Ceptava 180 mg gastro-resistant tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Ceptava 180 mg gastro-resistant tablets EFG

mycophenolic acid (as sodium mycophenolate)

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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 adverse 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 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, since 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-phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan and 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 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 check for 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 monitor your antibody levels in the blood during treatment with mycophenolic acid, particularly if infections recur, 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 wish to monitor your white blood cell count during treatment with mycophenolic acid and will advise you whether you can continue taking mycophenolic acid,
• the active substance, 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,
• 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).

Children and adolescents

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

Elderly patients

Elderly patients (aged 65 years and older) may take Ceptava without the need to adjust the recommended normal 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, 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 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 plan to receive any vaccinations.

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 drinks

Ceptava 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. 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 you may consider 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, or 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, you must inform your doctor immediately. However, continue taking mycophenolate until you see your doctor.

Pregnancy

Mycophenolate causes spontaneous abortions (50%) and serious congenital malformations (23–27%) in the fetus very frequently. Reported birth defects include malformations of the ears, eyes, face (cleft lip/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 newborn baby 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 must 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 of childbearing potential, you must always use an effective method of contraception while taking mycophenolic acid. This includes:

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

Consult your doctor about the most appropriate 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).
• You have had both fallopian tubes or 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 gynaecology specialist).
• You were born with any 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 birth defects or spontaneous abortion if the father is taking mycophenolate. However, the risk cannot be completely excluded. As a precautionary measure, it is recommended that you and your female partner use effective contraceptive methods during treatment and for 3 months after stopping treatment with 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 12.93 mg of sodium (the main component of table/cooking salt) in each gastro-resistant tablet. This corresponds to 0.65% of the maximum daily recommended sodium intake for an adult.

This medicine contains lactose. If your doctor has informed you of 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 as 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.

What dose to take

The recommended daily dose of mycophenolic acid is 1,440 mg (8 tablets of Ceptava 180 mg). It should be taken in 2 separate doses of 720 mg each (4 tablets of Ceptava 180 mg). Take your tablets in the morning and in the evening.

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

If you have severe kidney problems

Your daily dose must not exceed 1,440 mg (8 tablets of Ceptava 180 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 be continued as long as immunosuppression is needed to prevent your body from rejecting your 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Bring the tablets with you; if you have run out, 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 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 your 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 gets them.

Elderly patients may experience more adverse effects because they have a weakened immune system.

Immunosuppressants, including mycophenolic acid, reduce the body's natural defences in order 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 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 counts or 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, with the kidneys, bladder, and upper and/or lower respiratory tract being the most commonly affected,
• blood in vomit, dark or bloody stools, gastric or intestinal ulcer,
• swelling of glands, development of a new skin thickening or growth of an existing one, or changes in an existing mole. As may 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 above effects 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,
• reduced level of calcium in the blood (hypocalcaemia),
• reduced level of potassium in the blood (hypokalaemia),
• increased level of uric acid 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),
• increased level of potassium in the blood (hyperkalaemia),
• reduced level of magnesium 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 unwell (nausea), dizziness (vomiting),
• fatigue, fever,
• abnormal results in liver and kidney function tests,
• 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 heartbeats (ventricular extrasystoles), fluid in the lungs (pulmonary oedema),
• a fluid-filled sac-like thickening (lymphocele),
• tremor, insomnia,
• redness and swelling of the eyes (conjunctivitis), blurred vision,
• wheezing,
• belching, bad breath, intestinal obstruction (ileus), lip ulcers, heartburn, discolouration of the tongue, dry mouth, inflammation of the 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, feeling thirsty or weak,
• nightmares, believing in things that are not true (delusions),
• inability to get or maintain an erection,
• cough, difficulty breathing, pain when breathing (possible symptoms of interstitial lung disease).

Frequency not known (cannot be estimated from available data)

• fever, sore throat, frequent infections (possible symptoms of low white blood cell count) (agranulocytosis),
• skin rash, itching, hives, difficulty breathing or shortness of breath, 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 white blood cells 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, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways in the lungs are abnormally widened), and other less common bacterial infections that typically 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 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. Storage of Ceptava

Keep Ceptava in its original packaging to protect it from light and moisture. Store at room temperature (15–25°C) unless otherwise specified by the manufacturer. Do not use Ceptava after the expiry date stated on the container. Keep out of reach and sight of children. Do not dispose of unused medication via wastewater or household waste. Ask your pharmacist how to properly dispose of medications no longer required to help protect the environment.

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage temperature.

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 packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 180 mg of mycophenolic acid.
• The other components are:

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

Coating: hypromellose phthalate HP50, titanium dioxide (E 171), iron oxide yellow (E 172)/ferric oxide, indigotine (Indigo Carmine) FD&C Blue No. 2, aluminium lake (E 132).

Appearance of the product and contents of the pack

Round, lime-green, film-coated tablets with bevelled edges and engraved with the letter “C” on one side.

Dimensions: approximately 10.4 x 4.2 mm.

Blister packs made of PA/AL/PVC-Aluminum.

Pack sizes: 20, 50, 100, 120 or 250 gastro-resistant tablets.

Some pack sizes may not 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 most recent review of this leaflet: January 2026

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