Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Certican.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine.
You can also download the most up to date leaflet from www.novartis.com.au. Those
updates may contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Certican against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Certican is used for
Certican is used to treat adult patients who have had kidney, heart or liver transplants.
It helps to prevent your body from rejecting the transplanted organ.
Certican contains the active ingredient everolimus. It belongs to a group of medicines
called immunosuppressants. These medicines help to control your body's immune system.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
Certican is available only with a doctor's prescription and is not addictive.
There is not enough information to recommend the use of this medicine in children
Before you take Certican
When you must not take it
Do not take Certican if you have an allergy to:
everolimus, the active ingredient in Certican
any of the ingredients listed at the end of this leaflet.
a similar medicine called Rapamune which contains the active ingredient sirolimus.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing; sudden difficulty swallowing; swelling of the face, lips,
tongue or other parts of the body; rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have or have had any of the following medical conditions:
problems with your liver
Tell your doctor if you are pregnant or plan to become pregnant.
Certican is not recommended for use during pregnancy. Your doctor can discuss with
you the risks and benefits involved.
Tell your doctor if you are breast-feeding.
Breastfeeding is not recommended while you are taking Certican. It is not known whether
Certican passes into breast milk and could affect your baby.
Tell your doctor if you are male and you want to father children.
Certican may reduce sperm production in men, thus reducing the ability to father children.
The effect is generally reversible.
Tell your doctor if you have intolerance to certain sugars (glucose, galactose, lactose).
Certican tablets contain lactose.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Your doctor will want to know if you are prone to allergies.
Medicines that suppress the immune system like Certican reduce your body's ability
to fight against infections. It is advisable to consult your doctor if you have a
fever or generally feel unwell, or have local symptoms such as coughing or a burning
sensation when urinating that are severe or persistent over several days. Consult
your doctor right away if you feel confused, have problems speaking, memory loss,
a headache, impaired vision or seizures, as these may be symptoms of a rare but very
serious condition called progressive multiple leukoencephalopathy (PML).
Tell your doctor if you have had recent major surgery, or if you still have an unhealed
wound following surgery,
Certican may increase the risk of wound-healing problems.
If you have not told your doctor about any of the above, tell him/her before you start
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines and Certican may interfere with each other. These include:
Immunosuppressive medicines other than cyclosporin for microemulsion, tacrolimus or
Antibiotics such as rifampicin, clarithromycin, erythromycin and rifabutin
Antifungal medicines such as ketoconazole, fluconazole and itraconazole
Medicines for high blood pressure or heart problems such as diltiazem and verapamil
dronedarone, a medicine used to help regulate your heart beat
Medicines used to treat HIV/AIDS such as nelfinavir, indinavir, amprenavir, efavirenz
medicines used to lower blood cholesterol, such as atorvastatin, pravastatin or fibrates
Midazolam, a medicine used to treat acute seizures, or used as a sedative before or
during surgery or other medical procedure.
Epilepsy medicines such as carbamazepine, phenobarbitone and phenytoin
octreotide, a medicine used to treat acromegaly, a rare hormonal disorder that usually
occurs in middle-aged adults
Medicines for stomach ulcer or reflux such as cimetidine and cisapride
Medicines to prevent nausea and vomiting such as metoclopamide
Danazol which is used to treat endometriosis
Bromocriptine which is used to treat Parkinson's disease
imatinib, a medicine used to inhibit the growth of abnormal cells
St John's wort, a herbal product used to treat depression and other conditions.
Such medicines may be affected by Certican or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Some vaccines may be less effective if given when taking Certican.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to take Certican
Certican tablets are swallowed whole.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label ask your doctor or pharmacist
How much to take
Kidney and heart transplantations
The usual starting dose is 0.75 mg Certican twice daily, taken in the morning and
in the evening together with cyclosporine.
The first dose of Certican will be given as soon as possible after transplantation.
The general recommended daily dose is 1 mg Certican twice daily, taken in the morning
and in the evening, together with tacrolimus.
The first dose of Certican will be given approximately four weeks after transplantation.
Your doctor will take regular blood tests to measure the amount of Certican in your
blood. If needed, your doctor will adjust your dose depending on the results from
your blood tests.
When to take it
Always take Certican twice a day. It is best to take the doses 12 hours apart if possible.
Taking your doses 12 hours apart and at the same time each day will have the best
effect. It will also help you remember when to take them.
Certican can be taken with or without food but should always be taken the same way.
(e.g. always with food or always without food).
If you are taking cyclosporine or tacrolimus, you should take it at the same time
How to take it
Swallow the tablets whole with a full glass of water.
Do not crush or chew them.
Do not take Certican with grapefruit juice.
How long to take it
Keep taking this medicine for as long as your doctor tells you.
