, Eyes, Face (Cleft Lip/Palate), Fingers, Heart, Esophagus (the Tube That Connects the Throat to the Stomach), Kidneys, or Nervous System (Such as Spina Bifida). One or More of These Birth Defects May Occur in the Baby.
Women Who Can Become Pregnant Must Have a Negative Pregnancy Test Before Starting Treatment and Must Follow the Advice on Contraception Given by Their Doctor. The Doctor May Ask for More Than One Pregnancy Test to Make Sure That the Woman Is Not Pregnant Before Starting Treatment.

Breast-Feeding

Do Not Take Marelim If You Are Breast-Feeding. This Is Because Small Amounts 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 0.61 Mmol (13.9 Mg) of Sodium per Tablet. This Should Be Taken into Consideration for Patients on a Controlled Sodium Diet.

3. How to Take Marelim

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Check with Your Doctor or Pharmacist. Marelim Should Only Be Prescribed by Doctors Who Have Experience in Treating Patients Who Have Had a Transplant.

How Much to Take

The Recommended Daily Dose of Marelim Is 1440 Mg (8 Tablets of 180 Mg), Taken as 2 Separate Doses of 720 Mg Each (4 Tablets of 180 Mg).
Take the Tablets in the Morning and Evening.
The First Dose of 720 Mg Should Be Taken Within 72 Hours of Transplantation.

In Patients with Severe Kidney Problems

The Daily Dose Should Not Be More Than 1440 Mg (8 Tablets of 180 Mg).

Taking Marelim

Swallow the Tablets Whole, with a Glass of Water.
Do Not Break or Crush the Tablets.
Do Not Take Tablets That Have Been Broken or Crushed.
Treatment Should Continue for as Long as You Need Immunosuppression to Prevent Rejection of the Transplanted Organ.

If You Take More Marelim Than You Should

If You Have Taken More Tablets Than You Should, Contact Your Doctor or Go to the Nearest Hospital Immediately. Medical Attention May Be Necessary. Take the Tablets and Show Them to Your Doctor or Hospital Staff. If You Do Not Have the Tablets, Take the Empty Packet.

If You Forget to Take Marelim

If You Forget to Take a Dose, Take It as Soon as You Remember, Unless It Is Almost Time for Your Next Dose. Then Continue with Your Normal Dosing Schedule. Ask Your Doctor for Advice. Do Not Take a Double Dose to Make Up for a Forgotten Dose.

Stopping Treatment with Marelim

Do Not Stop Taking Marelim Unless Your Doctor Tells You to. Stopping Treatment with Marelim May Increase the Risk of Rejection of the Transplanted Kidney.
If You Have Any Further Questions on the Use of This Product, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
In Elderly Patients, More Side Effects May Occur Due to a Weakened Immune System.
Immunosuppressive Medicines, Including Marelim, Weaken the Body's Defense System, Which Can Increase the Risk of Infections, Such as Infections of the Brain, Skin, Mouth, Stomach, and Intestines, Lungs, and Urinary Tract.
Your Doctor Will Ask You to Have Regular Blood Tests to Monitor Any Changes in the Number of Blood Cells 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, Sweating, Feeling Tired, Sleepiness, or Lack of Energy. If You Are Taking Marelim, You May Be More Likely to Get Infections. This Can Affect Different Parts of the Body, Most Often the Kidneys, Bladder, Upper and/or Lower Respiratory Tract;
• Vomiting Blood, Black or Bloody Stools, Stomach or Intestinal Ulcer;
• Enlarged Lymph Nodes, New or Enlarged Lumps on the Skin, or Changes in Existing Moles. Because These Can Occur in Patients Taking Immunosuppressive Medicines, a Small Number of Patients Taking Marelim May Develop Skin Cancer or Lymph Node Cancer.

If You Get Any of These Symptoms, Tell Your Doctor Immediately.

Other Side Effects, Including:

Very Common(Affects 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 Uric Acid Levels in the Blood (Hyperuricemia)
• High Blood Pressure (Hypertension)
• Joint Pain (Arthralgia)
• Anxiety

Common(Affects Less Than 1 in 10 People)

• Low Red Blood Cell Count, Which Can Cause Tiredness, Shortness of Breath, and Pale Skin (Anemia)
• Low Platelet Count, Which Can Cause Unusual Bruising or Bleeding (Thrombocytopenia)
• Headache
• Cough
• Abdominal Pain or Stomach Pain, Gastritis, Abdominal Distension, Constipation, Nausea, Vomiting
• Fatigue, Fever
• Abnormal Liver or Kidney Function Tests
• 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, Feet, or Ankles (Peripheral Edema)
• Itching

Uncommon(Affects Less Than 1 in 100 People)

• Fast Heartbeat (Tachycardia) or Irregular Heartbeat (Ventricular Extrasystoles), Fluid in the Lungs (Pulmonary Edema)
• Growth of a Cyst Containing Fluid (Lymphocele)
• Tremor, Difficulty Sleeping
• Redness and Swelling of the Eyes (Conjunctivitis), Blurred Vision
• Wheezing
• Belching, Bad Breath, Intestinal Blockage, Ulceration of the Lips, Heartburn, Discoloration of the Tongue, Dry Mouth, Gingivitis, Pancreatitis Causing Severe Abdominal Pain
• Bone, Blood, or Skin Infections
• Blood in the Urine, Kidney Damage, Pain or Difficulty Passing Urine
• Hair Loss, Skin Bruising
• Arthritis, Back Pain, Muscle Cramps
• Loss of Appetite, High Levels of Lipids (Hyperlipidemia), Sugar (Diabetes), Cholesterol (Hypercholesterolemia), or Low Levels of Phosphate in the Blood (Hypophosphatemia)
• Flu-Like Symptoms (Such as Fatigue, Chills, Sore Throat, Joint or Muscle Pain), Swelling of the Feet or Ankles, Pain, Shaking, 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 (Agranulocytosis)

Other Side Effects Reported for Medicines Similar to Marelim

Additionally, the Following Side Effects Have Been Reported for the Class of Medicines to Which Marelim Belongs: Colitis (Inflammation of the Large Intestine), Cytomegalovirus Infection of the Stomach, 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 Overly Expanded) and Other Less Common Bacterial Infections Causing Severe Lung Disease (Such as Tuberculosis and Atypical Mycobacterial Infections). If You Get a Persistent Cough or Shortness of Breath, Contact Your Doctor.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Marelim

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton.
The Expiry Date Refers to the Last Day of That Month.
There Are No Special Storage Conditions for This Medicine.
Store in the Original Package to Protect from Light.
Do Not Use This Medicine If You Notice That the Packaging Is Damaged.
Medicines Should 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 Pack and Other Information

What Marelim Contains

• The Active Substance Is Mycophenolic Acid (as Mycophenolate Sodium). Each Tablet Contains 180 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 Green 93O510003: Methacrylic Acid - Ethyl Acrylate Copolymer (1:1), Talc, Titanium Dioxide (E 171), Triethyl Citrate, Colloidal Anhydrous Silica, Sodium Hydrogen Carbonate, Yellow Iron Oxide (E 172), Indigo Carmine, Lake (E 132), 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 Yellow-Green, Round, Biconvex Tablet with a Black Print M1 on One Side and a Smooth Surface on the Other.
Marelim Is Available in Packs Containing 20, 50, 100, 120, or 250 Tablets in Blisters.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Tel: +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