Certican

Certican, 0.25 mg, tablets
Certican, 0.5 mg, tablets
Certican, 0.75 mg, tablets
everolimus
Please read the entire leaflet before using this medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Certican is and what it is used for
2. Important information before taking Certican
3. How to take Certican
4. Possible side effects
5. How to store Certican
6. Contents of the package and other information

1. What Certican is and what it is used for

The active substance in Certican is everolimus.
Everolimus belongs to a group of medicines called immunosuppressants. It is used in adult patients to prevent the immune system from rejecting a transplanted kidney, heart, or liver. Certican is taken together with other medicines, such as cyclosporine in the case of kidney or heart transplantation, tacrolimus in the case of liver transplantation, and corticosteroids.

2. Important information before using Certican

When not to use Certican

• if the patient is allergic (hypersensitive) to everolimus or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to sirolimus. If either of the above points applies to the patient, inform the doctor and do not use Certican.

Warnings and precautions
Before starting treatment with Certican, discuss the following with your doctor:

• Medicines that suppress the immune system, such as Certican, reduce the body's ability to fight infections. Consult your doctor or transplant center if the patient develops fever, general malaise, or localized symptoms such as cough or a burning sensation during urination, especially if symptoms are severe or persist for several days. Seek immediate medical advice from your doctor or transplant center if the patient experiences confusion, speech disturbances, memory loss, headache, vision problems, or seizures, as these may be symptoms of a rare but serious condition called progressive multifocal leukoencephalopathy (PML).

• If the patient has recently undergone major surgery or still has an unhealed surgical wound, Certican may increase the risk of wound healing complications.

• Medicines that suppress the immune system, such as Certican, may increase the risk of developing malignancies, particularly of the skin and lymphatic system. Therefore, exposure to sunlight and ultraviolet (UV) radiation should be minimized by wearing protective clothing and frequently applying high-protection sunscreen.

• The doctor will closely monitor kidney function, blood lipid (fat) levels, blood glucose levels, and the amount of protein in the urine.

• If the patient has impaired liver function or a history of liver disease, inform the doctor, as this may require an adjustment of the Certican dose.

• If the patient experiences respiratory symptoms (e.g. cough, difficulty breathing, wheezing), inform the doctor. The doctor will assess whether and how to continue treatment with Certican and whether additional medications are needed.

• Certican may reduce sperm production in men, thereby reducing fertility. This effect is usually reversible. Men planning fatherhood should discuss treatment with their doctor.

Elderly patients (aged 65 years and older)
Experience with the use of Certican in elderly patients is limited.
Children and adolescents
Certican should not be used in children and adolescents following kidney, heart, or liver transplantation.
Certican with other medicines
Inform your doctor about all medicines currently taken, recently taken, or planned for use, including those available without a prescription.
Certain medicines may affect how Certican works in the body. It is very important to inform your doctor if the patient is taking any of the following medicines:

• immunosuppressive medicines other than cyclosporine, tacrolimus, or corticosteroids;
• antibiotics such as rifampicin, rifabutin, clarithromycin, erythromycin, or telithromycin;
• antiviral medicines such as ritonavir, efavirenz, nevirapine, nelfinavir, indinavir, or amprenavir, used in the treatment of 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 conditions, such as verapamil, nicardipine, or diltiazem;
• dronedarone, a medicine used to regulate heart rhythm disorders;
• medicines used to lower blood cholesterol levels, such as atorvastatin, pravastatin, or fibrates;
• medicines used to treat acute seizures or sedatives used before or during surgical or other medical procedures, such as midazolam;
• cannabidiol (used, among others, in the treatment of seizures);
• octreotide, a medicine used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults;
• imatinib, a medicine used to inhibit the growth of abnormal cells;
• St John's wort (Hypericum perforatum), a herbal remedy used to treat depression;
• if vaccination is required, consult your doctor beforehand.

Taking Certican with food and drink
Food may affect the absorption of Certican. To maintain consistent drug levels in the body, the patient should always take Certican in the same way—either always with food or always on an empty stomach.
Do not take Certican with grapefruit juice or grapefruit. These affect how Certican works in the body.
Pregnancy, breastfeeding, and fertility
Always consult a doctor or pharmacist before taking any medicine.
Certican must not be used during pregnancy unless clearly recommended by a doctor.
An effective method of contraception must be used during treatment with Certican and for 8 weeks after stopping the medicine.
If the patient suspects she may be pregnant, she should consult her doctor before taking Certican.
Breastfeeding must not be undertaken during treatment with Certican. It is not known whether Certican passes into breast milk.
Certican may affect male fertility.
Driving and operating machinery
Certican has no effect or negligible effect on the ability to drive vehicles and operate machinery.
Certican contains lactose
Certican tablets contain lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Certican

Your doctor will decide the dose and timing for administering Certican.
Certican must always be used exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist again.

