КЕРТИКАН 0.25 MG Coated tablet

Содержание инструкции

1. Certican 0.25 mg tablets, 0.5 mg tablets, 0.75 mg tablets, 1.0 mg tablets
   1. What is Certican and what is it 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. Package Contents and Other Information
2. Certican 0.1 mg dispersible tablets, 0.25 mg dispersible tablets
   1. What is Certican and what is it 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. Package contents and other information

Certican 0.25 mg tablets, 0.5 mg tablets, 0.75 mg tablets, 1.0 mg tablets

everolimus

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Certican and what is it used for

The active ingredient of Certican is everolimus.
Everolimus belongs to a group of medicines known as immunosuppressants. It is used in adults to
prevent your immune system from rejecting a transplanted kidney, heart or liver.
Certican is used in combination with other medicines such as ciclosporin for kidney and heart transplantation,
tacrolimus for liver transplantation, and corticosteroids.

2. What you need to know before you take Certican

Do not take Certican

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

Warnings and precautions
Talk to your doctor before taking Certican:

• Medicines that suppress the immune system, such as Certican, decrease your body's ability to fight infections. It is advisable to consult your doctor or transplant center if you have a fever or if you generally feel unwell or experience local symptoms such as cough or a burning sensation when urinating that are severe or persist for several days. Immediately consult your
  doctor or transplant center if you become confused, experience speech disorders, memory loss,
  headache, vision disturbances or convulsions, as these may be symptoms of a
  rare but very serious condition known as progressive multifocal leukoencephalopathy (PML).

Elderly (65 years or older)
There is limited experience regarding the administration of Certican in the elderly population.

Children and adolescents
Certican must not be used in children and adolescents who have undergone kidney, heart or liver transplantation.

Other medicines and Certican
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
Some medicines can interfere with the action of Certican. 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 for example rifampicin, rifabutin, clarithromycin, erythromycin or telithromycin.
• antiviral medicines, such as for example ritonavir, efavirenz, nevirapine, nelfinavir, indinavir or amprenavir, used to treat HIV infection.
• medicines used to treat fungal infections, such as for example voriconazole, fluconazole, ketoconazole or itraconazole.
• medicines used to treat epilepsy, such as for example phenytoin, phenobarbital or carbamazepine.
• medicines used to treat high blood pressure or heart problems, such as for example verapamil, nicardipine or diltiazem.
• dronedarone, a medicine used to help regulate the heartbeat.
• medicines used to lower cholesterol levels in the blood, such as for example atorvastatin or pravastatin or fibrates.
• medicines used to treat acute seizures or as a sedative before or during surgery or other medical procedures, such as midazolam.
• cannabidiol (uses include, also, the treatment of convulsive crises).
• octreotide, a medicine used to treat acromegaly, a rare hormonal disease that usually develops in middle-aged adults.
• imatinib, a medicine used to inhibit the growth of abnormal cells.
• St John's wort (Hypericum perforatum), a medicine based on a medicinal plant used to treat depression.
• if you need a vaccination, talk to your doctor about it immediately.

Certican with food and drink
The presence of food can affect the amount of Certican that is absorbed. To maintain consistent
levels in the body, Certican must always be taken under the same conditions. You should always take it with food or
always fasting.
Certican should not be taken with grapefruit juice or grapefruit. They interfere with the action
of Certican.

Pregnancy, breastfeeding and fertility
Do not take Certican if you are pregnant unless your doctor considers it absolutely necessary. If you
are a woman of childbearing potential, you should use an effective method of contraception during treatment with Certican
and for 8 weeks after stopping treatment.
If you suspect you are pregnant, ask your doctor or pharmacist for advice before taking Certican.
You should not breastfeed 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
Certican does not alter or alters negligibly the ability to drive vehicles and use machines.

Certican contains lactose
Certican tablets contain lactose. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.

3. How to take Certican

The 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 instructed. If you have any doubts, ask your
doctor or pharmacist.

