Mycophenolate mofetil Sandoz 250 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Micofenolato de mofetilo Sandoz 250 mg hard capsules 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 known as "immunosuppressants."

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

• Kidney, heart, or liver.

Mycophenolate mofetil must be used in combination 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 lactation".

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 lactation"),
• 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

Consult your doctor or pharmacist immediately before starting this medicine:

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

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

Effect of sunlight

Mycophenolate mofetil reduces your body's defenses. 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 also covers your head, neck, arms, and legs,
• using a sunscreen with a high sun protection factor.

Other medicines and Micofenolato de mofetilo Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription, including 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 other medicines that suppress the immune system, which are given after a transplant operation,
• colestyramine, 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 suitable 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

Taking food and drink does not affect your treatment with mycophenolate mofetil.

Pregnancy, contraception and lactation

Contraception in women taking Micofenolato de mofetilo Sandoz

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

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

Talk to your doctor to determine the most appropriate contraceptive method for your personal situation. It is preferable to use two contraceptive methods, 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 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, e.g., 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),
• you have 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 girl 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 is taking mycophenolate. However, the risk cannot be completely ruled out.

As a precaution, you or your female partner are advised to use reliable contraceptive methods during treatment and for up to 3 months after stopping treatment with mycophenolate mofetil.

If you are planning to have a child, consult your doctor about potential risks and alternative treatments.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 miss a period or think you may have missed a menstrual 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 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 birth defects include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, 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.

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

Lactation

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

Driving and using machines

Mycophenolate mofetil has a moderate influence on the ability to drive or use machines. If you feel dizzy, lightheaded, or confused, speak with your doctor or nurse and do not drive or operate machinery until you feel better.

Micofenolato de mofetilo Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

3. How to take Mycophenolate mofetil Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. 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 the transplant surgery.
• The daily dose is 8 capsules (2 g of medicine), given in two separate doses.
• Take 4 capsules in the morning and 4 capsules in the evening.

Children (between 2 and 18 years of age)

• The dose administered varies depending on the child's size.
• Your doctor will decide 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, administered twice daily.

Heart transplant

Adults

• The first dose is administered within 5 days after the transplant surgery.
• The daily dose is 12 capsules (3 g of medicine), given in two separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children

• There is no information available on the use of mycophenolate mofetil in children who have undergone heart transplantation.

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 12 capsules (3 g of medicine), given in two separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children

• There is no information available on the use of mycophenolate mofetil in children who have undergone liver transplantation.

How to take this medicine

Swallow the capsules whole with a glass of water.

• Do not break or crush them.
• Do not take any capsule that has been broken or opened.

Take care to avoid the powder inside a broken capsule coming into contact with your eyes or mouth.

• If this happens, rinse thoroughly with running water.

Take care to avoid the powder inside a broken capsule coming into contact with your skin.

• If this happens, wash the area thoroughly with plenty of water and soap.

If you take more Mycophenolate mofetil Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. 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 ever forget to take your 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 instructed by your doctor. If you discontinue 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, decreased number of white or red blood cells in the blood, infection, and vomiting. Your doctor will carry out regular blood tests to monitor for any changes in:

• blood cell counts or signs of infection.

The occurrence of adverse effects is more likely in children than in adults. These include diarrhea, infections, and decreased white and red blood cells in the blood.

Fighting infections

Mycophenolate mofetil reduces the body's defenses. 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 be more prone to infections than usual. These may include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

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

General unwanted effects

General adverse effects affecting the whole body may occur.

These include severe allergic reactions (such as anaphylaxis, angioedema), fever, extreme tiredness, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other possible 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,
• sinus problems.

Other problems such as:

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

Reporting of adverse effects

If you experience any 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: 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 blister and packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

HDPE container after first opening: use within 2 months.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to 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 capsule contains 250 mg of mycophenolate mofetil.
• The other components in the capsule contents are pregelatinized maize starch, croscarmellose sodium, povidone (K90F), magnesium stearate. The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and FD&C Blue #2 indigo carmine aluminum lake (E132).

Appearance of the product and pack contents

Hard gelatin capsules (size 1) with an opaque blue cap and an opaque orange body.

PVC/PE/PVDC/Aluminum blister packs: 30, 50, 100, 150, 200, 300, 360 and 600 capsules.

HDPE bottle: 250 capsules.

Only certain pack sizes may be marketed.

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.

Verovskova 57,

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

LEK S.A.

Ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Sandoz GMBH

Biochemiestrasse, 10

Kundl,

Tirol - Austria

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

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

Germany: Mycophenolat - 1 A Pharma 250 mg Hard capsules

Poland: Mycophenolate mofetil Sandoz 250 mg hard capsules

United Kingdom (Northern Ireland): Mycolat 250 mg hard capsule

Czech Republic: MYCOPHENOLAT MOFETIL SANDOZ 250 mg hard capsules

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/