Leaflet: information for the user

Mycophenolate mofetil cinfa 500 mg film-coated tablets

Read this leaflet carefully before you start to take 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The full name of the medication is mycophenolate mofetil cinfa 500 mg film-coated tablets EFG.

• In this leaflet, the abbreviated name of mycophenolate mofetil cinfa is used.
• Mycophenolate mofetil cinfacontains mycophenolate mofetil.
• It belongs to a group of medicines called “immunosuppressants”.
• MMycophenolate mofetil is used to prevent the body from rejecting a transplanted organ(kidney, heart and liver).
• Mycophenolate mofetil must be used in combination with other medicines:
• Ciclosporin and corticosteroids.

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions.If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor.

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

If you do not fully understand these instructions, please consult your doctor again to have them explained to you before taking mycophenolate.See more information in this section, under the headings “Warnings and Precautions” and “Pregnancy and Breastfeeding”.

Do not take mycophenolate mofetil cinfa

• If you are allergic to mycophenolate mofetil, acid mycophenolic, or any of the other components of this medication (listed in section 6).
• If you are a woman who can become pregnant and have not obtained a negative pregnancy test result before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.
• If you are pregnant or intend to become pregnant or believe you may be pregnant.
• If you are not using effective contraceptives (see section “Pregnancy, Fertility, and Breastfeeding”).
• If you are breastfeeding.

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

Warnings and Precautions

Consult your doctor before starting to take mycophenolate mofetil cinfa

• If you have any signs of infection such as fever or sore throat.
• If you experience unexpected petechiae or bleeding.
• If you have ever had a gastrointestinal problem such as stomach ulcers.
• If you are planning to become pregnant or have become pregnant during treatment with mycophenolate mofetil.

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

Effect of sunlight

Mycophenolate mofetil reduces your body's defenses. Therefore, there is a greater risk of developing skin cancer. Limit the amount of sunlight and UV light you absorb by:

• Wearing appropriate clothing that protects you and also covers your head, neck, arms, and legs.
• Using a high-protection sunscreen cream.

Other medications and mycophenolate mofetil cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes over-the-counter medications, including herbal supplements.

This is because mycophenolate mofetil may affect how other medications work. Other medications may also affect how mycophenolate mofetil works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications before starting mycophenolate mofetil:

• Azathioprine or another immunosuppressive medication (administered after transplant surgery).
• Colestiramine (used to treat high cholesterol levels).
• Rifampicin (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 chelators (used in patients with chronic kidney disease to reduce phosphate absorption in the blood).
• Antibiotics (used to treat bacterial infections).
• Isavuconazol (used to treat fungal infections).
• Telmisartán (used to treat high blood pressure).

Vaccines

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

You should not donate blood during treatment with mycophenolate mofetil and for at least 6 weeks after completing treatment. Men should not donate semen during treatment with mycophenolate mofetil and for at least 90 days after completing treatment.

Taking mycophenolate mofetil cinfa with food and drinks

The consumption of food and drinks has no effect on your treatment with mycophenolate mofetil.

Pregnancy, breastfeeding, and fertility

Contraception in women taking mycophenolate mofetil cinfa

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

-Before starting to take mycophenolate mofetil cinfa.

-During the entire treatment with mycophenolate mofetil cinfa.

-For at least 6 weeks after stopping mycophenolate mofetil cinfa.

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your individual situation. It is recommended to use two contraceptive methods as this will reduce the risk of unintended pregnancy.

Consult your doctor as soon as possible if you believe your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You are considered not susceptible to becoming pregnant if your case is one of the following:

Contraception in men taking mycophenolate mofetil cinfa

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for at least 90 days after stopping mycophenolate mofetil. If you are planning to have a child, consult your doctor about the possible risks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will discuss the risks and alternative treatment options with you that you can take to prevent organ transplant rejection if:

• You intend to become pregnant.
• You have missed a period or suspect you may be pregnant.
• You have had unprotected sex.

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 severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida) abnormalities. Your baby may be affected by one or more of these.

If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.

