Prospect: information for the user

Mycofenolic Acid Stada 180 mg gastro-resistant tablets EFG

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 must 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 isMycofenolic Acid Stadaand for what it is used

2. What you need to know before starting to takeMycofenolic Acid Stada

3. How to takeMycofenolic Acid Stada

4. Possible adverse effects

5. Storage ofMycofenolic Acid Stada

6. Contents of the package and additional information

This medication contains a substance called micophenolic acid. It belongs to a class of medications known as immunosuppressants.

Micophenolic acid is used to prevent the body's immune system from rejecting the transplanted kidney. It is used in combination with other medications that contain ciclosporin and corticosteroids.

WARNING

Mycophenolic acid 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 follow the contraceptive advice provided by your doctor.

Your doctor will explain and provide written information, particularly about the effects of mycophenolic acid 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 “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 medication (including those 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 intend to become pregnant or believe you may be pregnant

•If you are not using effective contraception (see Contraception in Women and Men).

•If you are breastfeeding (see “Pregnancy and Breastfeeding”).

If any of the above cases apply to you, inform your doctor without taking mycophenolic acid.

Warnings and Precautions

Consult your doctor or pharmacist or nurse before starting to take this medication:

•If you have or have had severe digestive disorders, such as gastric ulcers.

•If you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

Be aware that:

•Mycophenolic acid reduces the level of skin protection against the sun, increasing the risk of skin cancer. You should limit your exposure to sunlight and ultraviolet (UV) rays by covering exposed skin as much as possible and applying sunscreen frequently. Consult your doctor on how to protect yourself from the sun.

•If you have had hepatitis B or C, mycophenolic acid may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and check for symptoms of these diseases. If you experience any symptoms (yellow skin and eyes, nausea, loss of appetite, dark urine), inform your doctor immediately.

•If you have persistent cough or shortness of breath, especially when taking other immunosuppressants, inform your doctor immediately.

•Your doctor may want to check your blood levels of antibodies during treatment with mycophenolic acid, particularly when the infection recurs, especially if you are also taking other immunosuppressants and will inform you if you can continue taking mycophenolic acid.

•If you experience any symptoms of infection (such as fever or throat inflammation) or unexpected bruising or bleeding, contact your doctor immediately.

•Your doctor may want to check your white blood cell count in the blood during treatment with mycophenolic acid and will inform you if you can continue taking this medication.

•The active ingredient, mycophenolic acid, is not the same as other medications that sound similar, such as mycophenolate mofetil. Do not exchange medications unless your doctor tells you to.

•The use of mycophenolic acid during pregnancy may harm the fetus (see also “Pregnancy and Breastfeeding”) and increase the risk of fetal loss (spontaneous abortion).

Use of Mycophenolic Acid Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Particularly, you should inform your doctor if you are taking any of the following medications:

•Other immunosuppressants such as azathioprine or tacrolimus.

•Medications used to treat high cholesterol in the blood, such as cholestyramine.

•Activated charcoal used to treat digestive disorders, such as diarrhea, stomach upset, and gas.

•Antacids containing magnesium and aluminum.

•Medications used to treat viral infections, such as acyclovir or ganciclovir.

Also, inform your doctor if you plan to receive anyvaccines.

Do not donate blood during treatment with mycophenolic acid and at least 6 weeks after completing treatment. Men should not donate semen during treatment with mycophenolic acid and at least 90 days after completing treatment.

Taking Mycophenolic Acid Stada with food, drinks, and alcohol

Mycophenolic acid can be taken with or without food. You should choose whether to take your tablets with or without food and from that first moment take them always in the same way every day. This ensures that every day the same amount of your medication is absorbed by your body.

Older patients

Older patients (65 years of age or older) can take this medication without the need to adjust the normal recommended dose.

Children and adolescents

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

Pregnancy, breastfeeding, and fertility

Contraception in women taking Mycophenolic Acid Stada

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

•Before starting to take mycophenolic acid

•During the entire treatment with mycophenolic acid

•Until 6 weeks after stopping mycophenolic acid

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your personal situation. Two methods of contraception are preferred, 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 are considered not susceptible to becoming pregnant if your case is one of the following:

•You are postmenopausal, that is, 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)

•Your fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy)

•Your uterus has been surgically removed (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 yet started menstruating

Contraception in men taking Mycophenolic Acid Stada

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 method of contraception during treatment and for 90 days after stopping mycophenolic acid.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatment options that you can take to prevent rejection of the transplanted organ 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 sexual intercourse without using an effective method of contraception.

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

Pregnancy

Mycophenolic acid causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations that have been reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat with the stomach), kidney, and nervous system (for example, spina bifida (where the bones of the spine do not develop correctly)). 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 follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure that you are not pregnant before starting treatment.

Breastfeeding

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

Driving and using machines

The influence of mycophenolic acid on the ability to drive and use machines is small.

Mycophenolic Acid Stada contains sodium

This medication contains 0.61 mmol (13.9 mg) of sodium per tablet. This should be taken into account for patients on a sodium-controlled diet.

Follow exactly the medication administration instructions provided by your doctor. Micophenolic acid can only be prescribed by an experienced doctor who treats transplant patients. If you are unsure, ask your doctor, pharmacist, or nurse.

How much to take

The recommended daily dose of micophenolic acid is 1,440 mg (8 tablets of 180 mg). They should be taken in 2 separate doses of 720 mg each (4 tablets with 180 mg).

