Ceptava 360 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ceptava 360 mg gastro-resistant tablets EFG

mycophenolic acid (as mycophenolate sodium)

Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
• 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ceptava is and what it is used for

Ceptava contains a substance called mycophenolic acid. It belongs to a class of medicines 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 medicines containing cyclosporine and corticosteroids.

2. What you need to know before starting Ceptava

WARNING

Mycophenolate causes birth defects and miscarriage. If you are a woman who can become pregnant, you must provide proof of a negative pregnancy test before starting treatment and must follow the contraceptive advice indicated by your doctor.

Your doctor will discuss this with you and provide written information, particularly regarding the effects of mycophenolate on fetuses. Read this information carefully and follow the instructions. If you do not fully understand these instructions, please ask your doctor to explain them again before taking mycophenolate. See more information in the sections "Warnings and precautions" and "Pregnancy and breastfeeding".

Do not take Ceptava:

• if you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil, or to any of the other components of this medicine (listed 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 mycophenolic acid causes birth defects and miscarriage,
• if you are pregnant, planning to become pregnant, or think you might be pregnant,
• if you are not using an effective method of contraception (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 medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ceptava:

• if you have or have previously had severe digestive disorders, such as gastric ulcer,
• if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine-phosphoribosyl-transferase (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, cover exposed skin areas as much as possible, and frequently apply a sunscreen with a high sun protection factor. Consult your doctor on 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 while taking other immunosuppressants, inform your doctor immediately,
• your doctor may wish to check your antibody levels in the blood during treatment with mycophenolic acid, particularly if infection recurs, especially if you are also taking other immunosuppressants, and will advise 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 wish to monitor your white blood cell count during treatment with mycophenolic acid and will advise whether you can continue taking mycophenolic acid,
• the active ingredient, mycophenolic acid, is not the same as other medicines that sound similar, such as mycophenolate mofetil. Do not interchange these medicines unless instructed by your doctor,
• using mycophenolic acid during pregnancy may harm the fetus (see also “Pregnancy and breastfeeding”) 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 Ceptava without the need to adjust the normal recommended dose.

Other medicines and Ceptava

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

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

• other immunosuppressants such as azathioprine or tacrolimus,
• medicines used to treat high blood cholesterol levels such as colestyramine,
• activated charcoal used to treat digestive disorders such as diarrhea, 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 are planning to receive any vaccination.

You must not donate blood during treatment with Ceptava and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Ceptava and for at least 3 months after stopping treatment.

Taking Ceptava with food and drink

Ceptava may be taken with or without food. You should choose whether to take your tablets with or without food and then continue taking them the same way every day. This is to ensure that the same amount of medicine is absorbed into your body each day.

Pregnancy and breastfeeding

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 associated with pregnancy and alternative treatments to prevent rejection of your 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 are pregnant,
• you have sexual intercourse without using an effective contraceptive method.

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

Pregnancy

Mycofenolate causes spontaneous abortions (50%) and serious congenital malformations (23–27%) in the fetus with very high frequency. Reported birth defects include malformations of the ears, eyes, face (cleft lip/palate), finger development, heart, esophagus (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 newborn child may be affected by one or more of these defects.

If you are a woman of childbearing potential, you must provide a negative pregnancy test before starting treatment and follow your doctor’s contraceptive advice. Your doctor may require more than one test to confirm you are not pregnant before starting treatment.

Breastfeeding

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

Contraception in women taking Ceptava

If you are a woman who could become pregnant, you must always use an effective method of contraception while taking mycophenolic acid. This includes:

• Before starting mycophenolic acid.
• Throughout treatment with mycophenolic acid.
• For 6 months after stopping treatment with mycophenolic acid.

Consult your doctor about the most suitable contraception 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 contraception may not have been effective or if you have missed taking your contraceptive pill.

You are considered not at risk of becoming pregnant if any of the following apply to you:

• You are postmenopausal, i.e., you are over 50 years old and your last period was more than one year ago (if your periods have stopped due to cancer treatment, you may still have a chance of becoming pregnant).
• Your fallopian tubes or both 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 gynecology specialist).
• 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 Ceptava

Available evidence does not indicate an increased risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precautionary measure, it is recommended that you and your female partner use effective contraception during treatment and for up to 3 months after stopping Ceptava.

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

Driving and use of machines

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

Ceptava contains sodium and lactose

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

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ceptava

Follow exactly the instructions for use of this medicine given by your doctor. Ceptava can only be prescribed by a physician experienced 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 tablets of Ceptava 360 mg). It should be taken in two separate doses of 720 mg each (2 tablets of Ceptava 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 must not exceed 1,440 mg (4 tablets of Ceptava 360 mg).

How to take Ceptava

Swallow the tablets whole with a glass of water.

Do not break or crush the tablets.