Breastfeeding

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

Driving and using machines

The influence of mycophenolate mofetil on your ability to drive and use machines is moderate. If you feel drowsy, drowsy, or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate mofetil cinfa contains sodium

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

Follow exactly the administration instructions of thismedication as indicated byyour doctor or pharmacist. In case of doubt, consult your doctoror pharmacist again.

Amount to take

The amount to take depends on the type of transplant you have. The recommended doses areshown below. Treatment will continue until it is necessary to prevent rejection of thetransplanted 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 medication), administered in 2 separate doses.
• This means taking 2 tablets in the morning and other 2 tablets at night.

Children (between 2 and 18 years)

• The dose varies according to the child's height.
• Your doctor will decide which is the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2“). The recommended dose is 600 mg/m2, administered twice a day.

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 medication), administered in 2 separate doses.
• Take 3 tablets in the morning and other 3 tablets at night.

Children

• There is no information on the use of mycophenolate mofetil in children with heart transplant.

Liver transplant

Adults

• The first dose should be administered at least 4 days after the transplant surgery and when you are able to take oral medication.
• The daily dose is 6 tablets (3 g of the medication), administered in 2 separate doses.
• Take 3 tablets in the morning and other 3 tablets at night.

Children

• There is no information on the use of mycophenolate mofetil in children with liver transplant.

Taking this medication

Swallow the tablets whole with a glass of water. Do not break or crush them. Do not take any tablet that has broken.

If you take more mycophenolate mofetil cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.Do this also if someone accidentally takes your medication. Bring the medication packaging with you.

If you forget to take mycophenolate mofetil cinfa

If you ever forget to take the medication, take it as soon as you remember. Then continuetaking it at the usual hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with mycophenolate mofetil cinfa

Do not stop taking this medication unless your doctor tells you to. If you interrupt treatment, you mayincrease the risk of rejection of the transplanted organ.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

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

Common problems

Some of the most common problems are diarrhea, decreased white blood cell or red blood cell count in the blood, infection, and vomiting.Your doctor will perform regular blood tests to monitor any changes in:

• the number of blood cells or signs of infection.

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

Fighting infections

The treatment with mycophenolate mofetil reduces the body's defenses. This is to prevent transplant rejection.For this reason, the body cannot fight infections as effectively as in normal conditions.This means you may contract more infections than usual.In these include infections that affect the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and lymphatic cancer

Like what happens in patients taking this type of medicine (immunosuppressants), a very small number of patients treated with mycophenolate mofetil have developed skin and lymphoid tissue cancer.

Unwanted general effects

You may experience general side effects that affect your entire body.These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty sleeping, pains (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other side effects may be:

Skin problemssuch as:

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

Urinary problemssuch as:

• blood in the urine.

Digestive system and mouth problemssuch as:

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

Nervous system problemssuch as:

• dizziness, drowsiness, or numbness.
• shaking, muscle spasms, convulsions.
• feeling anxious or depressed, changes in mood or thought.

Cardiac and vascular problemssuch as:

• changes in blood pressure, rapid heartbeat, and blood vessel dilation.

Pulmonary problemssuch as:

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

Other problemssuch as:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not use this medication if you observe any visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of cinfa micophenolate mofetil

• The active ingredient is micophenolate mofetil. Each film-coated tablet contains 500 mg of micophenolate mofetil.
• The other components are:

• Core: Microcrystalline cellulose (Avicel PH101), Croscarmellose sodium (Ac-di-sol), Povidone (Kollidon K90), Magnesium stearate.
• Coating: Hypromellose 3cP, Hydroxypropyl cellulose, Titanium dioxide (E-171), Macrogol 400, Hypromellose 50cP, Indigo carmine (E-132), Iron oxide red (E-172).

Appearance of the product and content of the container

Micophenolate mofetil cinfa 500 mg is presented in the form of film-coated, oval-shaped, violet-colored tablets.

It is presented in PVC+PCTFE+PE/Al blisters, containing 50 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Tecnimede-Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos,

Portugal

Date of the last review of this leaflet: January 2022

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