Mycophenolate mofetil Accord 250 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Micofenolato de mofetilo Accord 250 mg hard capsules EFG

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Micofenolato de mofetilo Accord is and what it is used for
2. What you need to know before taking Micofenolato de mofetilo Accord
3. How to take Micofenolato de mofetilo Accord
4. Possible side effects
5. How to store Micofenolato de mofetilo Accord
6. Contents of the pack and other information

1. What Micofenolato de mofetilo Accord is and what it is used for

The full name of the medicine is Micofenolato de mofetilo Accord 250 mg hard capsules EFG.

Micofenolato de mofetilo 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 cyclosporines and corticosteroids.

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

WARNING

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

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

If you do not fully understand these instructions, please consult your doctor again for further explanation 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 could become pregnant and have not obtained a negative result on a pregnancy test before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.
• If you are pregnant or planning to become pregnant, or think you might be pregnant.
• If you are not using effective contraception (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 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:

• You are over 65 years of age, 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 develop unexpected bruising or bleeding.
• You have ever had a gastrointestinal disorder, such as a stomach ulcer.
• You are planning to become pregnant or become pregnant while you or your partner are taking Mycophenolate Mofetil.
• You have a rare inherited enzymatic deficiency known as Lesch-Nyhan or Kelley-Seegmiller syndrome.

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

Effect of sunlight

Mycophenolate mofetil reduces your body's defenses. For this reason, there is an increased risk of developing skin cancer. Limit your exposure to sunlight and UV light by:

• Wearing appropriate protective clothing that also covers your head, neck, arms, and legs.
• Using a sunscreen with high protection factor.

Children

Do not give this medicine to children, as the safety and efficacy of administration in pediatric patients has not been established.

Taking Mycophenolate Mofetil Accord with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. This is because Mycophenolate Mofetil Accord may affect how other medicines work. Also, other medicines may affect how Mycophenolate Mofetil Accord works. Specifically, inform your doctor or pharmacist if you are taking any of the following medicines before starting Mycophenolate Mofetil Accord:

• Azathioprine or other immunosuppressive medicines – given after transplant surgery.
• 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 renal 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 for the treatment and prevention of viral infections.

Vaccines

If you need to receive 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 are suitable for you.

You must not donate blood during treatment with Mycophenolate Mofetil Accord and for at least 6 weeks after stopping treatment. Men must 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 could become pregnant, you must always use an effective contraceptive method. This includes:

• Before starting mycophenolate mofetil.
• Throughout treatment with mycophenolate mofetil.
• Up to 6 weeks after stopping mycophenolate mofetil.

Consult your doctor to determine the most appropriate contraceptive method for you. This will depend on your personal circumstances. The use of two contraceptive methods is recommended, as this reduces 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 missed taking your contraceptive pill.

You cannot become pregnant if you meet any of the following criteria:

• You are post-menopausal, i.e., you are at least 50 years old and your last menstrual period was more than one 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 surgically removed (bilateral salpingo-oophorectomy).
• You have had your uterus surgically removed (hysterectomy).
• Your ovaries do not function (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 yet started menstruating.

Contraception in men taking mycophenolate mofetil

Available evidence does not indicate an increased risk of congenital malformations or miscarriage if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precautionary measure, you or your female partner are advised to use a reliable contraceptive method during treatment and for up to 90 days after stopping mycophenolate mofetil.

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 taking this medicine. Your doctor will discuss the risks and alternative treatments available to prevent rejection of the transplanted organ if:

• You plan to become pregnant.
• You have missed a period or think you may have missed a menstrual period, have unusual menstrual bleeding, or suspect you may be pregnant.
• You have had sexual intercourse without using effective contraceptive methods.

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 rate of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Reported malformations include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, heart, esophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida, where the spinal bones do not develop properly). 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 effect of mycophenolate mofetil on the ability to drive and use machines is moderate. If you feel drowsy, dizzy, or confused, speak to your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Mycophenolate Mofetil Accord contains sodium

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

3. How to take Micofenolato de mofetilo Accord

Follow exactly your doctor's instructions for taking this medicine. If you are not sure, consult your doctor or pharmacist.

Dosage

The dose you need depends on the type of transplant you have received. The usual doses are shown below. Treatment will continue for as long as necessary to prevent rejection of the transplanted organ.

Kidney transplant

Adults:

• The first dose is administered within 3 days after the transplant surgery.
• The daily dose is 8 capsules (2 g of medicine), given in two separate doses.
• Take 4 capsules in the morning and 4 capsules in the evening.

