Certican

Patient Information Leaflet: User Information

Certican, 0.25 mg, tablets

Certican, 0.5 mg, tablets

Certican, 0.75 mg, tablets

Everolimus

You should read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Certican and what is it 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 pack and other information

1. What is Certican and what is it used for

The active substance of Certican is everolimus.
Everolimus belongs to a group of medicines called immunosuppressants. It is used in adult patients to prevent the rejection of a transplanted kidney, heart, or liver by the body's immune system. Certican is used 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 taking Certican

When not to take Certican

If any of the above points apply to you, you should tell your doctor and not take Certican.

Warnings and precautions

Before starting treatment with Certican, you should discuss it with your doctor:

• Medicines that weaken the immune system, such as Certican, reduce the body's ability to fight infections. It is recommended to consult a doctor or contact the transplant center if you have a fever or feel unwell, or if you have local symptoms such as cough or burning sensation when urinating, and if these symptoms are severe or persist for several days. You should immediately consult your doctor or the transplant center if you experience symptoms of confusion, speech disorders, memory loss, headache, vision disorders, or seizures, as these may be symptoms of a rare but very serious disease called progressive multifocal leukoencephalopathy (PML).

if you have recently undergone major surgery or still have an unhealed postoperative wound, Certican may increase the risk of wound healing problems.

• Medicines that weaken the immune system, such as Certican, increase the risk of developing cancer, especially skin and lymphatic system cancer. Therefore, you should limit your exposure to sunlight and ultraviolet (UV) radiation by wearing protective clothing and using sunscreens with a high protection factor frequently.
• Your doctor will closely monitor your kidney function, blood lipid levels, and blood sugar levels, as well as the amount of protein in your urine.
• Certican may reduce sperm production in men and thereby reduce fertility. This effect is usually reversible. Men planning to become fathers should discuss treatment with their doctor.

Elderly patients (65 years and older)

There is limited experience with the use of Certican in elderly patients.

Children and adolescents

Certican should not be used in children and adolescents after kidney, heart, or liver transplantation.

Certican and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Certain medicines may affect the way Certican works on the body. It is very important to tell your doctor if you are taking any of the following medicines:

• immunosuppressants 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 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 disease, such as verapamil, nicardipine, or diltiazem;
• dronedarone, a medicine used to regulate heart rhythm disorders;
• medicines used to lower cholesterol levels in the blood, such as atorvastatin, pravastatin, or fibrates;
• medicines used to treat acute seizures or used as sedatives before or during surgical operations or other medical procedures, such as midazolam;
• cannabidiol (used, among other things, to treat seizures);
• 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;

Taking Certican with food and drink

Food may affect the absorption of Certican. To maintain a constant level of the medicine in the body, you should always take Certican in the same way.
You should always take the medicine with a meal or always take it on an empty stomach.
You should not take Certican with grapefruit juice or grapefruit. They affect the action of Certican in the body.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, you should consult your doctor or pharmacist.
Certican should not be used during pregnancy unless clearly prescribed by your doctor.
You should use effective contraception during treatment with Certican and for 8 weeks after stopping treatment.
If you suspect you may be pregnant, you should consult your doctor before taking Certican.
You should not breastfeed while taking Certican. It is not known whether Certican passes into breast milk.
Certican may affect fertility in men.

Driving and using machines

Certican has no or negligible influence on the ability to drive and use machines.

Certican contains lactose

Certican tablets contain lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Certican

Your doctor will decide what dose and when you should take Certican.
Certican should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose

The usual starting dose is 1.5 mg per day for kidney or heart transplantation and 2.0 mg per day for 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.
You should not crush the tablets.
The tablets should be swallowed whole with a glass of water.
The first dose should be taken as soon as possible after kidney or heart transplantation and about 4 weeks after liver transplantation.
The tablets should be taken together with cyclosporine in the form of a microemulsion in the case of kidney or heart transplantation and together with tacrolimus in the case of liver transplantation.
You should not switch from Certican tablets to Certican oral suspension without consulting your doctor first.

Control tests while taking Certican

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

Taking a higher dose of Certican than recommended

If you have taken more tablets than recommended, you should immediately tell your doctor.

Missing a dose of Certican

If you forget to take Certican, you should do so as soon as possible and then return to your regular dosing schedule. You should consult your doctor. You should not take a double dose to make up for a missed tablet.

Stopping treatment with Certican

You should not stop taking Certican unless your doctor decides to do so. You should take the medicine for 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 doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects require immediate medical attention

• infections,
• pneumonia,
• allergic reactions,
• fever and bruising under the skin, which can appear as red spots, with unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output (thrombotic microangiopathy, hemolytic-uremic syndrome) or without these symptoms.

