MOFETIL MYCOPHENOLATE CINFA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Myphenolate Mofetil Cinfa 500 mg film-coated tablets 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 or pharmacist.
• 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 get 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 pack

1. What Myphenolate Mofetil Cinfa is and what it is used for
2. What you need to know before you take Myphenolate Mofetil Cinfa
3. How to take Myphenolate Mofetil Cinfa
4. Possible side effects
5. Storage of Myphenolate Mofetil Cinfa
6. Contents of the pack and other information

1. What Myphenolate Mofetil Cinfa is and what it is used for

The full name of the medicine is Myphenolate Mofetil Cinfa 500 mg film-coated tablets EFG.

• In this leaflet, the shorter name Myphenolate Mofetil Cinfa will be used.
• Myphenolate Mofetil Cinfa contains the active substance 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 together with other medicines:
• Cyclosporine and corticosteroids.

2. What you need to know before you take Myphenolate Mofetil Cinfa

WARNING

Mycophenolate causes birth defects and miscarriages. 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 provide 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 Myphenolate Mofetil Cinfa

• 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 miscarriages.
• If you are pregnant or plan to become pregnant or think you may be pregnant.
• If you are not using effective contraception (see section "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 before starting to take Myphenolate Mofetil Cinfa

• If you have any signs of infection, such as fever or sore throat.
• If you have unexpected bruising or bleeding.
• If you have had any problems with your digestive system, such as stomach ulcers.
• If you plan to become pregnant or become pregnant during treatment with mycophenolate mofetil.

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

Effect of sunlight

Mycophenolate mofetil reduces the 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 high-factor sunscreen.

Other medicines and Myphenolate Mofetil Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

This is because mycophenolate mofetil can affect how other medicines work. Other medicines can also affect how mycophenolate mofetil works.

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

• Azathioprine or other medicines that suppress the immune system (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 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 have a vaccine (live organism vaccine) during treatment with mycophenolate mofetil, 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 and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with mycophenolate mofetil and for at least 90 days after stopping treatment.

Taking Myphenolate Mofetil Cinfa with food and drinks

Taking food and drinks has no effect on your treatment with mycophenolate mofetil.

Pregnancy, breastfeeding, and fertility

Contraception in women taking Myphenolate Mofetil Cinfa

If you are a woman who can become pregnant, you must use a reliable method of contraception. This includes:

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

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 are considered not to be at risk of becoming 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 surgically removed (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (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 yet started menstruating.

Contraception in men taking Myphenolate Mofetil Cinfa

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precaution, you or your female partner are advised to 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 possible risks.

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 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 until you see your doctor.

Pregnancy

Mycophenolate causes a very high frequency of miscarriages (50%) and severe damage to the unborn baby (23-27%). Among the birth defects 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 spine bones do not develop correctly). 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 doctor's advice on contraception. Your doctor may request more than one pregnancy test to ensure you are not pregnant before starting treatment.

Breastfeeding

Do not take mycophenolate mofetil 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 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.

Myphenolate Mofetil Cinfa contains sodium

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

3. How to take Myphenolate Mofetil Cinfa

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

Amount to be taken

The amount to be taken depends on the type of transplant you have. The recommended 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 divided 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 height.
• 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 divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information on the use of mycophenolate mofetil 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 divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

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

Taking this medicine

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

If you take more Myphenolate Mofetil Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. Do this even if someone has accidentally taken your medicine. Bring the medicine packaging with you.

If you forget to take Myphenolate Mofetil Cinfa

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 Myphenolate Mofetil Cinfa

Do not stop taking this medicine 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:

• If you have symptoms of infection such as fever or sore throat.
• If you develop bruises or bleeding unexpectedly.
• If you have a rash, swelling of the face, lips, tongue, or throat 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, 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 or signs of infection.

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 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 Lymph Cancer

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

General Undesired Effects

General adverse effects that affect the whole body may occur. 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 adverse 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 of the Digestive System and Mouthsuch 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, 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, rapid heartbeat, and dilation 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 (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 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, 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. Conservation of Mycophenolate Mofetil Cinfa

Keep this medicine 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.

This medicine does not require special storage conditions. Do not use this medicine if you observe any visible signs of deterioration.

Medicines should not be thrown away through 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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mycophenolate Mofetil Cinfa

• The active ingredient is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.
• The other components are:

• Core: Microcrystalline cellulose (Avicel PH101), Sodium croscarmellose (Ac-di-sol), Povidone (Kollidon K90), Magnesium stearate.
• Coating: Hypromellose 3cP, Hydroxypropyl cellulose, Titanium dioxide (E-171), Macrogol 400, Hypromellose 50cP, Indigo carmine lake (E-132), Red iron oxide (E-172).

Appearance of the Product and Package Contents

Mycophenolate mofetil cinfa 500 mg is presented in the form of film-coated tablets, oblong, and purple in color.

It is presented in PVC+PCTFE+PE/Al blisters, containing 50 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Tecnimede-Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos,

Portugal

Date of the Last Revision of this Prospectus:January 2022

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80225/P_80225.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80225/P_80225.html