MICOPHENOLIC ACID STADA 360 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Myphenolic 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Myphenolic acid is used to prevent your immune system from rejecting your transplanted kidney. It is used together with other medicines that contain ciclosporin and corticosteroids.

2. What you need to know before you take Myphenolic Acid Stada

Warning

Myphenolic acid causes birth defects and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the contraceptive advice given by your doctor.

Your doctor will explain and give you written information, in particular about the effects of myphenolic acid on unborn babies. Read the information carefully and follow the instructions.

If you do not understand these instructions completely, please consult your doctor again so that they can explain them to you again before you take myphenolic acid. See more information in this section, under the headings "Warnings and Precautions" and "Pregnancy and Breast-feeding".

Do not take Myphenolic Acid Stada

• If you are allergic to myphenolic acid, mycophenolate sodium, mycophenolate mofetil, or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who can become pregnant and have not had a negative pregnancy test before the first prescription, as mycophenolate can cause birth defects 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 Contraception in women and men).
• If you are breast-feeding (see "Pregnancy and Breast-feeding").

If any of the above applies to you, tell your doctor without taking myphenolic acid.

Warnings and Precautions

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

• if you have or have previously had severe gastrointestinal disorders, such as stomach ulcers.
• if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan and Kelley-Seegmiller syndromes.

You should also be aware that:

• myphenolic acid decreases the level of protection of your skin to the sun, which increases the risk of 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 a sunscreen with a high protection factor. Consult your doctor on how to protect yourself from the sun.
• if you have previously had hepatitis B or C, myphenolic acid may increase the risk of recurrence of these diseases. Your doctor may perform blood tests and check for symptoms of these diseases. If you experience any symptoms (yellowing of the skin and eyes, nausea, loss of appetite, dark urine), inform your doctor immediately.
• if you have a persistent cough or shortness of breath, especially when taking other immunosuppressants, inform your doctor immediately.
• your doctor may want to check your blood antibody levels during treatment with myphenolic acid, in particular when the infection recurs, especially if you are also taking other immunosuppressants, and will discuss with you whether you can continue treatment with myphenolic acid.
• if you experience any symptoms of infection (such as fever or throat inflammation) or an unexpected bruise or bleeding, contact your doctor immediately.
• your doctor may want to check your white blood cell count in the blood during treatment with myphenolic acid and will inform you whether you can continue taking this medicine.
• the active substance, myphenolic acid, is not the same as other medicines that sound similar, such as mycophenolate mofetil. Do not switch medicines unless your doctor tells you to.
• the use of myphenolic acid during pregnancy may harm the fetus (see also "Pregnancy and Breast-feeding") and increase the risk of fetal loss (spontaneous abortion).

Using Myphenolic Acid Stada with other medicines

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

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

• other immunosuppressant medicines such as azathioprine or tacrolimus.
• medicines used to treat high cholesterol levels in the blood, such as colestyramine.
• activated charcoal used to treat gastrointestinal disorders, such as diarrhea, upset stomach, and gas.
• antacids that contain magnesium and aluminum.
• medicines used to treat viral infections, such as acyclovir or ganciclovir.

You must also tell your doctor if you are scheduled to receive any vaccine.

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

Taking Myphenolic Acid Stada with food, drinks, and alcohol

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

Elderly patients

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

Children and adolescents

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

Pregnancy, breast-feeding, and fertility

Contraception in women taking Myphenolic Acid Stada

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

• Before starting to take myphenolic acid
• During the entire treatment with myphenolic acid
• Until 6 weeks after stopping myphenolic acid

Consult your doctor to determine the most suitable contraceptive method for you. This will depend on your personal situation. Two contraceptive methods are preferred, as this will reduce the risk of unwanted 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 to be at risk of becoming pregnant if your situation is one of the following:

• You are post-menopausal, i.e., you are at least 50 years old and your last period was 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 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 Myphenolic Acid Stada

Available evidence does not indicate an increased risk of birth defects or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precaution, you or your female partner are advised to use a reliable contraceptive method during treatment and for 90 days after stopping myphenolic acid.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss the risks and alternative treatments that you can take to prevent organ 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 myphenolic acid until you see your doctor.

Pregnancy

Myphenolic acid causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the birth defects reported 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) 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 pregnancy test before starting treatment and must follow the contraceptive advice given by your doctor. Your doctor may request more than one pregnancy test to ensure that you are not pregnant before starting treatment.

Breast-feeding

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

Driving and using machines

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

Myphenolic Acid Stada contains sodium

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

3. How to take Myphenolic Acid Stada

Follow exactly the administration instructions of the medicine given by your doctor. Myphenolic acid can only be prescribed by a doctor with experience in treating transplant patients. If you are unsure, ask your doctor or pharmacist or nurse.

