Package Insert: Information for the User

Mycophenolate Mofetil Aurovitas Spain 500 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

6. Contents of the pack and additional information

The full name of the medication is Micofenolato de mofetilo Aurovitas Spain 500 mg film-coated tablets EFG.

- In this leaflet, the abbreviated name Micofenolato de mofetilo Aurovitas Spain is used. Micofenolato de mofetilo Aurovitas Spain contains micofenolato de mofetilo.

-It belongs to a group of medications called “immunosuppressants”.

This medication is used to prevent your body from rejecting a transplanted organ.

-Kidney, heart, or liver.

Micofenolato de mofetilo should be used in combination with other medications:

-Ciclosporina and corticosteroids.

WARNING

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

Your doctor will explain and provide you with written information, in particular 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 below in this section, under the headings "Warnings and Precautions" and "Pregnancy and Breastfeeding".

Do not take Mycophenolate Mofetil Aurovitas Spain

• If you are allergic to mycophenolate mofetil, acid mycophenolic, or any of the other components of this medication (listed in section 6).
• If you are a woman who can become pregnant and have not obtained a negative result on a 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, Fertility, 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 this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Mycophenolate Mofetil Aurovitas Spain:

• If you are over 65 years old, as you may have a higher risk of developing adverse reactions such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients.
• If you have any signs of infection such as fever or sore throat.
• If you experience unexpected petechiae or bleeding.
• If you have had any digestive system problems such as stomach ulcers.
• If you plan to become pregnant or have become pregnant while taking mycophenolate mofetil.
• If you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

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

Effect of sunlight

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

- Wearing protective clothing that covers your head, neck, arms, and legs.

- Using a high-factor sunscreen.

Children

Do not administer this medication to children under 2 years of age, as the safety and efficacy data are limited in this age group and no dosage recommendations can be made.

Other medications and Mycophenolate Mofetil Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal supplements. 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 to take Mycophenolate Mofetil Aurovitas Spain:

- Azathioprine or other immunosuppressive medications administered after a transplant operation.

- Colestiramine - 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 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 receive a vaccine (live vaccine) during treatment with this medication, consult your doctor or pharmacist first. Your doctor will advise you on the vaccines you can receive.

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

Taking Mycophenolate Mofetil Aurovitas Spain with food and drinks

The consumption of food and drinks has no effect on the treatment with mycophenolate mofetil.

Contraception in women taking Mycophenolate Mofetil Aurovitas Spain

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

• Before starting to take Mycophenolate Mofetil Aurovitas Spain.

• During the entire treatment with Mycophenolate Mofetil Aurovitas Spain.

• Until 6 weeks after stopping treatment with Mycophenolate Mofetil Aurovitas Spain.

Consult your doctor to see which contraceptive method is most suitable 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 believe your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You cannot become pregnant if your case is one of the following:

Contraception in men taking Mycophenolate Mofetil Aurovitas Spain

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 treatment with this medication.

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 using 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 or suspect you may have missed a period or have unusual menstrual bleeding.

• You have had unprotected sex.

If you become pregnant during treatment with mycophenolate mofetil, inform your doctor immediately. However, continue taking this medication 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 reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat with 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 result on a pregnancy test 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 this medication if you are breastfeeding. This is because small amounts of the medication may pass into breast milk.

Driving and using machines

The influence of Mycophenolate Mofetil Aurovitas Spain on your ability to drive and use machines is moderate. If you feel drowsy, dizzy, or confused, speak with your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate Mofetil Aurovitas Spain contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; 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 should be administered within 3 days after the transplant surgery.
• The daily dose is 4 tablets (2 g of the medication) administered in 2 separate doses.
• Take 2 tablets in the morning and 2 tablets at night.

Children (between 2 and 18 years)

• The 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 or "m2"). The recommended dose is 600 mg/m2, administered twice a day.

Heart transplant

Adults

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

Children

• There is no information on the use ofthis medication in children with a heart transplant.

Liver transplant

Adults

• The first dose of this medication will be administered orally, at least 4 days after the transplant surgery, and when you can swallow oral medications.
• The daily dose is 6tablets(3 g of medication) administered in 2 separate doses.
• Take 3tabletsin the morning and 3tabletsat night.

Children

• There is no information on the use ofthis medication in children with a liver transplant.

Taking this medication

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

Treatment will continue while immunosuppression is necessary to prevent rejection of the transplanted organ.

If you take more Micofenolato de mofetilo Aurovitas Spain than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you take more micofenolato de mofetilo than you should, talk to a doctor or go to the hospital immediately. Do the same if someone accidentally takes your medication.Bring the medication packaging with you.

If you forget to take Micofenolato de mofetilo Aurovitas Spain

If you forget to take the medication, take it as soon as you remember. Take the next dose as you normally do. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Micofenolato de mofetilo Aurovitas Spain

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

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

Like all medicines, this medicine may 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 a rash, swelling of the face, lips, tongue, or throat with difficulty breathing. You may be experiencing 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 blood cell and red blood cell count in the blood.

Fighting infections

The treatment withmycophenolate mofetilreduces 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 what happens in patients taking this type of medicine (immunosuppressants), a very small number of patients treated withmycophenolate mofetilhave developed skin and lymphoid tissue cancer.

Unwanted general effects

Various unwanted general effects that affect the entire body may occur. 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 system and mouth problemssuch as:

• inflamed gums and mouth ulcers.
• pancreatitis, colitis, or gastritis.
• gastrointestinal disorders that include bleeding
• hepatic disorders
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

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

Cardiac and vascular problemssuch as:

• change in blood pressure, rapid heartbeat, and vasodilation.

Pulmonary problemssuch as:

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

Other problemssuch as:

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

However, do not stop taking your medicine unless you have first consulted with your doctor.

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 the Vigilance of Medicines for Human Use: 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 medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Micofenolato de mofetilo Aurovitas Spain

• The active ingredient is micofenolato de mofetilo. Each film-coated tablet contains 500 mg of micofenolato de mofetilo.
• The other components are:

Tablet core : microcrystalline cellulose (E460), povidone, hydroxypropyl cellulose, croscarmellose sodium, talc, magnesium stearate.

Tablet coating : hypromellose 6 cps (E464), titanium dioxide (E171), macrogol, iron oxide red (E172), aluminium lake indigo carmine (E132), iron oxide black (E172), talc.

Appearance of the product and contents of the packaging

Film-coated tablet, elongated, biconvex, violet in color, with the marks "AHI" on one face and "500" on the other, 18.0 mm in length, 9.0 mm in width, and 7.0 mm in thickness.

PVC opaque white/PVdC-Aluminium blister packaging.

Packaging sizes: 50, 100, and 150 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Aurobindo Pharma B.V.

Baarnsche Dijk 1

3741 LN Baarn, Holland

Fundació Dau

C/ De la letra C, 12-14,

Polígono Industrial de la Zona,

Franca, 08040 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2022

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