How much Certican to take

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

How to take Certican
Certican is for oral use only.
Do not crush the tablets.
Swallow the tablets whole with a glass of water.
You should take the first dose of this medicine as soon as possible after kidney and heart transplant and
about four weeks after liver transplant.
You should take the tablets together with cyclosporine microemulsion in case of kidney and
heart transplant and with tacrolimus in case of liver transplant.
Do not switch from Certican tablets to Certican dispersible tablets without first talking to your doctor.

Monitoring during treatment with Certican
The doctor may adjust the dose based on the amount of Certican in the blood and based on
how you respond to treatment. The doctor will regularly perform blood tests to measure the
amount of everolimus and cyclosporine in the blood. Your doctor will also carefully monitor your
kidney function, blood fats, blood sugar as well as the amount of protein in the urine.

If you take more Certican than you should
If you have taken more medicine than you should, contact your doctor immediately.

If you forget to take Certican
If you forget to take your dose of Certican, take it as soon as you remember and then take your
next dose as usual. Ask your doctor for advice. Do not take a double dose to make up for a
missed dose.

If you stop taking Certican
Do not stop taking the tablets unless you have been told to do so by your doctor. You will need to take
this medicine for the period necessary to prevent rejection of the kidney, heart or
liver transplant. If you stop taking Certican, you will have a higher risk of organ rejection.
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 Certican is taken 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 require immediate medical attention:

• infections,
• lung inflammation,
• allergic reactions,
• fever and bruises under the skin that may appear as red dots, with or without unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine production (thrombotic microangiopathy, hemolytic uremic syndrome).

If you develop any of the following symptoms:

• persistent or worsening respiratory/lung symptoms such as cough, shortness of breath, or wheezing,
• fever, general feeling of unwellness, chest or abdominal pain, chills, burning sensation when urinating,
• swelling of the face, lips, tongue, and throat,
• difficulty swallowing,
• spontaneous bruising or bleeding for no obvious reason,
• skin rash,
• pain, unusual warmth, swelling, or discharge from the surgical wound,

you must stop taking Certican and tell your doctor immediately.

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

• infections (viral, bacterial and fungal infections),
• lower respiratory tract infections, such as lung infections, including pneumonia,
• upper respiratory tract infections, such as pharyngitis and the common cold,
• urinary tract infections,
• anemia (reduced number of red blood cells),
• low levels of white blood cells leading to an increased risk of infection, reduced number of platelets which can lead to bleeding and/or bruising under the skin,
• high levels of fats (lipids, cholesterol and triglycerides) in the blood,
• onset of diabetes (high blood sugar levels),
• decreased potassium levels in the blood,
• anxiety,
• problems falling asleep (insomnia),
• headache,
• fluid collection around the heart, which if severe, can decrease the heart's ability to pump blood,
• high blood pressure,
• venous thrombosis (blockage of a large vein by a blood clot),
• fluid collection in the lungs and chest cavity, which if severe can make breathing difficult,
• cough,
• shortness of breath,
• diarrhea,
• feeling unwell (nausea),
• vomiting,
• stomach pain (abdominal level),
• generalized pain,
• fever,
• fluid accumulation in the tissues,
• impaired wound healing

Common(may affect up to 1 in 10 people)

• blood poisoning,
• wound infection,
• malignant and benign tumors,
• skin cancer,
• kidney damage with low platelets and low red blood cells with or without skin rash (thrombocytopenic purpura/hemolytic uremic syndrome),
• red blood cell breakdown,
• low levels of red blood cells and platelets,
• fast heartbeat,
• nosebleeds,
• decreased number of red blood cells (symptoms may include weakness, bruising, and frequent infections),
• blood clots in the kidney vessels that can lead to rejection mostly within the first 30 days after kidney transplantation,
• bleeding disorders,
• cysts containing lymphatic fluid,
• pain in the mouth or throat,
• pancreatitis,
• mouth sores,
• acne,
• hives (urticaria) and other allergy symptoms, such as swelling of the face or throat (angioedema),
• skin rash,
• joint pain,
• muscle pain,
• protein in the urine,
• kidney disorders,
• impotence,
• hernia at the site of the surgery,
• abnormal liver test results,
• menstrual disorders (including absent periods and heavy menstrual flow)

