Ceptava

Package leaflet: Information for the patient

Ceptava 180 mg gastro-resistant tablets

mycophenolic acid (as sodium mycophenolate)
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this 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 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 group of
medicines known as immunosuppressants.
Ceptava is used to prevent rejection of the transplanted kidney by the immune system. It is used in combination with other medicines containing cyclosporine and corticosteroids.

2. What you need to know before taking Ceptava

WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant,
you must have a negative pregnancy test before starting treatment and follow your doctor’s advice
regarding contraception.
Your doctor will discuss this with you and provide written information, particularly on the effects of
mycophenolate on the unborn child. Read this information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking
mycophenolate. Also read the information within this section under “Warnings and precautions” and
“Pregnancy and breastfeeding”.
Do not take Ceptava:

• if you are allergic (hypersensitive) to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil, or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman of childbearing potential and have not provided a negative pregnancy test before starting treatment, because mycophenolate causes birth defects and miscarriage.
• if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• if you are not using an effective contraceptive method (see Contraception in women and men).
• if you are breastfeeding (also see Pregnancy and breastfeeding).

If any of the above conditions apply to you, speak with your doctor before taking
Ceptava.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ceptava:

• if you have or have ever 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 syndrome or Kelley-Seegmiller syndrome.

You should also be aware that:

• Ceptava reduces the skin’s natural protection from sunlight. This increases the risk of skin cancer. You should limit exposure to sunlight and ultraviolet (UV) rays, protect exposed areas as much as possible, and regularly apply high-protection sunscreen. Ask your doctor for advice on sun protection.
• If you have previously had hepatitis B or C, Ceptava may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these conditions. If you develop any symptoms (yellowing of eyes or skin, 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 request regular monitoring of antibody levels during treatment with Ceptava, particularly if you experience recurrent infections, especially if you are also taking other immunosuppressants, and will inform you whether you can continue treatment with Ceptava.
• If you show signs of infection (such as fever or sore throat) or experience unexpected bruising or bleeding, inform your doctor immediately.
• Your doctor may request regular monitoring of white blood cell counts during treatment with Ceptava and will inform you whether you can continue treatment.
• The active substance, mycophenolic acid, is different from that in other medicines with similar names, such as mycophenolate mofetil. Do not switch from one medicine to another unless instructed by your doctor.
• Use of Ceptava during pregnancy may harm the unborn child (also see Pregnancy and breastfeeding) and may increase the risk of pregnancy loss (miscarriage).

Children and adolescents
Due to lack of data, use of Ceptava is not recommended in children and adolescents.
Elderly
Elderly patients (aged 65 years or older) can take Ceptava without the need to adjust the usual recommended dose.
Other medicines and Ceptava
Inform 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, 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 cholestyramine.
• activated charcoal used to treat digestive disorders such as diarrhoea, stomach upset, and flatulence.
• 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 sperm during treatment with Ceptava and for at least 3 months after stopping treatment.
  Ceptava with food and drinks
  Ceptava can be taken with or without food. You should choose whether to take the tablets with or without food and then continue taking them the same way every day. This ensures you absorb the same amount of medicine each day.
  Pregnancy and breastfeeding
  If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, 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 undergo to prevent organ transplant rejection if:

• you are planning a pregnancy.
• you miss a menstrual period or think you may have missed one, have unusual menstrual bleeding, or suspect you are pregnant.
• you have had sexual intercourse without using an effective contraceptive method. If you become pregnant while taking mycophenolate, inform your doctor immediately. In any case, continue taking mycophenolate until you see your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriage (50%) and serious birth defects (23–27%) in the unborn child. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, oesophagus (the tube connecting the throat and stomach), kidneys, and nervous system (e.g. spina bifida [where the bones of the spine are not fully developed]). The baby may have one or more of these defects.
If you are a woman of childbearing potential, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice on contraception. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Ceptava if you are breastfeeding. 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 use an effective contraceptive method while taking Ceptava. This means:

• before starting Ceptava.
• throughout the entire duration of treatment with Ceptava.
• for 6 months after stopping treatment with Ceptava.

Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your individual situation. Using two contraceptive methods is preferred to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you missed taking your oral contraceptive pill.
You are considered a woman who is not able to become pregnant if any of the following apply to you:

• you are postmenopausal, i.e. you are at least 50 years old and your last menstrual period was more than one year ago (if your menstrual cycle has stopped due to cancer treatment, you may still be able to become pregnant).
• both your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• your uterus has been surgically removed (hysterectomy).
• your ovaries no longer function (premature ovarian failure, confirmed by a gynaecology 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 child or adolescent who has not yet had her first menstrual period.

