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CERTICAN 0.75 MG TABLETS

Active substance(s): EVEROLIMUS

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3. How to take Certican
2. What you need to know before you take
Certican

Package leaflet: Information for the user

Certican 0.25 mg tablets
Certican® 0.5 mg tablets
Certican® 0.75 mg tablets
Certican® 1 mg tablets
®

Do not take Certican

• if you are allergic (hypersensitive) to everolimus or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to sirolimus.
If any of the above applies to you, tell your doctor and do not take
Certican.

Warnings and precautions

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 Certican is and what it is used for
2. What you need to know before you take Certican
3. How to take Certican
4. Possible side effects
5. How to store Certican
6. Contents of the pack and other information

1. What Certican is and what it is used for
The active substance of Certican is everolimus.
Everolimus belongs to a group of medicines called immunosuppressants.
It is used in adults to prevent the body’s immune system from rejecting
a transplanted kidney, heart or liver.
Certican is used together with other medicines, such as ciclosporin for
kidney and heart transplantation, tacrolimus for liver transplantation,
and corticosteroids.

Talk to your doctor before taking Certican:
• Medicines that suppress the immune system like Certican reduce your
body´s ability to fight against infections. It is advisable to consult your
doctor or transplant centre 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 or transplant centre 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).
• 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.
• Medicines that suppress the immune system like Certican increase
the risk of developing cancers, particularly of the skin  and the
­lymphoid system. Therefore, you should limit your exposure to
­sunlight and UV light by wearing appropriate protective clothing and
frequently applying a sunscreen with a high protection factor.
• Your doctor will monitor your kidney function, the amounts of fats
(lipids) and sugar in your blood as well as the amount of proteins in
your urine.
• If you have liver problems or have ever had a disease which may have
affected your liver, please tell your doctor. Your doctor may need to
modify the dose of Certican you are taking.
• If you experience respiratory symptoms (e.g. coughing, difficulty in
breathing and wheezing), please inform your doctor. Your doctor may
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Everolimus

There is limited experience with the administration of Certican in
elderly people.

Children and adolescents (younger than 18 years of age)

Certican is not recommended for use in children and adolescents with
a transplanted kidney because there is not enough experience in the
use of Certican in this age group. Certican should not be used in
children and adolescents with a transplanted liver.

Other medicines and Certican

Tell your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines, including medicines obtained
without a prescription.
Certain medicines may affect the way in which Certican works in the
body. It is very important that you tell your doctor if you are taking any
of the following medicines:
• immunosuppressive medicines other than ciclosporin, tacrolimus or
corticosteroids.
• antibiotics, such as rifampicin, rifabutin, clarithromycin, erythromycin
or telithromycin.
• antiviral medicines, such as ritonavir, efavirenz, nevirapine, nelfinavir,
indinavir or amprenavir, which are used to treat HIV infection.
• medicines used to treat fungal infections, such as voriconazole,
fluconazole, ketoconazole or itraconazole.
• medicines used to treat epilepsy, such as phenytoin, phenobarbital
or carbamazepine.
• medicines used to treat high blood pressure or heart problems, such
as verapamil, nicardipine or diltiazem.
• dronedarone, a medicine used to help regulate your heart beat.

Certican with food and drink

The presence of food can affect how much Certican is absorbed. In
order to keep constant levels in your body, you should always take
Certican in the same way. You should either always take it with food, or
always on an empty stomach.
Do not take Certican with grapefruit juice or grapefruit. They affect how
Certican works in the body.

Pregnancy, breast-feeding and fertility

If you are pregnant, do not take Certican unless your doctor thinks it is
absolutely necessary. If you are a woman and you could get pregnant,
you should use an effective method of contraception during treatment
with Certican and for 8 weeks after stopping treatment.
If you think you may be pregnant, ask your doctor or pharmacist for
advice before taking Certican.
You should not breast-feed while taking Certican. It is not known whether
Certican passes into breast milk.
Certican may have an impact on male fertility.

Driving and using machines

No studies on the effects on the ability to drive and use machines have
been performed.

Certican contains

Certican tablets contain lactose. If you do not tolerate certain sugars
(glucose, galactose, lactose), you should talk to your doctor before
taking Certican.

Your doctor will decide exactly what dose of Certican you should take
and when you should take it.
Always take Certican exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

How much to take

• The usual starting dose is 1.5 mg/day in kidney and heart transplantation
and 2.0 mg/day in liver transplantation.
• This is usually divided into two doses, one in the morning and one in
the evening.