Uncommon(may affect up to 1 in 100):

• cancer of the lymphatic tissue (lymphoma / lymphoproliferative disease after transplantation),
• low levels of testosterone,
• lung inflammation,
• liver inflammation,
• jaundice,
• ovarian cysts

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),
• inflammation of blood vessels,
• swelling, feeling of heaviness or tightness, pain, limited mobility of some parts of the body (this could occur in any part of the body and is a potential sign of abnormal fluid accumulation in the soft tissue due to a blockage in the lymphatic system, also known as lymphedema),
• severe skin rash with skin swelling,
• low levels of iron in the blood.

If you have any doubts about any of these effects, talk to your doctor.
There may also be side effects of which you are not aware, such as abnormal laboratory test results, including kidney function tests. This means that your doctor will have you undergo
blood tests to check for changes in your kidneys during treatment with Certican.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Certican

• Keep Certican out of the sight and reach of children.
• Do not use Certican after the expiry date that is reported on the carton after Scad. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage temperature.
• Store the blisters in the original package to protect the medicine from light and moisture.
• Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
• Do not dispose of any medicine in 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 Certican contains

• The active ingredient is everolimus. Each tablet contains 0.25, 0.5, 0.75 or 1.0 mg of 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).
• 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 1.0 mg tablets: butylhydroxytoluene (E321), magnesium stearate, lactose monohydrate (9 mg), hypromellose, crospovidone and anhydrous lactose (149 mg).

Description of the appearance of Certican and package contents

• Certican 0.25 mg tablets are off-white to pale yellow, striated, round, flat tablets of 6 mm with a beveled edge with “C” imprinted on one side and “NVR” on the other.
• Certican 0.5 mg tablets are off-white to pale yellow, striated, round, flat tablets of 7 mm with a beveled edge with “CH” imprinted on one side and “NVR” on the other.
• Certican 0.75 mg tablets are off-white to pale yellow, striated, round, flat tablets of 8.5 mm with a beveled edge with “CL” imprinted on one side and “NVR” on the other.
• Certican 1.0 mg tablets are off-white to pale yellow, striated, round, flat tablets of 9 mm with a beveled edge with “CU” imprinted 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 as
dispersible tablets.

Marketing Authorisation Holder and Manufacturer
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Farma S.p.A.
Via Provinciale Schito 131
Torre Annunziata (Na)
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Sandoz S.R.L.
Livezeni Street Nr. 7A
Targu Mures, 540472
Romania

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following names:
Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (http://www.aifa.gov.it/)

Certican 0.1 mg dispersible tablets, 0.25 mg dispersible tablets

everolimus

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Certican and what is it used for

The active ingredient of Certican is everolimus.
Everolimus belongs to a group of medicines known as immunosuppressants. It is used in adults to
prevent your immune system from rejecting transplanted kidneys, hearts.
Certican is used in combination with other medicines such as cyclosporine for kidney and heart transplantation,
tacrolimus for liver transplantation, and corticosteroids.

2. What you need to know before you take Certican

Do not take Certican

• if you are allergic (hypersensitive) to everolimus or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to sirolimus.

If this applies to you, tell your doctor and do not take Certican.
Warnings and precautions
Talk to your doctor before taking Certican:

