MOFETIL MYCOPHENOLATE AUROVITAS SPAIN 500 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Myphenolate Mofetil Aurovitas Spain 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 and other information

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

1. Contents of the pack and other information

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

The full name of the medicine is Myphenolate Mofetil Aurovitas Spain 500 mg film-coated tablets EFG.

• In this leaflet it is referred to as Myphenolate Mofetil Aurovitas Spain. Myphenolate Mofetil Aurovitas Spain contains mycophenolate mofetil.
• It belongs to a group of medicines called “immunosuppressants”.

This medicine 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 Spain

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 advice on contraception 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 Spain

• 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, since 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, fertility 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting Myphenolate Mofetil Aurovitas Spain:

• 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 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 apply 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 developing skin cancer. Limit the amount of sunlight and UV light you absorb by:

• Wearing protective clothing that also covers your head, neck, arms, and legs.
• Using sunscreen with a high protection factor.

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 Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, such as herbal 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 Myphenolate Mofetil Aurovitas Spain:

• Azathioprine or other medicines that suppress your immune system – given after a transplant operation.
• Colestyramine – 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 Spain with food and drink

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

Contraception in women taking Myphenolate Mofetil Aurovitas Spain

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

• Before starting Myphenolate Mofetil Aurovitas Spain.

• During treatment with Myphenolate Mofetil Aurovitas Spain.
• Until 6 weeks after stopping Myphenolate Mofetil Aurovitas Spain.

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 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 your fallopian tubes and both ovaries removed surgically (bilateral salpingo-oophorectomy).
• You have had your uterus removed surgically (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 Myphenolate Mofetil Aurovitas Spain

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 method of contraception during treatment and for 90 days after stopping this medicine.

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss the risks and alternative treatments 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 taking this medicine until you see your doctor.

Pregnancy

Mycophenolate 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 correctly). 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 advice on contraception 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

The influence of Myphenolate Mofetil Aurovitas Spain 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.

Myphenolate Mofetil Aurovitas Spain contains sodium

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

3. How to take Myphenolate Mofetil Aurovitas Spain

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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 as long as immunosuppression is needed 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 the most suitable dose based on 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.

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

If you take more Myphenolate Mofetil Aurovitas Spain than you should

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

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.

If you forget to take Myphenolate Mofetil Aurovitas Spain

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

If you stop taking Myphenolate Mofetil Aurovitas Spain

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 other questions about the use of this medicine, 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 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 very tired, 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 unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous System Problemssuch as:

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

Cardiac and Blood Vessel Problemssuch as:

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

Lung 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.

However, do not stop taking your medicine unless you have first consulted your doctor.

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 is not listed in this leaflet. 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. Storage of Mycophenolate Mofetil Aurovitas Spain

Keep this medicine out of the 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.

Do not store above 25°C. Store in the original packaging to protect it from light.

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

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

Tablet core: microcrystalline cellulose (E460), povidone, hydroxypropyl cellulose, sodium croscarmellose, talc, magnesium stearate.

Tablet coating: hypromellose 6 cps (E464), titanium dioxide (E171), macrogol, red iron oxide (E172), aluminum lake indigo carmine (E132), black iron oxide (E172), talc.

Appearance of the Product and Package Contents

Film-coated tablet of elongated shape, biconvex, purple in color, with the marks "AHI" on one face and "500" on the other, 18.0 mm long, 9.0 mm wide, and 7.0 mm thick.

Opaque white PVC/PVdC-Aluminum blister pack.

Package sizes: 50, 100, and 150 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Aurobindo Pharma B.V.

Baarnsche Dijk 1

LN Baarn, 3741

Netherlands

O

Laboratori FUNDACIO DAU

C/ De la letra C, 12-14,

Polígono Industrial de la Zona,

Franca, 08040 Barcelona

Spain

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

Date of the Last Revision of this Leaflet:April 2022

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/)