MYCOPHENOLATE 250 mg Hard Capsule

Зміст інструкції

1. What is Micofenolate Mofetil Teva and what is it used for
2. What you need to know before you take Micofenolate Mofetil Teva
3. How to take Micofenolato Mofetile Teva
4. Possible side effects
5. How to store Micofenolato Mofetile Teva
6. Package Contents and Other Information
7. What is Micofenolate Mofetil Teva and what is it used for
8. What you need to know before you take Micofenolate Mofetil Teva
9. How to take Micofenolato Mofetile Teva
10. Possible side effects
11. How to store Micofenolato Mofetile Teva
12. Package Contents and Other Information

Micofenolato Mofetile Teva 250 mg hard capsules
micofenolato mofetile

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Micofenolate Mofetil Teva is a medicine used to reduce the immune system's activity.
The active ingredient of this medicine is called micofenolate mofetil.
Micofenolate Mofetil Teva is used to prevent your body from rejecting a kidney, heart or
liver transplant. It is used in combination with other medicines that perform a similar function (e.g.
cyclosporine and corticosteroids).

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

WARNING
Micofenolate causes congenital defects and miscarriage. If you are a woman who can become pregnant, you must
have a negative pregnancy test result before starting treatment and follow your doctor's advice regarding
contraception.
Your doctor will talk to you and give you written information, particularly about the effects of
micofenolate on the unborn child. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before
taking micofenolate. Also read the information within this paragraph under the headings
“Warnings and precautions” and “Pregnancy, contraception and breastfeeding”.

Do not take Micofenolate Mofetil Teva

• if you are allergic to micofenolate mofetil, mycohenolic 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 result before your first prescription, as micofenolate causes congenital defects and miscarriage
• if you are currently pregnant, if you suspect you are pregnant or are planning a pregnancy
• if you are not using any effective contraceptive method (see Pregnancy, contraception and breastfeeding)
• if you are breastfeeding with breast milk

Do not take this medicine if any of the above conditions apply to you. If you have any
doubts, talk to your doctor or pharmacist before using Micofenolate Mofetil Teva.

Warnings and precautions
Tell your doctor immediately before starting treatment with Micofenolate Mofetil Teva:

• if you are over 65 years of age, as you may have an increased risk of developing adverse events such as some viral infections, gastrointestinal bleeding and pulmonary edema compared to younger patients.
• if you have signs of infection (e.g. fever, sore throat), bruising and/or unexpected bleeding.
• if you have or have ever had digestive problems, such as a stomach ulcer.
• if you are planning a pregnancy or if you become pregnant while you or your partner are being treated with Micofenolate Mofetil Teva.
• if you suffer from a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

Micofenolate Mofetil Teva lowers the body's defenses, determining a greater risk of
skin cancer. It is therefore necessary to limit exposure to the sun and ultraviolet (UV) rays
through the use of suitable protective clothing and a sunscreen with a high protection factor.
You must not donate blood during treatment with Micofenolate Mofetil Teva and for at least
6 weeks after stopping treatment. Men must not donate sperm during
treatment with Micofenolate Mofetil Teva and for at least 90 days after stopping
treatment.

Children and adolescents
Micofenolate Mofetil Teva is used in children and adolescents (aged between 2 and 18
years) to prevent rejection of a transplanted kidney.
Micofenolate Mofetil Teva should not be used in children and adolescents (aged between 2 and 18 years) for
heart or liver transplantation.
Micofenolate Mofetil Teva should not be used in children under 2 years of age because
based on limited safety and efficacy data for this age group, it is not possible to formulate
dosage recommendations.

Other medicines and Micofenolate Mofetil Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If you answer yes to any of these questions, talk to your doctor before starting to take
Micofenolate Mofetil Teva:

• Are you currently taking medicines that contain: azathioprine or other immunosuppressants (which are sometimes prescribed to patients after organ transplantation), colestyramine (used to treat patients with high blood cholesterol), rifampicin (an antibiotic), antacids or proton pump inhibitors (used for problems with acidity in the stomach such as indigestion), phosphate binders (used in patients with chronic renal failure to reduce phosphate absorption), antibiotics (used to treat bacterial infections), isavuconazole (used to treat fungal infections (mycoses)), telmisartan (used to treat high blood pressure) or any other medicine (including over-the-counter medicines) that your doctor is not aware of?
• Do you need to have a vaccination (live vaccines)? Your doctor will inform you about what is appropriate for you.