• Medicines that suppress the immune system like Certican decrease your body’s ability to fight infections. You should consult your doctor or transplant center if you have a fever or if you generally feel unwell or experience local symptoms such as cough or a burning sensation when urinating that are severe or persist for several days. Immediately consult your doctor or transplant center if you become confused, experience speech disturbances, memory loss, headache, vision disturbances or convulsions, as these may be symptoms of a rare but very serious condition known as progressive multifocal leukoencephalopathy (PML).
• If you have recently undergone major surgery or if you have wounds that have not yet healed following surgery, Certican may increase the risk of wound healing problems.
• Medicines that suppress the immune system like Certican increase the risk of developing malignant tumors, particularly of the skin and lymphatic system. Therefore, you should limit exposure to sunlight and UV light by wearing appropriate protective clothing and frequently applying a sunscreen with a high protection factor.
• The doctor will check your kidney function, the amount of fats (lipids) and sugar in your blood, as well as the amount of protein in your urine.
• If you have liver disorders or have had a disease that may have affected your liver, tell your doctor. The doctor may need to adjust the dose of Certican you are taking.
• If you experience respiratory symptoms (e.g. cough, difficulty breathing and wheezing), tell your doctor. The doctor may decide whether and how to continue Certican, and/or whether the administration of other medicines is necessary to resolve this problem.
• Certican may reduce sperm production in men, thus decreasing the ability to conceive children. The effect is generally reversible. Male patients who want to conceive children should discuss their treatment with their doctor.

Elderly (65 years or older)
There is limited experience regarding the administration of Certican in the elderly population.

Children and adolescents
Certican must not be used in children and adolescents undergoing kidney, heart or liver transplantation.

Other medicines and Certican
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
Some medicines may interfere with the action of Certican. It is very important that you tell your doctor if
you are taking any of the following medicines:

• immunosuppressive medicines excluding cyclosporine, tacrolimus or corticosteroids.
• antibiotics, such as for example rifampicin, rifabutin, clarithromycin, erythromycin or telithromycin.
• antiviral medicines, such as for example ritonavir, efavirenz, nevirapine, nelfinavir, indinavir or amprenavir, used for the treatment of HIV infection.
• medicines used for the treatment of fungal infections, such as for example voriconazole, fluconazole, ketoconazole or itraconazole.
• medicines used for the treatment of epilepsy, such as for example phenytoin, phenobarbital or carbamazepine.
• medicines used for the treatment of hypertension or heart disorders, such as for example verapamil, nicardipine or diltiazem.
• dronedarone, a medicine used to help regulate the heartbeat.
• medicines used to lower cholesterol in the blood, such as for example atorvastatin or pravastatin or fibrates.
• medicines used for the treatment of acute seizures or as a sedative before or during surgery or other medical procedures, such as midazolam.
• cannabidiol (uses include, also, the treatment of convulsive crises).
• octreotide, a medicine used for the treatment of acromegaly, a rare hormonal disease that usually manifests in middle-aged adults.
• imatinib, a medicine used to inhibit the growth of abnormal cells.
• St. John's wort (Hypericum perforatum), a medicine based on a medicinal plant used for the treatment of depression.
• if you need to be vaccinated, talk to your doctor about it immediately.

Certican with food and drink
The presence of food may influence the amount of Certican that is absorbed. To maintain constant levels
in the body, Certican must always be taken under the same conditions. You should always take it with food or
always fasting.
Certican must not be taken with grapefruit juice or with grapefruit. They interfere with the action
of Certican.

Pregnancy, breastfeeding and fertility
Do not take Certican if you are pregnant unless your doctor considers it absolutely necessary. If you
are a woman of childbearing potential, you must use an effective contraceptive method during treatment with Certican
and for 8 weeks after discontinuation of treatment.
If you suspect you are pregnant, ask your doctor or pharmacist for advice before taking Certican.
You must not breastfeed 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
Certican does not impair or negligibly impairs the ability to drive vehicles and operate machines.

Certican contains lactose
The Certican dispersible tablets contain lactose. If your doctor has diagnosed you with intolerance
to certain sugars, contact him/her before taking this medicine.

3. How to take Certican

The 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. If you have any doubts, ask your
doctor or pharmacist.

How much Certican to take

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

How to take Certican
Certican is for oral use only.
You should take the first dose of this medicine as soon as possible after kidney and heart transplant and
about four weeks after liver transplant.
You should take the tablets together with cyclosporine microemulsion in the case of kidney and
heart transplant and with tacrolimus in the case of liver transplant.
Do not switch from Certican dispersible tablets to Certican tablets without first talking to your doctor

• Place the Certican dispersible tablets in a plastic measuring glass containing approximately 25 ml of water.
• The maximum amount of Certican that can be dispersed in 25 ml of water is 1.5 mg.
• Leave the measuring glass for about 2 minutes to allow the tablets to disperse and, before drinking, stir gently.
• Immediately rinse the measuring glass with a further 25 ml of water and drink it all.

