CEPTAVA 180 mg GASTRO-RESISTANT TABLETS

1. What is Ceptava and what is it used for

Ceptava contains a substance called mycophenolic acid. It belongs to a group of medicines called immunosuppressants.

Ceptava 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 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 given by your doctor.

Your doctor will discuss with you and give you written information, in particular about the effects of mycophenolate on the fetus. 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 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 ingredients 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 or planning 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 applies 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 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:

• mycophenolic 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, mycophenolic 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 antibody levels in your blood during treatment with mycophenolic acid, in particular when the infection recurs, especially if you are also taking other immunosuppressants, and will indicate if you can continue treatment with mycophenolic 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 your blood during treatment with mycophenolic acid and will indicate if 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 switch these medicines 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 (miscarriage).

Other medicines and Ceptava

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

In particular, you should 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 aciclovir or ganciclovir.

You should also tell your doctor if you are planning to receive any vaccine.

Do not donate blood during treatment with mycophenolic acid and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with mycophenolic 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 from then on always take them in the same way every day. This is to ensure that the same amount of your medicine is absorbed by your body every day.

Elderly

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

Pediatric population and adolescents

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the risks and benefits of taking this medicine during pregnancy and the alternatives you can take to prevent rejection of your transplanted organ if:

• you plan to become pregnant,
• you have missed a period, or have unusual menstrual bleeding, or suspect you are pregnant,
• you have had sex without using an effective contraceptive method.

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

Pregnancy

Mycophenolate causes miscarriage (50%) and severe birth defects (23-27%) in the fetus. The birth defects that have been reported include malformations of the ears, eyes, face (cleft lip/palate), fingers, heart, esophagus (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 who can become pregnant, you must provide a negative pregnancy test before starting treatment and must 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 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 can become pregnant, you must always use an effective contraceptive method if you are taking mycophenolic acid. This includes:

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

Consult your doctor about the most suitable contraception 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 think your contraceptive method may not have been effective or if you have forgotten to take your contraceptive pill.

You are considered not to be at risk of becoming pregnant if you are:

• Post-menopausal, i.e., you are over 50 years of age and your last period was more than a year ago (if your periods have stopped due to cancer treatment, you may still be at risk 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 work (premature ovarian failure, which has been 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 started having periods.

Contraception in men taking Ceptava

Available evidence does not indicate an increased risk of birth defects or miscarriage 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 reliable contraceptive methods during treatment and for 90 days after stopping treatment with Ceptava.

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

Driving and using machines

Mycophenolic acid has not been shown to affect your ability to drive or use machines.

Ceptava contains sodium and lactose

This medicine contains 12.93 mg of sodium (main component of cooking/table salt) in each gastro-resistant tablet. This is equivalent to 0.65% of the maximum recommended daily intake of sodium for an adult.

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

3. How to take Ceptava

Follow exactly the administration instructions of this medicine given by your doctor. Ceptava can only be prescribed by a doctor with experience in treating transplant patients. If you are unsure, consult your doctor or pharmacist again.

How much 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 divided doses of 720 mg each (4 tablets of Ceptava 180 mg). Take your tablets in the morning and in the evening.

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

If you have severe kidney problems

Your daily dose should not be more than 1,440 mg (8 tablets of Ceptava 180 mg).

Taking 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 contact of the powder with 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 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, 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 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 the usual time. Ask your doctor for advice. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Ceptava

Do not stop treatment with this medicine unless your doctor tells you to. Stopping treatment 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.

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 conditions to fight against infections. Therefore, if you are taking mycophenolic acid, you may contract more infections than usual, 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 in the levels of substances transported in your blood, such as sugar, fat, and cholesterol.

Some effects can be serious:

• infection symptoms including fever, chills, sweating, feeling of tiredness, drowsiness, or lack of energy. If you are taking mycophenolic acid, you may contract more viral, bacterial, and fungal infections than usual, which can affect different systems of the body, with the most commonly affected being the kidneys, bladder, and 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 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 adverse effects may include:

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

• reduced white blood cell count,
• reduced calcium level in the blood (hypocalcemia),
• reduced potassium level in the blood (hypokalemia),
• increased uric acid level 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 result in tiredness, shortness of breath, and pale appearance (anemia),
• reduced platelet count in the blood, which can result in bleeding and unexpected bruising (thrombocytopenia),
• increased potassium level in the blood (hyperkalemia),
• reduced magnesium level in the blood (hypomagnesemia),
• dizziness,
• headache,
• cough,
• low blood pressure (hypotension),
• shortness of breath (dyspnea),
• abdominal or stomach pain, inflammation of the stomach walls, abdominal distension, constipation, indigestion, gas (flatulence), soft stools, feeling of dizziness (nausea), vomiting,
• fatigue, fever,
• alteration in liver and kidney function test results,
• respiratory tract infections,
• acne,
• weakness (asthenia),
• muscle pain (myalgia),
• swelling of 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 looks like 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), salivary gland obstruction, peritonitis (inflammation of the inner walls of the abdomen),
• bones, 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 available data)

• skin rash,
• fever, sore throat, frequent infections (possible symptoms of lack of white blood cells in the blood) (agranulocytosis).

Other adverse effects reported with medicines similar to Ceptava

Additional adverse 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 or all blood cells, severe infections, such as heart and valve inflammation and inflammation of the membrane covering the brain and spinal cord, shortness of breath, cough, which may be due to bronchiectasis (a situation in which the pulmonary airways are abnormally dilated) and other less common bacterial infections that usually result in severe lung damage (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, 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 Ceptava

Keep this medicine out of sight and reach of children

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is 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 observe that the packaging is damaged or shows signs of having been tampered with.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ceptava

• The active ingredient is mycophenolic acid (as sodium mycophenolate). Each gastro-resistant tablet contains 180 mg of mycophenolic acid.
• The other components are:

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

Coating: hypromellose phthalate HP50, titanium dioxide (E 171), yellow iron oxide (E 172)/ferric oxide, indigo carmine (FD&C blue No. 2), aluminum lake (E 132).

Appearance of the product and package contents

Round, greenish-yellow, film-coated tablets with beveled edges and the inscription "C" on one side.

Dimensions: approximately 10.4 x 4.2 mm.

PA/AL/PVC-Aluminum blisters.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033, Madrid

Spain

Manufacturer

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 medicine is authorized in the EU Member States and in the United Kingdom (Northern Ireland) under the name:

Austria:Mycophenolsäure Sandoz 180 mg magensaftresistente Tabletten

Cyprus:Mycophenolate Sodium Sandoz

France:Acide Mycophenolique Sandoz 180mg comprimé gastro-résistant

Italy:Ceptava

United Kingdom (Northern Ireland):Ceptava 180 mg gastro-resistant tablets

Date of last revision of this leaflet:February 2022

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./