MICOFENOLATE MOFETIL TEVA 500 mg FILM-COATED TABLETS

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

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, in particular 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, contraception, and breastfeeding".

Do not take Mycophenolate Mofetil Teva,

• 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 Mycophenolate Mofetil Teva.

Warnings and precautions

Consult your doctor before starting treatment with Mycophenolate Mofetil Teva:

• 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 experience any signs of infection (e.g., fever, sore throat), unexpected bruising, and/or bleeding.
• if you have or have had any digestive problems, such as stomach ulcers.
• if you plan to become pregnant or have become pregnant while you or your partner are taking Mycophenolate Mofetil Teva.
• if you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

Mycophenolate Mofetil Teva reduces the body's defense mechanism. For this reason, there is a higher risk of skin cancer. Therefore, you should limit your exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and using a sunscreen with a high protection factor.

Do not donate blood during treatment with Mycophenolate Mofetil Teva and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Mycophenolate Mofetil Teva and for at least 90 days after stopping treatment.

Children and adolescents

Mycophenolate Mofetil Teva is used in children and adolescents (between 2 and 18 years) to prevent kidney transplant rejection.

Mycophenolate Mofetil Teva should not be used in children and adolescents (between 2 and 18 years) for heart or liver transplants.

Mycophenolate Mofetil Teva should never be used in children under 2 years of age, as safety and efficacy data in this age group are limited and cannot be recommended.

Other medicines and Mycophenolate Mofetil Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If the answer to any of the following questions is yes, consult your doctor before starting to take Mycophenolate Mofetil Teva:

• Are you taking any medicine that contains:
• • azathioprine or another immunosuppressive agent (which is sometimes given after a transplant operation),
  • cholestyramine (used to treat patients with high blood cholesterol levels),
  • rifampicin (an antibiotic),
  • 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),
  • antibiotics (used to treat bacterial infections),
  • isavuconazole (used to treat fungal infections),
  • telmisartan (used to treat high blood pressure),
  • or any other medicine (including those sold without a prescription) that your doctor does not know about?
• Do you need to be vaccinated (live organism vaccine)? Your doctor will advise you on the most suitable one for you.

Pregnancy, contraception, and breastfeeding

Contraception in women taking Mycophenolate Mofetil Teva

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

• Before starting to take Mycophenolate Mofetil Teva
• During treatment with Mycophenolate Mofetil Teva
• Until 6 weeks after stopping Mycophenolate Mofetil Teva

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 cannot become pregnant if:

• 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 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 Mycophenolate Mofetil Teva

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 precautionary measure, it is recommended that you or your female partner use a reliable contraceptive method during treatment and until 90 days after stopping Mycophenolate Mofetil Teva.

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 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 Teva 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 (the tube connecting the throat to the stomach), kidney, and nervous system abnormalities (e.g., 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 doctor's advice on contraception. Your doctor may request more than one pregnancy test to ensure that you are not pregnant before starting treatment.

Breastfeeding

Do not take Mycophenolate Mofetil Teva 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 Teva 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 Teva contains sodium

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

3. How to take Mycophenolate Mofetil Teva

Follow exactly the instructions for administration of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Your treatment will be started and monitored by a transplant specialist doctor.

The usual way to take Mycophenolate Mofetil Teva is as follows:

Kidney transplant

Adults

The first dose should be given within 72 hours after the transplant operation. The recommended daily dose is 4 tablets (2 g of active substance), given in 2 divided 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 size. The doctor will decide the most suitable dose based on body surface area (weight and height). 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 recommended daily dose is 6 tablets (3 g of active substance), given in 2 divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children

There is no information on the use of Mycophenolate Mofetil Teva in children with heart transplants.

Liver transplant

Adults

The first dose of Mycophenolate Mofetil Teva should be given orally at least 4 days after the transplant operation and when you are able to swallow oral medicines. The recommended daily dose is 6 tablets (3 g of active substance), given in 2 divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children

There is no information on the use of Mycophenolate Mofetil Teva in children with liver transplants.

Method of administration and route of administration

Swallow the tablets whole with a glass of water. You can take it with or without food. Do not break or crush them.

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

If you take more Mycophenolate Mofetil Teva than you should

It is important not to take too many tablets. If you take more tablets than you should, or if you think a child has taken some, contact your doctor or the nearest hospital emergency department.

If you forget to take Mycophenolate Mofetil Teva

If you forget to take a dose, take it as soon as you remember and then continue as before.

Do not take a double dose to make up for forgotten doses.

If you stop taking Mycophenolate Mofetil Teva

Do not stop taking Mycophenolate Mofetil Teva even if you feel better. It is important that you take the medicine for as long as your doctor tells you. Stopping treatment with Mycophenolate Mofetil Teva 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 on 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 a doctor immediately if you notice any of the following serious adverse effects; you may need urgent medical treatment:

• you have a sign of infection, such as fever or sore throat.
• you have a bruise or unexpected bleeding.
• you have a skin rash, swelling of the face, lips, tongue, or throat, with difficulty breathing; you may be suffering from a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).
• you have black or bloody stools or vomit blood or dark particles resembling ground coffee. They may be signs of bleeding in the stomach or intestines.

