Mycophenolate mofetil Aristo 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Micofenolato de mofetilo Aristo 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

This medicine contains mycophenolate mofetil, which belongs to a group of medicines called "immunosuppressants".

Mycophenolate mofetil tablets are used to prevent the body from rejecting a transplanted kidney, heart, or liver. This medicine should be used in combination with other medicines such as cyclosporine and corticosteroids.

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

WARNING

Micofenolato causes congenital malformations 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 lactation”.

Do not take Micofenolato de mofetilo Aristo:

• 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 obtained a negative result on a pregnancy test before the first prescription, as micofenolato may cause congenital malformations 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 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with mycophenolate mofetil:

• 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 digestive system disorder, such as a stomach ulcer.
• If you are planning to become pregnant, or become pregnant while you or your partner are taking Mycophenolate mofetil.
• 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 if you are unsure), consult your doctor immediately before taking this medicine.

Effect of sunlight

Mycophenolate mofetil reduces your body's defense mechanisms. 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, lower red blood cell counts, lower white blood cell counts, 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 Aristo

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription, such as herbal remedies. This is because mycophenolate mofetil may affect how other medicines work, and other medicines may affect how mycophenolate mofetil works.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting Mycophenolate mofetil:

• Azathioprine or other agents that suppress the immune system—administered after a transplant.
• Cholestyramine—used to treat high blood cholesterol levels.
• Rifampicin—an antibiotic used to prevent and treat infections such as tuberculosis (TB).
• Antacids or proton pump inhibitors—used for stomach acidity problems such as indigestion.
• Phosphate binders—used in patients with chronic renal 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 you may receive.

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 90 days after stopping treatment.

Taking mycophenolate mofetil with food and drinks

Taking food and drinks does not affect your treatment with this medicine.

Contraception in women taking mycophenolate mofetil

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

• Before starting to take this medicine.
• Throughout the entire treatment with mycophenolate mofetil.
• Up to 6 weeks after stopping this medicine.

Consult 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 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 were born with one of the following rare 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 mycophenolate mofetil

Available evidence does not indicate an increased risk of congenital malformations or miscarriage if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precautionary measure, you or your female partner are advised to use a reliable contraceptive method during treatment and for up to 90 days after stopping this medicine.

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

Lactation

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

Driving and using machines

The influence of mycophenolate mofetil 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 Aristo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Mycophenolate Mofetil Aristo

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist.

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 recommended daily dose is 4 tablets (2 g of medication), given in two separate doses.
• This means you should take 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.
• 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 (maximum total daily dose of 2 g). The dose should be individualized based on the doctor's clinical assessment.

Heart transplant

Adults

• The first dose should be administered within 5 days after the transplant surgery.
• The recommended daily dose is 6 tablets (3 g of active substance), given in two separate 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 the doctor's clinical assessment. 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 of oral mycophenolate mofetil should be administered at least 4 days after the transplant surgery and once you are able to swallow oral medication.
• The daily dose is 6 tablets (3 g of medication), given in two separate 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 the doctor's clinical assessment. 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 Aristo than you should

If you have taken more mycophenolate mofetil tablets than prescribed or have accidentally ingested the contents of the package, contact your doctor or pharmacist or the Toxicology Information Service immediately, telephone: 91 562 04 20, stating the medication and the amount ingested.

If you take more tablets than instructed, or if someone accidentally takes your medicine, you must go immediately to your doctor or to a hospital.

If you forget to take Mycophenolate Mofetil Aristo

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

If you stop taking Mycophenolate Mofetil Aristo

Do not stop taking it unless your doctor tells you to. 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, Micofenolato de mofetilo Aristo may produce adverse effects, although not everyone experiences 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 bruises or unexpected bleeding
• rash, itching, hives, difficulty breathing or shortness of breath, wheezing, coughing, dizziness, lightheadedness, changes in level of consciousness, hypotension, with or without mild generalized itching, skin redness, and swelling of the face or throat (symptoms of a severe allergic reaction).

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 perform regular blood tests to monitor for any changes in:

• Blood cell counts or signs of infection

Fighting infections

Treatment with this medicine reduces the body's defenses. This is intended 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 may include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

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

General unwanted adverse effects

General unwanted 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 overgrowth, hair loss, skin rash, itching.

Urinary problems such as:

• blood in the urine.

Digestive system 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
• feeling anxious or depressed, changes in mood or thinking

Heart and blood vessel problems such as:

• changes in blood pressure, rapid heartbeat, and dilation 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 in the nasal 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 blood cell counts, lower white blood cell counts, and an increased risk of lymphoma or skin cancer.

Reporting of adverse effects

If you experience any 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 through 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 Aristo

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

Do not use the tablets after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the outer packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Micofenolato de mofetilo Aristo

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

Tablet core: microcrystalline cellulose, povidone (K-30), sodium croscarmellose, magnesium stearate.

Tablet coating:
titanium dioxide (E171), polyvinyl alcohol, polyethylene glycol, talc.

Appearance of Micofenolato de mofetilo Aristo and contents of the pack

White, round tablets.

Packaged in PVC/aluminum blisters, available in the following pack sizes:

1 box containing 50 tablets (in blister packs of 10 tablets).

1 box containing 150 tablets (in blister packs of 10 tablets).

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850, Torrejón de Ardoz
Madrid. Spain

Manufacturer:

Steiner & co Deutsche Arzneimittelgesellschaft mbH & Co. KG
Ostpreußendamm 72/74, 12207 Berlin, Germany

Or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)
C/ Solana, 26
28850 – Torrejón de Ardoz, Madrid – Spain

Date of the most recent review of this leaflet: April 2026

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