Pregnancy, contraception and breastfeeding
Contraception in women taking Micofenolate Mofetil Teva
If you are a woman who can become pregnant, you must use an effective contraceptive method with
Micofenolate Mofetil Teva. This means:

• before starting to take Micofenolate Mofetil Teva
• during the entire treatment with Micofenolate Mofetil Teva
• for 6 weeks after stopping treatment with Micofenolate Mofetil Teva. Talk to your doctor about the most suitable contraceptive method for you. This will depend on your individual situation. The use of two contraceptive methods is preferable to reduce the risk of unwanted pregnancy. Contact your doctor as soon as possible if you think the contraceptive used may not have been effective or if you have forgotten to take your contraceptive pill.

You cannot become pregnant if any of the following conditions apply to you:

• You are menopausal, i.e. you are at least 50 years old and your last menstrual period was more than a year ago (if your menstrual cycle has stopped because you have undergone cancer treatment, there is still a possibility that you may become pregnant).
• Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (hysterectomy)
• Your ovaries no longer function (premature ovarian failure, which has been confirmed by a gynecologist).
• You were born with one of the rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis.
• You are a child or adolescent who has not yet had her first menstrual period.

Contraception in men taking Micofenolate Mofetil Teva
Although the available clinical data do not indicate an increased risk of malformations or miscarriages
when the father takes micofenolate, this risk cannot be completely ruled out.
As a precaution, therefore, both you and your partner are advised to use a reliable contraceptive
method during treatment and for 90 days after stopping therapy with Micofenolate
Mofetil Teva.
If you are planning a pregnancy, talk to your doctor about the potential risks and alternative therapies.

Pregnancy and breastfeeding
If you are pregnant, if you suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine. The doctor
will discuss with you the risks in case of pregnancy and the alternative treatments you can undergo
to prevent organ rejection if:

• you are planning a pregnancy
• you miss or think you have missed a menstrual period, if you have unusual menstrual bleeding or if you suspect a pregnancy
• you have had unprotected sex. If you become pregnant during treatment with micofenolate, you should inform your doctor immediately. In any case, continue to take Micofenolate Mofetil Teva until you see your doctor.

Pregnancy
Micofenolate very frequently causes miscarriage (50%) and serious birth defects (23-27%) in
the unborn child. The reported birth defects include abnormalities of the ears, eyes, face
(cheiloschisis/palatoschisis), finger development, heart, esophagus (tubular organ that
connects the throat and stomach), kidneys and nervous system (for example spina bifida [where the bones
of the spine are not fully developed]). The baby may have one or more of these defects.
If you are a woman who can become pregnant, you must have a negative pregnancy test
before starting treatment and follow your doctor's advice regarding contraception. The doctor
may require more than one test to ensure that you are not pregnant before starting
treatment.

Breastfeeding
Do not take Micofenolate Mofetil Teva if you are breastfeeding with breast milk. Small amounts of
medicine can pass into breast milk.

Driving and using machines
Micofenolate Mofetil Teva moderately impairs the ability to drive vehicles or use
tools or machinery. If you feel sleepy, dizzy or confused, consult your doctor or nurse
and do not drive vehicles or use tools or machinery until you feel better.

Micofenolate Mofetil Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e. essentially
‘sodium-free’.

3. How to take Micofenolato Mofetile Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Your treatment is started and monitored by a transplant specialist doctor.
Usually Micofenolato Mofetile Teva is taken as follows:

Kidney transplant
Adults
The first dose will be administered within 72 hours after the transplant surgery. The recommended
dose is 8 capsules (2 g of active ingredient) per day, divided into 2 administrations, i.e.
4 capsules in the morning and 4 capsules in the evening.
Children and adolescents (aged between 2 and 18 years):
The dose to be administered will depend on the child's body surface area. The doctor will decide the
appropriate dose based on the body surface area (weight and height). The recommended dose is 600 mg/m
administered twice a day.

