Prospecto: Information for the User

Micofenolato de mofetilo STADA 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, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should 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, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What isMicofenolato de mofetilo Stadaand what is it used for

2. What you need to know before starting to takeMicofenolato de mofetilo Stada

3. How to takeMicofenolato de mofetilo Stada

4. Possible side effects

5. Storage ofMicofenolato de mofetilo Stada

6. Contents of the pack and additional information

Mycophenolate Mofetil tablets contain mycophenolate mofetil which belongs to a group of medicines called “immunosuppressants”.

Mycophenolate Mofetilis used to prevent the body from rejecting a kidney, heart, or liver transplant.

Mycophenolate Mofetil should be used in combination with other medicines known asciclosporina 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 written information, particularly about the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not fully understand these instructions, please consult your doctor again to have them explained to you before taking mycophenolate. See more information in this section, under the headings “Adverse reactions and precautions” and “Pregnancy and breastfeeding”.

Do not take Mycophenolate Mofetil Stada

• If you are allergic to mycophenolate mofetil, to mycophenolic acid, or 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 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, breastfeeding, and fertility”).
• 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 Stada.

Adverse reactions and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Mycophenolate Mofetil Stada.

• 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 effects (or are unsure), inform your doctor immediately before starting treatment with mycophenolate mofetil.

Effect of sunlight

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

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

Children and adolescents

Pediatric population between 2 and 18 years:

Mycophenolate mofetil tablets are used in children and adolescents (between 2 and 18 years) to prevent renal transplant rejection.

Mycophenolate mofetil tablets should not be used in children and adolescents (between 2 and 18 years) for heart or liver transplants.

Mycophenolate mofetil tablets should not be used in children under 2 years, as the safety and efficacy data in this age group are limited and no dosage recommendations can be made.

Other medications and Mycophenolate Mofetil Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes medications purchased without a prescription, such as herbal medications. This is because mycophenolate mofetil may affect the action of other medications. Other medications may also affect the action of mycophenolate mofetil.

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

• Azathioprine or other immunosuppressive medications – administered after the transplant operation.
• Colestiramine – used to treat high cholesterol levels.
• Rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB).
• Antacids and other proton pump inhibitors – used for stomach acid problems such as indigestion.
• Phosphate binders – used by people with chronic kidney disease to regulate phosphate absorption in 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.

Vaccinations

If you need to be vaccinated (live vaccines) while taking mycophenolate mofetil, inform your doctor or pharmacist beforehand. Your doctor will inform you of the vaccines you can receive.

You should not donate blood during treatment with mycophenolate mofetil 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 Stada with food and drinks

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

Pregnancy, fertility, and breastfeeding

Contraception in women taking mycophenolate mofetil

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.

•During the entire treatment with mycophenolate mofetil.

•Until 6 weeks after stopping mycophenolate mofetil.

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 think 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:

•You are postmenopausal, i.e., you are at least 50 years old and your last 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 both fallopian tubes and ovaries removed by surgery (bilateral salpingo-oophorectomy).

•You have had your uterus removed by surgery (hysterectomy).

•Your ovaries do not function (premature ovarian failure confirmed by a specialist gynecologist).

•You were born with one of the following rare diseases 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

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 at least 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 taking this medication. Your doctor will discuss the risks and alternative treatments you can take to prevent transplant rejection if:

•You intend 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, 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 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 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 mycophenolate mofetil 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 on your ability to drive and use machines is moderate. If you feel drowsy, sleepy, or confused, speak with your doctor or nurse and do not drive or use tools or machines until you feel better.

Mycophenolate Mofetil Stada contains sodium

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

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

Amount to take

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

Kidney transplant:

Adults:

• The first dose is administered during the 3 days following the transplant.
• The daily dose is 4 tablets (2 g of active ingredient) 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 will vary depending on the child's size.
• Your doctor will decide which is the most suitable dose taking into account the child's weight and height (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 should be administered within the 5 days following the transplant surgery.
• The recommended daily dose is 6 tablets (3 g of active ingredient), administered in two separate doses.
• Take 3 tablets in the morning and 3 tablets at night.

Children:

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

Liver transplant:

Adults:

• The first oral dose of mofetil mycophenolate should be administered at least 4 days after the transplant surgery and when able to take oral medication.
• The recommended daily dose is 6 tablets (3 g of active ingredient), administered in two separate doses.
• Take 3 tablets in the morning and 3 tablets at night.

Children:

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

Form of use and route of administration:

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

If you take more Micofenolato de mofetilo Stada than you should

If you have taken more mofetil mycophenolate than you should or if someone has accidentally taken mofetil mycophenolate, consult your doctor or go to the hospital immediately. Bring the packaging of the medication with you.

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 taken.

If you forgot to take Micofenolato de mofetilo Stada

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 compensate for the missed doses.

If you interrupt treatment with Micofenolato de mofetilo Stada

Do not stop taking mofetil mycophenolate unless your doctor tells you to. If you interrupt treatment with mofetil mycophenolate, you may increase the risk of rejection of the transplanted organ.

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

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

Consult your doctor immediately if you experience any of the following side effects – you may need urgent medical treatment:

• if you experience signs of infection such as fever or sore throat.
• if you experience bruising or unexpected bleeding.
• if you experience 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 or 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 occurrence of side effects is more likely 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 withmofetil mycophenolatereduces 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 withmofetil mycophenolatehave 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, swelling.

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

Nervous system problemssuch as:

• feeling dizzy, drowsy, or numb,
• shaking, muscle spasms, convulsions,
• feeling anxious or depressed, changes in mood or thought.

Cardiovascular and blood vessel 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 if you are short of breath

• fluid in the lungs or inside the chest,
• problems with the nasal sinuses.

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 Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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 point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Mycophenolate Mofetil Stada

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

-The other components (excipients) are:

Core of the tablets:microcrystalline cellulose (Avicel PH 102), povidone (K-90), hydroxypropyl cellulose, sodium croscarmellose, purified talc, and magnesium stearate

Coating:hypromellose 6cps, titanium dioxide (E171), macrogol 400, iron oxide red (E172), indigo carmine in aluminum lacquer (E132), iron oxide black (E172), and purified talc.

Appearance of the product and content of the container

Mycophenolate Mofetil Stada 500 mg tablets are purple-coated, capsule-shaped, biconvex tablets with the inscription “AHI” on one face and “500” on the other.

Mycophenolate mofetil tablets are available in containers of 50, 150, and 250 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Fundació DAU Laboratory

C/ C, 12-14 Pol. Ind.Zona Franca,

08040 Barcelona

Spain

or

Accord Healthcare B.V.

Utrecht, Winthontlaan 200 3526 KV at Utrecht,

Netherlands

or

Accord Healthcare Polska Sp.z.o.o

ul Lutomierska 50,

95-200 Pabianice,

Poland

Last review date of this leaflet:November 2023

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