MOFETIL MYCOPHENOLATE ACCORD 500 mg FILM-COATED TABLETS

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

WARNING

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

Your doctor will explain and give you written information, in particular about the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not understand these instructions completely, please consult your doctor again so that they can explain them to you 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 ingredients of this medicine (listed in section 6).
• If you are a woman who can become pregnant and have not had a negative pregnancy test before the first prescription, as mycophenolate can cause birth defects and spontaneous abortions.
• If you are pregnant or plan to become pregnant or think you may be pregnant.
• If you are not using effective contraceptives (see Pregnancy, fertility, and breastfeeding).
• If you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are not sure, 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 get bruising or bleeding unexpectedly.
• If you have ever had a digestive problem, such as a stomach ulcer.
• If you plan to become pregnant or become pregnant during treatment with Mycophenolate Mofetil 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 not sure), consult your doctor immediately before taking Mycophenolate Mofetil Accord.

Sunlight effect

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

• wearing protective clothing that covers your head, neck, arms, and legs.
• using a sunscreen with a high protection factor.

Children

Do not give this medicine to children under 2 years of age, as safety and efficacy data are limited in this age group and dosage recommendations cannot be made.

Other medicines and Mycophenolate Mofetil Accord

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

This includes medicines obtained without a prescription, including herbal medicines. This is because Mycophenolate Mofetil Accord may affect the way other medicines work. Other medicines may also affect the way Mycophenolate Mofetil Accord works.

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

• azathioprine or other immunosuppressive medicines – which you were given after the transplant operation.
• 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 into 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 have a vaccine (live organism vaccine) during treatment with Mycophenolate Mofetil Accord, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you can have.

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

Taking Mycophenolate Mofetil Accord with food and drinks

Taking food and drink 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 a reliable method of contraception. This includes:

• before starting to take Mycophenolate Mofetil Accord.
• during 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 personal 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 think your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You cannot become pregnant if:

• You are post-menopausal, i.e., you are at least 50 years old and your last period was more than a year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant).
• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy).
• Your uterus has been removed by surgery (hysterectomy).
• Your ovaries do not work (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 started menstruating.

Contraception in men taking Mycophenolate Mofetil Accord

Available evidence does not indicate an increased risk of birth defects or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precaution, it is recommended that you or your female partner use a reliable method of contraception during treatment and for 90 days after stopping Mycophenolate Mofetil 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss the risks and alternative treatments that you can take to prevent organ transplant rejection if:

• You plan 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 reported birth defects are ear, eye, facial (cleft lip and palate), finger, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system defects (e.g., spina bifida, where the spine bones do not develop properly). 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 before starting treatment and must follow the contraceptive advice given by your doctor. Your doctor may request more than one pregnancy test 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 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, sleepy, or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

3. How to take Mycophenolate Mofetil Accord

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much 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 organ transplant rejection.

Kidney transplant:

Adults:

• The first dose should be given within 3 days after the transplant operation.
• The daily dose is 4 tablets (2 g of the medicine), given in 2 separate doses.
• This means taking 2 tablets in the morning and 2 tablets in the evening.

Children (between 2 and 18 years):

• The dose varies depending on the child's size.
• The doctor will decide the most suitable dose based on the child's height and weight (body surface area measured in square meters “m2”). The recommended dose is 600 mg/m2, given twice a day.

Heart transplant:

Adults:

• The first dose should be given within 5 days after the transplant operation.
• The daily dose is 6 tablets (3 g of the medicine), given in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:

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

Liver transplant:

Adults:

• The first dose should be given at least 4 days after the transplant operation and when you are able to take oral medication.
• The daily dose is 6 tablets (3 g of the medicine), given in 2 separate doses.
• This means taking 3 tablets in the morning and 3 tablets in the evening.

Children:

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

Taking 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 the hospital immediately. Do this also if someone accidentally takes your medicine. Take the medicine package with you. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 the 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 your doctor tells you to. If you stop taking mycophenolate mofetil, you may increase the risk of organ transplant rejection. Do not stop taking it unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 occurrence 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

Treatment with Mycophenolate Mofetil Accord reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as under normal conditions. This means you may get more infections than usual. These include infections that affect the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and lymph cancer

As with patients taking this type of medicine (immunosuppressants), a very small number of patients treated with Mycophenolate Mofetil have developed lymphoid and skin cancer.

General unwanted effects

General unwanted effects may occur that affect the whole body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, pain (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, 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 sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

• feeling dizzy, sleepy, or numb.
• tremors, muscle spasms, seizures.
• feeling anxious or depressed, mood or thought changes.

Heart and blood vessel problemssuch as:

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

Lung problemssuch as:

• pneumonia, bronchitis.
• breathing difficulties, 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 if you are short of breath.
• fluid in the lungs or inside the chest.
• problems in the nasal passages.

Other problemssuch as:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micofenolate Mofetil Accord

• Keep out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store above 25°C. Keep the blister pack in the outer packaging to protect it from light.
• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Micofenolate Mofetil Accord

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

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

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

Appearance of the Product and Package Contents

Micofenolate Mofetil Accord are film-coated tablets of purple color, capsule-shaped, biconvex, with the inscription "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

Netherlands

or

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

ul. Lutomierska, 50-95-200 Pabianice

Poland

Date of the Last Revision of this Leaflet:April 2024

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