Heart transplant
Adults
The first dose will be administered within 5 days after the transplant surgery. The recommended
dose is 12 capsules (3 g of active ingredient) per day, divided into 2 administrations, i.e.
6 capsules in the morning and 6 capsules in the evening.
Children
There is no information on the use of Micofenolato Mofetile Teva in children with a heart
transplant.

Liver transplant
Adults
The first dose of oral Micofenolato Mofetile Teva will be administered at least 4 days after the
transplant and when you are able to ingest medicines orally. The recommended dose is
12 capsules (3 g of active ingredient) per day, divided into 2 administrations, i.e. 6 capsules in the
morning and 6 capsules in the evening.
Children
There is no information on the use of Micofenolato Mofetile Teva in children with a liver
transplant.

Method and route of administration
Swallow the capsules whole with a glass of water. You can take them with or without food. The capsules must not
be broken or crushed and do not take any broken or open capsules. Avoid contact with the
powder leaking from damaged capsules. If a capsule accidentally breaks, wash the skin
with soap and water where it has come into contact with the powder. If any powder gets into your eyes or
mouth, rinse thoroughly with plenty of fresh running water.
Therapy will be continued as long as immunosuppression is necessary to prevent rejection
of the organ that has been transplanted.

If you take more Micofenolato Mofetile Teva than you should
It is important not to ingest too many capsules. Contact the nearest emergency room or your doctor for
advice if you have ingested more capsules than you were told to take or if you think a child has
ingested them.

If you forget to take Micofenolato Mofetile Teva
If you forget to take the medicine, take it as soon as you remember, then continue to take it
as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Micofenolato Mofetile Teva
Do not stop taking Micofenolato Mofetile Teva because you feel better. It is important
to take the medicine for the duration prescribed by your doctor. If you stop treatment with
Micofenolato Mofetile Teva, the risk of rejection of your transplanted organ may increase. Do not stop
taking the medicine unless your doctor tells you to.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek immediate medical attention if you notice any of the following serious side effects – urgent medical treatment may be needed:

• you have signs of infection such as fever or sore throat.
• you have unexpected bruising or bleeding.
• you have a rash, swelling of the face, lips, tongue or throat with difficulty breathing - this may be a serious allergic reaction to the medicine (such as anaphylaxis, angioedema).
• you have black or tarry stools, or vomit blood or dark particles that look like coffee grounds. These may be signs of bleeding in the stomach or intestine.

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

Other side effects

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

• Bacterial, viral and/or fungal infections
• Serious infections that can affect the whole body
• Decreased number of white blood cells, platelets or red blood cells, which may result in an increased risk of infections, bruising, bleeding, shortness of breath and weakness
• Bleeding under the skin
• Increased 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 restless, thought abnormalities, perception abnormalities and level of consciousness abnormalities, depression, feeling anxious, difficulty sleeping
• Increased muscle tension, tremor, drowsiness, dizziness, headache, tingling, prickling or numbness
• Fast heartbeat
• High/low blood pressure, widening of blood vessels
• Fluid accumulation in the lungs, shortness of breath, cough
• Bloated stomach
• Vomiting, stomach pain, diarrhea, nausea
• Constipation, indigestion, flatulence
• Decreased appetite
• Changes in various laboratory parameters
• Inflammation of the liver, yellowing of the skin and whites of the eyes
• Skin growth, rash, acne
• Muscle weakness
• Joint pain
• Kidney problems
• Blood in urine
• Fever, feeling cold, pain, feeling weak
• Fluid retention in the body
• Part of an internal organ or tissue protruding through a weak spot in the abdominal muscles
• Muscle pain, neck and back pain

Common (may affect up to 1 in 10 people)

• Skin tumors, non-cancerous skin growth
• Abnormal and excessive tissue growth
• Decreased number of all blood cells
• Benign enlargement of lymph nodes, inflammatory skin changes (pseudolymphoma)
• Weight loss
• Abnormal thoughts
• Convulsions
• Distortion of the sense of taste
• Formation of a blood clot in a vein
• Inflammation of the tissue lining the inner wall of the abdomen and covering most of the abdominal organs
• Bowel obstruction
• Inflammation of the colon causing abdominal pain or diarrhea (sometimes caused by cytomegalovirus), ulcers of the mouth and/or stomach and/or duodenum, inflammation of the stomach, esophagus and/or mouth and lips
• Belching
• Hair loss
• Feeling unwell
• Excessive growth of gum tissue
• Inflammation of the pancreas, causing severe pain in the abdomen and back

