MOFETIL MYCOPHENOLATE STADA 500 mg FILM-COATED TABLETS

Introduction

Prospect: Information for the user

Mycophenolate Mofetil STADA 500 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus

1. What Mycophenolate Mofetil Stada is and what it is used for
2. What you need to know before starting to take Mycophenolate Mofetil Stada
3. How to take Mycophenolate Mofetil Stada
4. Possible adverse effects
5. Storage of Mycophenolate Mofetil Stada
6. Package contents and additional information

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

Mycophenolate Mofetil tablets contain mycophenolate mofetil, which belongs to a group of medications called "immunosuppressants".

Mycophenolate Mofetil is used to prevent the body from rejecting a transplanted kidney, heart, or liver.

Mycophenolate Mofetil should be used in conjunction with other medications known as cyclosporine and corticosteroids.

2. What you need to know before starting to take Mycophenolate Mofetil Stada

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 must follow the contraception 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 explain them to you before taking mycophenolate. See more information in this section, under the headings "Warnings and precautions" and "Pregnancy and breastfeeding".

Do not take Mycophenolate Mofetil Stada

• If you are allergic to mycophenolate mofetil, mycophenolic acid, 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 pregnancy test result before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.
• If you are pregnant or plan to become pregnant or think 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 any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Mycophenolate Mofetil Stada.

Warnings 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 bruising or bleeding.
• If you have had any gastrointestinal problems, such as stomach ulcers.
• If you plan to become pregnant or have become pregnant while you or your partner is taking mycophenolate mofetil.
• If you have a hereditary enzyme deficiency, such as Lesch-Nyhan syndrome or 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 the body's defense mechanism. For this reason, 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-protection sunscreen.

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 kidney 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 of age, as 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 recently taken, or may need to take any other medication. This includes medications purchased without a prescription, such as herbal remedies. 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 treatment with mycophenolate mofetil:

• azathioprine or other medications that suppress the immune system, which were administered after the transplant operation.
• cholestyramine, 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 failure to regulate phosphate absorption into 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.

Vaccines

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

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

Taking Mycophenolate Mofetil Stada with food and drinks

Consuming 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 determine 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 the contraceptive pill.

You cannot become pregnant if 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, you may still be able to become pregnant).
• You have had your fallopian tubes and both ovaries removed through surgery (bilateral salpingo-oophorectomy).
• You have had your uterus removed through 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

Available evidence does not indicate an increased risk of malformations 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 until 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 plan to become pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatments you can take to prevent organ transplant rejection 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, 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 reported malformations are ear, eye, facial (cleft lip and palate), finger, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida) anomalies. 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 must follow the contraception advice provided by your doctor. Your doctor may request more than one pregnancy test 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 the ability to drive and use machines is moderate. If you feel drowsy, dizzy, or confused, talk to 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".

3. How to take Mycophenolate Mofetil Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, 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 should continue until it is necessary to prevent organ transplant rejection.

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 in the evening.

Children (between 2 and 18 years):

• The dose administered will vary depending on the child's size.
• Your doctor will decide the most suitable dose based on 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 5 days after the transplant operation.
• 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 in the evening.

Children:

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

Liver transplant:

Adults:

• The first dose of mycophenolate mofetil should be administered once, at least 4 days after the transplant operation, and when you are able to swallow the 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 in the evening.

Children:

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

Method of use and administration route:

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

If you take more Mycophenolate Mofetil Stada than you should

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

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

If you forget to take Mycophenolate Mofetil Stada

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

If you interrupt treatment with Mycophenolate Mofetil Stada

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

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

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 suffer from any of the following adverse effects – you may need urgent medical treatment:

• if signs of infection such as fever or sore throat appear.
• if unexpected bruising or bleeding occurs.
• if you experience a rash, swelling of the face, lips, tongue, or throat, with difficulty breathing – you may be suffering from a severe allergic reaction to the medicine (such as anaphylaxis or 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

Treatment with 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 that 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 Lymphatic 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 that affect the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling of great fatigue, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, swelling.

Other adverse effects may be:

Skin Problemssuch as:

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

Urinary Problemssuch as:

• blood in the urine.

Problems of the Digestive System and Mouthsuch as:

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

Nervous System Problemssuch as:

• feeling of dizziness, drowsiness, or numbness,
• tremors, muscle spasms, convulsions,
• feeling of anxiety or depression, changes in mood or thinking.

Cardiac and Vascular Problemssuch as:

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

Pulmonary Problemssuch as:

• pneumonia, bronchitis,
• breathing difficulties, 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 a persistent cough or if you are short 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 of Adverse Effects:

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

5. Conservation of Mycophenolate Mofetil Stada

Do not store above 25°C. Keep in the outer packaging to protect from light.

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

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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), hydroxypropylcellulose, croscarmellose sodium, purified talc, and magnesium stearate

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

Appearance of the Product and Package Contents

Mycophenolate Mofetil Stada 500 mg tablets are film-coated, purple, capsule-shaped, biconvex, with the inscription "AHI" on one side and "500" on the other

The mycophenolate mofetil tablets are available in packages of 50, 150, and 250 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Laboratori Fundació DAU

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

or

Accord Healthcare single member S.A.

64th Km National Road Athens, Lamia

Schimatari, 32009

Greece

Date of the Last Revision of this Prospectus:November 2023

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