Contraception in men taking Ceptava
Although available clinical data do not indicate an increased risk of birth defects or miscarriage when the father takes mycophenolate, this risk cannot be completely ruled out. As a precaution, you or your partner are therefore advised to use effective contraception during treatment and for 3 months after stopping treatment with Ceptava.
If you are planning a pregnancy, talk to your doctor about potential risks.
Driving and using machines
Ceptava has a minor influence on the ability to drive and use machines.
Ceptava contains sodium and lactose
This medicine contains 12.93 mg of sodium (a main component of table salt) per gastro-resistant tablet. This corresponds to 0.65% of the maximum daily intake recommended in the adult diet.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ceptava

Take this medicine exactly as instructed by your doctor. Ceptava will be prescribed only by doctors experienced in treating transplant patients. If you have any doubts, consult your doctor or pharmacist.

What dose to take
The recommended daily dose of Ceptava is 1440 mg (8 tablets of Ceptava 180 mg). This is taken as two separate doses of 720 mg each (4 tablets of Ceptava 180 mg), one in the morning and one in the evening.
Your first 720 mg dose will be administered within 72 hours after transplantation.

If you have severe kidney problems
The daily dose must not exceed 1440 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 the powder or allowing direct contact of the powder with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with water.

Treatment will continue as long as immunosuppression is needed to prevent rejection of the transplanted organ.

If you take more Ceptava than you should
If you have taken more Ceptava than prescribed, or if someone else has taken your tablets, contact your doctor or go to hospital immediately. Medical treatment may be necessary. Bring the tablets with you and show them to the doctor or hospital staff. If you have run out of tablets, bring the empty packaging with you.

If you forget to take Ceptava
If you forget to take Ceptava, take it as soon as you remember, unless it is almost time for your next dose. In that case, take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose. Consult your doctor if in doubt.

If you stop taking Ceptava
Do not stop taking Ceptava unless instructed by your doctor. Stopping treatment with Ceptava may increase the risk of rejection of the transplanted kidney.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Elderly patients may experience more side effects due to a weakened immune defence.
Immunosuppressants, including Ceptava, reduce your body's defence mechanisms to prevent it from rejecting the transplanted organ. As a result, your body will not be able to defend itself against infections as effectively as normal. Therefore, if you are taking Ceptava, you may get more infections than usual, such as infections of the brain, skin, mouth, stomach and intestine, lungs, and urinary tract.
You will be regularly monitored by your doctor with blood tests to check for changes in blood cell counts or levels of substances carried in the blood, such as sugar, fats, and cholesterol.

Some side effects can be serious:

• signs of infection including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. While taking Ceptava, you may get viral, bacterial, and fungal infections more frequently than usual. These infections may affect various parts of the body but most commonly the kidneys, bladder, and upper and/or lower airways.
• vomiting blood, dark or bloody stools, gastric or intestinal ulcer.
• swelling of glands, development of new skin growths, increase in size of existing growths, or changes in existing growths. As may occur in patients treated with immunosuppressants, a very small number of patients receiving Ceptava have developed skin or lymph node tumours.

If you experience any of the above side effects after taking Ceptava, contact your doctor immediately.

Other possible side effects include:
Very common ( may affect more than 1 in 10 people )

• low levels of white blood cells
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• high levels 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 )

• low levels of red blood cells, which may cause tiredness, shortness of breath, and paleness (anaemia)
• low levels of platelets in the blood, which may cause unexpected bleeding and bruising (thrombocytopenia)
• high levels of potassium in the blood (hyperkalaemia)
• low levels 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 lining, abdominal swelling, constipation, indigestion, flatulence, loose stools, feeling unwell (nausea), vomiting
• fatigue, fever
• abnormal results in liver or kidney function tests
• respiratory infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of the hands, ankles, or feet (peripheral oedema)
• itching

Uncommon ( may affect up to 1 in 100 people )

• fast heartbeat (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• skin lesion similar to a fluid-filled cyst (lymphocele)
• tremor, difficulty falling asleep
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, difficulty breathing, intestinal blockage (ileus), ulceration of the lips, heartburn, change in tongue colour, dry mouth, inflammation of the gums, inflammation of the pancreas causing severe pain in the upper stomach (pancreatitis), blockage of the salivary glands, inflammation of the inner lining of the abdomen (peritonitis)
• bone, blood, and skin infections
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, bruising (ecchymosis on the skin)
• joint inflammation (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased levels of phosphates in the blood (hypophosphataemia)
• flu-like symptoms (such as tiredness, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, chills, thirst, or weakness
• abnormal dreams, believing things that are not true (delusion)
• inability to achieve or maintain an erection
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease)

