Mycophenolate mofetil Sandoz 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Micofenolato de mofetilo Sandoz 500 mg film-coated tablets EFG

mycophenolate mofetil

Read all of this 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Micofenolato de mofetilo Sandoz is and what it is used for
2. What you need to know before taking Micofenolato de mofetilo Sandoz
3. How to take Micofenolato de mofetilo Sandoz
4. Possible adverse effects
5. How to store Micofenolato de mofetilo Sandoz
6. Contents of the pack and other information

1. What Micofenolato de mofetilo Sandoz is and what it is used for

Micofenolato de mofetilo Sandoz contains mycophenolate mofetil. This belongs to a group of medicines called "immunosuppressants."

Mycophenolate mofetil is used to prevent the body from rejecting a transplanted organ:

• Kidney, heart, or liver.

Mycophenolate mofetil must be used together with other medicines:

• Cyclosporine and corticosteroids.

2. What you need to know before taking Micofenolato de mofetilo Sandoz

WARNING

Micofenolato causes birth defects and spontaneous abortions. If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment and must follow your doctor's advice on contraception.

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

If you do not fully understand these instructions, please consult your doctor again for further explanation before taking micofenolato. See more information in this section under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Micofenolato de mofetilo Sandoz:

• if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6),
• if you are a woman who could become pregnant and have not had a negative pregnancy test result before the first prescription, as micofenolato may cause birth defects and spontaneous abortions,
• if you are pregnant or planning to become pregnant, or think you might be pregnant,
• if you are not using effective contraception (see “Pregnancy, contraception and breastfeeding”),
• if you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking mycophenolate mofetil.

Warnings and precautions:

Contact your doctor immediately before starting treatment with mycophenolate mofetil:

• if you have any signs of infection such as fever or sore throat,
• if you experience unexpected bruising or bleeding,
• if you have ever had gastrointestinal problems, such as a stomach ulcer,
• if you plan to become pregnant or if you or your partner become pregnant while being treated with mycophenolate mofetil.

If any of the above apply (or if you are unsure), consult your doctor immediately before taking mycophenolate mofetil.

Effect of sunlight

Mycophenolate mofetil suppresses your body's immune system. For this reason, there is an increased risk of developing skin cancer. Limit your exposure to sunlight and UV light by:

• wearing appropriate protective clothing that covers your head, neck, arms, and legs,
• using a high-protection sunscreen.

Other medicines and Micofenolato de mofetilo Sandoz

Tell 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, as well as herbal medicines. This is because mycophenolate mofetil may affect how other medicines work. Likewise, other medicines may affect how mycophenolate mofetil works. Specifically, inform your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• azathioprine or any other medicine that suppresses the immune system, which may have been given after a transplant surgery,
• cholestyramine, used to treat high cholesterol levels,
• rifampicin, an antibiotic used to prevent and treat infections such as tuberculosis (TB),
• antacids or “proton pump inhibitors”, used for stomach acid problems such as indigestion,
• phosphate binders, used in patients with chronic kidney failure to reduce phosphate absorption in the blood,
• antibiotics, used to treat bacterial infections,
• isavuconazole, used to treat fungal infections,
• telmisartan, used to treat high blood pressure.

Vaccines

If you need to receive a vaccine (live organism vaccine) during treatment with mycophenolate mofetil, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines are safe for you.

You must not donate blood during treatment with mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with mycophenolate mofetil and for at least 3 months after stopping treatment.

Taking Micofenolato de mofetilo Sandoz with food and drink

Food and drink do not affect your treatment with mycophenolate mofetil.

Pregnancy, contraception and breastfeeding

Contraception in women taking Micofenolato de mofetilo Sandoz

If you are a woman who could become pregnant, you must use an effective method of contraception:

• before starting treatment with mycophenolate mofetil,
• during treatment with mycophenolate mofetil,
• for 6 months after stopping treatment with mycophenolate mofetil.

Talk to your doctor to determine the most appropriate contraceptive method for you, which will depend on your personal circumstances. The use of two contraceptive methods is recommended, as this reduces the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you have missed taking your contraceptive pill.

You are considered not able to become pregnant if you meet any of the following criteria:

• you are post-menopausal, 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 gynecologist),
• you have been diagnosed with one of the following rare congenital conditions that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis,
• you are a child or adolescent who has not yet started menstruating.

Contraception in men taking Micofenolato de mofetilo Sandoz

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 precaution, you or your female partner should use reliable contraception during treatment and for up to 3 months after stopping treatment with mycophenolate mofetil.

If you are planning to have a child, discuss possible risks and alternative treatments with your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss the risks and alternative treatments available to prevent rejection of the transplanted organ if:

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

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

Pregnancy

Mycophenolate causes a very high rate of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Reported malformations include abnormalities of the ears, eyes, face (cleft lip and palate), fingers, heart, esophagus (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 conditions.

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 contraception advice. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Breastfeeding

Do not take mycophenolate mofetil if you are breastfeeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines

The effect of mycophenolate mofetil on the ability to drive and use machines is moderate. If you feel drowsy, dizzy, or confused, speak to your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Micofenolato de mofetilo Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Mycophenolate Mofetil Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The dose you should take depends on the type of transplant you have received. The usual doses are shown below. Treatment will continue as long as necessary to prevent rejection of the transplanted organ.

Kidney transplant

Adults

• The first dose is administered within 3 days after transplant surgery.
• The daily dose is 4 tablets (2 g of medicine), given in two divided doses.
• Take 2 tablets in the morning and 2 tablets in the evening.

