Prospect: information for the user

Micophenolate mofetil TecniGen 500 mg film-coated tabletsEFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you:

• Keep this prospect, as you may need to read it again.

• If you have any doubts, consult your doctor, pharmacist or nurse.

•This medicine has been prescribed only for you and should not be given to other people, even if they present the same symptoms of the disease, as it may harm them.

•If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this prospect. See section 4.

1. What is Micophenolate mofetil TecniGen and for what it is used

2. What you need to know before starting to take Micophenolate mofetil TecniGen

3. How to take Micophenolate mofetil TecniGen

4. Possible adverse reactions

5. How to store Micophenolate mofetil TecniGen

6. Contents of the package and Additional information

Mycophenolate Mofetil TecniGen contains mycophenolate mofetil. It belongs to a group of medications called “immunosuppressants”.

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

• Kidney, heart, or liver.

Mycophenolate mofetil should be used in combination with other medications:

• ciclosporina and corticosteroids.

WARNING

Mycophenolate 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, 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 to have them explained to you 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, to mycophenolic acid, or 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 mycophenolate 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 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 experience unexpected petechiae or bleeding.

•If you have ever had a gastrointestinal problem, such as stomach ulcers.

•If you have a planned pregnancy or have become pregnant during treatment with mycophenolate mofetil.

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

Effect of sunlight:

Mycophenolate mofetil reduces your body's defenses. Therefore, there is a greater risk of developing skin cancer. Limit the amount of sunlight and UV light absorbed by:

• The use of appropriate clothing that protects you and also covers your head, neck, arms, and legs
• The use of a high-protection sunscreen cream.

Taking Mycophenolate Mofetil TecniGen with other medications:

Inform your doctor or pharmacist if you are taking, or have recently taken, other medications.This includes medications purchased without a prescription, including herbal medications.

This is because mycophenolate mofetil may affect how other medications work. Other medications may also affect how mycophenolate mofetil works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications before starting mycophenolate mofetil:

• Azathioprine or another immunosuppressive medication – administered after organ transplantation.

• Cholestyramine – used to treat high cholesterol levels

• Rifampicin – 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 disease 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

Vaccinations:

If you need to have a vaccine (live vaccine) during treatment with mycophenolate mofetil, consult your doctor or pharmacist first. Your doctor will advise on the vaccines that can be given to you.

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

Taking Mycophenolate Mofetil TecniGen with food, drinks, and alcohol:

The taking of 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 contraceptive methods. This includes:

• Before starting to take mycophenolate mofetil

• During the entire treatment with mycophenolate mofetil

• Until 6 weeks after stopping mycophenolate mofetil

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 believe 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 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 mycophenolate mofetil:

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. 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 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, or believe you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatments you can take to prevent organ transplant rejection if:

• You intend to become pregnant.

• You have missed or suspect a 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 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 malformations reported are ear, eye, facial (cleft lip and palate), finger development, 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 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 mycophenolate mofetil if you are breastfeeding. This is because small amounts of the medication may pass into breast milk.

Driving and using machines:

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

Mycophenolate Mofetil TecniGen contains sodium:

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

Amount to take

The amount you need to take depends on the type of transplant you have. The usual doses are shown below. Treatment will continue until it is necessary to prevent rejection of the transplanted organ.

Kidney Transplant

Adults:

• The first dose should be administered within 3 days after the transplant surgery.
• The recommended daily dose is 4 tablets (2 g of the medication), administered in 2 separate doses.
• This means taking 2 tablets in the morning and another 2 tablets at night.

Children and adolescents (between 2 and 18 years):

• The dose varies according to the child's height.
• The doctor will decide which is the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2"). The recommended 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 the medication), administered in 2 separate doses.
• Take 3 tablets in the morning and another 3 tablets at night.

Children:

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

Liver Transplant

Adults:

• The first dose should be administered at least 4 days after the transplant surgery and when you are able to swallow oral medication.
• The daily dose is 6 tablets (3 g of the medication), administered in 2 separate doses.
• Take 3 tablets in the morning and another 3 tablets at night.

Children:

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

Taking this medication

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

If you take more Micofenolato de mofetilo TecniGen than you should

If you take more tablets than you should, or if someone accidentally takes your medication, you should go immediately to your doctor or a hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Micofenolato de mofetilo TecniGen

If you ever forget to take the medication, take it as soon as you remember. Then continue taking it at the usual hours. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Micofenolato de mofetilo TecniGen

Do not stop taking Micofenolato de mofetilo unless your doctor tells you to.

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

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

Like all medicines, Mycophenolate mofetil may cause side effects in some patients, although not everyone will experience them.

Consult your doctor immediately if you notice any of the following severe 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 and/or red blood cell count 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

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 mycophenolate mofetil 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 that 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 lymphoid and skin tissue cancer.

Unwanted general effects

You may experience unwanted general effects that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty sleeping, pains (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.

Digestive system and mouth problemssuch as:

• swollen gums and mouth ulcers
• pancreatitis, colon inflammation, stomach inflammation
• gastrointestinal disorders that include bleeding
• liver disorders

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

Nervous system problemssuch as:

• dizziness, drowsiness, or numbness
• convulsions, tremors, muscle spasms,
• feeling anxious or depressed, changes in mood or thought.

Cardiac and vascular problemssuch as:

• changes in blood pressure, rapid heartbeat, 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/inside the chest
• problems in the nasal sinuses.

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 nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaran.es.

Keep the remaining medication out of sight and reach of children

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Micofenolato de mofetilo TecniGen

• The active principle is micofenolato mofetilo. Each tablet contains 500 mg of micofenolato de mofetilo.
• The other components are:

Core:

Microcrystalline cellulose (Avicel PH101),

Sodium croscarmellose (Ac-di-sol),

Povidone (Kollidon K90),

Magnesium stearate.

Coating:

3cP hypromellose,

Hydroxypropyl cellulose,

Titanium dioxide (E171),

Macrogol 400,

50cP hypromellose,

Indigo carmine (E132) lacquer,

Red iron oxide (E172).

Appearance of the product and content of the container

Micofenolato de Mofetilo TecniGen 500 mg tablets are presented in the form of coated tablets, oblong and violet in color. They are packaged in PVC+PCTFE+PE/Aluminum blisters, containing 50 tablets.

Holder of the marketing authorization and Responsible for the manufacture:

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid), Spain

Responsible for the manufacture:

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 following names:

Spain:Micofenolato de Mofetilo TecniGen 500 mg coated tablets EFG

Portugal:Micofenolato de Mofetilo TecniGen

Date of the last review of this leaflet:October 2021.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.es/