Mycophenolic acid Stada 360 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mycophenolic acid Stada 360 mg gastro-resistant tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Mycophenolic Acid Stada and what is it used for

This medicine contains a substance called mycophenolic acid. It belongs to a class of medicines known as immunosuppressants.

Mycophenolic acid is used to prevent your body's immune system from rejecting the transplanted kidney. It is used in combination with other medicines containing cyclosporine and corticosteroids.

2. What you need to know before starting to take Mycophenolic Acid Stada

WARNING

Mycophenolic acid causes congenital malformations and spontaneous abortions. If you are a woman who could 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 you with written information, particularly about the effects of mycophenolic acid 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 mycophenolate. See further information in this section under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Mycophenolic Acid Stada

• If you are allergic to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil, or any of the other components of this medicine (listed in section 6).
• If you are a woman who could become pregnant and have not obtained a negative pregnancy test result before the first prescription, as mycophenolate can 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 Contraception in women and men).
• If you are breastfeeding (see “Pregnancy and Lactation”).

If any of the above situations apply to you, inform your doctor before taking mycophenolic acid.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine:

• If you have or have previously had serious gastrointestinal disorders, such as gastric ulcer.
• If you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan or Kelley-Seegmiller syndromes.

You should also be aware that:

• Mycophenolic acid reduces your skin's protection against sunlight, increasing the risk of developing skin cancer. You should limit your exposure to sunlight and ultraviolet (UV) rays by covering exposed skin areas as much as possible and frequently applying sunscreen with a high protection factor. Consult your doctor about how to protect yourself from the sun.
• If you have previously had hepatitis B or C, mycophenolic acid may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these conditions. If you experience any symptoms (yellowing of the skin or eyes, nausea, loss of appetite, dark urine), inform your doctor immediately.
• If you develop a persistent cough or shortness of breath, especially if you are taking other immunosuppressants, inform your doctor immediately.
• Your doctor may want to check your blood antibody levels during treatment with mycophenolic acid, particularly if infection recurs, especially if you are also taking other immunosuppressants, and will advise you whether you can continue treatment with mycophenolic acid.
• If you experience any signs of infection (such as fever or sore throat) or unexpected bruising or bleeding, contact your doctor immediately.
• Your doctor may want to monitor your white blood cell count during treatment with mycophenolic acid and will inform you whether you can continue taking this medicine.
• The active substance, mycophenolic acid, is not the same as other medicines with similar-sounding names such as mycophenolate mofetil. Do not interchange medicines unless instructed by your doctor.
• The use of mycophenolic acid during pregnancy may harm the fetus (see also “Pregnancy and lactation”) and increase the risk of fetal loss (spontaneous abortion).

Children and adolescents

Due to lack of data, the use of mycophenolic acid is not recommended in children and adolescents.

Elderly patients

Elderly patients (aged 65 years and older) may take this medicine without the need to adjust the normal recommended dose.

Use of Mycophenolic Acid Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.

In particular, you must inform your doctor if you are taking any of the following medicines:

• Other immunosuppressive medicines such as azathioprine or tacrolimus.
• Medicines used to treat high blood cholesterol levels such as colestyramine.
• Activated charcoal used to treat gastrointestinal disorders such as diarrhoea, upset stomach, and gas.
• Antacids containing magnesium and aluminium.
• Medicines used to treat viral infections such as aciclovir or ganciclovir.

You should also inform your doctor if you plan to receive any vaccination.

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

Taking Mycophenolic Acid Stada with food, drinks and alcohol

Mycophenolic acid may be taken with or without food. You should choose whether to take your tablets with or without food and then take them the same way every day from that point on. This ensures that the same amount of medicine is absorbed into your body each day.

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 organ transplant rejection if:

• You plan to become pregnant.
• You have missed 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 an effective contraceptive method.

If you become pregnant while taking mycophenolate, inform your doctor immediately. However, continue taking mycophenolic acid until you see your doctor.

Pregnancy

Mycophenolic acid causes a very high rate of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Reported malformations include abnormalities of the ears, eyes, face (cleft lip and palate), fingers, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida, where the bones of the spine 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 pregnancy test result before starting treatment and must follow your doctor’s contraception advice. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Lactation

Do not take mycophenolic acid if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.