Recommended dose
The usual initial dose is 1.5 mg once daily in the case of kidney or heart transplantation,
and 2.0 mg once daily in the case of liver transplantation.
This dose is usually divided into two doses, one taken in the morning and one in the evening.

How to take Certican
Certican is intended for oral use only.
Do not crush the tablets.
Swallow the tablets whole with a glass of water.
The first dose should be taken as soon as possible after kidney or heart transplantation,
and approximately four weeks after liver transplantation.
Take the tablets at the same time as cyclosporine microemulsion in the case of kidney or heart transplantation,
and at the same time as tacrolimus in the case of liver transplantation.
Do not switch from Certican tablets to Certican oral suspension tablets without first consulting your doctor.

Monitoring during treatment with Certican
Your doctor may adjust the dose based on blood levels of Certican and your response to treatment.
To monitor blood levels of everolimus and cyclosporine, your doctor will order regular blood tests.
Your doctor will also closely monitor kidney function, blood lipid levels, blood glucose levels, and protein levels in the urine.

If you take more Certican than you should
If you take more tablets than recommended, inform your doctor immediately.

If you forget to take Certican
If you forget to take a dose of Certican, take it as soon as possible, then return to your regular dosing schedule.
Consult your doctor. Do not take a double dose to make up for a missed tablet.

Stopping Certican
Do not stop taking Certican unless instructed by your doctor. Continue taking the medicine as long as immunosuppression is needed to prevent rejection of the transplanted kidney, heart, or liver. Stopping treatment with Certican may increase the risk of rejection of the transplanted organ.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since Certican is used together with other medicines, side effects are not always due to Certican; they may be caused by another medicine.

The following side effects require immediate medical attention:

• infections,
• pneumonia,
• allergic reactions,
• fever and bruising under the skin appearing as red spots, with or without unexplained fatigue, confusion, yellowing of the skin or eyes, reduced urine output (microangiopathic haemolytic anaemia, haemolytic-uraemic syndrome).

If any of the following symptoms occur:

• persistent or worsening respiratory/lung disease symptoms such as cough, difficulty breathing or wheezing,
• fever, feeling unwell, chest or abdominal pain, chills, burning sensation when passing urine,
• swelling of the face, lips, tongue or throat,
• difficulty swallowing,
• spontaneous bruising or bleeding without obvious cause,
• rash,
• pain, warmth, swelling or discharge from a surgical wound,

you should stop taking Certican and tell your doctor immediately.

Other reported side effects included:

Very common (may affect more than 1 in 10 people)

• infections (viral, bacterial and fungal),
• lower respiratory tract infections such as lung infections, including pneumonia,
• upper respiratory tract infections such as sore throat and colds,
• urinary tract infections,
• anaemia (reduced number of red blood cells),
• low white blood cell count leading to increased risk of infection, low platelet count which may cause bleeding and/or bruising,
• high levels of fats (lipids, cholesterol and triglycerides) in the blood,
• development of diabetes (high blood sugar levels),
• low potassium levels in the blood,
• anxiety,
• difficulty sleeping (insomnia),
• headache,
• fluid accumulation around the heart, which, if severe, may reduce the heart's ability to pump blood,
• high blood pressure,
• venous thrombosis (blockage of a large vein due to a blood clot),
• fluid accumulation in the lungs and chest cavity, which, if severe, may cause shortness of breath,
• cough,
• shortness of breath,
• diarrhoea,
• nausea,
• vomiting,
• stomach (abdominal) pain,
• generalised pain,
• fever,
• fluid accumulation in tissues,
• impaired wound healing.

Common (may affect up to 1 in 10 people)

• sepsis,
• wound infections,
• malignant and benign tumours,
• skin cancer,
• kidney damage with low platelet and red blood cell counts, with or without rash (thrombocytopenic purpura or haemolytic-uraemic syndrome),
• haemolysis (breakdown of red blood cells),
• low red blood cell and platelet counts,
• rapid heartbeat,
• nosebleeds,
• low blood cell counts (symptoms may include weakness, bruising and frequent infections),
• blood clot in a blood vessel of the transplanted kidney, which may lead to graft loss, most commonly occurring within the first 30 days after kidney transplantation,
• bleeding disorders,
• cyst containing lymphatic fluid,
• mouth or throat pain,
• pancreatitis,
• mouth ulcers,
• acne,
• urticaria and other allergic reactions such as facial or throat swelling (angioedema),
• rash,
• joint pain,
• muscle pain,
• protein in the urine,
• kidney disorders,
• impotence,
• hernia at the surgical site,
• abnormal liver function test results,
• menstrual disorders (including absence of periods or excessive menstrual bleeding).

