Mycophenolate mofetil CINFA 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

mycophenolate 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What micofenolato de mofetilo cinfa is and what it is used for

The full name of the medicine is micofenolato de mofetilo cinfa 500 mg film-coated tablets EFG.

• The abbreviated name micofenolato de mofetilo cinfa is used in this leaflet.
• micofenolato de mofetilo cinfa contains 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, and liver).
• Mycophenolate mofetil must be used together with other medicines:
• Cyclosporine and corticosteroids.

2. What you need to know before starting to take mycophenolate mofetil cinfa

WARNING

Mycophenolate causes birth defects 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 your doctor's advice on contraception.

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 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 could become pregnant and have not obtained a negative result on a pregnancy test before the first prescription, as mycophenolate may cause birth defects 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 section “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

Talk to your doctor before starting to take mycophenolate mofetil cinfa

• If you have any signs of infection such as fever or sore throat.
• If you experience unexpected bruising or bleeding.
• If you have ever had a gastrointestinal problem such as a stomach ulcer.
• If you plan to become pregnant or become pregnant during treatment with mycophenolate mofetil.

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

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 covers your head, neck, arms, and legs.
• Using a sunscreen with a high protection factor.

Other medicines and mycophenolate mofetil cinfa

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

This is because mycophenolate mofetil may affect how other medicines work. Also, other medicines may affect how mycophenolate mofetil works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• Azathioprine or another medicine that suppresses the immune system (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 acid 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).

Vaccines

If you need to receive a vaccine (live organism vaccine) during treatment with mycophenolate mofetil, 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 and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with mycophenolate mofetil and for at least 90 days after stopping treatment.

Taking mycophenolate mofetil cinfa with food and drink

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

Pregnancy, breastfeeding and fertility

Contraception in women taking mycophenolate mofetil cinfa

If you are a woman who could become pregnant, you must use an effective method of contraception. This includes:

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

Talk to your doctor to determine which contraceptive method is most suitable 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.

Contact 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 are considered not able to become pregnant if any of the following apply to you:

• You are post-menopausal, i.e., you are at least 50 years old and your last period occurred 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 both 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 gynaecologist).
• 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 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 ruled out. As a precaution, you or your female partner are advised to use a reliable method of contraception during treatment and for up to 90 days after stopping mycophenolate mofetil. If you are planning to have a child, discuss possible risks with your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss with you the risks and alternative treatments available to prevent rejection of the transplanted organ if:

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

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 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, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida (where the bones of the spine do not develop properly)). Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment and you must follow your doctor's advice on contraception. Your doctor may require more than one pregnancy test to confirm 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, speak to your doctor or nurse and do not drive or operate tools or machinery until you feel better.

mycophenolate mofetil cinfa contains sodium

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

3. How to take mycophenolate mofetil cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Kidney transplant

Adults

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

Children (between 2 and 18 years of age)

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

Heart transplant

Adults

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

Children

• There is no information available on the use of mycophenolate mofetil in children undergoing heart transplantation.

Liver transplant

Adults

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

Children

• There is no information available on the use of mycophenolate mofetil in children undergoing liver transplantation.

How to take this medicine

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

If you take more mycophenolate mofetil cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Do this even if someone accidentally takes your medicine. Take the medicine packaging with you.

If you forget to take mycophenolate mofetil cinfa

If you forget to take a dose, take it as soon as you remember. 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 mycophenolate mofetil cinfa

Do not stop taking this medicine 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• If you have symptoms of infection such as fever or sore throat.
• If you develop bruises or unexpected bleeding.
• 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).

Frequent problems

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

• blood cell counts or signs of infection.

Adverse effects are more likely to occur 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 reduces the body's natural defenses. This is done 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 develop more infections than usual. These include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

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

General unwanted effects

General adverse effects affecting the entire body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, extreme tiredness, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other adverse effects may include:

Skin problems such as:

• acne, cold sores, shingles, skin overgrowth, 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.
• gastrointestinal disorders including bleeding.
• liver disorders.
• 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, rapid heartbeat, and widening of blood vessels.

Lung problems such as:

• pneumonia, bronchitis.
• difficulty breathing, 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 shortness of breath.
• fluid in the lungs or inside the chest cavity.
• problems with the sinuses.

Other problems such as:

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

Reporting of adverse effects

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

5. Storage of mycophenolate mofetil cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of mycophenolate mofetil cinfa

• The active substance 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 contents of the container

mycophenolate mofetil cinfa 500 mg is presented as film-coated, oblong, violet-colored tablets.

It is supplied 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 most recent review of this leaflet: January 2022

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/

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

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