Package Leaflet: Information for the Patient

Micofenolate Mofetil Accord 500 mg Film-Coated Tablets

Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

1. What isMicofenolate Mofetil Accordand what it is used for

2. What you need to know before takingMicofenolate Mofetil Accord

3. How to takeMicofenolate Mofetil Accord

4. Possible side effects

5. Storage ofMicofenolate Mofetil Accord

6. Contents of the pack and additional information

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.

• Kidney, heart, or liver.

Mycophenolate Mofetil should 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 before taking mycophenolate. See more information below in this section, under the headings “Warnings and Precautions” and “Pregnancy and Breastfeeding”.

Do not take Mycophenolate Mofetil Accord

- If you are allergic to mycophenolate mofetil, mycophenolic acid, 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 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 Accord.

Warnings and Precautions

Consult your doctor immediately before starting to take Mycophenolate Mofetil Accord:

- 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 digestive problem, such as stomach ulcers.

- If you are planning to become pregnant or have become pregnant during treatment with Mycophenolate Mofetil Accord.

- If you have an inherited enzyme deficiency such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

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

Effect of sunlight

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

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

Children

Do not administer this medication to children under 2 years of age, as the safety and efficacy data are limited in this age group, and no dosage recommendations can be made.

Other medications and Mycophenolate Mofetil Accord

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

This includes over-the-counter medications, including herbal medications. This is because Mycophenolate Mofetil Accord may affect how other medications work. Other medications may also affect how Mycophenolate Mofetil Accord works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications before starting Mycophenolate Mofetil Accord:

• Azathioprine or another immunosuppressive medication – administered after organ transplantation.
• Colestiramine – 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 to treat stomach acid problems such as indigestion.
• Phosphate binders – used in patients with chronic kidney disease 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 vaccine) during treatment with Mycophenolate Mofetil Accord, consult your doctor or pharmacist first. Your doctor will advise on the vaccines you can receive.

Do not donate blood during treatment with Mycophenolate Mofetil Accord and for at least 6 weeks after completing treatment. Men should not donate semen during treatment with Mycophenolate Mofetil Accord and for at least 90 days after completing treatment.

Taking Mycophenolate Mofetil Accord with food and drinks

The intake of food and drinks has no effect on your treatment with Mycophenolate Mofetil Accord.

Contraception in women taking Mycophenolate Mofetil Accord

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

• Before starting to take Mycophenolate Mofetil Accord.
• During the entire treatment with Mycophenolate Mofetil Accord.
• Until 6 weeks after stopping Mycophenolate Mofetil Accord.

Consult your doctor to determine the most suitable contraceptive method 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 cannot become pregnant if your case is one of the following:

• You are postmenopausal, i.e., you are at least 50 years old and your last period occurred more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may become pregnant).
• You have had your fallopian tubes and ovaries removed by surgery (bilateral salpingo-oophorectomy).
• You have had your uterus removed by surgery (hysterectomy).
• Your ovaries do not function (confirmed by a specialist gynecologist).
• You were born with one of the following rare diseases 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 Accord

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 90 days after stopping Mycophenolate Mofetil Accord.

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

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 treatments you can take to prevent organ transplant rejection if:

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

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking Mycophenolate Mofetil Accord 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, where the spine bones do not develop correctly) 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 Accord if you are breastfeeding. This is because small amounts of the medication may pass into breast milk.

Driving and using machines

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount to take

The amount you need to take depends on the type of transplant you have.

The usual doses are shown below.

Treatment will continue until it is 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 gof the medication), administered in 2 separate doses.
• This means taking 2 tablets in the morning and another 2 tablets at night.

Children (between 2 and 18 years):

• The dose varies depending on the child's size.
• Your doctor will decide on 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 gof the medication), administered in 2 separate doses.
• Take 3 tablets in the morning and another 3 tablets at night.

Children:

• There is no information on the use of this medication in children with heart transplants.

Liver transplant:

Adults:

• The first dose should be administered at least 4 days after the transplant surgery and when able to take oral medication.
• The daily dose is 6 tablets (3 gof the medication), administered in 2 separate doses.
• This means taking 3 tablets in the morning and another 3 tablets at night.

Children:

• There is no information on the use of this medication in children with liver transplants.

Taking this medication

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

If you take more Micofenolato de mofetilo Accord than you should

If you take more micofenolato de mofetilo than you should, consult your doctor or go to the hospital immediately. Do this also if someone accidentally takes your medication. Bring the packaging of the medication.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 taken.

If you forget to take Micofenolato de mofetilo Accord

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

If you interrupt treatment with Micofenolato de mofetilo Accord

Do not stop taking this medication unless your doctor tells you to. If you interruptthe treatment with micofenolato de mofetilo, you may increase the chances of organ rejection. Do not stop taking it unless your doctor tells you to.

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

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

Common problems

Some of the most common problems are diarrhea, decrease in the number of white blood cells and/or red blood cells 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 appearance of side effects is more likely in children than in adults.These include diarrhea, infections, decrease in white blood cells and red blood cells in the blood.

Fighting infections

The treatment with Micofenolato de mofetilo Accord 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 that you may contract more infections than usual. 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 withMicofenolato de mofetilohave developed skin and lymphoid tissue cancer.

Unwanted general effects

You may experience general side effects that affect the whole 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, 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 and bleeding gums, 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:

• feeling dizzy, drowsy, or numb,

• tremors, muscle spasms, convulsions,

• feeling anxious or depressed, changes in mood or thought.

Cardiovascular and vascular problemssuch as:

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

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 cough or shortness of breath

• fluid in the lungs or inside the chest,

• 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 nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use,https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep out of 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.
• Do not store above25°C. Store the blister pack in the outer packaging to protect it from light.
• Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Micophenolate Mofetil Accord

- The active ingredient is micophenolate mofetil. Each tablet contains 500 mg of micophenolate mofetil.

- The other components (excipients) are:

Core of the tablets: microcrystalline cellulose, povidone (K-90), hydroxypropyl cellulose, sodium croscarmellose, purified talc, and magnesium stearate.

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

Appearance of the product and contents of the packaging

Micophenolate Mofetil Accordare film-coated tablets with a purple film, capsule-shaped, biconvex, with the inscription “AH1” on one face and “500”on the other.

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

Only some 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

Responsible for Manufacturing

Accord Healthcare B.V.

Winthontlaan 200, Utrecht

3526KV

Netherlands

or

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

ul. Lutomierska, 50-95-200 Pabianice

Poland

Last review date of this leaflet:April 2024

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