Monitoring during treatment with Certican
The doctor may adjust the dose depending on the amount of Certican in the blood and depending on
how you respond to treatment. The doctor will regularly perform blood tests to measure the
amount of everolimus and cyclosporine in the blood. The doctor will also carefully monitor your
kidney function, blood fats, blood sugar as well as the amount of protein in the urine.

If you take more Certican than you should
If you have taken more medicine than you should have, contact your doctor immediately.

If you forget to take Certican
If you forget to take your dose of Certican, take it as soon as you remember and then take your
next dose as usual. Ask your doctor for advice. Do not take a double dose to make up for a
missed dose.

If you stop taking Certican
Do not stop taking the tablets unless you are told to do so by your doctor. You will need to take
this medicine for the period necessary to prevent rejection of the kidney, heart or
liver transplant. If you stop taking Certican, you will have a higher risk of organ rejection.
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 Certican is taken 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 require immediate medical attention:

• infections,
• lung inflammation,
• allergic reactions,
• fever and bruises under the skin that may appear as red dots, with or without unjustified fatigue, confusion, yellowing of the skin or eyes, reduced urine output (thrombotic microangiopathy, hemolytic uremic syndrome).

If you develop any of the following symptoms:

• persistent or worsening respiratory/lung symptoms such as cough, shortness of breath, or wheezing,
• fever, general feeling of unwellness, chest or abdominal pain, chills, burning sensation when urinating,
• swelling of the face, lips, tongue, and throat,
• difficulty swallowing,
• spontaneous bruising or bleeding for no obvious reason,
• skin rash,
• pain, unusual warmth, swelling, or discharge from the surgical wound,

you must stop taking Certican and tell your doctor immediately.

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

• infections (viral, bacterial and fungal infections),
• lower respiratory tract infections, such as lung infections, including pneumonia,
• upper respiratory tract infections, such as pharyngitis and the common cold,
• urinary tract infections,
• anemia (reduced number of red blood cells),
• low levels of white blood cells leading to an increased risk of infection, reduced number of platelets which may lead to bleeding and/or bruising under the skin,
• high levels of fats (lipids, cholesterol and triglycerides) in the blood,
• onset of diabetes (high blood sugar levels),
• reduced potassium levels in the blood,
• anxiety,
• problems falling asleep (insomnia),
• headache,
• fluid collection around the heart, which if severe, can decrease the heart’s ability to pump blood,
• high blood pressure,
• venous thrombosis (blockage of a large vein by a blood clot),
• fluid collection in the lungs and chest cavity, which if severe can make breathing difficult
• cough,
• shortness of breath,
• diarrhea,
• feeling unwell (nausea),
• vomiting,
• stomach pain (abdominal level),
• generalized pain,
• fever,
• fluid accumulation in the tissues,
• impaired wound healing

Common(may affect up to 1 in 10 people)

• blood poisoning,
• wound infection,
• malignant and benign tumors,
• skin cancer,
• kidney damage with low platelets and low red blood cells with or without skin rash (thrombocytopenic purpura/hemolytic uremic syndrome),
• red blood cell breakdown,
• low levels of red blood cells and platelets,
• fast heartbeat,
• nosebleeds,
• reduction in the number of red blood cells (symptoms may include weakness, bruising and frequent infections),
• blood clots in the kidney vessels that can lead to rejection mostly within the first 30 days after kidney transplantation,
• bleeding disorders,
• cysts containing lymphatic fluid,
• pain in the mouth or throat,
• pancreatitis,
• mouth sores,
• acne,
• hives (urticaria) and other allergic symptoms, such as swelling of the face or throat (angioedema),
• skin rash,
• joint pain,
• muscle pain,
• protein in the urine,
• kidney disorders,
• impotence,
• hernia at the site of the surgery,
• abnormal liver test results,
• menstrual disorders (including absent periods and heavy menstrual flow)

