Mycophenolate mofetil Stada 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Micofenolato de mofetilo STADA 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not pass it on 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 these effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Micofenolato de mofetilo STADA is and what it is used for
2. What you need to know before taking Micofenolato de mofetilo STADA
3. How to take Micofenolato de mofetilo STADA
4. Possible side effects
5. How to store Micofenolato de mofetilo STADA
6. Contents of the pack and other information

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

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

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

Mycophenolate mofetil must be used in combination with other medicines known as cyclosporine and corticosteroids.

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

WARNING

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

Your doctor will explain and provide you with written information, particularly about the effects of micofenolato on unborn babies. Read this information carefully and follow the instructions.

If you do not fully understand these instructions, please consult your doctor again for further explanation before taking micofenolato. See more information in this section under the headings “Warnings and precautions” and “Pregnancy and lactation”.

Do not take Micofenolato de mofetilo Stada

• If you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who could become pregnant and have not obtained a negative result on a pregnancy test before the first prescription, as micofenolato may cause congenital malformations and spontaneous abortions.
• If you are pregnant or planning to become pregnant, or think you might be pregnant.
• If you are not using effective contraception (see “Pregnancy, lactation and fertility”).
• If you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Micofenolato de mofetilo Stada.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Micofenolato de mofetilo Stada.

• If you are over 65 years of age, as you may have an increased 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 develop unexpected bruising or bleeding.
• If you have ever had a gastrointestinal disorder such as stomach ulcers.
• If you are planning to become pregnant, or become pregnant while you or your partner are 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 effects described above (or are unsure), inform your doctor immediately before starting treatment with mycophenolate mofetil.

Effect of sunlight

Mycophenolate mofetil reduces your body's defense mechanisms. For this reason, there is an increased risk of developing skin cancer. Limit your exposure to sunlight and UV light by:

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

Children and adolescents

Paediatric 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 transplant.

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 dosage recommendations cannot be made.

Other medicines and Micofenolato de mofetilo Stada

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

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

• Azathioprine or other medicines that suppress the immune system – administered after transplant surgery.
• Colestyramine – 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 advise you on which vaccines you may receive.

You must not donate blood during treatment with mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with mycophenolate mofetil and for at least 90 days after stopping treatment.

Taking Micofenolato de mofetilo Stada with food and drinks

The intake of food and drinks does not affect your treatment with mycophenolate mofetil.

Pregnancy, fertility and lactation

Contraception in women taking mycophenolate mofetil

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

• Before starting to take mycophenolate mofetil.
• Throughout the entire treatment with mycophenolate mofetil.
• Up to 6 weeks after stopping mycophenolate mofetil.

Consult your doctor to determine the most appropriate contraceptive method for you. This will depend on your personal circumstances. The use of two contraceptive methods is recommended, as this reduces 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 missed taking your contraceptive pill.

You cannot become pregnant if you meet any of the following criteria:

• You are postmenopausal, i.e., 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, you may still be able to become pregnant).
• You have had both fallopian tubes and both ovaries surgically removed (bilateral salpingo-oophorectomy).
• You have had your uterus surgically removed (hysterectomy).
• Your ovaries do not function (premature ovarian failure confirmed by a specialist gynaecologist).
• You were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis.
• You are a girl or adolescent who has not yet started menstruating.

Contraception in men taking mycophenolate mofetil

Available evidence does not indicate an increased risk of congenital malformations or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precautionary measure, you or your female partner are advised to use a reliable contraceptive method during treatment and for up to 90 days after stopping mycophenolate mofetil.

If you are planning to have a child, consult your doctor about possible risks and alternative treatments.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks and alternative treatments available to prevent rejection of the transplanted organ if:

• You plan to become pregnant.
• You miss a period or think you may have missed a period, have unusual menstrual bleeding, or suspect you may be pregnant.
• You have had sexual intercourse without using effective contraceptive methods.

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 rate of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Malformations reported include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida, where the spinal bones do not develop properly). Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must have a negative result on a pregnancy test before starting treatment and must follow your doctor's contraceptive advice. Your doctor may require more than one pregnancy test to ensure you are not pregnant before starting treatment.

Lactation

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, dizzy, or confused, speak with your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Micofenolato de mofetilo Stada contains sodium

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

3. How to take Mycophenolate mofetil Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The dose you should take depends on the type of transplant you have received. The usual doses are shown below. Treatment should continue as long as necessary to prevent rejection of the transplanted organ.

Kidney transplant:

Adults:

• The first dose is administered within 3 days after transplantation.
• The daily dose is 4 tablets (2 g of active ingredient), given in two separate doses.
• Take 2 tablets in the morning and 2 tablets in the evening.

Children (between 2 and 18 years of age):

• The dose administered will vary depending on the child's size.
• Your doctor will decide the most appropriate 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 daily.

Heart transplant:

Adults:

• The first dose should be administered within 5 days after heart transplant surgery.
• The recommended daily dose is 6 tablets (3 g of active ingredient), given in two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children:

• There is no information available on the use of mycophenolate mofetil in children who have received a heart transplant.

Liver transplant:

Adults:

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

Children:

• There is no information available on the use of mycophenolate mofetil in children who have received a liver transplant.

Method 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 Mycophenolate mofetil Stada than you should

If you have taken more mycophenolate mofetil than you should, or if someone has accidentally ingested it, contact your doctor or go to a hospital immediately. Take the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mycophenolate mofetil Stada

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

If you stop taking Mycophenolate mofetil Stada

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• signs of infection such as fever or sore throat.
• unexpected bruising or bleeding.
• 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).

Frequent problems

Some of the more common problems include diarrhea, decreased number of white or red blood cells in the blood, infections, and vomiting. Your doctor will carry out regular blood tests to monitor for any changes in:

• blood cell counts or signs of infection.

Adverse effects are more likely to occur in children than in adults. These include diarrhea, infections, and decreased white and red blood cells in the blood.

Fighting infections

Treatment with mycophenolate mofetil reduces the body's natural defenses. This is intended to prevent transplant rejection. For this reason, the body is also less able to fight infections as effectively as under normal conditions. This means you may get more infections than usual. These may include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

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

General unwanted effects

General adverse effects affecting the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, extreme tiredness, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other adverse effects may include:

Skin problems such as:

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

Urinary problems such as:

• blood in the urine.

Digestive system and mouth problems such as:

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

Nervous system problems such as:

• dizziness, drowsiness, or numbness,
• tremor, muscle spasms, seizures,
• feelings of anxiety or depression, changes in mood or thought.

Heart and blood vessel problems such as:

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

Lung problems such as:

• pneumonia, bronchitis,
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the lung airways are abnormally widened) or pulmonary fibrosis (scarring of the lung).

Consult your doctor if you develop a persistent cough or shortness of breath.

• fluid in the lungs or inside the chest,
• sinus problems.

Other problems such 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mycophenolate Mofetil Stada

• The active substance is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose (Avicel PH 102), povidone (K-90), hydroxypropylcellulose, sodium croscarmellose, purified talc, and magnesium stearate.

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

Appearance of the product and contents of the pack

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

Mycophenolate mofetil tablets are available in packs containing 50, 150, and 250 tablets.

Only certain pack 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 most recent revision of this leaflet: November 2023

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