Not known ( frequency cannot be estimated from the available data )

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

Other side effects reported with medicines similar to Ceptava
Additional side effects have been reported with the group of medicines to which Ceptava belongs:
inflammation of the colon (large intestine), inflammation of the stomach lining caused by cytomegalovirus, formation of a lesion in the intestinal wall causing severe abdominal pain with possible bleeding, gastric or duodenal ulcer, low levels of specific white blood cells or of all blood cells, severe infections such as inflammation of the heart and heart valves and of the membranes covering the brain and spinal cord, shortness of breath, cough, which may lead to bronchiectasis (a condition in which the airways of the lungs are abnormally widened), and other less common bacterial infections usually causing serious lung disorders ( tuberculosis and infections from atypical mycobacteria ). Contact your doctor if you develop a persistent cough or shortness of breath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ceptava

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Ceptava contains
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/maize, colloidal anhydrous silica/colloidal silicon dioxide, magnesium stearate
Coating
Hypromellose phthalate HP50, titanium dioxide (E171), yellow iron oxide (E172)/iron oxide,
indigotine (Indigo Carmine), FD&C Blue No. 2 – Aluminium Lake (E132).

Description of the appearance of Ceptava and pack contents
Film-coated, round-shaped tablets, yellowish-green in colour, with bevelled edges and
imprinted with "C" on one side.
Size: approximately 10.4 x 4.2 mm
PA/AL/PVC-aluminium blister packs.
Pack sizes: 20, 50, 100, 120, 250 gastro-resistant tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Legal representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo 43, 20154 Milan, Italy

Manufacturer
Novartis Pharma GmbH
Roonstraße 25, 90429 Nuremberg
Germany
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany
Lek d.d.,
Trimlini 2D,
9220 Lendava,
Slovenia

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Germany Mycophenolat - 1 A Pharma 180 mg magensaftresistente Tabletten
Italy Ceptava
Spain Ácido micofenólico Sandoz 180 mg comprimidos gastrorresistentes EFG

Patient Information Leaflet

Ceptava 360 mg gastro-resistant tablets

mycophenolic acid (as mycophenolate sodium)
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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 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 group of
medicines known as immunosuppressants.
Ceptava is used to prevent rejection of the transplanted kidney by the immune system. It is used in combination with other medicines containing cyclosporine and corticosteroids.

2. What you should know before taking Ceptava

WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman who could have children,
you must have a negative pregnancy test before starting treatment and follow your doctor’s
advice regarding contraception.
Your doctor will discuss this with you and provide written information, particularly about the effects of
mycophenolate on the unborn child. Read this information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking
mycophenolate. Also read the information in this section under “Warnings and precautions” and “Pregnancy and breastfeeding”.
Do not take Ceptava:

• if you are allergic (hypersensitive) to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil, or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman capable of having children and have not provided a negative pregnancy test before starting treatment, because mycophenolate causes birth defects and miscarriage.
• if you are pregnant, suspect you are pregnant, or are planning a pregnancy.
• if you are not using an effective contraceptive method (see Contraception in women and men).
• if you are breastfeeding (also see Pregnancy and breastfeeding).

If any of the above conditions apply to you, speak with your doctor before taking
Ceptava.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ceptava:

• if you have or have ever 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 syndrome or Kelley-Seegmiller syndrome.

You should also be aware that:

• Ceptava reduces the skin’s natural protection from sunlight. This increases the risk of skin cancer. You should limit exposure to sunlight and ultraviolet (UV) rays by protecting exposed areas as much as possible and regularly applying high-protection sunscreen. Ask your doctor for advice on sun protection.
• If you have previously had hepatitis B or C, Ceptava may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these conditions. If you develop any symptoms (yellowing of eyes or skin, 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 request regular blood tests to monitor antibody levels during treatment with Ceptava, particularly if you experience recurrent infections, especially if you are also taking other immunosuppressants, and will inform you whether you can continue Ceptava treatment.
• If you show signs of infection (such as fever or sore throat) or experience unexpected bruising or bleeding, inform your doctor immediately.
• Your doctor may request regular monitoring of white blood cell counts during Ceptava treatment and will inform you whether you can continue treatment.
• The active substance, mycophenolic acid, is different from that of other medicines with similar names, such as mycophenolate mofetil. Do not switch from one medicine to another unless instructed by your doctor.
• Use of Ceptava during pregnancy may harm the fetus (also see Pregnancy and breastfeeding) and may increase the risk of pregnancy loss (miscarriage).