How to take Certican

Certican should only be taken by mouth.
Do not crush the tablets.
Swallow the tablets whole with a glass of water.
You should take the first dose of this medicine as early as possible after
kidney and heart transplantation and approximately four weeks after
liver transplantation.
You should take the tablets together with ciclosporin for microemulsion
in kidney and heart transplantation, and with tacrolimus in liver
transplantation.
Do not switch from Certican tablets to Certican dispersible tablets
without first telling your doctor.

Monitoring during your treatment with Certican

Your doctor may adjust your dose depending on how much Certican
there is in your blood and depending on how well you respond to the
treatment. Your doctor will perform regular blood tests to measure the
amount of everolimus and ciclosporin in your blood. Your doctor will
also carefully monitor your kidney function, blood lipids and blood
sugar, as well as the amount of proteins in your urine.

If you take more Certican than you should

If you take more of this medicine than you should, talk to your doctor
immediately.

If you forget to take Certican

If you have forgotten to take your dose of Certican, take it as soon as you
remember and then take the next dose at the usual time. Ask your doctor
for advice. Do not take a double dose to make up for a forgotten tablet.

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Older people (65 years and over)

• medicines used to lower blood cholesterol, such as atorvastatin,
pravastatin or fibrates.
• medicines used to treat acute seizures, or used as a sedative before or
during surgery or other medical procedures, such as midazolam.
• octreotide, a medicine used to treat acromegaly, a rare hormonal
disorder that usually occurs in middle-aged adults.
• imatinib, a medicine used to inhibit the growth of abnormal cells.
• St. John’s wort (Hypericum perforatum), a herbal medicine used to
treat depression.
• If you need to have a vaccination, talk to your doctor first.

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decide whether and how you need to continue Certican, and/or
whether you need to receive other medicines to resolve this condition.
• Certican may reduce sperm production in men, thereby reducing the
ability to father children. The effect is generally reversible. Male
­patients wanting to father children should discuss their treatment
with their physician.

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If you stop taking Certican

Do not stop taking the tablets unless your doctor tells you to. You will
need to take this medicine for as long as you need to have
immunosuppressants to prevent the rejection of your transplanted
kidney, heart or liver. If you stop taking Certican, you will have a greater
risk of your body rejecting the transplanted organ.
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.
Because you take Certican together with other medicines, it is not
always clear whether the side effects are caused by Certican or by the
other medicines.

The following side effects need immediate medical attention:

• infections,
• inflammation of the lungs,
• allergic reactions,
• fever and bruising under the skin that may appear as red dots, with
or without unexplained tiredness, confusion, yellowing of the skin or
eyes, reduced urine output (thrombotic microangiopathy, haemolytic
uraemic syndrome).
Should you develop any of the following:
• persistent or worsening lung/breathing symptoms such as coughing,
difficulty breathing, or wheezing,
• fever, generally feeling unwell, chest or abdominal pain, chills,
burning sensation when urinating,
• swelling of face, lips, tongue or throat,
• difficulty swallowing,
• spontaneous bruising or bleeding for no obvious reason,
• rash,
• pain, unusual warmth, swelling or oozing from the site of surgery
you should stop taking Certican and tell your doctor straight away.

Other reported side effects include:
Very common (may affect more than 1 in 10 patients)
• infections (viral, bacterial and fungal infections),
• lower respiratory tract infections, such as lung infections, including
pneumonia

• upper respiratory tract infections, such as inflammation of the pharynx,
and common cold,
• urinary tract infections,
• anaemia (reduced red blood cell count),
• low levels of white blood cells, leading to a higher risk of infection,
reduced blood platelet count, which can lead to bleeding and/or
bruising underneath the skin,
• high level of fats (lipids, cholesterol and triglycerides) in the blood,
• onset of diabetes (high level of sugar in the blood),
• reduced level of potassium in the blood,
• anxiety,
• problems falling asleep (insomnia),
• headache,
• fluid collection in the sac around the heart, which if severe, can
decrease the heart’s ability to pump blood,
• high blood pressure,
• venous thrombosis (blockage of a major vein by a blood clot),
• fluid collection on the lungs and in the chest cavity, which, if severe,
could make you breathless,
• coughing,
• breathlessness,
• diarrhoea,
• feeling sick (nausea),
• being sick (vomiting),
• stomach (abdominal) pain,
• general pain,
• fever,
• accumulation of fluid in the tissues,
• abnormal wound healing.
Common (may affect up to 1 in 10 patients)
• blood poisoning,
• wound infection,
• cancers and benign tumours,
• skin cancer,
• kidney damage with low blood platelets and low red blood cell counts,
with or without a rash (thrombocytopenic purpura/haemolytic uraemic
syndrome),