Children (between 2 and 18 years)

• The dose administered varies depending on the child's size.
• Your doctor will determine the most appropriate dose based on the child's height and weight (body surface area measured in square meters “m²”). The recommended dose is 600 mg/m², given twice daily.

Use in special populations

Elderly

The recommended dose of 1 g given twice daily for kidney transplant patients and 1.5 g twice daily for liver or heart transplant patients is appropriate for elderly patients.

Heart transplant

Adults:

• The first dose is administered within 5 days after transplant surgery.
• The daily dose is 6 tablets (3 g of medicine), given in two divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

There is no information available on the use of mycophenolate mofetil in children who have had a heart transplant.

Liver transplant

Adults

• The first dose of oral mycophenolate mofetil should be administered no sooner than 4 days after transplant surgery and once the patient is able to swallow oral medication.
• The daily dose is 6 tablets (3 g of medicine), given in two divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information available on the use of mycophenolate mofetil in children who have had a liver transplant.

How to take this medicine

• Swallow the tablets whole with a glass of water.
• Do not break or crush them.

If you take more Mycophenolate Mofetil Sandoz than you should

If you have taken more of this medicine than you should, contact your doctor immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken. Do the same if someone else accidentally takes your medicine. Take the medicine packaging with you.

If you forget to take Mycophenolate Mofetil Sandoz

If you forget to take a dose, take it as soon as you remember. Then continue taking it at your usual times. Do not take a double dose to make up for a missed dose.

If you stop taking Mycophenolate Mofetil Sandoz

Do not stop taking this medicine unless your doctor tells you to. If you stop treatment, you may increase the risk of rejection of the transplanted organ.

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.

Contact your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• if you have symptoms of infection such as fever or sore throat,
• if you develop bruising or unexpected bleeding,
• if you develop a rash, swelling of the face, lips, tongue or throat with difficulty breathing, as you may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the more common problems include diarrhea, reduced number of white or red blood cells in the blood, infections, and vomiting. Your doctor will carry out regular blood tests to monitor for any changes in:

• blood cell counts or signs of infection.

Adverse effects are more likely to occur in children than in adults. These include diarrhea, infections, and reduced white and red blood cells in the blood.

Fighting infections

Mycophenolate mofetil reduces the body's defences. This is to prevent transplant rejection. For this reason, the body is also less able to fight infections as effectively as under normal conditions. This means you may get more infections than usual. These include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

As with patients taking this type of medicine (immunosuppressants), a very small number of patients treated with mycophenolate mofetil have developed lymphoid tissue and skin cancers.

General unwanted effects

General adverse effects affecting the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, pains (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other unwanted adverse effects may include:

Skin problems such as:

• acne, cold sores, shingles, skin growths, hair loss, skin rash, itching.

Urinary problems such as:

• blood in the urine.

Digestive and mouth problems such as:

• swollen gums and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• gastrointestinal disorders including bleeding,
• liver disorders,
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous system problems such as:

• dizziness, drowsiness or numbness,
• tremor, muscle spasms, seizures,
• feelings of anxiety or depression, changes in mood or thought.

Heart and blood vessel problems such as:

• changes in blood pressure, rapid heartbeat, widening of blood vessels.

Lung problems such as:

• pneumonia, bronchitis,
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the lung airways are abnormally widened) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop a persistent cough or shortness of breath,
• fluid in the lungs or inside the chest,
• problems with the nasal sinuses.

Other problems such as:

• weight loss, gout, high blood sugar levels, bleeding, bruising.

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mycophenolate Mofetil Sandoz

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

Do not use this medicine after the expiry date stated on the container, blister pack, or label following CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Mycophenolate mofetil Sandoz

• The active substance is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.

• The other components are:

Core ingredients: microcrystalline cellulose, povidone, talc, magnesium stearate and sodium croscarmellose.

Coating ingredients: hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol (400), black iron oxide (E172) and red iron oxide (E172).

Nature of the product and pack size

Mycophenolate mofetil Sandoz are lavender-colored, biconvex, film-coated tablets, flat on both sides.

PVC/PE/PVdC/Al blister packs

Pack sizes: 50, 100, 120, 150, 180, 250 film-coated tablets.

HDPE bottle

Pack sizes: 50, 150 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2d

9220 Lendava

Slovenia

or

Lek S.A.

Ul Domaniewska 50 C

Warszawa, PL 02-672

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

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

Austria: Mycophenolat mofetil Sandoz 500 mg - Filmtabletten

Belgium: Mycophenolat Mofetil Sandoz 500 mg filmomhulde tabletten

Czech Republic: MYCOPHENOLAT MOFETIL SANDOZ 500 mg

Denmark: Mycophenolatemofetil Sandoz

Finland: Mycophenolate mofetil Sandoz 500 mg kalvopäällysteinen

France: MYCOPHENOLATE MOFETIL Sandoz 500 mg, comprimé pelliculé

Italy: MICOFENOLATO MOFETILE mofetile Sandoz 500 mg

Netherlands: Mycofenolaat mofetil Sandoz 500 mg, filmomhulde tabletten

Poland: Mycophenolate mofetil SANDOZ 500 mg tabletki powlekane

Romania: Micofenolat mofetil Sandoz 500 mg, comprimate filmate

Slovakia: Mykofenolát mofetil Sandoz 500 mg filmom obalené tablety

Sweden: Mycophenolate mofetil Sandoz 500 mg filmdragerade tabletter

Date of the most recent review of this leaflet: September 2025

Detailed 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/