Children and adolescents
Due to lack of data, use of Ceptava is not recommended in children and adolescents.
Elderly
Elderly patients (aged 65 years or older) can take Ceptava without the need to adjust the usual recommended dose.
Other medicines and Ceptava
Inform 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, 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 cholestyramine.
• activated charcoal used to treat digestive disorders such as diarrhoea, stomach upset, and flatulence.
• 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 sperm during treatment with Ceptava and for at least 3 months after stopping treatment.
Ceptava with food and drink
Ceptava may be taken with or without food. You should choose whether to take the tablets with or without food and then continue taking them the same way every day. This ensures that you absorb the same amount of medicine each day.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, 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 organ transplant rejection if:

• you are planning a pregnancy.
• you miss a menstrual period or think you may have missed one, have unusual menstrual bleeding, or suspect you are pregnant.
• you have had sexual intercourse without using an effective contraceptive method. If you become pregnant while taking mycophenolate, inform your doctor immediately. In any case, continue taking mycophenolate until you see your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriage (50%) and severe congenital malformations (23–27%) in the unborn child. Reported congenital malformations include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, oesophagus (the tube connecting the throat and stomach), kidneys, and nervous system (e.g. spina bifida [where the bones of the spine are not fully developed]). The baby may have one or more of these defects.
If you are a woman capable of having children, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception. Your doctor may require more than one test to confirm that you are not pregnant before starting treatment.
Breastfeeding
Do not take Ceptava if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Contraception in women taking Ceptava
If you are a woman capable of becoming pregnant, you must use an effective contraceptive method while taking Ceptava. This means:

• before starting Ceptava.
• throughout the entire treatment with Ceptava.
• for 6 months after stopping Ceptava treatment.

Discuss with your doctor the most suitable contraceptive method for you. This will depend on your individual situation. Using two contraceptive methods is preferred to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you missed taking your oral contraceptive pill.
You are considered a woman who is not capable of having children if any of the following applies to you:

• you are postmenopausal, i.e. you are at least 50 years old and your last menstrual period was over a year ago (if your menstrual periods stopped due to cancer treatment, you may still be able to become pregnant).
• both fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• the uterus has been surgically removed (hysterectomy).
• your ovaries no longer function (premature ovarian failure, confirmed by a gynaecology 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 child or adolescent who has not yet had her first menstrual period.

Contraception in men taking Ceptava
Although available clinical data do not indicate an increased risk of birth defects or miscarriage when the father takes mycophenolate, this risk cannot be completely ruled out. As a precaution, you or your partner are advised to use effective contraception during treatment and for 3 months after stopping Ceptava treatment.
If you are planning a pregnancy, talk to your doctor about potential risks.
Driving and using machines
Ceptava has a minor influence on the ability to drive and use machines.
Ceptava contains sodium and lactose
This medicine contains 25.9 mg of sodium (a main component of table salt) per gastro-resistant tablet. This corresponds to 1.3% of the maximum daily dietary intake recommended for an adult.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ceptava

Take this medicine exactly as your doctor has told you. Ceptava will only be prescribed by doctors experienced in the treatment of transplant patients. If you have any doubts, consult your doctor or pharmacist.

What dose to take
The recommended daily dose of Ceptava is 1440 mg (4 tablets of Ceptava 360 mg). These are taken as 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 will be administered within 72 hours after transplantation.

If you have severe kidney problems
The daily dose must not exceed 1440 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 tablet.
Avoid inhaling the powder or having direct contact of the powder with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with water.
Treatment will continue as long as immunosuppression is needed to prevent rejection of the transplanted organ.

If you take more Ceptava than you should
If you have taken more Ceptava than you were told to take, or if someone else has taken your tablets, contact your doctor or go to hospital immediately. Medical treatment may be necessary. Take the tablets with you and show them to your doctor or hospital staff. If you have no tablets left, take the empty packaging with you.

If you forget to take Ceptava
If you forget to take Ceptava, take it as soon as you remember, unless it is almost time for your next dose. In that case, take your next dose at the scheduled time. Ask your doctor for advice. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ceptava
Do not stop taking Ceptava unless your doctor tells you to. Stopping treatment with Ceptava may increase the risk of rejection of the transplanted kidney.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Elderly patients may experience more side effects due to a reduced immune defence.
Immunosuppressants, including Ceptava, reduce your body's defence mechanisms to prevent rejection of the transplanted organ. As a result, your body will not be able to defend itself against infections as effectively as under normal conditions. Therefore, if you are taking Ceptava, 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 regularly perform blood tests to monitor changes in the number of blood cells or levels of substances carried in the blood, such as sugar, fats, and cholesterol.

