Prospect: Information for the user

Micofenolato mofetilo Normon 500 mg film-coated tablets EFG

(micofenolato mofetilo)

6. Contentsof the package and additional information

The Micofenolato mofetilo tablets are used to prevent the body from rejecting a kidney, heart or liver transplant. It is an immunosuppressant medication used to suppress rejection in an organ transplant, reducing the activity of the immune system.

This medication is used in combination with other medications known as ciclosporina and corticosteroids.

WARNING

Micofenolato causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative result on a pregnancy test before starting treatment and follow the contraceptive advice provided by your doctor.

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

If you do not fully understand these instructions, please consult your doctor again to have them explained to you before taking micofenolato. See more information below in this section, under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

?Do not takemicofenolato mofetilo Normon:

• If you are allergic (hypersensitive) to micofenolato mofetilo, to micofenolic acid, or any of the other components of this medication (including those listed in section 6).
• If you are a woman who can become pregnant and have not obtained a negative result on a pregnancy test before the first prescription, as micofenolato may cause congenital malformations and spontaneous abortions.
• If you are pregnant or intend to become pregnant or believe you may be pregnant.
• If you are not using effective contraceptives (see Pregnancy and breastfeeding).
• If you are breastfeeding.

Do not take this medication if you experience any of the above. If you are unsure, consult your doctor or pharmacist before taking Micofenolato mofetilo Normon.

?Warnings and precautions

Consult your doctor immediately before taking Micofenolato mofetilo Normon:

-If you experience any indication of infection (e.g. fever, sore throat), cardenals not caused by a blow and/or unexpected bleeding, as this medication may suppress your immune system and make you more susceptible to infections, such as skin, mouth, respiratory tract, stomach and intestinal, lung, and urinary tract infections.

-If you have, or have had in the past, any digestive system problems, for example, stomach ulcers.

-If you are planning to become pregnant, or have become pregnant during treatment with this medication.

Consult your doctor immediately before taking this medication if you experience any of the above (or are unsure).

Effect of sunlight

This medication reduces your body's defenses. As a result, there is a greater risk of developing skin cancer. Limit the amount of sunlight and UV light you absorb by:

-Wearing appropriate clothing that protects you and also covers your head, neck, arms, and legs.

-Using a high-protection sunscreen cream.

?Taking Micofenolato mofetilo Normon with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, as this medication may affect how other medications work. Also, other medications may affect how Micofenolato mofetilo works. Especially:

• Medications containing azathioprine or other immunosuppressive agents (which are sometimes administered after a transplant operation),
• Cholestyramine (used to treat high cholesterol levels),
• Rifampicin (antibiotic used to prevent and treat infections such as tuberculosis (TB)),
• Antacids or proton pump inhibitors (for stomach acid problems such as indigestion),
• Phosphate binders used in patients with chronic kidney disease to reduce phosphate absorption in the blood.

Vaccines: If you need to be vaccinated(live vaccines), during treatment withthis medication, consult your doctor or pharmacist. Your doctor will advise on the vaccine that can be given to you

Do not donate blood during treatment with this medication and at least 6 weeks after completing treatment. Men should not donate semen during treatment with this medication and at least 90 days after completing treatment.

?Taking Micofenolato mofetilo Normon with food and drinks

The taking of food and drinks does not affect your treatment with this medication.

?Pregnancy, fertility, and breastfeeding

Contraception in women taking Micofenolato mofetilo Normon

If you are a woman who can become pregnant, you must always use two effective contraceptive methods. This includes:

• Before starting to take this medication
• During the entire treatment with this medication
• Until 6 weeks after stopping this medication

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your individual 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 believe your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You are considered not susceptible to becoming pregnant if your case is one of the following:

• You are postmenopausal, i.e., you are at least 50 years old and your last period took place more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may 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 function (premature ovarian failure confirmed by a specialist gynecologist)
• You were born with one of the following rare diseases that make it impossible to become pregnant: XY genotype, Turner syndrome, or uterine agenesis
• You are a girl or adolescent who has not yet started menstruating.

Contraception in men taking Micofenolato mofetilo Normon

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes micofenolato. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for 90 days after stopping this medication.

If you are planning to have a child, consult your doctor about the possible risks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatment options that you can take to prevent organ transplant rejection if:

• You intend to become pregnant.
• You have missed or suspect you may 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 micofenolato, inform your doctor immediately. However, continue taking Micofenolato mofetilo until you see your doctor.

Pregnancy

Micofenolato mofetilo causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations that have been reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g. spina bifida) abnormalities. 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 result on a pregnancy test before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.

Breastfeeding

Do not take this medication if you are breastfeeding. This is because small amounts of the medication may pass into breast milk.

?Driving and operating machinery

This medication is unlikely to affect your ability to drive or operate machinery.

