Prospecto: Information for the User

Micofenolato de mofetilo Sandoz 250 mg Hard Capsules EFG

Micofenolato de mofetilo

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 to 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 Micofenolato de mofetilo Sandoz and for what it is used

2.What you need to know before starting to take Micofenolato de mofetilo Sandoz

3.How to take Micofenolato de mofetilo Sandoz

4.Possible adverse effects

5.Storage of Micofenolato de mofetilo Sandoz

6. Contents of the package and additional information

Mycophenolate Mofetil Sandoz contains mycophenolate mofetil.

This belongs to a group of medicines called“immunosuppressants”.

Mycophenolate Mofetil is used to prevent the body from rejecting a transplanted organ.

• Kidney, heart, or liver.

Mycophenolate Mofetil should be used in combination with other medicines:

- Cyclosporin 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 result 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 medication (including those listed in section 6),
• if you are a woman who can become pregnant and have not obtained a negative pregnancy test result 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 contraception (see Pregnancy, Contraception, and Breastfeeding),
• if you are breastfeeding.

Do not take this medication 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 or pharmacist immediately before starting to take this medication:

• if you experience any signs of infection, such as fever or sore throat,
• if you haveunexplained bruises and/or bleeding,
• if you have ever had any gastrointestinal 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 medications and Mycophenolate Mofetil Sandoz

Inform your doctor or pharmacist if you are taking,have taken recently, ormay need to take any other medication.This includes over-the-counter medications, including herbal medications. This is because mycophenolate mofetil may affect how other medications work. Other medications may also affect how mycophenolate mofetil works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications before starting mycophenolate mofetil:

• azathioprine or other immunosuppressive medications that were administered after a transplant operation,
• cholestyramine 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 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.

Vaccinations

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 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 always 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 most suitable for you based 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 believe 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, for example, 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),

-you have had your Fallopian tubes and both ovaries surgically removed (bilateral salpingo-oophorectomy),

-you have had your uterus surgically removed (hysterectomy),

-you have premature ovarian failure, confirmed by a specialist gynecologist,

-you have been diagnosed with one of the following rare birth defects that make it impossible to become pregnant: 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 potential 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 taking this medication. Your doctor will discuss the risks and alternative treatments you can take to prevent rejection of the transplanted organ if:

• you intend to become pregnant,
• you have missed a menstrual period or have unusual menstrual 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, 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 (the tube that connects the throat to the stomach), kidney, and nervous system (such as 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 result before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.

Breastfeeding

Do not take mycophenolate mofetil if you are breastfeeding. This is because small amounts of the medication may pass into breast milk.

Driving and operating machines

Mycophenolate mofetil has a moderate effect on your ability to drive or operate machines. If you feel dizzy, dazed, or confused, talk to your doctor or nurse and do not drive or operate machines until you feel better.

Mycophenolate Mofetil Sandoz contains sodium

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

Follow exactly the administration instructions of this medication 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 8 capsules (2 g of medication), administered in 2 separate doses.
• Take 4 capsules in the morning and another 4 capsules 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.

Heart transplant

Adults

• The first dose is administered 5 days after the transplant surgery.
• The daily dose is 12 capsules (3 g of medication), administered in 2 separate doses.
• Take 6 capsules in the morning and another 6 capsules at night.

Children

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

Liver transplant

Adults

• The first dose of oral mycophenolate mofetil should be administered at least 4 days after the transplant surgery and when you are able to take oral medication.
• The daily dose is 12 capsules (3 gof medication), administered in 2 separate doses.
• Take 6 capsules in the morning and another 6 capsules at night.

Children

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

Take this medication

Swallow the capsules whole with a glass of water.

• Do not break or crush them.
• Do not take any capsule that has been broken or opened.

Be careful not to let the powder inside the broken capsule get into your eyes or mouth.

• If this happens, rinse thoroughly with running water.

Be careful not to let the powder inside the broken capsule come into contact with your skin.

• If this happens, wash the area with plenty of water and soap.

If you take moreMycophenolate mofetil Sandozthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the medication packaging 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 stop 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.

Side effects are more likely to occur in children than in adults. These include diarrhea, infections, decreased white and red blood cell count 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 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 unwanted 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 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 problems and mouth problemssuch as:

• swollen gums and mouth ulcers,
• pancreatitis, colon inflammation, 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 inside the chest,
• 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 leaflet. You can also report them directly through the Spanish System for the Vigilance 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 use this medication after the expiration date that appears on the blister and the packaging after CAD/EXP.The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

HDPE packaging after the first opening: use within the next 2 months.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition ofMycophenolate Mofetil Sandoz:

• The active ingredient is mycophenolate mofetil.Each capsule contains250 mg ofmycophenolate mofetil.
• The other components in the capsule content are pregelatinized cornstarch, sodium croscarmellose, povidone (K90F), magnesium stearate. The capsule coating is composed of gelatin, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171) and FD&C Blue #2 indigo carmine in aluminum lacquer (E132).

Appearance of the productand contents of the package

Hard gelatin capsules (size 1) with a blue opaque cap and an orange opaque body.

PVC/PE/PVDC/Aluminum blister: 30, 50, 100, 150, 200, 300, 360 and 600 capsules.

HDPE container: 250 capsules.

Only some package sizes may be marketed.

Marketing authorization holder andresponsible 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.

Verovskova 57,

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

LEK S.A.

Ul. Domaniewska 50 C,

02-672 WarszawaPoland

or

Sandoz GMBH

Biochemiestrasse, 10

Kundl,

Tirol- Austria

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

This medicine is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Germany:Mycophenolat - 1 A Pharma 250 mg Hard Capsules

Poland:Mycophenolate mofetil Sandoz 250 mg hard capsules

United Kingdom (Northern Ireland):Mycolat 250 mg hard capsule

United Kingdom:Mycophenolate mofetil Sandoz 250 mg capsules, hard

Czech Republic:MYCOPHENOLAT MOFETIL SANDOZ 250 mg hard capsules

Last review date of this leaflet:March 2022

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