Uncommon (may affect up to 1 in 100 people)

• Protozoal infections
• Proliferation of lymphatic tissue, including malignant tumors
• Insufficient production of red blood cells
• Severe bone marrow diseases
• Accumulation of lymphatic fluid inside the body
• Shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways in the lungs are abnormally dilated) or pulmonary fibrosis (scarring of the lungs). See a doctor if you have a persistent cough or shortness of breath.
• Reduced amount of antibodies in the blood
• Severe decrease in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)

Not known (frequency cannot be estimated from available data)

• Changes in the inner wall of the small intestine (atrophy of the intestinal villi)
• Severe inflammation of the membrane covering the brain and spinal cord
• Severe inflammation of the heart and its valves
• Bacterial infections that usually cause severe lung disease (tuberculosis, atypical mycobacterial infection)
• Severe kidney disease (BK virus-associated nephropathy)
• Severe disease of the central nervous system (progressive multifocal leukoencephalopathy associated with JC virus)
• Decreased number of certain white blood cells (neutropenia)
• Change in the shape of certain white blood cells

Do not stop treatment before talking to your doctor.

Reporting suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micofenolato Mofetile Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Micofenolato Mofetile Teva Contains

• The active ingredient is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
• The other ingredients are: Capsule contents Pregelatinized maize starch Povidone K-30 Sodium croscarmellose Magnesium stearate Capsule shell Closing capsuleIndigo carmine (E132) Titanium dioxide (E171) Gelatin BodyRed iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Black ink containing: lacquer, black iron oxide (E172), propylene glycol and potassium hydroxide

Description of the appearance of Micofenolato Mofetile Teva and package contents
Hard capsules
Body: opaque caramel-colored with “250” printed in black, axially.
Closing capsule: opaque blue with “M” printed in black, axially.
Micofenolato Mofetile Teva 250 mg hard capsules are available in transparent aluminum-
PVC/PVdC blisters in packs of 100 or 300 or 100 x 1 capsules per box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar Α.Β.Ε.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar Α.Β.Ε.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

This leaflet was last updated on {MM/YYYY}
More detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu

Micofenolato Mofetile Teva 500 mg film-coated tablets
mycophenolate mofetil

Read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Micofenolate Mofetil Teva is a medicine used to suppress the immune system.
The active ingredient of this medicine is called micofenolate mofetil.
Micofenolate Mofetil Teva is used to prevent your body from rejecting a transplanted kidney, heart or
liver. It is used in combination with other medicines with a similar function (e.g.
cyclosporine and corticosteroids).

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

WARNING
Micofenolate causes birth defects and miscarriage. If you are a woman who can become pregnant you must
have a negative pregnancy test before starting treatment and follow your doctor's advice regarding
contraception.
Your doctor will talk to you and give you written information, particularly about the effects of
micofenolate on the unborn child. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before
taking micofenolate. Also read the information within this paragraph under the headings
“Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Micofenolate Mofetil Teva

• if you are allergic to micofenolate mofetil, mycohenolic 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 your first prescription, as micofenolate causes birth defects and miscarriage
• if you are pregnant, if you suspect you may be pregnant or are planning to become pregnant
• if you are not using any effective method of contraception (see Pregnancy, contraception and breastfeeding)
• if you are breastfeeding

Do not take this medicine if any of the above conditions apply to you. If you have any
doubts, talk to your doctor or pharmacist before using Micofenolate Mofetil Teva.

Warnings and precautions
Tell your doctor immediately before starting treatment with Micofenolate Mofetil Teva:

• if you are over 65 years old, as you may have an increased risk of developing adverse events such as some viral infections, gastrointestinal bleeding and pulmonary oedema compared to younger patients.
• in cases of signs of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding
• if you have or have ever had digestive problems, such as a stomach ulcer
• if you are planning a pregnancy or if you become pregnant while you or your partner are being treated with Micofenolate Mofetil Teva
• if you suffer from a rare inherited enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

Micofenolate Mofetil Teva lowers your body's defenses, leading to a higher risk of
skin cancer. Therefore, you must limit exposure to the sun and ultraviolet (UV) rays
by using suitable protective clothing and high-factor sunscreens.
You must not donate blood during treatment with Micofenolate Mofetil Teva and for at least
6 weeks after stopping treatment. Men must not donate sperm during treatment with Micofenolate
Mofetil Teva and for at least 90 days after stopping treatment.

