MOFETIL MYCOPHENOLATE ARISTO 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Myphenolate Mofetil Aristo 250 mg Hard Capsules 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 Aristo is and what it is used for
2. What you need to know before you take Myphenolate Mofetil Aristo
3. How to take Myphenolate Mofetil Aristo
4. Possible side effects
5. Storage of Myphenolate Mofetil Aristo
6. Contents of the pack and other information

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

This medicine contains mycophenolate mofetil, which belongs to a group of medicines called "immunosuppressants". Mycophenolate mofetil capsules are used to prevent the body from rejecting a transplanted kidney, heart, or liver. This medicine should be used together with other medicines such as cyclosporine and corticosteroids.

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

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. 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 provide written information, particularly 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 Aristo:

• 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 congenital malformations and spontaneous abortions.
• If you are pregnant or plan to become pregnant or think you may be pregnant.
• If you are not using effective contraceptives (see 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• If you experience any signs of infection, e.g., fever, sore throat.
• If you have, or have had in the past, any digestive system problems, such as stomach ulcers.
• If you have a rare metabolic disorder called familial phenylketonuria.
• If you plan to become pregnant or have become pregnant during treatment with this medicine.

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

The effect of sunlight

Mycophenolate mofetil reduces the body's defense mechanism. For this reason, there is a higher risk of skin cancer. Therefore, you should limit exposure to sunlight and UV light using protective clothing and a high sun protection factor cream.

Other medicines and Myphenolate Mofetil Aristo

Tell your doctor or pharmacist if you are taking or 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.

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

• azathioprine or other immunosuppressants (which are sometimes given after organ transplantation);
• cholestyramine used to treat patients with high cholesterol levels in the blood;
• rifampicin (an antibiotic);
• antacids or proton pump inhibitors (for stomach acid or indigestion);
• phosphate binders (used in patients with chronic kidney failure to reduce phosphate absorption);
• any other medicine (including those sold without a prescription) that your doctor does not know about;
• vaccinesIf you need to be given 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;
• you must not donate bloodduring 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 with food and drinks

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

Pregnancy, breastfeeding, and fertility

Contraception in women taking mycophenolate mofetil

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

• Before starting to take this medicine.
• During the entire treatment with mycophenolate mofetil.
• Until 6 weeks after stopping this medicine.

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 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 your fallopian tubes and both 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 mycophenolate mofetil

Available evidence does not indicate an increased risk of malformations or spontaneous abortion if the father takes mycophenolate mofetil. However, the risk cannot be completely excluded. As a precautionary measure, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for 90 days after stopping this medicine.

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 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 mofetil, 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 severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida, where the bones of the spine do not develop correctly) anomalies. 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 that 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 has not been shown to reduce the ability to drive or use machines.

Mycophenolate Mofetil Aristo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., it is essentially "sodium-free".

3. How to take Myphenolate Mofetil Aristo

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

The recommended way to take Myphenolate Mofetil Aristo is as follows:

Kidney Transplant

Adults

The first dose should be given within 72 hours after the transplant operation. The recommended daily dose is 8 capsules (2 g of active ingredient), given in 2 divided doses. This means taking 4 capsules in the morning and 4 capsules in the evening.

Children and adolescents (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 dose per intake 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 12 capsules (3 g of active ingredient), given in 2 divided doses. This means taking 6 capsules in the morning and 6 capsules in the evening.

Children and adolescents

There are no data to recommend the use of this medicine in children or adolescents who have received a heart transplant.

Liver Transplant

Adults

The first dose of mycophenolate mofetil should be given orally at least 4 days after the transplant operation and when you are able to swallow oral medication. The recommended daily dose is 12 capsules (3 g of active ingredient), given in 2 divided doses. This means taking 6 capsules in the morning and 6 capsules in the evening.

Children and adolescents

There are no data to recommend the use of this medicine in children or adolescents who have received a liver transplant.

Form and route of administration

Swallow the capsules whole with a glass of water. Do not break or crush them, and do not take any capsule that has been broken or opened. Avoid contact with the powder that spills from damaged capsules. If you accidentally break or open a capsule, wash your skin with soap and water. If the powder gets into your eyes or mouth, rinse them with plenty of running water.

Treatment will continue as long as immunosuppression is necessary to prevent organ transplant rejection.

If you take more Myphenolate Mofetil Aristo than you should

If you have taken more mycophenolate mofetil than you should or have accidentally ingested the contents of the pack, consult your doctor or pharmacist or the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount ingested.

If you take more capsules than you should, or if someone accidentally takes your medicine, you must go immediately to your doctor or hospital.

If you forget to take Myphenolate Mofetil Aristo

Do not take a double dose to make up for forgotten doses. If you forget to take your medicine, take it as soon as you remember and then continue at the usual times.

If you stop taking Myphenolate Mofetil Aristo

Stopping treatment with mycophenolate mofetil may increase the risk of organ transplant rejection. Do not stop taking it unless your doctor tells you to. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Myphenolate Mofetil Aristo 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 get bruising 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, reduction in the number of white or red blood cells, infection, and vomiting. Your doctor will perform regular blood tests to monitor any changes in:

• blood cell count
• 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, reduction in white and red blood cells, and vomiting.

Fighting infections

Treatment with this medicine 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 get more infections than usual. These include infections affecting 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 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 unwanted effects may be:

Skin problemssuch as:

• acne, cold sores, shingles, skin growth, hair loss, skin rash, itching.

Urinary problemssuch as:

• kidney problems or need to urinate frequently.

Digestive system and mouth problemssuch as:

• swollen gums and mouth ulcers
• inflammation of the pancreas, colon, or stomach
• intestinal problems, including bleeding, liver problems
• constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

• feeling dizzy, drowsy, or numb
• tremor, muscle spasms, convulsions
• feeling anxious or depressed, changes in mood or thinking

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 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 of side effects

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

5. Storage of Micofenolato de mofetilo Aristo

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

Do not use the medicine 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 moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your 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 Micofenolato de mofetilo Aristo

• The active ingredient is micofenolato de mofetilo. Each capsule contains 250 mg of micofenolato de mofetilo.
• The other components are:
• Capsule content: pregelatinized corn starch, sodium croscarmellose, povidone (K-30), magnesium stearate.

• Capsule shell: gelatin, titanium dioxide (E171).

Appearance of Micofenolato de mofetilo Aristoand package contents

Hard gelatin capsules, white and oblong in shape.

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

1 carton contains 100 capsules (in blister packs of 10 capsules)

1 carton contains 300 capsules (in blister packs of 10 capsules)

Only some package sizes may be marketed.

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid - Spain

Manufacturer:

Steiner & co Deutsche Arzneimittelgesellschaft mbH & Co. KG

Ostpreußendamm 72/74, 12207 Berlin, Germany

Or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850 – Torrejón de Ardoz, Madrid – Spain

Date of the last revision of this prospectus:March 2018

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/