Product Information for the Patient

Ceptava 360 mg gastro-resistant EFG tablets

micophenolic acid

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Product Information Contents

1.What Ceptava is and for what it is used

2.What you need to know before starting to take Ceptava

3.How to take Ceptava

4.Possible adverse effects

5.Storage of Ceptava

6.Contents of the package and additional information

Ceptava contains a substance called mycophenolic acid. It belongs to a class of medications known as immunosuppressants.

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

WARNING

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

Your doctor will talk to you and give you written information, particularly about the effects of micofenolate on fetuses. Read this information carefully and follow the instructions. If you do not understand these instructions completely, please ask your doctor to explain them again before taking micofenolate. See more information in the sections "Warnings and precautions" and "Pregnancy and breastfeeding".

Do not take Ceptava:

• if you are allergic (hypersensitive) to micophenolic acid, sodium micofenolate, mofetil micofenolate, or any of the other components of this medication (including in section 6),
• if you are a woman who could be pregnant and have not provided a negative pregnancy test before your first prescription, as micophenolic acid causes birth defects and spontaneous abortion,
• if you are pregnant or plan to become pregnant or think you may be pregnant,
• if you are not using an effective contraceptive method (see "Contraception in women/men"),
• if you are breastfeeding (see "Pregnancy and breastfeeding").

If any of the above situations apply to you, consult your doctor and do not take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ceptava:

• 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.

Also be aware that:

• micophenolic acid reduces the level of protection of your skin against the sun, increasing 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 applying sunscreen with a high protection factor frequently. Consult your doctor on how to protect yourself from the sun,
• if you have had hepatitis B or C, micophenolic 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 antibody levels during treatment with micophenolic acid, particularly when the infection recurs, especially if you are also taking other immunosuppressants and will indicate if you can continue treatment with micophenolic acid,
• if you experience any symptoms of infection (such as fever or throat inflammation) or unexpected hematoma or bleeding, contact your doctor immediately,
• your doctor may want to check your white blood cell count in the blood during treatment with micophenolic acid and will indicate if you can continue taking micophenolic acid,
• the active ingredient, micophenolic acid, is not the same as other medications that sound similar, such as mofetil micofenolate. Do not exchange these medications unless your doctor tells you to,
• the use of micophenolic acid during pregnancy may harm the fetus (see also "Pregnancy and breastfeeding") and increase the risk of fetal loss (spontaneous abortion).

Other medications and Ceptava

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Particularly, you must 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 levels 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 aciclovir or ganciclovir.

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

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

Taking Ceptava with food and drinks

Ceptava can be taken with or without food. You should choose whether to take your tablets with or without food and take them in the same way every day. This is to ensure that the same amount of medication is absorbed by your body every day.

Advanced age

Patients over 65 years of age may take micophenolic acid without the need to adjust the recommended normal dose.

Pediatric and adolescent population

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your 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 sexual intercourse without using an effective contraceptive method.

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

Pregnancy

Micofenolate causes a very high frequency of spontaneous abortions (50%) and severe congenital defects (23-27%) in the fetus. The congenital defects reported include ear malformations, eye malformations, facial malformations (cleft lip/palate), finger development malformations, heart malformations, esophageal malformations (tube connecting the throat to the stomach), kidney malformations, and nervous system malformations (e.g., spina bifida, where the bones of the spine do not develop correctly). Your newborn baby may be affected by one or more of these defects.

If you are a woman who can become pregnant, you must provide a negative pregnancy test before starting treatment and follow the contraceptive advice given by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.

Breastfeeding

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

Contraception in women taking Ceptava

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

• Before starting to take micophenolic acid.
• During all treatment with micophenolic acid.
• For 6 weeks after stopping treatment with micophenolic acid.

Consult your doctor about 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 consider that your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You are considered not to be susceptible to becoming pregnant if your case is one of the following:

• If you are postmenopausal, i.e., you are over 50 years old and your last period was more than a year ago (if your periods have stopped because you have been treated for cancer, then there may still be some possibility of becoming pregnant).
• If your fallopian tubes or both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• If your uterus has been surgically removed (hysterectomy).
• If your ovaries do not function (premature ovarian failure, which has been confirmed by a gynecologist).
• If you were born with one of the following rare diseases that make pregnancy impossible: Genotype XY, Turner syndrome, or uterine agenesis.
• If you are a girl or adolescent who has not started menstruating.

Contraception in men taking Ceptava

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes micofenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you and your female partner use reliable contraceptive methods during treatment and for 90 days after stopping Ceptava.

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

Driving and using machines

Micophenolic acid has not been shown to affect your ability to drive and use machines.

Ceptava contains sodium and lactose

This medication contains 25.9 mg of sodium (main component of table salt/for cooking) in each gastro-resistant tablet. This is equivalent to 1.3% of the maximum daily sodium intake recommended for an adult.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. Ceptava can only be prescribed by a doctor with experience in treating transplant patients. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended daily dose of mycophenolic acid is 1,440 mg (4 Ceptava 360 mg tablets). It should be taken in 2 separate doses of 720 mg each (2 Ceptava 360 mg tablets). Take your tablets in the morning and at night.

