MICOFENOLATE MOFETIL TEVA 250 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Micofenolato Mofetil Teva 250 mg Hard Capsules EFG

micofenolato mofetil

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

Contents of the pack and other information

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

1. What is Micofenolato Mofetil Teva and what is it used for

Micofenolato Mofetil Teva is a medicine that is used to suppress the immune system.

The active substance of this medicine is micofenolato mofetil.

Micofenolato Mofetil Teva is used to prevent the body from rejecting a transplanted kidney, heart, or liver. It is used in combination with other medicines that have a similar function (i.e., ciclosporin and corticosteroids).

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

WARNING

Micofenolato causes congenital malformations 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 micofenolato 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 you take micofenolato. See more information in this section, under the headings “Warnings and precautions” and “Pregnancy, contraception and breastfeeding”.

Do not take Micofenolato Mofetil Teva,

• if you are allergic to micofenolato mofetil, to micofenolic acid or to 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 micofenolato can cause congenital malformations 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 Micofenolato Mofetil Teva.

Warnings and precautions

Consult your doctor before starting treatment with Micofenolato 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 Micofenolato Mofetil Teva.
• if you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

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

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

Children and adolescents

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

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

Micofenolato Mofetil Teva should never be used in children under 2 years of age, as the safety and efficacy data in this age group are limited and no dosage recommendations can be made.

Other medicines and Micofenolato 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 treatment with Micofenolato Mofetil Teva:

• Are you taking any medicine that contains:
• • azathioprine or another immunosuppressive agent (which is sometimes given after a transplant operation),
  • colestyramine (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 Micofenolato Mofetil Teva

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

• Before starting Micofenolato Mofetil Teva
• During treatment with Micofenolato Mofetil Teva
• Until 6 weeks after stopping Micofenolato 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 that has been 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 Micofenolato Mofetil Teva

Available evidence does not indicate an increased risk of malformations or spontaneous abortion if the father takes micofenolato. 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 Micofenolato 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 micofenolato, inform your doctor immediately. However, continue taking Micofenolato Mofetil Teva until you see your doctor.

Pregnancy

Micofenolato 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, heart, esophagus (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 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 Micofenolato 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 Micofenolato 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.

Micofenolato Mofetil Teva contains sodium

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

3. How to take Micofenolato Mofetil Teva

Follow exactly the administration instructions 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 specialist doctor in transplants.

The usual way to take Micofenolato 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 8 capsules (2 g of active substance), given in 2 divided doses. This means taking 4 capsules in the morning and 4 capsules in the evening.

Children and adolescents (between 2 and 18 years)

The dose varies depending on the child's size. The doctor will decide what dose is most suitable, taking into account the 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 12 capsules (3 g of active substance), given in 2 divided doses. This means taking 6 capsules in the morning and 6 capsules in the evening.

Children

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

Liver transplant

Adults

The first dose of Micofenolato 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 12 capsules (3 g of active substance), given in 2 divided doses. This means taking 6 capsules in the morning and 6 capsules in the evening.

Children

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

Method of use and route of administration

Swallow the capsules whole with a glass of water. You can take it with or without food. Do not break or crush them, and do not take any capsule that has been broken or opened. Avoid contact with the powder that spills from damaged capsules. If you accidentally break or open a capsule, wash your skin with soap and water. If the powder gets into your eyes or mouth, rinse them thoroughly with plenty of running water.

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

If you take more Micofenolato Mofetil Teva than you should

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

If you forget to take Micofenolato 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 Micofenolato Mofetil Teva

Do not stop taking Micofenolato 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 Micofenolato 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 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 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 levels of consciousness, 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 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 in 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 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 malaise
• 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 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
• intense reduction in 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's 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 severe lung disorders (tuberculosis, atypical mycobacterial infection)
• severe kidney disease (BK virus-associated nephropathy)
• severe central nervous system disease (JC virus-associated progressive multifocal leukoencephalopathy)
• 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 box 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 thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Micofenolato Mofetilo Teva Composition

• The active ingredient is micofenolato mofetilo.

Each capsule contains 250 mg of micofenolato mofetilo.

• The other ingredients are:

Capsule content

Pregelatinized corn starch

Povidone K-30

Croscarmellose sodium

Magnesium stearate

Capsule shell

Cap

Indigo carmine (E 132)

Titanium dioxide (E 171)

Gelatin

Body

Red iron oxide (E 172)

Yellow iron oxide (E 172)

Titanium dioxide (E 171)

Gelatin

Black ink containing: shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

Product Appearance and Package Contents

Hard capsules

Body: opaque caramel color, printed with "250" axially in black ink

Cap: light blue opaque printed with "M" axially in black ink

Micofenolato Mofetilo Teva 250 mg hard capsules are available in PVC/PVdC-aluminum blister packs in package sizes of 100 or 300 or 100 x 1 capsules per box.

Only some package 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 Prospectus: {month YYYY}

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