Package Leaflet: Information for the Patient

Mycophenolate Mofetil Accord 250 mgHard Capsules EFG

Read this leaflet carefully before you start taking this medicinebecause 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you take Mycophenolate Mofetil Accord

3. How to take Mycophenolate Mofetil Accord

4. Possible side effects

5. Storage of Mycophenolate Mofetil Accord

6. Contents of the pack and additional information

The full name of the medication is Mycophenolate Mofetil Accord 250 mg hard capsules EFG.

Mycophenolate Mofetil Accord contains 250 mg of mycophenolate mofetil. It belongs to a group of medications known as “immunosuppressants”.

Mycophenolate Mofetil Accord is used to prevent your body from rejecting a transplanted kidney, heart, or liver and is used in combination with other medications known as cyclosporines 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 Accord

• If you are allergic to mycophenolate mofetil, to mycophenolic acid, or to 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.

Warnings and Precautions

Consult your doctor immediately before starting treatment with Mycophenolate Mofetil Accord if:

• 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.
• You have any signs of infection such as fever or sore throat.
• You experience unexpected cardinals or bleeding.
• You have had any digestive system problems, such as stomach ulcers.
• You are planning to become pregnant or have become pregnant while taking Mycophenolate Mofetil Accord.
• You have a rare inherited enzyme deficiency known as Lesch-Nyhan syndrome or 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 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 sun cream.

Children

Do not administer this medication to children, as the safety and efficacy of administration to pediatric patients have not been established.

Use of Mycophenolate Mofetil Accord with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications. This includes medications purchased without a prescription, such as 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 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.

•Aciclovir, ganciclovir, and valganciclovir – used to treat and prevent viral infections.

Vaccinations

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 you on the vaccines you can receive.

You should 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.

Mycophenolate Mofetil Accord with food and drinks

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

Pregnancy, Fertility, and Breastfeeding

Contraception in women taking mycophenolate mofetil

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

•Before starting to take mycophenolate mofetil.

•During the entire treatment with mycophenolate mofetil.

•For at least 6 weeks after stopping mycophenolate mofetil.

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 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).

•Your fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy).

•Your uterus has been surgically removed (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

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 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 taking this medication. Your doctor will discuss the risks and alternative treatments with you if:

•You intend to become pregnant.

•You have missed a period or have unusual menstrual bleeding 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 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 that have been 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.

Breastfeeding

Do not take Mycophenolate Mofetil Accord if you are breastfeeding, as small amounts of the medication may pass into breast milk.

Driving and operating machines

The influence of Mycophenolate Mofetil Accord on your ability to drive and operate 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.

Mycophenolate Mofetil Accord contains sodium

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

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

Amount to take

The amount 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 is administered in the 3 days following the transplant surgery.
• The daily dose is 8 capsules (2 gof medication) administered in 2 separate doses.
• Take 4 capsules in the morning and 4 capsules at night.

Pediatric population (between 2 and 18 years):

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

Heart transplant

Adults:

• The first dose is initiated in the 5 days following the transplant surgery.
• The daily dose is 12 capsules (3 gof medication), administered in 2 separate doses.
• Take 6 capsules in the morning and 6 capsules at night.

Pediatric population:

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

Liver transplant:

Adults:

• The first oral dose will be administered at least 4 days after the transplant surgery and when you can swallow the medication orally.
• The daily dose is 12 capsules (3 gof medication administered in 2 separate doses.
• Take 6 capsules in the morning and 6 capsules at night.

Pediatric population:

• There is no information on the use of mycophenolate mofetil in children who have received a liver transplant.

Form and route of administration

• Swallow the capsules whole with a glass of water.
• Do not break or crush
• Do not take any capsule that has been broken or split in two.

Be careful not to let the powder from the inside of a broken capsule get into your eyes or mouth.

• If this happens, rinse them with plenty of running water. Be careful not to let the powder from the inside of a broken capsule come into contact with your skin.
• If this happens, wash the area with plenty of water and soap.

If you take more Micofenolato de mofetilo Accord than you should

If you take more mycophenolate mofetil 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 with you.

If you forget to take Micofenolato de mofetilo Accord

If you forget to take the medication at any time, take it as soon as you remember and then continue taking it at the usual hours. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Micofenolato de mofetilo Accord

Do not stop taking mycophenolate mofetil unless your doctor tells you to. If you interrupt treatment, you may increase 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 can 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 having 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:

•blood cell count

•blood levels of substances such as sugar, fat, or cholesterol.

Side effects are more likely to occur in children than in adults. These include diarrhea, infections, decreased white blood cell and red blood cell count in the blood.

Combating infections

The treatment withMicofenolato de mofetilo Accordreduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as normal. This means you may contract more infections than usual. These include infections affecting the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and lymphatic cancer

Like in patients taking this type of medicine (immunosuppressants), a very small number of patients treated withMicofenolato de mofetilo Accordhave developed skin and lymphoid tissue cancer.

Unwanted general effects

Various unwanted general effects that affect the whole body may occur. 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 unwanted 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.

•pancreatitis, colon, or stomach inflammation

•intestinal problems that include bleeding, liver problems

•diarrhea,constipation, nausea, indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

•dizziness, somnolence, or numbness

•shaking, muscle spasms, convulsions

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

Cardiac and vascular problemssuch as:

•changes in blood pressure, abnormal heart rhythm, andswellingof blood vesselsat the perfusion site..

Pulmonary problemssuch as:

•pneumonia, bronchitis

•difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the respiratory airways are abnormally dilated) or pulmonary fibrosis (pulmonary scarring). Talk to your doctor if you develop persistent cough or dyspnea

•fluid in the lungs or inside 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 or nurse, 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 of 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 dateis the last day of the month indicated.
• Store below 30°C.
• Do not use this medication if you observe any visible sign of deterioration.
• Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Micophenolato de mofetilo Accord

The active ingredient is micophenolato de mofetilo. Each capsule contains 250 mg of micophenolato mofetilo.

The other components are: microcrystalline cellulose, hydroxypropylcellulose, povidone K-90, croscarmellose sodium, talc, and magnesium stearate.

Composition of the capsule coating: gelatin, sodium lauryl sulfate, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and indigo carmine (E132).

Appearance of the product and contents of the package

Micophenolato de mofetilo Accord are hard gelatin capsules, light blue/orange, size "1", with the inscription "MMF" printed on the cap and "250" on the body, containing white or almost white powder.

The 250 mg micophenolato de mofetilo capsules are packaged in blisters and are available in boxes of 100 and 300 capsules.

Only some package 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 Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

This medicine is authorized in the Member States of the European Economic Area with the following names

Last review date of this leaflet:December 2023

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