Mycophenolate mofetil Sandoz

Package leaflet: Information for the patient

Mycophenolate Mofetil Sandoz 500 mg film-coated tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What Mycophenolate Mofetil Sandoz is and what it is used for
2 What you need to know before taking Mycophenolate Mofetil Sandoz
3 How to take Mycophenolate Mofetil Sandoz
4 Possible side effects
5 How to store Mycophenolate Mofetil Sandoz
6 Contents of the pack and other information

1. What Micofenolato Mofetile Sandoz is and what it is used for

Micofenolato Mofetile Sandoz contains mycophenolate mofetil. This belongs to a group of
medicines called "immunosuppressants".
Micofenolato Mofetile Sandoz is used to prevent your body from rejecting transplanted organs:

• a kidney, a heart, or a liver

Micofenolato Mofetile Sandoz is used in combination with other medicines:

• Cyclosporine and corticosteroids.

2. What you should know before taking Mycophenolate Mofetil Sandoz

WARNINGS
Mycophenolate causes birth defects and spontaneous abortion. If you are a woman who could become pregnant,
you must provide a negative pregnancy test before starting treatment and follow the contraceptive advice
provided by your doctor.
Your doctor will discuss with you and provide written information, particularly about the effects of mycophenolate on unborn children. 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
mycophenolate. See also further information in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".
Do not take Mycophenolate Mofetil Sandoz:

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or to any of the excipients of this medicine (listed in section 6).
• If you are a woman who could potentially be pregnant and have not provided a negative pregnancy test before starting treatment, as mycophenolate causes birth defects and spontaneous abortion.
• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• If you are not using effective contraception (see Pregnancy, contraception and breastfeeding).
• If you are breastfeeding.

Do not take this medicine if any of the situations listed above apply to you. If you are unsure, ask your doctor or pharmacist before taking Mycophenolate Mofetil Sandoz.
Warnings and precautions
Inform your doctor immediately before taking Mycophenolate Mofetil Sandoz:

• If you have signs of infection such as fever or sore throat
• If you have unexplained bruising or bleeding
• If you have ever had gastrointestinal problems, such as stomach ulcers
• If you are planning a pregnancy or become pregnant during treatment with Mycophenolate Mofetil Sandoz
• If you have a rare inherited enzyme deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or if you have any doubts), inform your doctor immediately before taking Mycophenolate Mofetil Sandoz.
Effect of sunlight
Mycophenolate Mofetil Sandoz reduces your body's natural defences. As a result, there is an increased risk of skin cancer.
Limit your exposure to sunlight and ultraviolet rays by:

• Wearing protective clothing covering your head, neck, arms, and legs
• Using high-protection-factor sunscreen creams.

Other medicines and Mycophenolate Mofetil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines without a prescription, including herbal medicines.
This is because Mycophenolate Mofetil Sandoz may alter the effects of other medicines. Other medicines may also alter the effects of Mycophenolate Mofetil Sandoz. In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting Mycophenolate Mofetil Sandoz:

• Azathioprine or other medicines that suppress the immune system – given after transplantation
• Colestyramine – used to treat high cholesterol
• Rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
• Antacids or proton pump inhibitors – used for stomach acid problems, such as indigestion
• Phosphate binders – used by people with chronic kidney failure to reduce the amount of phosphate absorbed into the blood
• Antibiotics – used to treat bacterial infections
• Isavuconazole – used to treat fungal infections
• Telmisartan – used to treat high blood pressure
• Aciclovir, valaciclovir, or ganciclovir – used to treat viral infections

Vaccines
If you need to receive a vaccine (a live vaccine) while taking Mycophenolate Mofetil Sandoz, inform your doctor or pharmacist first. Your doctor will advise you which vaccine is appropriate for you.
You must not donate blood during treatment with Mycophenolate Mofetil Sandoz and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment with Mycophenolate Mofetil Sandoz and for at least 90 days after stopping treatment.
Mycophenolate Mofetil Sandoz with food and drink
Taking food and drink does not affect treatment with Mycophenolate Mofetil Sandoz.
Pregnancy, contraception and breastfeeding
Contraception in women taking Mycophenolate Mofetil Sandoz
If you are a woman who could potentially become pregnant, you must use an effective contraceptive method while taking Mycophenolate Mofetil Sandoz:

• Before starting Mycophenolate Mofetil Sandoz
• Throughout the entire treatment with Mycophenolate Mofetil Sandoz
• For 6 weeks after stopping Mycophenolate Mofetil Sandoz

Consult your doctor about the most suitable contraceptive method for you. This depends on your individual situation.
Using two contraceptive methods is preferable to reduce the risk of an unintended pregnancy.
Contact your doctor as soon as possible if you think your contraceptive method has failed or if you have missed taking your contraceptive pill.
You are a woman who cannot become pregnant if any of the following apply to you:

• You are postmenopausal, e.g. you are at least 50 years old and your last menstrual period was more than one year ago (if your periods have stopped due to cancer treatment, there may still be a possibility of becoming pregnant).
• Both fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your womb (uterus) has been surgically removed (hysterectomy).
• Your ovaries no longer function (premature ovarian failure confirmed by a specialist gynaecologist).
• You were born with one of the following 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 Mycophenolate Mofetil Sandoz
Available data do not indicate an increased risk of birth defects or spontaneous abortions when the father is taking mycophenolate. However, this risk cannot be completely ruled out. As a precaution, therefore, you and your partner are advised to use a reliable contraceptive method during treatment and for 90 days after stopping therapy with Mycophenolate Mofetil Sandoz.
If you plan to have a child, discuss potential risks with your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Your doctor will inform you about the risks associated with pregnancy and alternative options to prevent organ transplant rejection if:

• You are planning a pregnancy.
• You have missed or think you may have missed a menstrual period, have unusual menstrual bleeding, or suspect you are pregnant.
• You have had sexual intercourse without using an effective contraceptive method. If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue taking Mycophenolate Mofetil Sandoz until you see your doctor.

Pregnancy
Mycophenolate causes a very high rate of spontaneous abortion (50%) and severe birth defects (23–27%) in the unborn child. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), fingers, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g. spina bifida, where the bones of the spine are not properly developed). Your baby may be affected by one or more of these.
If you are a woman who could potentially become pregnant, you must provide a negative pregnancy test before starting treatment and follow your doctor's contraceptive advice. Your doctor may require more than one test to confirm you are not pregnant before starting treatment.
Breastfeeding
Do not take Mycophenolate Mofetil Sandoz if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.
Driving and using machines
Mycophenolate mofetil is unlikely to affect your ability to drive or use tools or machinery.
Mycophenolate Mofetil Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per single dose, i.e. essentially 'sodium-free'.

3. How to take Micofenolato Mofetile Sandoz

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The dose you need depends on the type of transplant you have received. The usual doses are indicated
below. Treatment will continue as long as you need to prevent rejection of the transplanted organ.
Kidney transplant
Adults:

• The first dose is given within 3 days after the transplant surgery.
• The daily dose is 4 tablets (2 g of medicine) per day, divided into two separate doses.
• Take 2 tablets in the morning and 2 tablets in the evening.

Children (from 2 to 18 years of age):

• The dose administered will depend on the child's body surface area.
• Your doctor will determine the appropriate dose based on your child’s height and weight (body surface area measured in square meters or “m²”). The recommended dose is 600 mg/m² administered twice daily.

Use in special populations
Elderly
The recommended dose of 1 g twice daily for kidney transplant patients and 1.5 g twice daily for liver or heart transplant patients is appropriate for elderly patients.
Heart transplant
Adults:

• The first dose is administered within 5 days after the transplant surgery.
• The daily dose is 6 tablets (3 g of medicine), divided into two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:
There is no information available on the use of mycophenolate mofetil in children who have received a heart transplant.
Liver transplant
Adults:

• The first dose of oral mycophenolate mofetil will be administered at least 4 days after transplantation and when the patient is able to take oral medication.
• The daily dose is 6 tablets (3 g of medicine), divided into two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:
There is no information available on the use of mycophenolate mofetil in children who have received a liver transplant.
Administration of the medicine

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

If you take more Micofenolato Mofetile Sandoz than you should
If you have taken more of this medicine than you should, inform your doctor or go to hospital immediately. Do the same if someone else accidentally takes the medicine. Take the medicine pack with you.
If you forget to take Micofenolato Mofetile Sandoz
If you forget to take your medicine, take it as soon as you remember. Then continue taking it as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Micofenolato Mofetile Sandoz
Do not stop taking this medicine unless instructed by your doctor. If you stop treatment, you may increase the risk of rejection of the transplanted organ.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Speak to a doctor immediately if you experience any of the following serious side effects –
you may need urgent medical treatment:

• signs of infection such as fever or sore throat
• unexpected bruising or bleeding
• redness, swelling of the face, lips, tongue or throat, with difficulty breathing – you may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems
The most common problems are diarrhoea, decreased white or red blood cells, infections and vomiting.
Your doctor will carry out regular blood tests to check for possible changes:

• in the number of blood cells
• in blood levels of certain substances such as sugars, fats or cholesterol. Children may be more likely than adults to develop certain side effects. These include diarrhoea, infections, and decreased white and red blood cells in the blood. Very common (may affect more than 1 in 10 people)
  • severe infections that can affect the whole body
  • fungal infections of the gastrointestinal tract
  • urinary tract infections
  • cold sores, shingles
  • decreased number of white blood cells, platelets or red blood cells, which may result in increased risk of infections, bruising, bleeding, shortness of breath and weakness
  • vomiting, abdominal pain, diarrhoea, feeling unwell

Common (may affect up to 1 in 10 people)

