CEPTAVA 360 MG GASTRO-RESISTANT TABLETS
Active substance(s): MYCOPHENOLATE SODIUM
Ceptava 360 mg
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ceptava is and what it is used for
2. What you need to know before you take 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. This belongs to a group of medicines called
Ceptava is used to stop the body’s immune
system from rejecting a kidney transplant.
It is used together with other medicines containing
ciclosporin and corticosteroids.
2. What you need to know before you take
Mycophenolate causes birth defects and
miscarriage. If you are a woman who could become
pregnant, you must provide a negative pregnancy
test before starting treatment and must follow the
contraception advice given to you by your doctor.
Your doctor will speak to you and give you written
information, particularly on the effects of
mycophenolate on unborn babies. Read the
information carefully and follow the instructions.
If you do not fully understand these instructions,
please ask your doctor to explain them again before
you take mycophenolate. See also further
information in this section under “Warnings and
precautions” and “Pregnancy and breast-feeding”.
Do not take Ceptava:
• if you are allergic (hypersensitive) to mycophenolic
acid, mycophenolate sodium, mycophenolate
mofetil or any of the other ingredients of this
medicine (listed in section 6).
• if you are a woman who could be pregnant and you
have not provided a negative pregnancy test
before your first prescription, as mycophenolate
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 effective contraception (see
Contraception in women and men).
• if you are breast-feeding (see also “Pregnancy and
If any of the above apply to you, tell your doctor
without taking Ceptava.
Warnings and precautions
Talk to your doctor or pharmacist before taking
• if you have or have ever had serious
digestive problems, such as stomach ulcer.
• if you have a rare hereditary enzyme deficiency
phosphoribosyl-transferase (HGPRT) such as
Lesch-Nyhan or Kelley-Seegmiller syndrome.
You should also be aware that:
• Ceptava lowers the skin´s level of protection from
the sun. This increases the risk of skin cancer.
You should limit your exposure to sunlight and
ultraviolet (UV) light by covering exposed skin
areas as much as possible and regularly applying
sunscreen with a high protective factor. Ask
your doctor for advice on protection from the sun.
• if you already had hepatitis B or C, Ceptava may
increase the risk of these diseases re-appearing.
Your doctor may perform blood analysis and
check for symptoms of these diseases. If you
experience any symptoms (yellow skin and eyes,
nausea, loss of appetite, dark urine) you should
tell your doctor immediately.
• if you get a persistent cough or become
breathless, especially when taking other
immunosuppressants, you should tell your
doctor straight away.
• your doctor may want to check your blood level
of antibodies during treatment with Ceptava
particularly when the infections recur, especially
if you are also taking other immunosuppressants,
and will tell you whether you can continue
• if you get any signs of infection (such as fever
or a sore throat) or unexpected bruising or
bleeding you should tell your doctor straight away.
• your doctor may want to check your white blood
cell count during treatment with Ceptava, and will
tell you whether you can continue taking Ceptava.
• the active substance, mycophenolic acid, is not
the same as other similar-sounding medicines
such as mycophenolate mofetil. You should not
switch between medicines unless your doctor
tells you to.
• use of Ceptava in pregnancy may harm the
foetus (see also “Pregnancy and breast-feeding”)
and increase the risk of pregnancy loss
Other medicines and Ceptava
Tell your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines,
including medicines obtained without a prescription.
In particular, you should talk to your doctor if you are
taking any of the following:
• other immunosuppressant medicines such as
azathioprine or tacrolimus.
• medicines used to treat high blood cholesterol
levels such as cholestyramine.
• activated charcoal used to treat digestive
problems such as diarrhoea, upset stomach,
• antacids that contain magnesium and aluminium.
• medicines used to treat viral infections such as
aciclovir or ganciclovir.
You should also tell your doctor if you plan to have
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 90 days after
Ceptava with food and drink
Ceptava can be taken with or without food. You
need to choose whether to take your tablets with or
without food and then take them in the same way
each day. This is to make sure that the same amount
of your medication is absorbed into your body each
Elderly people (age 65 years or older) can take
Ceptava without any need to adjust the usual
Paediatric population and adolescents
The use of Ceptava in children and adolescents is
not recommended due to lack of data.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 talk to you about the risks
in case of pregnancy and the alternatives you can
take to prevent rejection of your transplant organ if:
• You plan to become pregnant.
• You miss or think you have missed a period, or
you have unusual menstrual bleeding, or
suspect you are pregnant.
• You have sex without using an effective method
If you do become pregnant during the treatment
with mycophenolate, you must inform your doctor
immediately. However, keep taking mycophenolate
until you see him or her.