Uncommon (may affect up to 1 in 100):

• cancer of the lymphatic tissue (lymphoma / lymphoproliferative disease after transplantation),
• low levels of testosterone,
• lung inflammation,
• liver inflammation,
• jaundice,
• ovarian cysts

Other side effects
Other side effects have occurred in a small number of people but their exact frequency is
unknown:

• abnormal accumulation of proteins in the lungs (symptoms may include persistent dry cough, fatigue and difficulty breathing),
• inflammation of blood vessels,
• swelling, feeling of heaviness or tightness, pain, limited mobility of some parts of the body (this may occur in any part of the body and is a potential sign of abnormal fluid accumulation in the soft tissue due to a blockage in the lymphatic system, also known as lymphedema),
• severe skin rash with skin swelling
• low levels of iron in the blood.

If you have any doubts about any of these effects, talk to your doctor.
There may also be side effects of which you are not aware, such as abnormal laboratory results, including kidney function tests. This means that your doctor will have you undergo
blood tests to check for changes in your kidneys during treatment with Certican.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Certican

• Keep Certican out of the sight and reach of children.
• Do not use Certican after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage temperature.
• Store the blisters in the original packaging to protect the medicine from light and 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 in 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 Certican contains

• The active ingredient is everolimus. Each dispersible tablet contains 0.1 mg or 0.25 mg of everolimus.
• The other ingredients are:
• Certican 0.1 mg dispersible tablets: butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate (1 mg), hypromellose, crospovidone, anhydrous colloidal silica and anhydrous lactose (72 mg).
• Certican 0.25 mg dispersible tablets: butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate (2 mg), hypromellose, crospovidone, anhydrous colloidal silica and anhydrous lactose (179 mg).

Description of Certican’s appearance and package contents

• Certican 0.1 mg dispersible tablets are off-white to yellowish-white, striated, round, flat tablets of 7 mm, with a bevelled edge with “I” imprinted on one side and “NVR” on the other.
• Certican 0.25 mg dispersible tablets are off-white to yellowish-white, striated, round, flat tablets of 9 mm, with a bevelled edge with “JO” imprinted on one side and “NVR” on the other.

Certican dispersible tablets are supplied in packs containing 50, 60, 100 or 250 dispersible tablets.
Not all pack sizes may be marketed. Certican is also available as tablets.

Marketing authorisation holder and manufacturer
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Farma S.p.A.
Via Provinciale Schito 131
Torre Annunziata (Na)
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (http://www.aifa.gov.it/)

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR HEALTHCARE
PROFESSIONALS
Information on the use and handling of dispersible tablets
Administration via a 10 ml oral syringe:place the Certican dispersible tablets in the syringe. The maximum amount of Certican that can be dispersed in a 10 ml syringe is 1.25 mg. Add water up to the mark corresponding to 5 ml. Gently shaking, wait 90 seconds. Once dispersed, administer directly into the mouth. Rinse the syringe with 5 ml of water and administer into the mouth. Drink a further 10 to 100 ml of water or diluted syrup.

Administration via a plastic measuring cup:place the Certican dispersible tablets in a plastic measuring cup containing approximately 25 ml of water. The maximum amount of Certican that can be dispersed in 25 ml of water is 1.5 mg. Leave the measuring cup for about 2 minutes to allow the tablets to disperse and, before drinking, shake gently. Immediately rinse the measuring cup with a further 25 ml of water and drink everything.

Administration via a nasogastric tube:place the Certican dispersible tablets in a small plastic container containing 10 ml of water, wait 90 seconds while gently shaking. Place the dispersion into a syringe and slowly inject (within 40 seconds) into the nasogastric tube. Rinse the container (and the syringe) 3 times with 5 ml of water and inject into the tube. Finally, pass 10 ml of water through the tube. After administering Certican, the nasogastric tube must be kept closed for at least 30 minutes.
If cyclosporine microemulsion is also administered via a nasogastric tube, this must be administered before Certican. The two medicines must not be mixed.