MOFETIL MYCOPHENOLATE SANDOZ 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Mycophenolate Mofetil Sandoz 500 mg Film-Coated Tablets EFG

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

Contents of the pack

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

1. What Mycophenolate Mofetil Sandoz is and what it is used for

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

Mycophenolate mofetil is used to prevent your body from rejecting a transplanted organ:

• Kidney, heart, or liver.

Mycophenolate mofetil should be used together with other medicines:

• Ciclosporin and corticosteroids.

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

WARNING

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

Your doctor will explain and give you written information, particularly on 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 so that they can explain them to you once more before you take 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, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6),
• if you are a woman who can become pregnant and have not had a negative pregnancy test before the first prescription, as mycophenolate can cause birth defects and spontaneous abortions,
• if you are pregnant or plan to become pregnant or think you may be pregnant,
• if you are not using effective contraception (see “Pregnancy, contraception and breastfeeding”),
• if you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are not sure, 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 bruising or bleeding,
• if you have ever had any digestive problems, such as stomach ulcers,
• if you plan to become pregnant or have become pregnant while you or your partner are being treated with mycophenolate mofetil.

If any of the above apply to you (or you are not sure), consult your doctor immediately before taking mycophenolate mofetil.

Effect of sunlight

Mycophenolate Mofetil Sandoz reduces your body's defenses. For this reason, there is a greater risk of skin cancer. Limit the amount of sunlight and UV light you absorb by:

• wearing protective clothing, including a hat, neck and sleeves, and trousers,
• using a high-factor sunscreen.

Other medicines and Mycophenolate Mofetil Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, including herbal medicines. This is because mycophenolate mofetil can affect the way other medicines work. Other medicines can also affect the way mycophenolate mofetil works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• azathioprine or other medicines that suppress the immune system, which were given after a transplant operation,
• colestyramine, 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 for stomach acid problems such as indigestion,
• phosphate binders, used in patients with chronic kidney failure to reduce phosphate absorption into 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 which vaccines you can have.

Do 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 drinks

Taking food and drinks 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 a reliable contraceptive method. This includes:

• before starting to take mycophenolate mofetil,
• during treatment with mycophenolate mofetil,
• for 6 weeks after stopping mycophenolate mofetil.

Consult your doctor about 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 your contraceptive pill.

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

• you are post-menopausal, i.e. you are over 50 years old and your last menstrual 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 both fallopian tubes and both ovaries removed surgically (bilateral salpingo-oophorectomy),
• you have had your uterus removed surgically (hysterectomy),
• your ovaries do not work (premature ovarian failure confirmed by a specialist gynecologist),
• you have been diagnosed with one of the following rare congenital diseases that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis,
• you are a girl or adolescent who has not started your period.

Contraception in men taking Mycophenolate Mofetil Sandoz

Available evidence does not indicate an increased risk of birth defects or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precautionary measure, it is recommended that you or your female partner use a reliable contraceptive method during treatment and 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, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss the risks and alternative treatments that you can take to prevent rejection of the transplanted organ if:

• you plan to become pregnant,
• you have missed a period or have unusual menstrual bleeding or suspect you may be pregnant,
• you have had unprotected sex.

If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue to take 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 birth defects that have been reported are ear, eye, facial (cleft lip and palate), finger, heart, esophagus (the tube that connects the throat to the stomach), kidney, and nervous system defects (such as spina bifida, where the bones of the spine do not develop properly). 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.

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 the 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 film-coated tablet; this is essentially “sodium-free”.

3. How to take Mycophenolate Mofetil Sandoz

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

How much 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 given 3 days after the transplant operation.
• The daily dose is 4 tablets (2 g of medicine), taken in 2 divided doses.
• Take 2 tablets in the morning and 2 tablets in the evening.

Children (between 2 and 18 years)

• The dose given varies depending on the child's height.
• The doctor will decide the most suitable dose based on the child's height and weight (body surface area measured in square meters “m2”). The recommended dose is 600 mg/m2, given twice a day.

Use in special populations

Elderly

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

Heart transplant

Adults:

• The first dose is given 5 days after the transplant operation.
• The daily dose is 6 tablets (3 g of medicine), given in 2 divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

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

Liver transplant

Adults

• The first dose of mycophenolate mofetil should be given once at least 4 days after the transplant operation and when you are able to swallow the oral medicine.
• The daily dose is 6 tablets (3 g of medicine), given in 2 divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

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

Taking this medicine

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

If you take more Mycophenolate Mofetil Sandoz than you should

If you have taken more of this medicine than you should, consult your doctor immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used. Also do this if someone else has taken your medicine by mistake. Take the medicine with you.

If you forget to take Mycophenolate Mofetil Sandoz

If you ever forget to take your medicine, take it as soon as you remember. Then continue to take it at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Mycophenolate Mofetil Sandoz

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• if you have symptoms of infection such as fever or sore throat,
• if you develop bruising or unexpected bleeding,
• if you have a rash, swelling of the face, lips, tongue, or throat 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, decrease in the number of white or red blood cells 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 adverse effects is more likely in children than in adults. These include diarrhea, infections, decrease in white and red blood cells in the blood.

Fighting 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 under normal conditions. This means you may contract more infections than usual. These include infections that affect the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and Lymph Cancer

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

General Undesired Effects

General adverse effects may occur that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other undesired 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,
• inflammation of the pancreas, colon, or stomach,
• gastrointestinal problems including bleeding,
• liver problems,
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous System Problemssuch as:

• feeling dizzy, drowsy, or numb,
• tremors, muscle spasms, convulsions,
• feeling anxious or depressed, mood or thinking changes.

Cardiac and Blood Vessel Problemssuch as:

• changes in blood pressure, rapid heartbeat, and dilation of blood vessels.

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 (scarring of the lung). Consult your doctor if you develop persistent cough or shortness of breath,
• fluid in the lungs or inside the chest,
• problems in the nasal sinuses.

Other Problemssuch as:

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

Reporting Adverse Effects

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

5. Storage of Mycophenolate Mofetil Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after 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 medicine does not require any special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofMycophenolate Mofetil Sandoz

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

• The other ingredients are:

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

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

Appearance of the Productand Package Contents

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

PVC/PE/PVdC/Al blister

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

HDPE bottle

Package sizes: 50, 150 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 medicine is authorized in the Member States of the European Economic Area 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

France: MYCOPHENOLATE MOFETIL Sandoz 500 mg, comprimé pelliculé

Italy: MICOFENOLATO MOFETILE mofetile Sandoz 500 mg

Iceland: Mycophenolate mofetil Sandoz

Netherlands: Mycofenolaat mofetil Sandoz 500 mg, filmomhulde tabletten

Poland: Mycophenolate mofetil SANDOZ 500 mg tabletki powlekane

Romania: Micofenolat mofetil Sandoz 500 mg, comprimate filmate

Slovak Republic: Mykofenolát mofetil Sandoz 500 mg filmom obalené tablety

Sweden: Mycophenolate mofetil Sandoz 500 mg filmdragerade tabletter.

Date of the last revision of this leaflet:October 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/