Contraception in women taking Mycophenolic Acid Stada

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

• Before starting to take mycophenolic acid
• Throughout treatment with mycophenolic acid
• For up to 6 weeks after stopping mycophenolic acid

Consult your doctor to determine the most suitable contraceptive method for you, which will depend on your personal circumstances. Using two contraceptive methods is preferred, 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 missed taking your contraceptive pill.

You are considered not able to become pregnant if you meet any of the following criteria:

• You are post-menopausal, i.e., you are at least 50 years old and your last period occurred more than one 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 Mycophenolic Acid Stada

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

If you are planning to have a child, consult your doctor about potential risks.

Driving and use of machines

The effect of mycophenolic acid on the ability to drive and use machines is minor.

Mycophenolic Acid Stada contains sodium

This medicine contains 27.9 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 1.4% of the maximum daily sodium intake recommended for an adult.

3. How to take Mycophenolic Acid Stada

Follow exactly the instructions for taking this medicine given by your doctor. Mycophenolic acid can only be prescribed by a doctor experienced in managing transplant patients. If in doubt, ask your doctor, pharmacist, or nurse.

Dosage

The recommended daily dose of mycophenolic acid is 1,440 mg (4 tablets of 360 mg). This should be given in two separate doses of 720 mg each (2 tablets of 360 mg).

Take your tablets in the morning and at night.

The first 720 mg dose should be administered within 72 hours after transplantation.

If you have severe kidney problems

Your daily dose should not exceed 1,440 mg (4 tablets of 360 mg).

How to take Mycophenolic Acid Stada

Swallow the tablets whole with a glass of water.

Do not break or crush the tablets.

Do not take any broken or divided tablets.

Treatment should continue as long as immunosuppression is needed to prevent your body from rejecting your transplanted organ.

If you take more Mycophenolic Acid Stada than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested. Take the tablets with you; if you have run out, bring the empty packaging.

If you forget to take Mycophenolic Acid Stada

If you forget to take a dose of mycophenolic acid, take it as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at your usual time. Seek advice from your doctor. Do not take a double dose to make up for a missed dose.

If you stop taking Mycophenolic Acid Stada

Do not stop treatment with mycophenolic acid unless your doctor tells you to. Stopping treatment with mycophenolic acid may increase the risk of your body rejecting your transplanted kidney.

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 can cause adverse effects, although not everyone will experience them.

Elderly patients may experience more adverse effects because they have a reduced immune defence.

Immunosuppressants, including mycophenolic acid, reduce the body's own defence mechanisms to prevent rejection of the transplanted organ. Consequently, the body will not be in a normal condition to fight infections. Therefore, if you are taking mycophenolic acid, you may get more viral, bacterial, and fungal infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.

Your doctor will carry out regular blood tests to monitor any changes in the number of your blood cells or in the levels of substances transported in your blood, such as sugar, fat, and cholesterol.

Some effects may be serious:

• symptoms of infection including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. If you are taking mycophenolic acid, you may get more infections than usual, which can affect different systems of the body, most commonly the kidneys, bladder, and upper and/or lower respiratory tract.
• blood in vomit, dark or bloody stools, gastric or intestinal ulcer.
• swelling of your glands, development of a new skin thickening or growth of an existing one, or changes in an existing mole. As can occur in patients taking immunosuppressants, a very small number of patients treated with mycophenolic acid have developed skin cancer or lymph nodes.

If you experience any of the above-mentioned effects after taking this medicine, inform your doctor immediately.

