MOFETIL MYCOPHENOLATE ACCORD 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Mycophenolate Mofetil Accord 250 mgHard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Mycophenolate Mofetil Accord and what is it 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 further information

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

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

Mycophenolate Mofetil Accord contains 250 mg of mycophenolate mofetil. It belongs to a group of medicines called “immunosuppressants”.

Mycophenolate mofetil is used to prevent your body from rejecting a transplanted kidney, heart, or liver, and is used together with other medicines known as ciclosporins and corticosteroids.

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 doctor's advice on contraception.

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 fully understand these instructions, please consult your doctor again so that they can explain them to you again 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, 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, since 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 applies to you. If you are not sure, consult your doctor or pharmacist before taking mycophenolate mofetil.

Warnings and precautions

Consult your doctor immediately before starting treatment with Mycophenolate Mofetil Accord 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 have unexpected bruising or bleeding.
• You have had any gastrointestinal problems, such as stomach ulcers.
• You plan to become pregnant or have become pregnant while you or your partner is taking Mycophenolate Mofetil Accord.
• You have a rare inherited enzyme deficiency known as Lesch-Nyhan and Kelley-Seegmiller syndrome.

If any of the above applies to you (or you are not sure), consult your doctor immediately before taking Mycophenolate Mofetil Accord.

Effect of sunlight

Mycophenolate Mofetil Accord reduces your body's defenses. For this reason, there is a higher 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, as the safety and efficacy of administration to pediatric patients have not been established.

Using Mycophenolate Mofetil Accord with other medicines

Tell 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 medicines. This is because Mycophenolate Mofetil Accord may affect the way other medicines work. Also, other medicines may 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 another medicine that suppresses the immune system – which was given to you 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 problems such as indigestion.
• phosphate binders – used in patients with chronic kidney 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.
• aciclovir, ganciclovir, and valganciclovir – used to treat and prevent viral infections.

Vaccines

If you need to be vaccinated (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.

Mycophenolate Mofetil Accord with food and drinks

Taking 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 a reliable method of contraception. This includes:

• before starting to take mycophenolate mofetil.
• during the entire treatment with mycophenolate mofetil.
• until 6 weeks after stopping mycophenolate mofetil.

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).
• You have had both fallopian tubes and ovaries removed surgically (bilateral salpingo-oophorectomy).
• You have had your uterus removed surgically (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

Available evidence does not indicate an increased risk of malformations 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.

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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking 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.

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, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system abnormalities (such as spina bifida, where the bones of the spine do not develop correctly). Your baby may be affected by one or more of these.

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 Mycophenolate Mofetil Accord on the ability to drive and use machines is moderate. If you feel drowsy, dazed, or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate Mofetil Accord contains sodium

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

3. How to take Mycophenolate Mofetil Accord

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist.

Amount to be taken

The amount to be taken 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 is given in the 3 days following the transplant operation.
• The daily dose is 8 capsules (2 g of medicine) given in 2 separate doses.
• Take 4 capsules in the morning and 4 capsules in the evening.

Pediatric population (between 2 and 18 years):

• The dose given will vary depending on the child's height.
• Your doctor will decide which dose is most suitable, taking into account your 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 started in the 5 days following the transplant operation.
• The daily dose is 12 capsules (3 g of medicine), given in 2 separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

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 given once you have been at least 4 days post-transplant and can swallow oral medicines.
• The daily dose is 12 capsules (3 g of medicine) given in 2 separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

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 them.
• Do not take any capsule that has been broken or divided into two.

Be careful not to get the powder from the inside of a broken capsule in 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 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.

If you forget to take Mycophenolate Mofetil Accord

If you forget to take your medicine, take it as soon as you remember and 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 mycophenolate mofetil unless your doctor tells you to. If you stop treatment, you may increase the risk of organ transplant rejection. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Common Problems

Some of the most common problems are diarrhea, decrease in the number of white 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
• blood levels of substances such as sugar, fat, or cholesterol.

The appearance of adverse effects is more likely in children than in adults. These include diarrhea, infections, decrease in white 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 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

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

General Undesired Effects

Various undesired general effects may occur that affect your entire 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, and swelling.

Other undesired effects may be:

Skin Problemssuch as:

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

Urinary Problemssuch as:

• blood in the urine.

Problems with the Digestive System and Mouthsuch as:

• swollen gums and mouth ulcers.
• inflammation of the pancreas, colon, or stomach
• intestinal problems including bleeding, liver problems
• 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 thinking.

Cardiac and Vascular Problemssuch as:

• changes in blood pressure, abnormal heart rhythm, and swelling of blood vessels at the infusion site.

Pulmonary Problemssuch as:

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

Other Problemssuch as:

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

Reporting Adverse Effects

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

5. Storage of Mycophenolate Mofetil Accord

• Keep this medicine out of the 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.
• Store below 30°C.
• Do not use this medicine if you notice any visible signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mycophenolate Mofetil Accord

The active ingredient is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.

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

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

Appearance of the Product and Package Contents

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

The 250 mg mycophenolate mofetil 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, 6ª planta

08039 Barcelona

Spain

Manufacturer

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

or

Accord Healthcare single member S.A.

64th Km National Road Athens, Lamia, Schimatari, 32009,

Greece

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

Date of Last Revision of this Prospectus:December 2023

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/