Uncommon (may affect up to 1 in 100 people)

• malignant lymphatic tissue tumour (lymphoma/post-transplant lymphoproliferative disorder),
• low testosterone levels,
• pneumonia,
• hepatitis,
• jaundice,
• ovarian cyst.

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

• abnormal accumulation of protein in the lungs (symptoms may include persistent dry cough, fatigue and difficulty breathing),
• vasculitis (inflammation of blood vessels),
• swelling, heaviness or pressure, pain, limited mobility of a body part (may occur in any part of the body and may indicate abnormal fluid accumulation in soft tissue due to lymphatic system blockage, also known as lymphoedema),
• severe rash with skin swelling,
• low iron levels in the blood.

If you are concerned about any of the above side effects, you should tell your doctor.

Additionally, there may be side effects you are not aware of, such as abnormal laboratory test results, including kidney function tests. Therefore, during treatment with Certican, your doctor will perform blood tests to monitor any changes in kidney function.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Certican

• Keep the medicine Certican out of the sight and reach of children.
• Do not use the medicine Certican after the expiry date stated on the outer carton after EXP. The expiry date refers to the last day of that month.
• There are no special requirements regarding the storage temperature of the medicine.
• Store in the original outer packaging to protect from light and moisture.
• Do not use this medicine if the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Certican contains

• The active substance is everolimus. Each tablet contains 0.25 mg, 0.5 mg, or 0.75 mg of everolimus, respectively.
• The other components are:
  • Certican 0.25 mg tablets: butylhydroxytoluene, magnesium stearate, monohydrate lactose (2 mg), hypromellose (type 2910), crospovidone (type A) and anhydrous lactose (51 mg).
  • Certican 0.5 mg tablets: butylhydroxytoluene, magnesium stearate, monohydrate lactose (4 mg), hypromellose (type 2910), crospovidone (type A) and anhydrous lactose (74 mg).
  • Certican 0.75 mg tablets: butylhydroxytoluene, magnesium stearate, monohydrate lactose (7 mg), hypromellose (type 2910), crospovidone (type A) and anhydrous lactose (112 mg).

What Certican looks like and contents of the pack

• Certican 0.25 mg tablets are white or yellowish, with a marbled appearance, round, flat, 6 mm in diameter, with bevelled edges, embossed with the code “C” on one side and “NVR” on the other side of the tablet.
• Certican 0.5 mg tablets are white or yellowish, with a marbled appearance, round, flat, 7 mm in diameter, with bevelled edges, embossed with the code “CH” on one side and “NVR” on the other side of the tablet.
• Certican 0.75 mg tablets are white or yellowish, with a marbled appearance, round, flat, 8.5 mm in diameter, with bevelled edges, embossed with the code “CL” on one side and “NVR” on the other side of the tablet.

Certican 0.25 mg; 0.5 mg; 0.75 mg tablets are available in packs containing 60 or
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Tel. +48 22 375 48 88
Manufacturer/Importer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Vienna
Austria
Novartis Pharma SAS
8-10 rue Henri Sainte-Claire Deville
92500 Rueil-Malmaison
France
Novartis (Hellas) SA
12th km National Road Athinon-Lamias
Metamorfosi
14451 Attiki
Greece
Novartis Pharma B.V.
Haaksbergweg 16
1101 BX Amsterdam
The Netherlands
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Novartis Farma - Productos Farmacêuticos S.A.
Avenida Professor Doutor Cavaco Silva
nº 10E, Porto Salvo 2740-255
Portugal
Novartis Pharmaceuticals S.R.L.
Str. Livezeni nr. 7A

Novartis Sverige AB
Torshamnsgatan 48
164 40 Kista
Sweden
Novartis Hungária Ltd.
Bartók Béla út 43-47
H-1114 Budapest
Hungary

Novartis Farma S.P.A.
Viale Luigi Sturzo 43
20154 - Milano (MI)
Italy
This medicinal product is authorised for marketing in the European Economic Area and the United Kingdom (Northern Ireland) under the following name:

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (https://www.gov.pl/web/urpl)