MOFETIL MYCOPHENOLATE TECNIGEN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mycophenolate Mofetil TecniGen 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Mycophenolate Mofetil TecniGen is and what it is used for
2. What you need to know before you take Mycophenolate Mofetil TecniGen
3. How to take Mycophenolate Mofetil TecniGen
4. Possible side effects
5. How to store Mycophenolate Mofetil TecniGen
6. Contents of the pack and further information

1. What Mycophenolate Mofetil TecniGen is and what it is used for

Mycophenolate Mofetil TecniGen 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:

• cyclosporine and corticosteroids.

2. What you need to know before you take Mycophenolate Mofetil TecniGen

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 doctor's advice on contraception.

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 below in this section, under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Mycophenolate Mofetil TecniGen:

• 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 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 mycophenolate mofetil.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take mycophenolate mofetil.

• 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 during treatment with mycophenolate mofetil.

If any of the above applies to you (or you are not sure), consult your doctor immediately before taking 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 that covers your head, neck, arms, and legs.
• Using a high-protection sunscreen.

Taking Mycophenolate Mofetil TecniGen with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken 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.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• azathioprine or other medicines that suppress the immune system – which were given to you after the 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 acid problems such as indigestion.
• phosphate binders – used in patients with chronic kidney failure to reduce phosphate absorption in 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 be vaccinated (live vaccines) during treatment with mycophenolate mofetil, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you can have.

You should not donate blood during treatment with mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with mycophenolate mofetil or for at least 90 days after stopping treatment.

Taking Mycophenolate Mofetil TecniGen with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Contraception in women taking mycophenolate mofetil

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

• Before starting to take mycophenolate mofetil.
• During all treatment with mycophenolate mofetil.
• Until 6 weeks after stopping mycophenolate mofetil.

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 birth defects or spontaneous abortion 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 mycophenolate mofetil.

If you are planning to have a child, consult your doctor about the possible 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 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, 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 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 (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 before starting treatment and must follow the doctor's advice on contraception. Your doctor may request more than one pregnancy test to ensure you are not pregnant before starting treatment.

Breastfeeding

Do not take mycophenolate mofetil 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, sleepy, or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate Mofetil TecniGen contains sodium

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

3. How to take Mycophenolate Mofetil TecniGen

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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 transplant rejection.

Kidney Transplant

Adults:

• The first dose should be given within 3 days after the transplant operation.
• The recommended daily dose is 4 tablets (2 g of the medicine), given in 2 separate doses.
• This means taking 2 tablets in the morning and 2 tablets in the evening.

Children and adolescents (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 “m2”). 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 the medicine), given in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:

There is no information on the use of mycophenolate mofetil in children with heart transplants.

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 daily dose is 6 tablets (3 g of the medicine), given in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:

There is no information on the use of mycophenolate mofetil in children with liver transplants.

Taking this medicine

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

If you take more Mycophenolate Mofetil TecniGen than you should

If you take more tablets than you should, or if someone accidentally takes your medicine, you must go to your doctor or hospital or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mycophenolate Mofetil TecniGen

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

If you stop taking Mycophenolate Mofetil TecniGen

Do not stop taking Mycophenolate Mofetil unless your doctor tells you to.

If you stop treatment, you may increase the risk of organ transplant rejection.

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

4. Possible side effects

Like all medicines, Mycophenolate Mofetil 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 unexpected 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 or angioedema).

Common problems

Some of the most common problems are diarrhea, decrease in the number of white blood cells and/or red blood cells in the blood, infection, and vomiting. Your doctor will regularly perform blood tests to monitor any changes in:

• the number of blood cells or signs of infection.

The occurrence of side effects is more likely in children than in adults. These include diarrhea, infections, decrease 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 transplant rejection. For this reason, your body cannot 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 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

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

Other side 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 with the digestive system and mouthsuch as:

• swollen gums and mouth ulcers.
• inflammation of the pancreas, colon, or stomach.
• gastrointestinal disorders that include bleeding.
• liver disorders.

• diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

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

Heart and blood vessel problemssuch as:

• changes in blood pressure, rapid heartbeat, and dilation 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 dilated) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop persistent cough or shortness of breath.
• fluid in the lungs or inside the chest.
• problems with the sinuses.

Other problemssuch as:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaran.es.

5. Storage of Micofenolate Mofetil TecniGen

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 (EXP.). The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you observe any visible signs of deterioration.

Medicines should not be disposed of via 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Micofenolate Mofetil TecniGen

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

Core:

Microcrystalline cellulose (Avicel PH101),

Croscarmellose sodium (Ac-di-sol),

Povidone (Kollidon K90),

Magnesium stearate.

Coating:

Hypromellose 3cP,

Hydroxypropyl cellulose,

Titanium dioxide (E171),

Macrogol 400,

Hypromellose 50cP,

Carmine indigo lake (E132),

Red iron oxide (E172).

Appearance of the Product and Package Contents

Micofenolate Mofetil TecniGen 500 mg tablets are presented in the form of film-coated, oblong, and purple tablets. They are packaged in PVC+PCTFE+PE/Aluminum blisters, containing 50 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid), Spain

Manufacturer:

Tecnimede - Sociedade Técnico –Medicinal, S.A. Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

This medicine is authorized in the following EU Member States under the names:

Spain:Micofenolate Mofetil TecniGen 500 mg film-coated tablets EFG

Portugal:Micofenolate Mofetil TecniGen

Date of the Last Revision of this Leaflet:October 2021.

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