How much to take

The recommended daily dose of myphenolic acid is 1,440 mg (4 tablets of 360 mg). They should be administered in 2 divided doses of 720 mg each (2 tablets of 360 mg).

Take your tablets in the morning and in the evening.

The first dose of 720 mg 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).

Taking Myphenolic Acid Stada

Swallow the tablets whole with the help of 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 kidney.

If you take more Myphenolic Acid Stada than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist or nurse immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. Bring the tablets with you, and if you have finished them, bring the empty pack.

If you forget to take Myphenolic Acid Stada

If you forget to take a dose of myphenolic 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 the usual time. Ask your doctor for advice. Do not take a double dose to make up for forgotten doses.

If you stop taking Myphenolic Acid Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Elderly patients may experience more adverse effects due to their reduced immune defense.

Immunosuppressants, including mycophenolic acid, decrease the body's defense mechanisms, preventing the rejection of the transplanted organ. Consequently, the body will not be in normal condition to fight against infections. Therefore, if you are taking mycophenolic acid, you may contract 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 perform 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 can be serious:

• Symptoms of infection, including fever, chills, sweating, feeling of tiredness, drowsiness, or lack of energy. If you are taking mycophenolic acid, you may contract more infections than usual, which can affect different systems of the body, with the most commonly affected being the kidneys, bladder, upper and/or lower respiratory tract.
• Blood in vomit, dark or bloody stools, gastric or intestinal ulcer.
• Inflammation of your glands, development of a new thickening of the skin or growth of an existing one, or changes in a 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 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)

• Diarrhea
• Reduced level of white blood cells
• Reduced level of calcium in the blood (hypocalcemia)
• Reduced level of potassium in the blood (hypokalemia)
• Increased level of uric acid in the blood (hyperuricemia)
• High blood pressure (hypertension)
• Pain in joints (arthralgia)
• Anxiety

Common(may affect up to 1 in 10 people)

• Reduced level of red blood cells, which can result in tiredness, shortness of breath, and pale appearance (anemia)
• Low levels of platelets, which can lead to bleeding and unexpected bruising (thrombocytopenia)
• Headache
• Cough
• Abdominal or stomach pain, inflammation of the stomach walls, abdominal distension, constipation, indigestion, gas (flatulence), soft stools, feeling of nausea (nausea), vomiting
• Fatigue, fever
• Alteration in liver and kidney function test results
• Respiratory tract infections
• Increased level of potassium in the blood (hyperkalemia)
• Reduced level of magnesium 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 heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary edema)
• A thickening that resembles a sac (cyst) containing fluid (lymph) (lymphocele)
• Tremor, insomnia
• Redness and swelling of the eyes (conjunctivitis), blurred vision
• Wheezing
• Belching, bad breath, intestinal obstruction (ileus), lip ulcers, heartburn, tongue discoloration, dry mouth, gum inflammation, pancreatitis (inflammation of the pancreas causing severe pain in the upper stomach), obstruction of the salivary glands, inflammation of the inner walls of the abdomen (peritonitis)
• Bone, blood, and skin infections
• Blood in urine, kidney alteration, pain and difficulty urinating
• Hair loss, skin wounds
• Joint inflammation (arthritis), back pain, muscle cramps
• Loss of appetite, increased levels of lipids (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolemia), or decreased levels of phosphate in the blood (hypophosphatemia)
• Flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, chills, feeling of thirst or weakness
• Nightmares, believing in things that are not true (delirium)
• Inability to have 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 that are possible symptoms of a lack of white blood cells in the blood (agranulocytosis)

Other adverse effects reported with medicines similar to Mycophenolic Acid Stada

Additional adverse 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, reduced level of white blood cells or all blood cells, severe infections, such as heart and valve inflammation and inflammation 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 usually 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your 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 Mycophenolic Acid Stada

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

Each tablet contains 360 mg of mycophenolic acid.

• The other ingredients are:

Tablet core: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30 (E1201), talc (E553b), colloidal anhydrous 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), colloidal anhydrous silica (E551), sodium hydrogen carbonate (E500), yellow iron oxide (E172), red iron oxide (E172), sodium lauryl sulfate (E487).

Tablet inscription: Shellac, partially esterified (E904), black iron oxide (E172), propylene glycol (E1520), ammonia (E527).

Appearance of the Product and Package Contents

Mycophenolic Acid Stada are oblong tablets with enteric coating, orange in color, biconvex, and with the inscription “M2” in black ink on one side and smooth on the other side.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

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

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009

Greece

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this leaflet:June 2023

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