If you experience any of the following symptoms:

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

you should stop taking Certican and immediately tell your doctor.

Other reported side effects include:

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

• infections (viral, bacterial, and fungal),
• lower respiratory tract infections, such as pneumonia,
• upper respiratory tract infections, such as pharyngitis and common cold,
• urinary tract infections,
• anemia (reduced red blood cell count),
• low white blood cell count, leading to increased risk of infection, low platelet count, which can cause bleeding and/or bruising,
• high levels of lipids (cholesterol and triglycerides) in the blood,
• development of diabetes (high blood sugar levels),
• low potassium levels in the blood,
• anxiety,
• sleep disorders (insomnia),
• headache,
• fluid accumulation in the sac around the heart, which, if severe, can 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, can cause shortness of breath,
• cough,
• shortness of breath,
• diarrhea,
• nausea,
• vomiting,
• abdominal pain,
• generalized pain,
• fever,
• fluid accumulation in tissues,
• wound healing disorders.

Common(may affect up to 1 in 10 people)

• sepsis,
• wound infections,
• malignant and benign tumors,
• skin cancer,
• kidney damage with low platelet and red blood cell count with or without rash (thrombocytopenic purpura or hemolytic-uremic syndrome),
• red blood cell destruction,
• low red and white blood cell count,
• rapid heartbeat,
• nosebleeds,
• low blood cell count (symptoms may include weakness, bruising, and frequent infections),
• blood clot in the transplanted kidney, which can lead to loss of the transplant, most commonly occurring within the first 30 days after kidney transplantation,
• bleeding disorders,
• lymph fluid-filled cyst,
• mouth or throat pain,
• pancreatitis,
• mouth ulcers,
• acne,
• hives and other allergic symptoms, 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 amenorrhea or excessive menstrual bleeding).

Uncommon(may affect up to 1 in 100 people)

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

Other side effects:

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

• abnormal protein accumulation in the lungs (symptoms may include persistent dry cough, fatigue, and difficulty breathing),
• blood vessel inflammation,
• swelling, feeling of heaviness or pressure, pain, limited mobility of a body part (may occur in any part of the body and is a potential symptom of abnormal fluid accumulation in soft tissue due to lymphatic system blockage, also known as lymphedema),
• 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 that 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 changes in your kidneys.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Certican

• Certican should be stored out of 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.
• There are no special storage instructions for the medicine.
• Store in the original outer packaging to protect from light and moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of opening.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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.
• The other ingredients are:
• Certican 0.25 mg tablets: butylhydroxytoluene, magnesium stearate, lactose monohydrate (2 mg), hypromellose (type 2910), crospovidone (type A), and lactose anhydrous (51 mg).
• Certican 0.5 mg tablets: butylhydroxytoluene, magnesium stearate, lactose monohydrate (4 mg), hypromellose (type 2910), crospovidone (type A), and lactose anhydrous (74 mg).
• Certican 0.75 mg tablets: butylhydroxytoluene, magnesium stearate, lactose monohydrate (7 mg), hypromellose (type 2910), crospovidone (type A), and lactose anhydrous (112 mg).

What Certican looks like and contents of the pack

• Certican 0.25 mg tablets are white or yellowish, marbled, round, flat, 6 mm in diameter, with beveled edges, with the inscription "C" on one side and "NVR" on the other side of the tablet.
• Certican 0.5 mg tablets are white or yellowish, marbled, round, flat, 7 mm in diameter, with beveled edges, with the inscription "CH" on one side and "NVR" on the other side of the tablet.
• Certican 0.75 mg tablets are white or yellowish, marbled, round, flat, 8.5 mm in diameter, with beveled edges, with the inscription "CL" on one side and "NVR" on the other side of the tablet.

Certican 0.25 mg, 0.5 mg, and 0.75 mg tablets are available in packs of 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Poland Sp. z o.o.
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 NV
Medialaan 40 bus 1
1800 Vilvoorde
Belgium
Novartis Healthcare A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Novartis Finland OY
Metsänneidonkuja 10
02130 Espoo
Finland
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
Netherlands
Novartis Pharma GmbH
Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Poland
Novartis Farma - Productos Farmacêuticos S.A.
Avenida Professor Doutor Cavaco Silva
n 10E, Porto Salvo 2740-255
Portugal
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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:10/2024

Other sources of information

Detailed information about this medicine is available on the website https://urpl.gov.pl/pl