Micofenolato mofetilo Normon contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Amount to take

The amount you need 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 rejection of the transplanted organ.

Kidney transplant

Adults:The first dose should be administered within 72 hours after the transplant surgery. The recommended daily dose is 4 tablets (2 gof active principle), administered in 2 separate doses. This means taking 2 tablets in the morning and other 2 tablets at night.

Children (between 2 and 18 years):The dose varies according to the child's height. The doctor will decide which is the most suitable dose taking into account the body surface (weight and height). The recommended dose is 600 mg/m2, administered twice a day.

Heart transplant

Adults:The first dose should be administered within 5 days after the transplant surgery. The recommended daily dose is 6 tablets (3 gof active principle), administered in two separate doses. This means taking 3 tablets in the morning and other 3 tablets at night.

Children:No data are available to recommend the use of this medication in children who have received a heart transplant.

Liver transplant:

Adults:The first dose should be administered once the operation has been performed, at least 4 days after, and when able to take oral medication. The recommended daily dose is 6 tablets (3 gof active principle), administered in two separate doses. This means taking 3 tablets in the morning and other 3 tablets at night.

Children:No data are available to recommend the use of this medicationin children who have received a liver transplant.

Taking this medication

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

If you take moremicofenolato mofetilo Normonthan you should

If you take more Micofenolato mofetilo Normonthan you should, consult your doctor or go to the hospital immediately. Do this also if someone accidentally takes your medication. Bring the packaging of the medication with you.

If you forget to takemicofenolato mofetilo Normon

If you ever forget to take the medication, take it as soon as you remember. Then continue taking it at the usual hours. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment withmicofenolato mofetilo Normon

Do not stop taking this medicationunless your doctor tells you to. If you interrupt the treatment, you may increase the risk of rejection of the transplanted organ.

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

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

• if you have symptoms of infection such as fever or sore throat

• if you develop petechiae or unexpected bleeding

• if you have a rash, facial swelling, lip, tongue, or throat swelling with difficulty breathing. You may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the most common problems are diarrhea, decreased white blood cell or red blood cell count in the blood, infection, and vomiting. Your doctor will perform regular blood tests to record any changes:

• in the number of blood cells or changes in
• blood levels of substances such as: sugar, fat, or cholesterol.

Side effects are more likely to occur in children than in adults. These include diarrhea, infections, and decreased white blood cell and red blood cell counts in the blood.

Fighting infections

The treatment withmicofenolato mofetilo reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as in normal conditions. This means you may contract more infections than usual. These include infections affecting the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and lymphatic cancer

As occurs in patients treated with other immunosuppressants, a very small number of patients treated with this medicine have developed skin and lymphoid tissue cancer.

Unwanted general effects

You may experience general side effects that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain, pain while urinating), headache, flu-like symptoms, and swelling.

Other adverse reactions may be:

Skin problemssuch as: acne, cold sores, shingles, skin growth, hair loss, skin rash, itching.

Urinary problemssuch as: kidney problems or frequent urination.

Digestive system and mouth problemssuch as constipation, nausea, indigestion, loss of appetite, flatulence, pancreatitis, colon or stomach inflammation, intestinal disorders including bleeding, liver problems, swollen gums, and mouth ulcers.

Nervous system problemssuch as: dizziness, drowsiness, numbness, seizures, tremors, vertigo, muscle spasms, anxiety or depression, mood or thought changes.

Cardiovascular and vascular problemssuch as: changes in blood pressure, abnormal heart rhythm, and blood vessel dilation.

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 (pulmonary scarring). Consult your doctor if you develop persistent cough or shortness of breath, fluid in the lung or thoracic cavity, nasal sinus problems.

Reporting side effects

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

Conserve below30°C. Conserve in the original packaging.

Keep out of the reach and sight of children.

Do not use this medicationafter the expiration date that appears on the packaging afterCad. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash.Deposit the packaging and medicines that you do not need at the SIGRE pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. By doing so, you will help protect the environment.

Composition ofmicofenolato mofetilo Normon

The active ingredient is micofenolato de mofetilo. Each tablet contains 500 mg of micofenolato de mofetilo.

The excipients are:

Core:microcrystalline cellulose (E-460), povidone (E-1201), croscarmellose sodium, magnesium stearate (E-470b).

Coating:indigo blue lacquer (E-132), iron oxide red (E-172), hypromellose (E-464), titanium dioxide (E-171) and macrogol 6000.

Appearance of Micofenolato mofetilo Normon and packaging size

Pinkish-colored, elongated, and biconvex tablets.

Each package contains 50 tablets.

Other presentations:

Micofenolato mofetilo Normon 250 mg film-coated tablets EFG.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6­28760 Tres Cantos­Madrid (SPAIN)

Review date of this leaflet: March 2018

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.