• lung infection, influenza, respiratory tract infections
• gastrointestinal infections
• inflammation of the gastrointestinal tract
• infection
• fungal infections (e.g. of the respiratory tract, skin and vagina)
• cold symptoms, sore throat, sinus inflammation, blocked and runny nose, sneezing
• skin cancer, non-tumour skin growth
• decreased number of all blood cells, increased number of white blood cells
• excess acid in the body
• high levels of potassium in the blood, low levels of potassium, magnesium, calcium and/or phosphate in the blood
• high blood sugar levels
• high levels of cholesterol and/or lipids in the blood
• high levels of uric acid in the blood, gout
• loss of appetite
• feeling restless, abnormal thinking, perception and levels of awareness, depression, feeling anxious, abnormal thoughts, difficulty sleeping
• convulsions, increased muscle tension, tremors, drowsiness, dizziness, headache, tingling, prickling or numbness
• muscle weakness in the limbs, drooping or lowering of the upper eyelid (myasthenic syndrome)
• altered sense of taste
• rapid heartbeat
• high/low blood pressure, widening of blood vessels
• fluid accumulation in the lungs, shortness of breath, cough
• inflammation of the tissue lining the inner abdominal wall and covering most abdominal organs
• intestinal blockage
• inflammation of the colon causing abdominal pain and diarrhoea (often caused by cytomegalovirus), stomach and/or duodenal ulcers, inflammation of the stomach, oesophagus and/or mouth and lips
• constipation, indigestion, flatulence, belching
• inflammation of the liver, yellowing of the skin and whites of the eyes
• skin growth, rash, hair loss
• joint pain
• kidney problems
• fluid retention in the body
• fever, chills, pain, feeling unwell, feeling weak and limp
• changes in various laboratory tests
• weight loss
• excessive growth of soft tissue
• inflammation of the pancreas, causing severe abdominal and back pain

Uncommon (may affect up to 1 in 100 people)

• Proliferation of lymphatic tissue, including malignant tumours
• Severe reduction in the number of certain types of white blood cells (possible symptoms include fever, sore throat, frequent infections) (agranulocytosis) Not known (frequency cannot be estimated from available data)
• changes in the inner lining of the small intestine (intestinal villi atrophy)
• severe inflammation of the membrane covering the brain and spinal cord
• severe inflammation of the heart and heart valves
• bacterial infections leading to serious lung disease (tuberculosis, atypical mycobacterial infection)
• severe kidney disease (BK virus-associated nephropathy)
• severe disease of the Central Nervous System (JC virus-associated progressive multifocal leukoencephalopathy)
• decrease in the number of certain white blood cells (neutropenia)
• severe bone marrow disease
• insufficient production of red blood cells
• change in the shape of certain white blood cells
• shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lung)
• decrease in the number of antibodies in the blood

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micofenolato Mofetile Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, or label, following the word "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 Sandoz contains

• The active substance is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients (excipients) are as follows:
  Core: microcrystalline cellulose, povidone, talc, magnesium stearate, sodium croscarmellose.
  Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol (400), black iron oxide (E172), red iron oxide (E172).

Description of the appearance of Micofenolato Mofetile Sandoz and contents of the pack
Micofenolato Mofetile Sandoz are lavender-coloured, film-coated tablets, biconvex on both sides.
Packs:
Blister packs in PVC/PE/PVdC/Al:
Pack sizes: 50, 100, 120, 150, 180 and 250 film-coated tablets.
HDPE bottles:
Pack sizes: 50, 150 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni, 1
21040 Origgio (VA)
Italy

Manufacturers responsible for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Salutas Pharma GmbH
Dieselstrasse 5, 70839 Gerlingen, Germany
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimline 2D, 9220 Lendava, Slovenia
LEK S.A.
ul. Domaniewska 50 C, 02-672 Warszawa, Poland

This medicinal product has been authorised in EEA Member States under the following names:
Austria: Mycophenolat mofetil Sandoz 500 mg – Filmtabletten
Belgium: Mycophenolat Mofetil Sandoz 500 mg filmomhulde tabletten
Czech Republic: MYCOPHENOLAT MOFETIL SANDOZ 500 mg
Denmark: Mycophenolatemofetil Sandoz
Finland: Mycophenolate mofetil Sandoz 500 mg kalvopäällysteinen tabletti / Mycophenolate mofetil Sandoz 500 mg tabletit
France: MYCOPHENOLATE MOFETIL SANDOZ 500 mg, comprimé
Hungary: Mycophenolate mofetil Sandoz 500 mg filmtabletta
Iceland: Mycophenolate mofetil Sandoz 500 mg filmuhúðaðar töflur
Italy: MICOFENOLATO MOFETILE SANDOZ
Latvia: Mycophenolate Mofetil Sandoz 500 mg apvalkotās tabletes
Netherlands: Mycofenolaat mofetil Sandoz 500 mg, filmomhulde tabletten
Poland: Mycophenolate mofetil SANDOZ 500 mg tabletki powlekane
Portugal: MICOFENOLATO DE MOFETIL SANDOZ 500 mg COMPRIMIDOS
Romania: Mycophenolat mofetil Sandoz 500 mg comprimate filmate
Slovakia: Mykofenolát mofetil Sandoz 500 mg filmom obalené tablety
Spain: Micofenolato de mofetilo Sandoz 500 mg comprimidos recubiertos con película EFG
Sweden: Mycophenolate mofetil Sandoz 500 mg filmdragerade tabletter
United Kingdom: Mycophenolate mofetil Sandoz 500 mg Film-coated Tablets

This summary of product characteristics was last approved on