Mycophenolate causes a very high frequency of
miscarriage (50%) and of severe birth defects
(23 - 27%) in the unborn baby. Birth defects which
have been reported include anomalies of ears, of
eyes, of face (cleft lip/palate), of development of
fingers, of heart, oesophagus (tube that connects
the throat with the stomach), kidneys and nervous
system (for example spina bifida (where the bones of
the spine are not properly developed)).
Your baby may be affected by one or more of these.
If you are a woman who could become pregnant,
you must provide a negative pregnancy test, before
starting treatment and must follow the contraception
advice given to you by your doctor. Your doctor may
request more than one test to ensure you are not
pregnant before starting treatment.
Do not take Ceptava if you are breast-feeding. This
is because small amounts of the medicine can pass
into the mother’s milk.
Contraception in women taking Ceptava
If you are a woman who could become pregnant you
must always use two effective methods of
contraception with Ceptava. This includes:
• Before you start taking Ceptava
• During your entire treatment with Ceptava
• For 6 weeks after you stop taking Ceptava.
In addition, female partners of male patients treated
with Ceptava are recommended to use highly
effective contraception during treatment and for a
total of 90 days after the last dose of Ceptava.
Talk to your doctor about the most suitable
contraception for you. This will depend on your
individual situation. Contact your doctor as soon
as possible, if you think your contraception
may not have been effective or if you have
forgotten to take your contraceptive pill.
You are a woman who is not capable of becoming
pregnant if any of the following applies to you:
• You are post-menopausal, i.e. at least 50 years
old and your last period was more than a year
ago (if your periods have stopped because you
have had treatment for cancer, then there is still
a chance you could become pregnant)
• Your fallopian tubes and both ovaries have
been removed by surgery (bilateral
• Your womb (uterus) has been removed by
• Your ovaries no longer work (premature ovarian
failure, which has been confirmed by a
• You were born with one of the following rare
conditions that make pregnancy impossible:
the XY genotype, Turner’s syndrome or uterine
• You are a child or teenager who has not started
Contraception in men taking Ceptava
You must always use condoms during treatment and
for at least 90 days after you stop taking
Ceptava. Condom use applies for both
reproductively competent and vasectomized men,
because the risks associated with the transfer of
seminal fluid also apply to men who have had a
vasectomy. If you are planning to have a child, your
doctor will talk to you about the risks and the
alternative treatments you can take to prevent
rejection of your transplant organ.
Driving and using machines
Ceptava has not been shown to affect your ability to
drive or use machines.
Ceptava contains lactose
If you have been told by a doctor that you have an
intolerance to some sugars (including lactose,
galactose, or glucose), contact your doctor before
3. How to take Ceptava
Always take this medicine exactly as your doctor has
told you. Ceptava will only be prescribed for you by a
doctor with experience in treating transplant patients.
Check with your doctor or pharmacist if you are not
Continued on next page >>
How much to take
The recommended daily dose of Ceptava is
1440 mg (4 tablets of Ceptava 360 mg). This is
taken as 2 separate doses of 720 mg each (2 tablets
of Ceptava. Take your tablets in the morning and in
The first dose of 720 mg will be given within
72 hours after transplantation.
If you have severe kidney problems
Your daily dose should not be more than 1440 mg
(4 tablets of Ceptava 360 mg).
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take any tablets that are broken or split.
Avoid inhalation of the powder or direct contact of
the powder with skin or mucous membrane. If such
contact occurs, wash thoroughly with soap and
water; rinse eyes with plain water.Treatment will
continue for as long as you need immunosuppression
to stop your body rejecting your transplant.
If you take more Ceptava than you should
If you take more Ceptava than you should, or if
someone else has taken your tablets, talk to a doctor
or go to a hospital straight away. Medical attention
may be necessary. Take the tablets with you and
show them to your doctor or to the hospital staff. If
you have run out of tablets, 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.
Then take your next dose at the usual 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 Ceptava may increase the chance of
your body rejecting your kidney transplant.
If you have any further questions on the use of 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, reduces
your body´s own defence mechanisms to stop you
rejecting your transplanted organ. Consequently
your body will not be as good as normal at fighting
infections. So if you are taking Ceptava, you may
therefore catch more infections than usual such as
infections of the brain, skin, mouth, stomach and
intestines, lungs and urinary tract.
Your doctor will perform regular blood tests to
monitor any changes in the number of your blood
cells or in the levels of substances carried in your
blood, such as sugar, fat and cholesterol.
Some effects could be serious:
• signs of infection including fever, chills,
sweating, feeling tired, drowsy, or lack of
energy. If you are taking Ceptava you may
be more likely to get viral, bacterial and
fungal infections than usual. Such infections
could affect various parts of your body, but the
parts most commonly affected are the kidneys,
bladder, upper and/or lower airways.
• vomiting blood, black or bloody stools, stomach
or intestinal ulcer.