Pediatric population (between 2 and 18 years of age):

• The dose administered will vary depending on the child's size.
• Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area) measured in square meters or “m²”. The recommended dose is 600 mg/m², twice daily.

Heart transplant

Adults:

• The first dose is started within 5 days after the transplant surgery.
• The daily dose is 12 capsules (3 g of medicine), given in two separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Pediatric population:

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

Liver transplant

Adults:

• The first oral dose will be administered at least 4 days after the transplant surgery and once you are able to swallow oral medication.
• The daily dose is 12 capsules (3 g of medicine), given in two separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Pediatric population:

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

Method 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 is broken or split.

Take care to avoid the powder from inside a broken capsule coming into contact with your eyes or mouth.

• If this happens, rinse thoroughly with plenty of running water. Take care to avoid skin contact with the powder from inside a broken capsule.
• If contact occurs, wash the area thoroughly with plenty of water and soap.

If you take more Micofenolato de mofetilo Accord than you should

If you take more mycophenolate mofetil than prescribed, contact your doctor or go to the hospital immediately. Do the same if someone accidentally takes your medicine. Take the medicine packaging with you.

If you forget to take Micofenolato de mofetilo Accord

If you forget to take a dose, take it as soon as you remember, and then continue taking it at your usual times. Do not take a double dose to make up for a missed dose.

If you stop taking Micofenolato de mofetilo Accord

Do not stop taking mycophenolate mofetil unless instructed by your doctor. If you interrupt treatment, you may increase the risk of rejection of the transplanted organ. If you have any further 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.

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

• if you have signs of infection such as fever or sore throat
• if you develop bruising or bleeding unexpectedly
• if you develop a rash, swelling of the face, lips, tongue or throat with difficulty breathing. You may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the more common problems include diarrhea, decreased number of white or red blood cells in the blood, infections, and vomiting. Your doctor will carry out regular blood tests to monitor for any changes in:

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

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

Fighting infections

Treatment with Mycophenolate mofetil Accord reduces the body's defenses. This is intended to prevent transplant rejection. For this reason, the body is also less able to fight infections as effectively as under normal conditions. This means you may get more infections than usual. These include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancers

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

General unwanted effects

Various general unwanted side effects affecting the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, and pain (such as stomach pain, chest pain, joint or muscle pain, headache, flu-like symptoms, and swelling).

Other unwanted side effects may include:

Skin problems such as:

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

Urinary problems such as:

• blood in the urine.

Digestive system and mouth problems such 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 problems such as:

• dizziness, drowsiness, or numbness
• tremor, muscle spasms, seizures
• feelings of anxiety or depression, changes in mood or thinking.

Heart and blood vessel problems such as:

• changes in blood pressure, irregular heartbeat, swelling of blood vessels at the infusion site.

Lung problems such as:

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

Other problems such as:

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

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide 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 expiry date which is stated on the packaging after EXP. The expiry date refers to 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. Dispose of empty containers and unused medicines at a SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mycophenolate Mofetil Accord

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

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

Capsule coating composition: 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 pack

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

The 250 mg mycophenolate mofetil capsules are packed in blisters and available in packs of 100 and 300 capsules.

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 Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Accord Healthcare single member S.A.

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

Greece

This medicinal product is authorized in the European Economic Area member states under the following names

Country name Proposed name Bulgaria ??????????? ??????? ????? 250 mg ??????? Cyprus Mycophenolate Mofetil Accord 250 mg Capsules Finland Mycophenolate Mofetil Accord 250 mg Capsules France MYCOPHENOLATE MOFETIL ACCORD HEALTHCARE 250 mg, capsule Germany Mycophenolate Mofetil Accord 250 mg Kapseln Malta Mycophenolate Mofetil 250 mg Capsules Poland Mycophenolate Mofetil Accord Portugal Mycophenolate Mofetil Accord Spain Mycophenolate Mofetil Accord 250 mg hard capsules EFG United Kingdom Mycophenolate Mofetil 250 mg Capsules Denmark Mycophenolate Mofetil Accord Ireland Mycophenolate Mofetil 250 mg capsules Italy Mycophenolate Mofetil Accord Netherlands Mycofenolaat Mofetil Accord 250 mg capsules Norway Mykofenolat Accord 250 mg capsules Sweden Mykofenolatmofetil Accord 250 mg capsules

Date of the most recent review of this leaflet: December 2023

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