Children and adolescents
Micofenolate Mofetil Teva is used in children and adolescents (aged between 2 and 18
years) to prevent rejection of a transplanted kidney.
Micofenolate Mofetil Teva should not be used in children and adolescents (aged between 2 and 18 years) for heart or liver transplantation.
Micofenolate Mofetil Teva should not be used in children under 2 years of age because
based on limited safety and efficacy data for this age group, it is not possible to make
dosage recommendations.

Other medicines and Micofenolate 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 these questions is yes, talk to your doctor before starting to take
Micofenolate Mofetil Teva:

• Are you currently taking medicines that contain: azathioprine or other immunosuppressants (sometimes prescribed to patients after organ transplantation), colestyramine (used to treat patients with high blood cholesterol), rifampicin (an antibiotic), antacids or proton pump inhibitors (used for problems with acidity in the stomach 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 (mycoses)), telmisartan (used to treat high blood pressure) or any other medicine (including over-the-counter medicines) that your doctor is not aware of?
• Do you need to have a vaccination (live vaccines)? Your doctor will advise you on what is appropriate for you.

Pregnancy, contraception and breastfeeding
Contraception in women taking Micofenolate Mofetil Teva
If you are a woman who can become pregnant, you must use effective contraception while
taking Micofenolate Mofetil Teva. This means:

• before starting to take Micofenolate Mofetil Teva
• during the entire treatment with Micofenolate Mofetil Teva
• for 6 weeks after stopping treatment with Micofenolate Mofetil Teva. Talk to your doctor about the most suitable method of contraception for you. This will depend on your individual situation. The use of two methods of contraception is preferable to reduce the risk of unwanted pregnancy. Contact your doctor as soon as possible if you think the contraceptive used may not have been effective or if you have forgotten to take your contraceptive pill.

You cannot become pregnant if any of the following conditions apply to you:

• You are menopausal, i.e. you are at least 50 years old and your last menstrual period was more than a year ago (if your menstrual cycle has stopped because you have undergone cancer treatment, there is still a possibility that you may become pregnant).
• Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (hysterectomy)
• Your ovaries no longer function (premature ovarian insufficiency, which has been confirmed by a specialist gynaecologist).
• You were born with one of the rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis.
• You are a child or adolescent who has not yet had her first menstrual period.

Contraception in men taking Micofenolate Mofetil Teva
Although the available clinical data do not indicate an increased risk of birth defects or miscarriage
when the father is taking micofenolate, this risk cannot be completely ruled out.
As a precaution, therefore, both you and your partner are advised to use reliable contraception during
treatment and for 90 days after stopping therapy with Micofenolate Mofetil Teva.
If you are planning a pregnancy, talk to your doctor about the potential risks and alternative therapies.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine. The doctor
will discuss with you the risks in case of pregnancy and alternative treatments you can undergo
to prevent organ rejection if:

• you are planning a pregnancy
• you miss or think you have missed a menstrual period, if you have unusual vaginal bleeding or if you suspect you are pregnant
• you have had unprotected sexual intercourse. If you become pregnant during treatment with micofenolate, you must inform your doctor immediately. In any case, continue to take Micofenolate Mofetil Teva until you see your doctor.

Pregnancy
Micofenolate very frequently causes miscarriage (50%) and serious birth defects (23-27%) in
the unborn child. The reported birth defects include abnormalities of the ears, eyes, face
(cleft lip/palate), finger development, heart, esophagus (the tube connecting the throat and stomach), kidneys and nervous system (e.g. spina bifida [where the bones
of the spine are not fully developed]). The baby may have one or more of these defects.
If you are a woman who can become pregnant, you must have a negative pregnancy test
before starting treatment and follow your doctor's advice regarding contraception. The doctor
may require more than one test to ensure that you are not pregnant before starting
treatment.