Other adverse effects may include:

Very common (may affect more than 1 in 10 people)

• diarrhoea
• reduced white blood cell count
• reduced calcium levels in the blood (hypocalcaemia)
• reduced potassium levels in the blood (hypokalaemia)
• increased uric acid levels in the blood (hyperuricaemia)
• high blood pressure (hypertension)
• joint pain (arthralgia)
• anxiety

Common (may affect up to 1 in 10 people)

• reduced red blood cell count which may result in tiredness, shortness of breath, and pale appearance (anaemia)
• low platelet levels which may lead to unexpected bleeding and bruising (thrombocytopenia)
• headache
• cough
• abdominal or stomach pain, inflammation of the stomach walls, bloating, constipation, indigestion, gas (flatulence), soft stools, feeling dizzy (nausea), dizziness (vomiting)
• fatigue, fever
• changes in liver and kidney function test results
• respiratory tract infections
• high potassium levels in the blood (hyperkalaemia)
• reduced magnesium levels in the blood (hypomagnesaemia)
• dizziness
• low blood pressure (hypotension)
• shortness of breath (dyspnoea)
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swollen hands, ankles, or feet (peripheral oedema)
• itching

Uncommon (may affect up to 1 in 100 people)

• rapid heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• a sac-like thickening (cyst) containing fluid (lymph) (lymphocele)
• tremor, insomnia
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• burping, bad breath, intestinal obstruction (ileus), lip sores, heartburn, discolouration of the tongue, dry mouth, gum inflammation, inflammation of the pancreas leading to severe upper stomach pain (pancreatitis), obstruction of the salivary glands, inflammation of the inner abdominal walls (peritonitis)
• bone, blood, and skin infections
• blood in urine, kidney problems, pain and difficulty urinating
• hair loss, skin lesions
• joint inflammation (arthritis), back pain, muscle cramps
• loss of appetite, increased lipid levels (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased phosphate levels in blood (hypophosphataemia)
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, chills, feeling thirsty or weak
• nightmares, believing in things that are not true (delusions)
• inability to achieve or maintain an erection
• cough, difficulty breathing, pain when breathing (possible symptoms of interstitial lung disease)

Frequency not known (cannot be estimated from the available data)

• skin rash
• fever, sore throat, frequent infections (possible symptoms of low white blood cell count in blood) (agranulocytosis)
• skin rash, itching, hives, difficulty breathing, wheezing or coughing, fainting, dizziness, changes in consciousness, hypotension, with or without mild generalized itching, red skin and facial and throat swelling (symptoms of severe allergic reactions)

Other adverse effects reported with medicines similar to mycophenolic acid

Additional adverse effects have been reported with the group of medicines to which mycophenolic acid belongs: inflammation of the colon (large intestine), inflammation of the stomach wall caused by cytomegalovirus, development of a cavity in the intestinal wall, resulting in severe abdominal pain with possible bleeding, gastric or duodenal ulcers, reduced white blood cell count specifically or of all blood cells, serious infections such as inflammation of the heart and its valves and of the membrane covering the brain and spinal cord, respiratory failure, cough, which may be due to bronchiectasis (a condition in which the airways of the lung are abnormally dilated), and other less common bacterial infections that typically result in severe pulmonary disorder (tuberculosis and atypical mycobacterial infection). Consult your doctor if you develop a persistent cough or shortness of breath.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mycophenolic Acid Stada

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original container to protect it from light.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in 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 Mycophenolic Acid Stada

• The active substance is mycophenolic acid (as mycophenolate sodium).

Each tablet contains 360 mg of mycophenolic acid.

• The other components are:

Tablet core: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30 (E1201), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b).

Tablet coating: Acryl-EZE pink 93054222 (methacrylic acid–ethyl acrylate copolymer (1:1), talc (E553b), titanium dioxide (E171), triethyl citrate (E1505), anhydrous colloidal silica (E551), sodium hydrogen carbonate (E500), yellow iron oxide (E172), red iron oxide (E172), sodium lauryl sulfate (E487).

Tablet imprint: shellac, partially esterified (E904), black iron oxide (E172), propylene glycol (E1520), ammonium (E527).

Appearance of the product and pack contents

Mycophenolic Acid Stada are orange, enteric-coated, oblong, biconvex tablets with "M2" printed in black ink on one side and plain on the reverse.

Mycophenolic Acid Stada 360 mg gastro-resistant tablets are available in blister packs containing 50, 100, 120 or 250 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009

Greece

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14,

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

Date of the most recent revision of this leaflet: November 2025

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