Take your tablets in the morning and at night.

The first dose of 720 mg will be administered within 72 hours after the transplant.

If you have severe kidney problems

Your daily dose should not exceed 1,440 mg (8 tablets of 180 mg).

Taking Micophenolic Acid Stada

Swallow the tablets whole with the help of a glass of water.

Do not break, crush, or divide 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 the transplanted organ.

If you take more Micophenolic Acid Stada than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the tablets with you and if you have finished them, bring the empty packaging.

If you forget to take Micophenolic Acid Stada

If you forget to take a dose of micophenolic 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 regular time. Ask your doctor for advice. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Micophenolic Acid Stada

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

If you have any other questions 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.

Older patients may experience more side effects because they have a reduced immune defense.

Immunosuppressants, including mycophenolic acid, reduce the body's defense mechanisms by preventing the rejection of the transplanted organ. Consequently, the body will not be in normal condition to fight infections. Therefore, if you are taking mycophenolic acid, you may contract more viral, bacterial, and fungal infections than normal, such as brain, skin, mouth, stomach, and intestinal infections, lungs, and urinary tract.

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

Some effects can be severe:

•infection symptoms, including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. If you are taking mycophenolic acid, you may contract more infections than normal, which can affect different systems of the body, with the kidneys, bladder, upper and lower respiratory tract being the most commonly affected.

•blood in vomit, dark or bloody stools, gastric or intestinal ulcers.

•inflammation 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 node tumors.

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

Other side effects may include:

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

•diarrhea

•reduced white blood cell count

•low calcium levels in the blood (hypocalcemia)

•low potassium levels in the blood (hypokalemia)

•high uric acid levels in the blood (hyperuricemia)

•high blood pressure (hypertension)

•joint pain (arthralgia)

•anxiety

Common(may affect up to 1 in 10 people)

•low red blood cell count, which can cause fatigue, shortness of breath, and pale complexion (anemia)

•low platelet count, which can cause bleeding and unexpected bruises (thrombocytopenia)

•headache

•cough

•abdominal or stomach pain, stomach inflammation, abdominal distension, constipation, indigestion, gas (flatulence), soft stools, nausea, vomiting

•fatigue, fever

•alteration in liver and kidney function test results

•respiratory tract infections

•high potassium levels in the blood (hyperkalemia)

•low magnesium levels in the blood (hypomagnesemia)

•dizziness

•low blood pressure (hypotension)

•shortness of breath (dyspnea)

•acne

•weakness (asthenia)

•muscle pain (myalgia)

•swollen hands, ankles, or feet (peripheral edema)

•itching

Uncommon(may affect up to 1 in 100 people)

•rapid or irregular heartbeat (tachycardia or ventricular extrasystoles), fluid in the lungs (pulmonary edema)

•a sac-like swelling (lymphocele) containing fluid (lymph)

•tremor, insomnia

•redness and swelling of the eyes (conjunctivitis), blurred vision

•whistling respiration

•eructation, bad breath, intestinal obstruction (ileus), lip ulcers, pyrosis, tongue discoloration, dry mouth, gum inflammation, pancreatitis causing severe upper stomach pain, salivary gland obstruction, peritonitis

•infection of bones, blood, and skin

•blood in urine, kidney alteration, pain and difficulty urinating

•hair loss, skin lesions

•joint inflammation (arthritis), back pain, muscle cramps

•loss of appetite, high levels of lipids (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolemia), or low levels of phosphate in the blood (hypophosphatemia)

•flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swollen ankles and feet, pain, chills, feeling thirsty or weak

•nightmares, believing things that are not true (delusions)

•inability to have or maintain an erection

•cough, difficulty breathing, chest pain (possible symptoms of interstitial lung disease)

Unknown frequency(cannot be estimated from available data)

•skin rash

•fever, sore throat, frequent infections that are possible symptoms of a lack of white blood cells in the blood (agranulocytosis)

Other side effects reported with similar medicines to Mycophenolic Acid Stada

Additional side effects have been reported with the group of medicines to which mycophenolic acid belongs: colon inflammation (large intestine), stomach wall inflammation caused by cytomegalovirus, development of a cavity in the intestinal wall, resulting in severe abdominal pain with possible bleeding, gastric or duodenal ulcers, low white blood cell count, specifically or all blood cells, severe infections, such as heart and valve inflammation and 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 normally result in severe lung alteration (tuberculosis and atypical mycobacterial infection).Consult your doctor if you develop a persistent cough or shortness of breath.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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 medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging, to protect it from light.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Mycophenolic Acid Stada

-The active ingredient is mycophenolic acid (as sodium mycophenolate).

Each tablet contains 180 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 930510003(copolymer of methacrylic acid-ethyl-acrylate (1:1), talc (E553b), titanium dioxide (E171), triethyl citrate (E1505),anhydrous colloidal silica (E551), sodium hydrogen carbonate (E500), yellow iron oxide (E172), indigo carmine lake (E132),sodium lauryl sulfate (E487).

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

Appearance of the product and contents of the package

Mycophenolic Acid Stada are round tablets with a green lime enteric coating, with beveled biconvex edges and the inscription “M1” in black ink on one face and smooth on the other face.

Mycophenolic Acid Stada 180 mg gastro-resistant tablets are presented in blister packs containing 20, 50, 100, 120 or 250 tablets.

Only some package sizes may be commercially available

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last revision date of this leaflet:June 2023

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