• breakdown of red blood cells,
• low levels of red blood cells and platelets,
• fast heart beat,
• nose bleeds,
• reduced numbers of blood cells (symptoms may include weakness,
bruising and frequent infections),
• clotting in the blood vessels of the kidney, which may result in graft
loss mostly within the first 30 days after kidney transplantation,
• bleeding disorders,
• cyst containing lymph fluid,
• pain in the mouth or throat,
• inflammation of the pancreas,
• mouth sores,
• acne,
• hives (urticaria) and other allergic symptoms, such as swelling of the
face or throat (angiooedema),
• rash,
• joint pain,
• muscle pain,
• protein in the urine,
• kidney disorders,
• impotence,
• hernia at the site of surgery,
• abnormal liver test results.
Uncommon (may affect up to 1 in 100 patients):

cancer of the lymph tissue (lymphoma/post-transplant
lymphoproliferative disorder),
• low levels of testosterone,
• inflammation of the lungs,
• inflammation of the liver,
• jaundice,

Other side effects:

Other side effects have occurred in a small number of people, but their
exact frequency is unknown:
• abnormal accumulation of protein in the lungs (symptoms may
include persistent dry cough, fatigue and difficulty breathing),

There may also be side effects of which you are not aware, such as
abnormal results of laboratory tests, including tests of kidney function.
This means that your doctor will perform blood tests to monitor any
changes to your kidneys during your treatment with Certican.

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 internet at 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 Certican
• Keep Certican out of the sight and reach of children.
• Do not use Certican after the expiry date which is stated on the carton
after EXP. The expiry date refers to the last day of that month.
• Store the blister packs in the original carton in order to protect from
light and moisture.
• Do not use any Certican pack that 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. Content of the pack and other information
What Certican contains

• The active substance is everolimus. Each tablet contains 0.25, 0.5,
0.75 or 1.0 mg everolimus.
• The other ingredients are:
– Certican 0.25 mg tablets: butylhydroxytoluene (E321), magnesium
stearate, lactose monohydrate (2 mg), hypromellose, crospovidone
and anhydrous lactose (51 mg).

What Certican looks like and contents of the pack

• Certican 0.25 mg tablets are white to yellowish, marbled, round, flat
tablets of 6 mm, engraved “C” on one side and “NVR” on the other.
• Certican 0.5 mg tablets are white to yellowish, marbled, round, flat
tablets of 7 mm, engraved “CH” on one side and “NVR” on the other.
• Certican 0.75 mg tablets are white to yellowish, marbled, round, flat
tablets of 8.5 mm, engraved “CL” on one side and “NVR” on the other.
• Certican 1  mg tablets are white to yellowish, marbled, round, flat
tablets of 9 mm, engraved “CU” on one side and “NVR” on the other.
Certican tablets are supplied in packs containing 50, 60, 100 or 250 tablets.
Not all pack sizes may be marketed. Certican is also available in the
form of dispersible tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR
United Kingdom.

Manufacturer:

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

This leaflet was last revised in
January 2016.

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If you have concerns regarding any of these effects, tell your doctor.

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• inflammation of blood vessels,
• severe rash with skin swelling.

– Certican 0.5 mg tablets: butylhydroxytoluene (E321), magnesium
stearate, lactose monohydrate (4 mg), hypromellose, crospovidone
and anhydrous lactose (74 mg).
– Certican 0.75 mg tablets: butylhydroxytoluene (E321), magnesium
stearate, lactose monohydrate (7 mg), hypromellose, crospovidone
and anhydrous lactose (112 mg).
– Certican 1 mg tablets: butylhydroxytoluene (E321), magnesium
stearate, lactose monohydrate (9  mg), hypromellose,
crospovidone and anhydrous lactose (149 mg).

No

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Production Site:
CTM:

Stein
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Leaflet_CERTICAN_TAB_GB

Printing Colours:

Black

1453135 GB
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420 x 148 mm
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Approval Box and Ready for Print Box only to be used
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Checking against manuscript according to
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Technical approval. To be signed by Manufacturing Site.

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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.

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