MICOFENOLATE MOFETIL NORMON 500 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Myfortic 500 mg film-coated tablets EFG

(mycophenolate mofetil)

Contents of the pack and other information

1. What Myfortic is and what it is used for
2. What you need to know before you take Myfortic
3. How to take Myfortic
4. Possible side effects
5. Storing Myfortic

1. Contents of the pack and further information

1. What is Myfortic and what is it used for

Myfortic tablets are used to prevent your body from rejecting a transplanted kidney, heart, or liver. It is a medicine called an immunosuppressant used to suppress the rejection of a transplanted organ by reducing the activity of the immune system.

This medicine is used together with other medicines known as cyclosporin and corticosteroids.

2. What you need to know before you take Myfortic

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 contraceptive advice given by your doctor.

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 understand these instructions completely, please consult your doctor again so that they can explain them to you again before taking mycophenolate. See more information below in this section, under the headings "Warnings and precautions" and "Pregnancy and breastfeeding".

? Do not takemycophenolate mofetil Myfortic:

• If you are allergic (hypersensitive) 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 "Pregnancy and breastfeeding").
• If you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are not sure, consult your doctor or pharmacist before taking Myfortic.

? Warnings and precautions

Consult your doctor immediately before taking Myfortic:

• If you experience any signs of infection (e.g., fever, sore throat), unexplained bruising, and/or unexpected bleeding, as this medicine may suppress your immune system, making you more prone to infections, such as skin, mouth, respiratory tract, stomach, and intestine, lung, and urinary tract infections.
• If you have or have had any digestive problems, such as stomach ulcers.
• If you plan to become pregnant or have become pregnant during treatment with this medicine.

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

Sunlight effect

This medicine 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 high sun protection factor sunscreen

? Taking Myfortic with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, including herbal medicines. This is because this medicine may affect how other medicines work. Other medicines may also affect how Myfortic works. Especially:

• Medicines containing azathioprine or other immunosuppressants (sometimes given after a transplant operation),
• cholestyramine (used to treat high cholesterol levels),
• rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis),
• antacids or proton pump inhibitors (for stomach acid problems such as indigestion),
• phosphate binders used in patients with chronic kidney failure to reduce phosphate absorption into the blood.

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

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

? Taking Myfortic with food and drinks

Taking food and drinks does not affect your treatment with this medicine.

? Pregnancy, fertility, and breastfeeding

Contraception in women taking Myfortic

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

• Before starting treatment with this medicine
• During treatment with this medicine
• Until 6 weeks after stopping treatment with this medicine

Consult your doctor to determine the most suitable contraceptive method for you. This will depend on your personal situation. Two contraceptive methods are recommended 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 your situation is one of the following:

• 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 by surgery (bilateral salpingo-oophorectomy)
• You have had your uterus removed by surgery (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 Myfortic

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, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for 90 days after stopping treatment.

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 taking this medicine. Your doctor will discuss the risks and alternative treatments that you can take to prevent organ 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 Myfortic until you see your doctor.

Pregnancy

Mycophenolate mofetil 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 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 can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the contraceptive advice given by your doctor. Your doctor may request more than one pregnancy test to ensure you are not pregnant before starting treatment.

Breastfeeding

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

? Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Myfortic contains sodium

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

3. How to take Myfortic

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The amount 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 organ rejection.

Kidney transplant

Adults: The first dose should be given within 72 hours after the transplant operation. The recommended daily dose is 4 tablets (2 g of active ingredient), 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 size. The doctor will decide the most suitable dose based on body surface area (weight and height). 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 recommended daily dose is 6 tablets (3 g of active ingredient), given in 2 divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children: There is no data to recommend the use of this medicine in children who have received a heart transplant.

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 recommended daily dose is 6 tablets (3 g of active ingredient), given in 2 divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children: There is no data to recommend the use of this medicine in children who have received a liver transplant.

Taking this medicine

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

If you take more Myfortic than you should

If you take more Myfortic than you should, consult your doctor or go to the hospital immediately. Do this also if someone accidentally takes your medicine. Take the medicine pack with you.

If you forget to take Myfortic

If you forget to take a dose, 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 Myfortic

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• if you have symptoms of infection such as fever or sore throat
• if you have unexplained bruising or bleeding
• 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, reduction in the number of white blood cells 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 changes in
• 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 reduction in white blood cells and red blood cells in the blood.

Fighting infections

Treatment with mycophenolate mofetil reduces your body's defenses. This is to prevent organ rejection. For this reason, your body may not be able to fight infections as effectively as under normal conditions. This means you may get more infections than usual. These include infections that affect the brain, skin, mouth, stomach, and intestine, lungs, and urinary tract.

Skin and lymph cancer

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

General unwanted effects

General unwanted effects may occur that affect your whole 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, pain when 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, feeling sick (nausea), indigestion, loss of appetite, flatulence, pancreas, colon, or stomach inflammation, intestinal disorders including bleeding, liver problems, swollen gums, and mouth ulcers.

Nervous system problemssuch as feeling dizzy, drowsy, or numb, seizures, tremors, vertigo, muscle spasms, feeling anxious or depressed, mood or thinking changes.

Heart and blood vessel problemssuch as changes in blood pressure, irregular heartbeat, and widening of blood vessels.

Lung problemssuch 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 lung cavity/chest, problems with the sinuses.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Myfortic

Store below 30°C. Keep in the original packaging.

Keep out of the reach and sight of children.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofmycophenolate mofetil Normon

The active ingredient is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.

The excipients are:

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

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

Appearance of Mycophenolate Mofetil Normon and Container Size

Pink, elongated, and biconvex tablets.

Each container contains 50 tablets.

Other Presentations:

Mycophenolate Mofetil Normon 250 mg film-coated tablets EFG.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 ­ 28760 Tres Cantos ­ Madrid (SPAIN)

Date of Revision of this Prospectus: March 2018

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