Some side effects can be serious:

• signs of infection including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. While taking Ceptava, you may get viral, bacterial, and fungal infections more frequently than usual. These infections may affect various parts of the body but most commonly the kidneys, bladder, and upper and/or lower airways.
• vomiting blood, dark or bloody stools, gastric or intestinal ulcer.
• swelling of glands, development of new skin growths, increase in size of existing growths, or changes in existing growths. As may occur in patients treated with immunosuppressants, a very small number of patients receiving Ceptava have developed skin or lymph node tumours. If you experience any of the above side effects after taking Ceptava, contact your doctor immediately.

Other side effects may include:
Very common ( may affect more than 1 in 10 people )

• low levels of white blood cells
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• high levels 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 )

• low levels of red blood cells which may cause tiredness, shortness of breath, and paleness (anaemia)
• low levels of platelets in the blood which may cause unexpected bleeding and bruising (thrombocytopenia)
• high levels of potassium in the blood (hyperkalaemia)
• low levels 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 lining, abdominal swelling, constipation, indigestion, flatulence, loose stools, feeling unwell (nausea), vomiting
• tiredness, fever
• abnormal results in liver or kidney function tests
• respiratory infections
• acne
• weakness (asthenia)
• muscle pain (myalgia)
• swelling of the hands, ankles, or feet (peripheral oedema)
• itching

Uncommon ( may affect up to 1 in 100 people )

• fast (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
• skin cyst-like fluid-filled formation (lymphocele)
• tremor, difficulty falling asleep
• redness and swelling of the eyes (conjunctivitis), blurred vision
• wheezing
• belching, difficulty breathing, intestinal blockage (ileus), ulceration of the lips, heartburn, change in tongue colour, dry mouth, inflammation of the gums, inflammation of the pancreas causing severe pain in the upper stomach (pancreatitis), blockage of the salivary glands, inflammation of the inner abdominal wall (peritonitis)
• bone, blood, and skin infections
• blood in the urine, kidney damage, pain and difficulty urinating
• hair loss, bruising (ecchymosis on the skin)
• joint inflammation (arthritis), back pain, muscle cramps
• loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased levels of phosphates in the blood (hypophosphataemia)
• flu-like symptoms (such as tiredness, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, chills, thirst, or weakness
• abnormal dreams, believing things that are not true (delusion)
• inability to achieve or maintain an erection
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease).

Not known ( frequency cannot be estimated from the available data )

• fever, sore throat, frequent infections (possible symptoms of lack of white blood cells in the blood) (agranulocytosis)
• skin rash, itching, hives, shortness of breath or breathing difficulties, wheezing or coughing, dizziness, drowsiness, changes in level of consciousness, hypotension, with or without mild generalized itching, skin redness, and swelling of the face/throat (symptoms of severe allergic reaction).

Other side effects reported with medicines similar to Ceptava
Additional side effects have been reported with the group of medicines to which Ceptava belongs:
inflammation of the colon (large intestine), inflammation of the stomach lining caused by cytomegalovirus, formation of a lesion in the intestinal wall causing severe abdominal pain with possible bleeding, gastric or duodenal ulcer, low levels of white blood cells specifically or of all blood cells, severe infections such as inflammation of the heart and heart valves and of the membranes covering the brain and spinal cord, shortness of breath, cough, which may lead to bronchiectasis (a condition in which the lung airways are abnormally widened), and other less common bacterial infections that usually cause serious lung disorders ( tuberculosis and infections from atypical mycobacteria ). Contact your doctor if you develop a persistent cough or shortness of breath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceptava

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceptava contains
The active substance 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, maize starch/maize, colloidal anhydrous silica/colloidal silicon dioxide, magnesium stearate
Coating
Hypromellose phthalate HP50, titanium dioxide (E171), yellow iron oxide (E172)/iron oxide, red iron oxide (E172)/iron oxide.
Description of the appearance of Ceptava and package contents
Film-coated oval-shaped tablets, pale red-orange in colour, with "CT" imprinted on one side.
Dimensions: approximately 17.6 x 7.2 x 6.3 mm
Blister PA/AL/PVC-aluminium.
Pack sizes: 50, 100, 120, 250 gastro-resistant tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Legal representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo 43, 20154 Milano, Italy
Manufacturer
Novartis Pharma GmbH
Roonstraße 25, 90429 Nuremberg
Germany
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany
Lek d.d.,
Trimlini 2D,
9220 Lendava,
Slovenia
This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:
Germany Mycophenolat - 1 A Pharma 360 mg magensaftresistente Tabletten
Italy Ceptava
Spain Ácido micofenólico Sandoz 360 mg comprimidos gastrorresistentes
EFG