The frequency of certain adverse effects depends on the transplanted organ, i.e., some adverse effects may occur more or less frequently depending on whether this medicine is being taken to prevent the body from rejecting a transplanted heart or a transplanted kidney. For the sake of clarity, each adverse effect is always listed classified according to its highest frequency.

Other Adverse Effects

Very Common (may affect more than 1 in 10 people)

• bacterial, viral, and/or fungal infections
• severe infection that can affect the whole body
• decrease in the number of white blood cells, platelets, or red blood cells, which can result in a higher risk of infections, bruising, bleeding, difficulty breathing, and weakness
• bleeding under the skin
• increase in the number of white blood cells
• excess acid in the body
• high levels of cholesterol and/or lipids in the blood
• high blood sugar levels
• high levels of potassium in the blood, low levels of potassium, magnesium, calcium, and/or phosphate in the blood, high levels of uric acid in the blood, gout
• feeling of restlessness, thinking abnormalities, perception and consciousness levels, depression, feeling of anxiety, difficulty sleeping
• increased muscle tension, spasms, drowsiness, feeling of dizziness, headache, tingling, pinching, or numbness
• faster heart rate
• low/high blood pressure, dilation of blood vessels
• fluid accumulation in the lungs, difficulty breathing, cough
• swollen abdomen
• vomiting, stomach pain, diarrhea, nausea
• constipation, indigestion, gas (flatulence)
• loss of appetite
• changes in different analytical parameters
• liver inflammation, yellowing of the skin and the whites of the eyes
• skin growth, skin rash, acne
• muscle weakness
• joint pain
• kidney problems
• blood in the urine
• fever, feeling of cold, pain, feeling of fatigue and weakness
• fluid retention in the body
• a part of an internal organ or tissue protruding through a weak point in the abdominal muscles
• muscle pain, neck and back pain

Common (may affect up to 1 in 10 people)

• skin cancer, non-cancerous skin growth
• abnormal and excessive growth of tissue
• decrease in the number of all blood cells
• benign increase in size of lymph nodes, inflammatory changes of the skin (pseudolymphoma)
• weight loss
• abnormal thinking
• seizures
• alteration of the sense of taste
• blood clot that forms inside a vein
• inflammation of the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs
• intestinal obstruction
• inflammation of the colon that causes abdominal pain or diarrhea (sometimes caused by cytomegalovirus), mouth and/or stomach and/or duodenum ulcers, stomach inflammation, esophagus and/or mouth and lips inflammation
• belching
• hair loss
• general discomfort
• overgrowth of gum tissue
• pancreas inflammation, which causes severe abdominal and back pain

Uncommon (may affect up to 1 in 100 people)

• protozoal infections
• lymph tissue growth, including malignant tumors
• insufficient production of red blood cells
• severe bone marrow diseases
• lymph fluid accumulation in the body
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop persistent cough or difficulty breathing.
• decrease in the amount of antibodies in the blood
• intensive reduction of the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)

Frequency Not Known (cannot be estimated from the available data)

• alterations of the small intestine inner wall (intestinal villous atrophy)
• severe inflammation of the membrane that covers the brain and spinal cord
• severe inflammation of the heart and its valves
• bacterial infections that usually cause a severe lung disorder (tuberculosis, atypical mycobacterial infection)
• severe kidney disease (BK virus-associated nephropathy)
• severe central nervous system disease (progressive multifocal leukoencephalopathy associated with JC virus)
• decrease in the number of certain white blood cells (neutropenia)
• change in the shape of certain white blood cells

Do not stop taking the medicine unless you have previously discussed it with your doctor.

Reporting of Adverse Effects

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

5. Storage of Micofenolato Mofetilo Teva

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

Do not use this medicine after the expiration date that appears on the blister and the carton after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. 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 Micofenolato Mofetilo Teva

• The active ingredient is micofenolate mofetil.

Each tablet contains 500 mg of micofenolate mofetil.

• The other ingredients are:

Tablet core:

Microcrystalline cellulose

Povidone K-30

Magnesium stearate

Sodium croscarmellose

Tablet coating:

Hypromellose (HPMC 2910)

Titanium dioxide (E 171)

Macrogol (PEG 400)

Talc

Carmine indigo lake (E 132)

Black iron oxide (E 172)

Red iron oxide (E 172)

Appearance of the Product and Package Contents

Film-coated tablets

Film-coated tablet, pale purple, oval, engraved with "M500" on one side and with the other side smooth.

Micofenolato Mofetilo Teva 500 mg film-coated tablets are available in: PVC/PVdC-aluminum blister packs in pack sizes of 50 or 150 or 50 x 1 tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturers

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042

Hungary

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet: {month YYYY}

Detailed information about this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.