Do not take any broken or divided tablets.

Avoid inhaling or direct skin or mucous membrane contact with the powder. If this occurs, wash thoroughly with soap and water and rinse eyes with plenty of water.

Treatment should continue for 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, contact a doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and amount ingested. Bring the tablets with you, and if you have finished them, take 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 usual time. Seek advice from your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Ceptava

Do not stop treatment with this medicine unless instructed by your doctor. Stopping treatment may increase the risk of your body rejecting the transplanted kidney.

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

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 weakened immune system.

Immunosuppressants, including mycophenolic acid, reduce your body's natural defences to prevent rejection of your transplanted organ. As a result, your body will be less able than normal to fight infections. Therefore, if you are taking mycophenolic acid, you may get more 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 your blood cell count or in the levels of substances carried in your blood, such as sugar, fat, and cholesterol.

Some effects may be serious:

• signs of infection including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. If you are taking mycophenolic acid, you may get more viral, bacterial, and fungal infections than usual, which can affect different systems of the body. The most commonly affected areas are 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 node tumours.

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

Other adverse effects may include:

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

• reduced number of white blood cells,
• low calcium levels in the blood (hypocalcaemia),
• low potassium levels in the blood (hypokalaemia),
• high uric acid levels in the blood (hyperuricaemia),
• high blood pressure (hypertension),
• anxiety,
• diarrhoea,
• joint pain (arthralgia).

Common (may affect up to 1 in 10 people)

• reduced number of red blood cells, which may result in tiredness, shortness of breath, and pale appearance (anaemia),
• reduced number of platelets in the blood, which may result in unexpected bleeding and bruising (thrombocytopenia),
• high potassium levels in the blood (hyperkalaemia),
• low magnesium levels in the blood (hypomagnesaemia),
• dizziness,
• headache,
• cough,
• low blood pressure (hypotension),
• shortness of breath (dyspnoea),
• abdominal or stomach pain, inflammation of the stomach walls, bloating, constipation, indigestion, gas (flatulence), soft stools, feeling of dizziness (nausea), dizziness (vomiting),
• fatigue, fever,
• changes in liver and kidney function test results,
• respiratory tract infections,
• 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 fluid-filled sac-like thickening (cyst) containing lymph (lymphocele),
• tremor, insomnia,
• redness and swelling of the eyes (conjunctivitis), blurred vision,
• wheezing,
• belching, bad breath, intestinal obstruction (ileus), lip sores, heartburn, discolouration of the tongue, dry mouth, swollen gums, inflammation of the pancreas causing severe upper stomach pain (pancreatitis), blockage of the salivary glands, inflammation of the inner abdominal walls (peritonitis),
• bone, blood, and skin infections,
• blood in urine, kidney problems, pain and difficulty passing urine,
• hair loss, skin lesions,
• joint inflammation (arthritis), back pain, muscle cramps,
• loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased levels of phosphate in the blood (hypophosphataemia),
• flu-like symptoms (such as fatigue, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, rigors, thirst, or weakness,
• nightmares, believing 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)

• fever, sore throat, frequent infections (possible symptoms of low white blood cell count) (agranulocytosis),
• skin rash, itching, hives, shortness of breath or difficulty breathing, wheezing or cough, dizziness, lightheadedness, changes in level of consciousness, hypotension, with or without mild generalized itching, skin redness, and swelling of the face and throat (symptoms of a severe allergic reaction).

Other adverse effects reported with medicines similar to Ceptava

Additional adverse effects have been reported with the group of medicines to which Ceptava 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 number of specific white blood cells 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, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways of the lungs are abnormally widened), and other less common bacterial infections that usually result in severe lung problems (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, talk to your doctor or pharmacist, even if it is a possible adverse effect 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. Conservation of Ceptava

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

Do not use this medicine after the expiry date stated on the packaging and blister pack after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Keep in the original packaging to protect it from moisture.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

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. If in doubt, ask your pharmacist how to properly 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 Ceptava

• The active substance is mycophenolic acid (as mycophenolate sodium). Each gastro-resistant tablet contains 360 mg of mycophenolic acid.
• The other components are:

Core: anhydrous lactose, crospovidone (type A), povidone K 30, maize starch, colloidal anhydrous silica/colloidal silicon dioxide, and magnesium stearate.

Coating: hypromellose phthalate HP 50, 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 pack

Pale orange-red, oval, film-coated tablets with the inscription “CT” on one side.

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 Manufacturing Responsibility

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Center

Roble Building

C/ Serrano Galvache, 56

28033, Madrid

Spain

Manufacturer

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg, Bayern
Germany

or

Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57;
1000 Ljubljana
Slovenia

or

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

or

Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220
Lendava,
Slovenia

Date of the most recent review of this leaflet: January 2026

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./