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

If you have severe kidney problems

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

Taking Ceptava

Swallow the tablets whole with a glass of water.

Do not break, crush, or divide the tablets.

Do not take any broken or divided tablets.

Avoid inhaling or having direct contact with the powder on the skin or mucous membranes. If this happens, wash thoroughly with water and soap and rinse your eyes with plenty of water.

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

If you take more Ceptava 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 Ceptava

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 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 Ceptava

Do not stop treatment with this medication unless your doctor tells you to. Stopping treatment 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 or pharmacist.

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, preventing the rejection of the transplanted organ. Consequently, the body will not be in normal conditions to fight infections. Therefore, if you are taking mycophenolic acid, you may contract more infections than normal, such as brain, skin, mouth, stomach, and intestinal infections, lung, and urinary tract infections.

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

Some side effects can be serious:

• infection symptoms, including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. If you are taking mycophenolic acid, you may contract more viral, bacterial, and fungal infections than normal, which can affect different systems of the body, with the kidneys, bladder, and upper or 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 mentioned side effects after taking this medicine, inform your doctor immediately.

Other side effects may include:

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

• reduced white blood cell count,
• reduced calcium levels in the blood (hypocalcemia),
• reduced potassium levels in the blood (hypokalemia),
• increased uric acid levels in the blood (hyperuricemia),
• high blood pressure (hypertension),
• anxiety,
• diarrhea,
• joint pain (arthralgia).

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which can cause fatigue, shortness of breath, and pale complexion (anemia),
• reduced platelet count in the blood, which can cause bleeding and unexpected bruises (thrombocytopenia),
• increased potassium levels in the blood (hyperkalemia),
• reduced magnesium levels in the blood (hypomagnesemia),
• dizziness,
• headache,
• cough,
• low blood pressure (hypotension),
• shortness of breath (dyspnea),
• 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,
• acne,
• weakness (asthenia),
• muscle pain (myalgia),
• swollen hands, ankles, or feet (peripheral edema),
• itching.

Rare(may affect up to 1 in 100 people)

• rapid or irregular heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary edema),
• a sac-like swelling (cyst) containing fluid (lymph) (lymphocele),
• tremor, insomnia,
• redness and swelling of the eyes (conjunctivitis), blurred vision,
• whistling breathing,
• eructation, bad breath, intestinal obstruction (ileus), lip ulcers, pyrosis, tongue discoloration, dry mouth, gum inflammation, pancreatitis, salivary gland obstruction, peritonitis,
• bone, blood, and skin infections,
• blood in urine, kidney alteration, pain and difficulty urinating,
• hair loss, skin lesions,
• joint inflammation (arthritis), back pain, muscle cramps,
• loss of appetite, increased lipid levels (hyperlipidemia), sugar (diabetes), cholesterol (hypercholesterolemia), or decreased phosphate levels in the blood (hypophosphatemia),
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swollen ankles and feet, pain, rigor, feeling thirsty or weak,
• nightmares, 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 (possible symptoms of low white blood cell count in the blood) (agranulocytosis).

Other side effects reported with similar medicines to Ceptava

Additional side effects have been reported with the group of medicines to which Ceptava 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 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, shortness of breath, cough, which may be due to bronchiectasis (a situation in which the respiratory tract is 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 persistent cough or shortness of breath.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directlythrough theSpanish System for the 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 and the blister pack after CAD/EXP. 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 moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.

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

Composition of Ceptava

-The active ingredient is mycophenolic acid (as sodium mycophenolate). Each gastro-resistant tablet contains 360 mg of mycophenolic acid.

-The other components are:

Core: anhydrous lactose, crospovidone (type A), povidone K 30, cornstarch, colloidal anhydrous silica/di oxide of colloidal silica, and magnesium stearate.

Coating: hypromellose HP 50 phthalate, titanium dioxide (E 171), yellow iron oxide (E 172)/ferric oxide and red iron oxide (E172)/ferric oxide.

Appearance of the product and contents of the package

Gastro-resistant oval-shaped tablets with a pale orange-red film coating with the inscription “CT” on one face.

Dimensions: approximately 17.6 x 7.2 x 6.3 mm.

PA/AL/PVC-Aluminum blisters.

Pack sizes:50, 100, 120, or 250 gastro-resistant tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033, Madrid

Spain

Responsible for Manufacturing

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg, Bayern

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57

SLO-1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1 39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.,

Trimlini 2D, 9220

Lendava,

Slovenia

This medicinal product is authorized in the Member States of the EU and in the United Kingdom (Northern Ireland) under the following names:

Austria:Mycophenolsäure Sandoz 360 mg magensaftresistente Tabletten

Cyprus:Mycophenolate Sodium Sandoz

France:Acide Mycophenolique Sandoz 360 mg comprimé gastro-résistant

Italy:Ceptava

United Kingdom (Northern Ireland):Ceptava 360 mg gastro-resistant tablets

Last review date of this leaflet:February 2022

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./