You will need to take Certican as long as you have your transplanted organ, or until
your doctor changes your immunosuppressive medication.
If you forget to take it
If it is almost time for your next dose skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you miss more than one dose, ask your doctor for advice.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much Certican. Do this even if there
are no signs of discomfort or poisoning.
While you are taking Certican
Things you must do
Keep all of your doctor's appointments so that your progress can be checked.
Regular check-ups with blood and urine tests are essential for your doctor to assess
the good function of your transplanted organ, to detect possible unwanted side effects
and to adapt the dosages of your medicines to obtain the best treatment.
Blood tests allow your doctor to measure levels of your medicines to check your kidney
activity and the levels of sugar and cholesterol in your blood.
Measurement of proteins in a urine sample also helps your doctor to assess kidney
Make sure you use a highly effective contraceptive to prevent pregnancy during treatment
with Certican. If you become pregnant while taking this medicine, tell your doctor
If you develop lumps anywhere in your body, or develop any moles, or you notice changes
in existing moles, tell your doctor.
This may be an early sign of a cancer. Immunosuppressant medicines, including Certican,
may increase the risk of developing certain cancers, including skin cancer and lymphoma
(cancer of the lymphatic system).
If you go out in the sun, wear a hat, protective clothing and sunscreen. Do not use
a sun lamp.
This will help to prevent the development of skin cancer.
If you want to be vaccinated, tell your doctor you are taking Certican before you
have the vaccination.
Certican may affect your response to vaccination. Some vaccines may not be suitable
If you are experiencing respiratory symptoms (e.g. coughing, difficulty in breathing
and wheezing), please inform your doctor. Your doctor may decide whether and how you
need to continue Certican, and/or whether you need to receive other medicines to resolve
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Certican.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
Things you must not do
Do not take Certican to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
Things to be careful of
Be careful driving or operating machinery until you know how Certican affects you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Certican.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
general pain, muscle or joint pain or tenderness
weakness, bruising and frequent infections
upper and lower respiratory tract infections
urinary tract infections
slowed wound healing or wound infection
nausea, vomiting, diarrhoea
cold sores, mouth sores
pain in the ear, nose or throat
jaundice (yellowing of the skin and eyes with darkened urine).
increased heart rate
If any of the following happen, tell your doctor immediately:
swelling of hands, feet or limbs due to fluid retention
symptoms of an allergic reaction such as shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue, throat or other parts of the body;
rash, itching or hives on the skin
burning sensation on urination or increased urgency to urinate
severe upper stomach pain, which may be accompanied by nausea and vomiting
constant "flu-like" symptoms such as fever (increased temperature), chills/shivering,
sore throat, aching joints, swollen glands, cough, or any other signs of infection
such as infection of a cut or scratch
new lumps or moles, or changes to existing moles, anywhere on the body
unusual bleeding or bruising without obvious cause
persistent or worsening lung/breathing symptoms like coughing, difficulty breathing,
pain, hernia, unusual warmth, swelling or oozing from the site of surgery
tiredness, headaches, shortness of breath when exercising, dizziness and looking pale,
which could be signs of anaemia
swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in
swallowing or breathing
sudden reduction in your urine output, especially if accompanied by pain where your
transplanted kidney is located.
signs that blood clots may have formed, such as severe sudden headache, sudden loss
of coordination, blurred vision, loss of vision, slurred speech, numbness in an arm
or leg, pain in the calves, thighs or chest, shortness of breath, coughing blood.
The above list includes serious side effects. You may need urgent medical attention
In addition, your doctor will do blood tests to check your kidneys to make sure they
are not being damaged during treatment with Certican.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed here or not yet known may happen in some people. Some
of these side effects can only be found by laboratory testing (e.g. blood level of
sugar, fat and cholesterol).
After taking Certican
Keep the tablets in the original packet and foils until it is time to take them.
Store the tablets in a cool, dark and dry place at room temperature.
Do not store Certican or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep the medicine where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What it looks like
Certican tablets are white to yellowish, round and marbled. Certican tablets are available
in four different strengths, supplied in packs of 60 tablets:
0.25 mg: with "C" on one side and "NVR" on the other
0.5 mg: with "CH" on one side and "NVR" on the other
0.75 mg: with "CL" on one side and "NVR" on the other
1.0 mg: with "CU" on one side and "NVR" on the other
Certican tablets contain 0.25, 0.5, 0.75 mg and 1.0 mg of everolimus as the active
ingredient. They also contain:
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Certican is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone 1 800 671 203
® = Registered Trademark
This leaflet was prepared in
Australian Registration Number.
0.25 mg tablets - AUST R 97500
0.5 mg tablets - AUST R 97506
0.75 mg tablets - AUST R 97509
1.0 mg tablets.-.AUST R 97516
(cer210518c.doc) based on PI (cer210518i.doc)