Breastfeeding
Do not take Micofenolate Mofetil Teva if you are breastfeeding. Small amounts of
medicine can pass into breast milk.

Driving and using machines
Micofenolate Mofetil Teva moderately impairs the ability to drive or operate tools or machines. If you feel sleepy, dizzy or confused, consult your doctor or nurse
and do not drive or operate tools or machines until you feel better.

Micofenolate Mofetil Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to take Micofenolato Mofetile Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
Your treatment is started and monitored by a doctor who is a specialist in transplantation.
Usually Micofenolato Mofetile Teva is taken as follows:

Kidney transplant
Adults
The first dose will be administered within 72 hours after the transplant surgery. The recommended dose is 4 tablets (2 g of active substance) per day, divided into 2 administrations,
i.e. 2 tablets in the morning and 2 tablets in the evening.
Children and adolescents (aged between 2 and 18 years)
The dose to be administered will depend on the child's body surface area. The doctor will decide the appropriate dose
based on the body surface area (weight and height). The recommended dose is 600 mg/m
administered twice a day.

Heart transplant
Adults
The first dose will be administered within 5 days after the transplant surgery. The recommended dose is 6 tablets (3 g of active substance) per day, divided into 2 administrations,
i.e. 3 tablets in the morning and 3 tablets in the evening.
Children
There is no information on the use of Micofenolato Mofetile Teva in children with a heart
transplant.

Liver transplant
Adults
The first dose of oral Micofenolato Mofetile Teva will be administered at least 4 days after the
transplant and when you are able to take medicines orally. The recommended dose is
6 tablets (3 g of active substance) per day, divided into 2 administrations, i.e. 3 tablets in the
morning and 3 tablets in the evening.
Children
There is no information on the use of Micofenolato Mofetile Teva in children with a liver
transplant.

Method and route of administration
Swallow the tablets whole with a glass of water. You can take them with or without food. The tablets
should not be broken or crushed.
Therapy will be continued as long as immunosuppression is necessary to prevent rejection
of the organ that has been transplanted.

If you take more Micofenolato Mofetile Teva than you should
It is important not to ingest too many tablets. Contact the nearest emergency room or your doctor for
advice if you have ingested more tablets than you were told to take or if you think a
child has ingested them.

If you forget to take Micofenolato Mofetile Teva
If you forget to take the medicine, take it as soon as you remember, then continue to take it
as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Micofenolato Mofetile Teva
Do not stop taking Micofenolato Mofetile Teva because you feel better. It is important
to take the medicine for the duration prescribed by your doctor. If you stop treatment with
Micofenolato Mofetile Teva, the risk of rejection of your transplanted organ may increase. Do not stop
taking the medicine unless your doctor tells you to.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek immediate medical attention if you notice any of the following serious side effects – urgent medical treatment may be needed:

• you have signs of infection such as fever or sore throat.
• you have unexpected bruising or bleeding.
• you have a skin rash, swelling of the face, lips, tongue or throat with difficulty breathing - this may be a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).
• you have black or tarry stools, or vomit blood or particles that look like coffee grounds. These may be signs of bleeding in the stomach or intestine.

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

Other side effects

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

• Bacterial, viral and/or fungal infections
• Serious infections that can affect the whole body
• Decreased number of white blood cells, platelets or red blood cells, which may result in an increased risk of infections, bruising, bleeding, shortness of breath and weakness
• Bleeding under the skin
• Increased number of white blood cells
• Excess acid in the body
• High levels of cholesterol and/or lipids in the blood
• High levels of sugar in the blood
• 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 restless, thought abnormalities, perceptual disturbances and level of consciousness abnormalities, depression, feeling anxious, difficulty sleeping
• Increased muscle tension, tremor, drowsiness, dizziness, headache, tingling, prickling or numbness
• Fast heartbeat
• High/low blood pressure, widening of blood vessels
• Fluid accumulation in the lungs, shortness of breath, cough
• Bloated stomach
• Vomiting, stomach pain, diarrhea, nausea
• Constipation, indigestion, flatulence
• Decreased appetite
• Changes in various laboratory parameters
• Inflammation of the liver, yellowing of the skin and whites of the eyes
• Skin growth, rash, acne
• Muscle weakness
• Joint pain
• Kidney problems
• Blood in urine
• Fever, feeling cold, pain, feeling weak
• Fluid retention in the body
• Part of an internal organ or tissue protruding through a weak spot in the abdominal muscles
• Muscle pain, neck and back pain

