Prospect: information for the patient

Micophenolate mofetil Sandoz 500 mg film-coated tablets

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

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

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

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. (see section 4).

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

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

3.How to take Micophenolate mofetil Sandoz

4.Possible adverse effects

5.Storage of Micophenolate mofetil Sandoz

6. Contents of the pack and additional information

Mycophenolate Mofetil Sandoz contains mycophenolate mofetil. This belongs to a group of medicines called“immunosuppressants”.

Mycophenolate Mofetilis used to prevent the body from rejecting a transplanted organ:

• Kidney, heart, or liver.

Mycophenolate Mofetil should be usedalong with other medicines:

• Ciclosporin and corticosteroids.

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and follow the contraceptive advice provided by your doctor.

Your doctor will explain and provide written information, particularly about the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not understand these instructions completely, please consult your doctor again before taking mycophenolate. See more information in this section, under the headings “Warnings and Precautions” and “Pregnancy and Breastfeeding”.

Do not take Mycophenolate Mofetil Sandoz:

• if you are allergic (hypersensitive) to mycophenolate mofetil, to mycophenolic acid, or to any of the other components of this medicine (including those listed in section 6),
• if you are a woman who can become pregnant and have not obtained a negative pregnancy test before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions,
• if you are pregnant or intend to become pregnant or believe you may be pregnant,
• if you are not using effective contraceptives (see “Pregnancy, Contraception, and Breastfeeding”),
• if you are breastfeeding.

Do not take this medicine if you experience any of the above. If you are unsure, consult your doctor or pharmacist before taking mycophenolate mofetil.

Warnings and Precautions:

Consult your doctor immediately before starting to take mycophenolate mofetil:

• if you have any signs of infection such as fever or sore throat,
• if you have unexpected bleeding or bruising,
• if you have ever had any digestive problems, such as stomach ulcers,
• if you are planning to become pregnant or have become pregnant while you or your partner are being treated with mycophenolate mofetil.

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

Effect of sunlight:

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

• wearing appropriate clothing that protects you and covers your head, neck, arms, and legs,
• using a high-protection sunscreen cream.

Other medicines and Mycophenolate Mofetil Sandoz:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription, including herbal medicines. This is because mycophenolate mofetil may affect how other medicines work. Other medicines may also affect how mycophenolate mofetil works. In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• azathioprine or another medicine that suppresses the immune system, which was administered after a transplant operation,
• cholestyramine, used to treat high cholesterol levels,
• rifampicin, an antibiotic used to prevent and treat infections such as tuberculosis (TB),
• antacids or “proton pump inhibitors”, used to treat stomach acid problems such as indigestion,
• phosphate binders, used in patients with chronic kidney disease to reduce phosphate absorption in the blood,
• antibiotics, used to treat bacterial infections,
• isavuconazole, used to treat fungal infections,
• telmisartan, used to treat high blood pressure.

Vaccines:

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

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

Taking Mycophenolate Mofetil Sandoz with food and drink:

Taking food and drink has no effect on your treatment with mycophenolate mofetil.

Pregnancy, Contraception, and Breastfeeding:

Contraception in women taking Mycophenolate Mofetil Sandoz:

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

-before starting to take mycophenolate mofetil,

-during treatment with mycophenolate mofetil,

-until 6 weeks after stopping mycophenolate mofetil.

Consult your doctor to see which contraceptive method is best for you.This will depend on your individual situation.It is recommended to use two contraceptive methods, as this will reduce the risk of unintended pregnancy.Consult your doctor as soon as possible if you think your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You are considered not to be at risk of becoming pregnant if your case is one of the following:

-you are postmenopausal, i.e., you are at least 50 years old and your last menstrual period occurred more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may become pregnant),

-your Fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy),

-your uterus has been surgically removed (hysterectomy),

-your ovaries do not function (premature ovarian failure confirmed by a specialist gynecologist),

-you have been diagnosed with one of the following rare birth defects 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 Sandoz:

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for 90 days after stopping mycophenolate mofetil.

If you are planning to have a child, consult your doctor about the possible risks and alternative treatments.

Pregnancy and Breastfeeding:

If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss the risks and alternative treatments you can take to prevent organ transplant rejection if:

• you intend to become pregnant,
• you have missed a menstrual period or have unusual bleeding or suspect you may be pregnant,
• you have had sexual intercourse without using an effective contraceptive method.

If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue taking mycophenolate mofetil until you see your doctor.

Pregnancy:

Mycophenolate causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations that have been reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida) abnormalities. Your baby may be affected by one or more of these.

If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request more than one pregnancy test.

Breastfeeding:

Do not take mycophenolate mofetil 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 on your ability to drive and use machines is moderate. If you feel drowsy, sleepy, or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate Mofetil Sandoz contains sodium:

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

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Amount to take

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

Kidney transplant

Adults

• The first dose is administered 3 days after the transplant surgery.
• The daily dose is 4 tablets (2 g of medication), administered in 2 separate doses.
• Take 2 tablets in the morning and 2 tablets at night..

