Mycophenolate mofetil Accord 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Micofenolato de mofetilo Accord 500 mg film-coated tablets EFG

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 may 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.

Leaflet contents

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

1. What is Mycophenolate Mofetil Accord and what is it used for?

Mycophenolate Mofetil Accord contains mycophenolate mofetil.

• It belongs to a group of medicines called "immunosuppressants".

Mycophenolate mofetil is used to prevent the body from rejecting a transplanted organ in adults and children.

• Kidney, heart, or liver.

Mycophenolate mofetil should be used together with other medicines:

• Cyclosporine and corticosteroids.

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

WARNING

Micofenolato causes birth defects and spontaneous abortions. 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 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 below in this section under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Micofenolato de mofetilo Accord

• If you are allergic 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 Contraception, pregnancy 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 Micofenolato de mofetilo Accord.

Warnings and precautions

Talk to your doctor immediately before starting to take Micofenolato de mofetilo Accord:

• If you are over 65 years old, as you may have a higher risk of developing adverse reactions such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients.
• If you have any signs of infection such as fever or sore throat.
• If you develop unexpected bruising or bleeding.
• If you have ever had a gastrointestinal problem, such as a stomach ulcer.
• If you are planning to become pregnant or become pregnant while you or your partner are taking Micofenolato de mofetilo Accord.
• If you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above apply to you (or you are unsure), consult your doctor immediately before taking Micofenolato de mofetilo Accord.

Effect of sunlight

Micofenolato de mofetilo Accord 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 protection factor.

Children

Children, especially those under 6 years of age, are more likely than adults to experience certain adverse reactions, including diarrhea, vomiting, infections, low red blood cell count, low white blood cell count, and an increased risk of lymphoma or skin cancer.

The tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor.

If you are unsure about anything related to your child’s treatment, speak with your doctor or pharmacist before administering the medicine.

Other medicines and Micofenolato de mofetilo Accord

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, such as herbal remedies. This is because Micofenolato de mofetilo Accord may affect how other medicines work, and other medicines may affect how Micofenolato de mofetilo Accord works.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting Micofenolato de mofetilo Accord:

• Azathioprine or any other medicine that suppresses the immune system – administered after 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 Micofenolato de mofetilo Accord, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines are suitable.

You must not donate blood during treatment with Micofenolato de mofetilo Accord and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Micofenolato de mofetilo Accord and for at least 90 days after stopping treatment.

Taking Micofenolato de mofetilo Accord with food and drinks

Taking food and drinks does not affect your treatment with Micofenolato de mofetilo Accord.

Contraception in women taking Micofenolato de mofetilo Accord

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

• Before starting to take Micofenolato de mofetilo Accord.
• Throughout the entire treatment with Micofenolato de mofetilo Accord.
• Up to 6 weeks after stopping Micofenolato de mofetilo Accord.

Talk to your doctor to determine the most appropriate contraceptive method for you. This will depend on your personal situation. 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 cannot become pregnant if any of the following apply to you:

• 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 were born with one of the following rare 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 Accord

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes micofenolato. However, the risk cannot be completely ruled out. As a precaution, you or your female partner are advised to use a reliable contraceptive method during treatment and for up to 90 days after stopping Micofenolato de mofetilo Accord.

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

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 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 menstrual period.
• You have unusual menstrual bleeding or suspect you might be pregnant.
• You have had sexual intercourse without using effective contraception.

If you become pregnant during treatment with micofenolato, inform your doctor immediately. However, continue taking Micofenolato de mofetilo Accord until you see your doctor.

Pregnancy

Micofenolato causes a very high frequency 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), finger development, heart, esophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida, where the spinal bones 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 contraception advice. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Breastfeeding

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

Driving and using machines

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

Micofenolato de mofetilo Accord contains sodium

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

3. How to take Mycophenolate Mofetil Accord

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, 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 should be administered within 3 days after the transplant surgery.
• The daily dose is 4 tablets (2 g of the medicine), given in two divided doses.
• This means taking 2 tablets in the morning and 2 tablets in the evening.

Children:

• The tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor. If you are unsure, speak with your doctor or pharmacist before taking it.
• The dose varies depending on the child's size.
• The 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 starting dose is 600 mg/m², administered twice daily. The recommended maintenance dose remains at 600 mg/m² twice daily (maximum total daily dose of 2 g). The dose should be individualized based on clinical assessment by the doctor.

Heart transplant:

Adults:

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

Children:

• The tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor. If you are unsure, speak with your doctor or pharmacist before taking it.
• The dose varies depending on the child's size.
• Your child’s 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 starting dose is 600 mg/m², administered twice daily. The dose should be individualized based on clinical assessment by the doctor. If well tolerated, the dose may be increased to 900 mg/m² twice daily if necessary (maximum total daily dose of 3 g).

Liver transplant:

Adults:

• The first dose should be administered at least 4 days after the transplant surgery and once the patient is able to swallow oral medication.
• The daily dose is 6 tablets (3 g of the medicine), given in two divided doses.
• This means taking 3 tablets in the morning and 3 tablets in the evening.

Children:

• The tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor. If you are unsure, speak with your doctor or pharmacist before taking it.
• The dose varies depending on the child's size.
• Your child’s 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 starting dose is 600 mg/m², administered twice daily. The dose should be individualized based on clinical assessment by the doctor. If well tolerated, the dose may be increased to 900 mg/m² twice daily if necessary (maximum total daily dose of 3 g).

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 Accord than you should

If you take more mycophenolate mofetil than you should, consult your doctor or go to hospital immediately. Do this also if someone accidentally takes your medicine. Take the medicine packaging with you. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mycophenolate Mofetil Accord

If you ever forget to take your medicine, 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 forgotten doses.

If you stop taking Mycophenolate Mofetil Accord

Do not stop taking this medicine unless instructed by your doctor. If you interrupt treatment with mycophenolate mofetil, 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 may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following adverse effects – you may need urgent medical treatment:

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

Frequent problems

Some of the more frequent problems include diarrhea, decreased number of white and/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.

Fighting infections

Treatment with Mycophenolate mofetil Accord 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 get more infections than usual. These include infections affecting the brain, skin, mouth, stomach and intestine, 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 cancer.

General adverse 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, swelling.

Other adverse effects may include:

Skin problems such as:

• acne, cold sores, shingles, skin growth, 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 thinking.

Heart and blood vessel problems such as:

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

Lung problems such as:

• pneumonia, bronchitis,
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the 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 sinuses.

Other problems such as:

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

Additional adverse reactions in children and adolescents

Children, especially those under 6 years of age, are more likely than adults to experience certain adverse reactions, including diarrhea, vomiting, infections, lower red and white blood cell counts, and increased risk of lymphoma or skin cancer.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, 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 Accord

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C. Keep the blister in the outer packaging to protect it from light.
• Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mycophenolate Mofetil Accord

• The active substance is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, povidone (K-90), hydroxypropylcellulose, sodium croscarmellose, purified talc, and magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172), indigo carmine aluminium lake (E132), iron oxide black (E172), and purified talc.

Appearance of the product and contents of the pack

Mycophenolate Mofetil Accord are purple, film-coated, capsule-shaped, biconvex tablets, marked with "AH1" on one side and "500" on the other.

The tablets are available in packs of 50 and 150 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare B.V.

Winthontlaan 200, Utrecht

3526KV

The Netherlands

or

Accord Healthcare Polska, S.p.z.o.o,

ul. Lutomierska, 50-95-200 Pabianice

Poland

Date of the most recent revision of this leaflet: December 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/