Common (may affect up to 1 in 10 people)

• Skin tumors, non-cancerous skin growth
• Abnormal and excessive tissue growth
• Decreased number of all blood cells
• Benign enlargement of lymph nodes, inflammatory skin changes (pseudolymphoma)
• Weight loss
• Abnormal thoughts
• Convulsions
• Distortion of the sense of taste
• Formation of a blood clot in a vein
• Inflammation of the tissue lining the inner wall of the abdomen and covering most of the abdominal organs
• Bowel obstruction
• Inflammation of the colon causing abdominal pain or diarrhea (sometimes caused by cytomegalovirus), ulcers of the mouth and/or stomach and/or duodenum, inflammation of the stomach, esophagus and/or mouth and lips
• Burping
• Hair loss
• Feeling unwell
• Excessive growth of gum tissue
• Inflammation of the pancreas, causing severe pain in the abdomen and back

Uncommon (may affect up to 1 in 100 people)

• Infections by protozoa
• Proliferation of lymphatic tissue, including malignant tumors
• Insufficient production of red blood cells
• Severe bone marrow diseases
• Accumulation of lymphatic fluid within the body
• Shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways in the lungs are abnormally dilated) or pulmonary fibrosis (scarring of the lung). See a doctor if you have a persistent cough or shortness of breath.
• Reduced amount of antibodies in the blood
• Severe decrease in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)

Not known (frequency cannot be estimated from available data)

• Changes in the inner wall of the small intestine (atrophy of the intestinal villi)
• Severe inflammation of the membrane covering the brain and spinal cord
• Severe inflammation of the heart and its valves
• Bacterial infections that typically cause severe lung disease (tuberculosis, atypical mycobacterial infection)
• Severe kidney disease (BK virus-associated nephropathy)
• Severe disease of the central nervous system (progressive multifocal leukoencephalopathy associated with JC virus)
• Decreased number of certain white blood cells (neutropenia)
• Change in the shape of certain white blood cells

Do not stop treatment before talking to your doctor.

Reporting suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micofenolato Mofetile Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Micofenolato Mofetile Teva contains

• The active ingredient is mycophenolate mofetil 500 mg.
• The other ingredients are: Tablet core Microcrystalline cellulose Povidone K-30

Magnesium stearate
Sodium croscarmellose
Tablet coating
Hypromellose (HPMC 910)
Titanium dioxide (E171)
Macrogol
Talc
Indigo carmine aluminium lake (E132)
Black iron oxide (E172)
Red iron oxide (E172)

Description of Micofenolato Mofetile Teva and package contents
Film-coated tablets
Light purple, oval-shaped film-coated tablet, with “M500” imprinted on one side and plain
on the other side.
Micofenolato Mofetile Teva 500 mg film-coated tablets are available in transparent blisters of
aluminium-PVC/PVdC in packs of 50 or 150 or 50 x 1 tablets per box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar Α.Β.Ε.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar Α.Β.Ε.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

This leaflet was last updated on {MM/YYYY}
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATIONS TO THE
MARKETING AUTHORISATION
Scientific conclusions
Taking into account the PRAC assessment report on PSURs for mycophenolate mofetil,
mycophenolic acid, the PRAC’s scientific conclusions are as follows:
In light of the available literature data regarding the excretion of mycophenolic acid into human
milk, the PRAC considers that the excretion of mycophenolic acid into human milk is at least a
reasonable possibility. The PRAC concluded that the medicinal product information for products
containing mycophenolate mofetil, mycophenolic acid should be amended accordingly.
Following examination of the PRAC recommendation, the CHMP agrees with the PRAC’s overall
conclusions and with the rationale for the recommendation.

Justification for variations to the marketing authorisation
Based on the scientific conclusions on mycophenolate mofetil, mycophenolic acid, the CHMP
considers that the benefit-risk ratio of the medicinal products containing mycophenolate mofetil, mycophenolic acid
remains unchanged, save for the proposed changes to the medicinal product information.
The CHMP recommends the variation to the marketing authorisation.