Leaflet: information for the user

Micofenolate mofetil Aristo 500 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Micofenolate mofetil Aristo is and what it is used for

2. What you need to know before taking Micofenolate mofetil Aristo

3. How to take Micofenolate mofetil Aristo

4. Possible side effects

5. Storage of Micofenolate mofetil Aristo

6. Contents of the pack and additional information

This medication contains mycophenolate mofetil, which belongs to a group of medications called “immunosuppressants”.

Mycophenolate mofetil tablets are used to prevent the body from rejecting a kidney, heart, or liver transplant. This medication must be used in combination with other medications such as cyclosporine and corticosteroids.

WARNING

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

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

If you do not fully understand these instructions, please consult your doctor again before taking micofenolate. See more information below in this section under the headings “Warnings and Precautions” and “Pregnancy and Breastfeeding.”

Do not take Micofenolato de mofetilo Aristo:

• If you are allergic (hypersensitive) to micofenolate mofetil, to micofenolic acid, or to 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 pregnancy test result before the first prescription, as micofenolate 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, Fertility, 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 this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication

• If you experience any sign of infection (e.g., fever, sore throat), bruises (petechiae) not caused by a blow and/or bleeding.
• If you have, or have had in the past, any gastrointestinal problems, for example, stomach ulcers.
• If you have a rare metabolic disorder called familial phenylketonuria.
• If you are planning to become pregnant, or have become pregnant during treatment with this medication.

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

Effect of sunlight

Micofenolate mofetil reduces your body's defense mechanism. Therefore, there is a greater risk of developing skin cancer. You must limit your exposure to sunlight and UV light by wearing protective clothing and using a high-protection sunscreen.

Other medications and Micofenolato de mofetilo Aristo

Inform your doctor or pharmacist if you are taking or have taken, or may need to take any other medication. This includes over-the-counter medications, including herbal remedies. This is because micofenolate mofetil may affect how other medications work. Other medications may also affect how micofenolate mofetil works.

Consult your doctor before starting to take this medication if you are taking any of the following medications:

• Azathioprine or other immunosuppressive agents (which are sometimes administered after an organ transplant);
• Colestiramine (used to treat patients with high cholesterol levels in the blood)
• Rifampicin (antibiotic);
• Antacids or proton pump inhibitors (for stomach acid or indigestion);
• Phosphate chelators (used in patients with chronic kidney failure to reduce phosphate absorption);
• Any other medication (including over-the-counter medications) that your doctor does not know about;
• VaccinesIf you need to receive a vaccine (live organism vaccine) during treatment with micofenolate mofetil, consult your doctor or pharmacist first. Your doctor will advise you on the vaccines you can receive;
• Do notdonate bloodduring treatment with micofenolate mofetil and at least 6 weeks after completing treatment. Men should not donate semen during treatment with micofenolate mofetil and at least 90 days after completing treatment.

Taking micofenolate mofetil with food and drinks

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

Pregnancy, breastfeeding, and fertility

Contraception in women taking micofenolate mofetil

If you are a woman who can become pregnant, you must use an effective contraceptive method. This includes:

• Before starting to takethis medication.
• During all treatment with micofenolate mofetil.
• Until 6 weeks after stoppingthis 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 think 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 occurred 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 pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis.

• You are a girl or adolescent who has not started menstruating.

Contraception in men taking micofenolate mofetil

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes micofenolate. 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 at least 90 days after stoppingthis 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, or intend to become pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatment options you can take to prevent organ transplant rejection if:

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

If you become pregnant during treatment with micofenolate, inform your doctor immediately. However, continue taking micofenolate mofetil until you see your doctor.

Pregnancy

Micofenolate causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat with 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 pregnancy test result 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 has not shown to decrease your ability to drive or operate machinery.

Micofenolato de mofetilo Aristo contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist before using this medication.

The recommended way to take Micofenolato de mofetilo Aristo is as follows:

Organ Transplant

Adults

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

Children and adolescents (between 2 and 18 years)

The dose varies depending on the child's height. The doctor will decide which is the most suitable dose taking into account the body surface (weight and height). The dose per 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 g of active principle), administered in 2 separate doses. This means you should take 3 tablets in the morning and other 3 tablets at night.

Children and adolescents

No data are available to recommend the use of the medication in children or adolescents who have received a heart transplant.

Liver Transplant

Adults

The first dose of oral micofenolato de mofetilo should be administered once at least 4 days have passed since the transplant surgery and when you are able to swallow oral medication. The recommended daily dose is 6 tablets (3 g of active principle), administered in 2 separate doses. This means you should take 3 tablets in the morning and other 3 tablets at night.

Children and adolescents

No data are available to recommend the use of the medication in children or adolescents who have received a liver transplant.

Form and route of administration

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

The treatment will continue as long as immunosuppression is needed to prevent rejection of the transplanted organ.

If you take more Micofenolato de mofetilo Aristo than you should

If you have taken more tablets of micofenolato de mofetilo than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you take more tablets than you have been told, or if someone accidentally takes your medication, you should go to your doctor or a hospital immediately.

If you forget to take Micofenolato de mofetilo Aristo

Do not take a double dose to make up for the missed doses.

If you ever forget to take the medication, take it as soon as you remember and then continue with your usual schedule.

If you interrupt the treatment with Micofenolato de mofetilo Aristo

Stopping treatment with micofenolato de mofetilo may increase the risk of organ rejection. Do not stop taking it unless your doctor tells you to.

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

Like all medicines, Mycophenolate Mofetil Aristo may cause side effects, although not everyone will experience 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 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 medication (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:

• White blood cell count
• 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, decreased white blood cell and red blood cell count in the blood.

Fighting infections

The treatment with this medication reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as normal. 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

Like in patients taking this type of medication (immunosuppressants), a very small number of patients treated with mycophenolate mofetil have developed skin and lymphoid tissue cancer.

Unwanted general effects

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

Other unwanted effects 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:

• swollen gums and mouth ulcers
• pancreatitis, colon, or stomach inflammation
• intestinal problems that include bleeding, liver problems
• constipation, nausea, indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

• dizziness, drowsiness, or numbness
• shaking, muscle spasms, convulsions
• feeling anxious or depressed, mood or thought changes

Cardiac 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 (lung scarring). Consult your doctor if you develop persistent cough or shortness of breath.
• fluid in the lungs or chest cavity
• nasal sinus problems.

Other problemssuch as:

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

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 Medicines Vigilance System:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use the tablets after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the outer packaging to protect it from humidity.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Micophenolate Mofetil Aristo

• The active ingredient is micophenolate mofetil. Each tablet contains 500 mg of micophenolate mofetil
• The other components are:

Tablet core: microcrystalline cellulose, povidone (K-30), sodium croscarmellose, magnesium stearate.

Tablet coating:

titania dioxide (E171), polyvinyl alcohol, polyethylene glycol, talc.

Appearance of Micophenolate Mofetil Aristoand content of the container

White and round tablets.

They are presented in a PVC/Aluminum blister and in the following formats:

1 pack contains 50 tablets (in blister packs of 10 tablets).

1 pack contains 150 tablets (in blister packs of 10 tablets).

Only some container sizes may be commercially marketed.

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible manufacturer:

Steiner & coDeutsche Arzneimittelgesellschaft mbH & Co. KG

Ostpreußendamm 72/74, 12207 Berlin.Germany

Ó

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850 – Torrejón de Ardoz, Madrid – Spain

Last review date of this leaflet:March 2018

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