MOFETIL MYCOPHENOLATE AUROVITAS 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Myphenolate Mofetil Aurovitas contains mycophenolate mofetil.

• It belongs to a group of medicines called “immunosuppressants”.

Mycophenolate mofetil is used to prevent your body from rejecting a transplanted organ.

• Kidney, heart or liver.

Mycophenolate mofetil should be used together with other medicines:

• Ciclosporin and corticosteroids.

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

WARNING

Mycophenolate causes birth defects 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 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 take Myphenolate Mofetil Aurovitas

• 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 can become pregnant and have not had a negative pregnancy test before the first prescription, as mycophenolate can cause birth defects 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, contraception 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 Myphenolate Mofetil Aurovitas:

• If you are over 65 years old, as you may have a higher risk of developing adverse reactions such as certain viral infections, gastrointestinal bleeding and pulmonary edema compared to younger patients.
• If you have any signs of infection such as fever or sore throat.
• If you have unexpected bruising or bleeding.
• If you have ever had a problem with your digestive system such as a stomach ulcer.
• If you plan to become pregnant or have become pregnant while you or your partner are taking mycophenolate mofetil.
• If you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above applies to you (or you are not sure), consult your doctor before starting treatment with mycophenolate mofetil.

Effect of sunlight

Mycophenolate mofetil 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, including a hat, neck and sleeves, and trousers.
• Using a high-factor sunscreen.

Children

Do not give this medicine to children under 2 years old, as safety and efficacy data are limited in this age group and no dosage recommendations can be made.

Other medicines and Myphenolate Mofetil Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because mycophenolate mofetil can affect the way other medicines work. Other medicines can also affect the way mycophenolate mofetil works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting to take mycophenolate mofetil:

• azathioprine or other medicines that suppress your immune system – given after a transplant operation
• 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 problems such as indigestion
• phosphate binders – used in patients with chronic kidney failure to reduce phosphate absorption into 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 have a vaccine (live organism vaccine) during treatment with this medicine, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you can have.

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 mycophenolate mofetil and for at least 90 days after stopping treatment.

Taking Myphenolate Mofetil Aurovitas with food and drinks

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

Contraception in women taking Myphenolate Mofetil Aurovitas

If you are a woman who can become pregnant, you must use a reliable contraceptive method with mycophenolate mofetil. This includes:

• Before starting to take mycophenolate mofetil.
• During the entire treatment with mycophenolate mofetil.
• For up to 6 weeks after stopping mycophenolate mofetil.

Consult your doctor about 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 your contraceptive pill.

You cannot become pregnant if:

• You are postmenopausal, 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 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 having periods.

Contraception in men taking Myphenolate Mofetil Aurovitas

Available evidence does not indicate an increased risk of malformations or spontaneous abortions if the father takes mycophenolate mofetil. 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 up to 90 days after stopping treatment.

If you are planning to have a child, consult your doctor about the potential risks and alternative treatments.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, 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 mofetil, inform your doctor immediately. However, continue to take this medicine 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 that have been 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 properly) 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 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

The influence of mycophenolate mofetil on the ability to drive and use machines is moderate. If you feel drowsy, dazed or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate Mofetil Aurovitas contains sodium

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

3. How to take Myphenolate Mofetil Aurovitas

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

Amount to be taken

The amount to be taken 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 3 days after the transplant operation.
• The daily dose is 4 tablets (2 g of the medicine) given in 2 divided doses.
• Take 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 height.
• The doctor will decide what dose is most suitable, taking into account the child's height and weight (body surface area - measured in square meters or “m2”). The recommended dose is 600 mg/m2, given twice daily.

Heart transplant

Adults

• The first dose should be given within 5 days after the transplant operation.
• The daily dose is 6 tablets (3 g of the medicine) given in 2 divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information on the use of this medicine in children with a heart transplant.

Liver transplant

Adults

• The first dose of this medicine will be given orally, at least 4 days after the transplant operation, and when you can swallow oral medicines.
• The daily dose is 6 tablets (3 g of the medicine) given in 2 divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information on the use of this medicine in children with 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 Myphenolate Mofetil Aurovitas than you should

If you take more mycophenolate mofetil than you should, talk to a doctor or go to a hospital immediately. Do the same if someone accidentally takes your medicine. Take the medicine package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Myphenolate Mofetil Aurovitas

If you forget to take your medicine, take it as soon as you remember. Take your next dose as you would normally. Do not take a double dose to make up for forgotten doses.

If you stop taking Myphenolate Mofetil Aurovitas

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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Common Problems

Some of the most common problems are diarrhea, decrease in the number of white 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 signs of infection.

The appearance of adverse effects is more likely in children than in adults. These include diarrhea, infections, decrease in white and red blood cells in the blood.

Fighting Infections

Treatment with mycophenolate mofetil 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 that you may contract more infections than usual. These include infections that affect 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 cancer of lymphoid tissues and skin.

General Undesired Effects

Various undesired adverse effects of a general nature may occur that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling of great fatigue, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other undesired adverse effects may be:

Skin Problemssuch as:

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

Urinary Problemssuch as:

• blood in the urine.

Problems of the Digestive System and Mouthsuch as:

• inflamed gums and mouth ulcers,
• inflammation of the pancreas, colon, or stomach,
• gastrointestinal disorders that include bleeding,
• liver disorders,
• diarrhea, constipation, feeling of discomfort (nausea), indigestion, loss of appetite, flatulence.

Nervous System Problemssuch as:

• feeling of dizziness, drowsiness, or numbness,
• tremors, muscle spasms, convulsions,
• feeling of anxiety or depression, changes in mood or thinking.

Cardiac and Blood Vessel Problemssuch as:

• change in blood pressure, rapid heartbeat, and dilation of blood vessels.

Pulmonary Problemssuch as:

• pneumonia, bronchitis,
• breathing difficulties, cough, which may be due to bronchiectasis (a disease in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of the lungs). Consult your doctor if you develop persistent cough or breathing difficulties, 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 Adverse Effects:

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

5. Conservation of Mycophenolate Mofetil Aurovitas

Keep this medicine out of sight and reach of children.

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

Store below 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the 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 Mycophenolate Mofetil Aurovitas

• The active ingredient is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.
• The other components are:

Tablet Core:microcrystalline cellulose (grades 101 and 102), sodium croscarmellose, povidone (K-90), anhydrous colloidal silica, and magnesium stearate.

Tablet Coating:hypromellose 2910 (3 mPas and 50 mPas), hydroxypropyl cellulose, macrogol 400, talc, red iron oxide, titanium dioxide, aluminum lake indigo carmine (FD & C Blue No. 2).

Product Appearance and Package Contents

Film-coated tablet.

Purple film-coated tablet, modified capsule-shaped with "M1" engraved on one side and smooth on the other.

Mycophenolate Mofetil Aurovitas 500 mg film-coated tablets EFG are available in blister packs.

Package Sizes:

Blister Pack:50, 100, 150, and 300 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19 Venda Nova

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:June 2024

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/)