• swelling of your glands, development of a new
skin growth or enlargement of an existing skin
growth, or changes in an existing mole. As can
happen in patients taking immunosuppressants,
a very small number of Ceptava patients have
developed cancer of the skin or lymph nodes.
If you experience any of the above after taking
Ceptava, talk to your doctor straight away.
Other side effects may include:
Very common (may affect more than 1 in 10 people)
• low level of white blood cells
• low level of calcium in the blood
• low level of potassium in the blood (hypokalemia)
• high level of uric acid in the blood (hyperuricemia)
• high blood pressure (hypertension)
• pain in joints (arthralgia)
Common (may affect up to 1 in 10 people)
• low level of red blood cells which can result in
tiredness, breathlessness and looking pale
• low level of blood platelets which can result in
unexpected bleeding and bruising
• high level of potassium in the blood (hyperkalemia)
• low level of magnesium in the blood
low blood pressure (hypotension)
shortness of breath (dyspnoea)
abdominal or stomach pain, inflammation of the
lining of the stomach, abdominal bloating,
constipation, indigestion, wind (flatulence),
loose stools, feeling sick (nausea), being sick
abnormal results of liver or kidney function tests
muscle pain (myalgia)
swollen hands, ankles or feet (oedema peripheral)
Uncommon (may affect up to 1 in 100 people)
• fast heart beat (tachycardia) or irregular heart
beat (ventricular extrasystoles), fluid in the
lungs (pulmonary oedema)
• a growth that looks like a sac (cyst) containing
fluid (lymph) (lymphocele)
• trembling, difficulty in sleeping
• redness and swelling of eyes (conjunctivitis),
• belching, bad breath, bowel blockage (ileus),
lip ulcers, heartburn, tongue discolouration, dry
mouth, inflammation of the gums, inflammation
of the pancreas leading to severe upper
stomach pain (pancreatitis), blockage of the
salivary glands, inflammation of the inner lining
of the abdomen (peritonitis)
• infection of the bones, blood and the skin
• blood in urine, damage to the kidney, pain and
difficulty passing urine
• hair loss, skin bruising
• inflammation of the joints (arthritis), back pain,
• loss of appetite, increased level of lipids
(hyperlipidemia), sugar (diabetes), cholesterol
(hypercholesterolemia), or decreased level of
phosphate in the blood (hypophosphatemia)
• signs of flu (such as tiredness, chills, sore throat,
aching joints or muscles), swelling of ankles
and feet, pain, rigors, feeling thirsty or weak
• strange dreams, believing things that aren´t true
• inability to get or keep an erection
• cough, difficulty breathing, painful breathing
(possible symptoms of interstitial lung disease)
Not known (frequency cannot be estimated from the
• fever, sore throat, frequent infections
(possible symptoms of lack of white cells in the
Other side effects reported with medicines
similar to Ceptava
Additional side effects have been reported with the
group of medicines that Ceptava belongs to:
inflammation of the colon (large intestine),
inflammation of the stomach lining caused by
cytomegalovirus, development of a hole in the
intestinal wall, resulting in severe abdominal pain
with possible bleeding, stomach or duodenal ulcers,
a low level 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 that
covers the brain and spinal cord, shortness of breath,
cough, which can be due to bronchiectasis
(a condition in which the lung airways are abnormally
dilated) and other less common bacterial infections
usually resulting in a serious lung disorder
(tuberculosis and atypical mycobacterial infection).
Talk to your doctor if you develop a persistent cough
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (www.
mhra.gov.uk/yellowcard). 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
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
temperature storage conditions.
Store in the original package in order to protect from
Do not use this medicine if you notice that the pack
is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other
What Ceptava contains
The active substance is mycophenolic acid
(as mycophenolate sodium).
Each gastro-resistant tablet contains 360 mg of
The other excipients are:
Lactose anhydrous, crospovidone (type A),
povidone K 30, maize starch/corn starch,
colloidal anhydrous silica / colloidal silicon
dioxide, magnesium stearate
Hypromellose phthalate HP 50, titanium dioxide (E
171), iron oxide yellow (E 172)/ ferric oxide, iron
oxide red (E 172)/ ferric oxide
What Ceptava looks like and contents of the pack
Pale orange-red film-coated ovaloid tablets with
imprint (debossing) ‘CT’ on one side.
Dimensions: approximately 17.6 x 7.2 x 6.3 mm
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Frimley Business Park,
Lek Pharmaceuticals d.d.
Verovškova ulica 57,
Salutas Pharma GmbH
Sachsen-Anhalt, 39179 Barleben
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nuernberg
This leaflet was last revised in 11/2016.
PA/AL/PVC-aluminium blister packs.
Pack sizes: 50, 100, 120, 250
Not all pack sizes may be marketed.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.