Children (between 2 and 18 years)

• The administered dose varies according to the child's height.
• Your doctor will decide which is the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2"). The recommended dose is 600 mg/m2, administered twice a day.

Use in special populations

Advanced age

The recommended dose of 1 g administered twice a day for patients with kidney transplant and 1.5 g twice a day for patients with liver or heart transplant is appropriate for elderly patients.

Heart transplant

Adults:

• The first dose is administered 5 days after the transplant surgery.
• The daily dose is 6 tablets (3 g of medication), administered in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets at night.

Children

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

Liver transplant

Adults

• Once the transplant surgery has been performed, at least 4 days should have passed, and when you are able to take oral medication, the first dose of mycophenolate mofetil oral should be administered.
• The daily dose is 6 tablets (3 g of medication), administered in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets at night.

Children

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

Taking this medication

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

If you take moreMycophenolate mofetil Sandozthan you should

If you have taken more of this medication than you should, consult your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.Also do this if another person accidentally takes your medication. Bring the medication with you.

If you forget to takeMycophenolate mofetil Sandoz

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

If you interrupt treatment withMycophenolate mofetil Sandoz

Do not stop taking this medication unless your doctor tells you to. If you interrupt treatment, you may increase the risk of organ transplant rejection.

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

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

Consult your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• if you have symptoms of infection such as fever or sore throat,
• if you develop petechiae or unexpected bleeding,
• if you have a rash, facial swelling, lip, tongue, or throat swelling with difficulty breathing, as you may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the most common problems are diarrhea, decreased white blood cell or red blood cell count in the blood, infection, and vomiting. Your doctor will perform regular blood tests to monitor any changes in:

• the number of blood cells or signs of infection.

The appearance of side effects is more likely in children than in adults. These include diarrhea, infections, decreased white and red blood cells in the blood.

Combating infections

Mycophenolate mofetil reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as normal. This means you may contract more infections than usual. These include infections affecting the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and lymphatic cancer

Like in patients taking this type of medicine (immunosuppressants), a very small number of patients treated with mycophenolate mofetil have developed skin and lymphoid tissue cancer.

Unwanted general effects

You may experience general side effects that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty sleeping, pains (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other unwanted side effects may be:

Skin problemssuch as:

• acne, cold sores, shingles, skin growth, hair loss, skin rash, itching.

Urinary problemssuch as:

• blood in the urine.

Digestive system and mouth problemssuch as:

• swollen gums and mouth ulcers,
• pancreatitis, colon, or stomach inflammation,
• gastrointestinal problems that include bleeding,
• liver problems,
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

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

Cardiovascular and vascular problemssuch as:

• changes in blood pressure, rapid heartbeat, and blood vessel dilation.

Pulmonary problemssuch as:

• pneumonia, bronchitis,
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (lung scarring). Consult your doctor if you develop persistent cough or shortness of breath,
• fluid in the lungs or chest cavity,
• nasal sinus problems.

Other problemssuch as:

• weight loss, gout, high blood sugar levels, bleeding, petechiae.

Reporting side effects

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

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

Do not usethis medicationafter the expiration date that appears on the packaging, blister, or label after CAD/EXP.The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

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

Composition ofMycophenolate Mofetil Sandoz

• The active ingredient is mycophenolate mofetil.Each film-coated tablet contains 500 mg of mycophenolate mofetil.

• The other components are:

Core content:microcrystalline cellulose, povidone, talc, magnesium stearate, and sodium croscarmellose.

Coating content:hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol (400), iron oxide black (E172), and iron oxide red (E172).

Appearance of the productand packaging content

Mycophenolate Mofetil Sandoz are lavender-colored, biconvex, and flat on both sides, film-coated tablets.

PVC/PE/PVdC/Al blister

Packaging sizes: 50, 100, 120, 150, 180, 250 film-coated tablets.

HDPE bottle

Packaging sizes: 50, 150 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2d

9220 Lendava

Slovenia

or

Lek S.A.

Ul Domaniewska 50 C

Warszawa, PL 02-672

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Austria:Mycophenolat mofetil Sandoz 500 mg - Filmtabletten

Bélgica:Mycophenolat Mofetil Sandoz 500 mg filmomhulde tabletten

República Checa:MYCOPHENOLAT MOFETIL SANDOZ 500 mg

Dinamarca:Mycophenolatemofetil Sandoz

Finlandia:Mycophenolate mofetil Sandoz 500 mg kalvopäällysteinen

Francia:MYCOPHENOLATE MOFETIL Sandoz 500 mg, comprimé pelliculé

Italia:MICOFENOLATO MOFETILE mofetile Sandoz 500 mg

Islandia:Mycophenolate mofetil Sandoz

Holanda:Mycofenolaat mofetil Sandoz 500 mg, filmomhulde tabletten

Polonia:Mycophenolate mofetil SANDOZ 500 mg tabletki powlekane

Rumania:Micofenolat mofetil Sandoz 500 mg, comprimate filmate

República Eslovaca:Mykofenolát mofetil Sandoz 500 mg filmom obalené tablety

Suecia:Mycophenolate mofetil Sandoz 500 mg filmdragerade tabletter.

Last review date of this leaflet:October 2021

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/