Prospecto: information for the user

Certican 0.1 mg dispersible tablets

Certican 0.25 mg dispersible tablets

everolimus

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Certican and what it is used for

2.What you need to know before starting to take Certican

3.How to take Certican

4.Possible adverse effects

5.Storage of Certican

6.Contents of the pack and additional information

The active ingredient of Certican is everolimus.

Everolimus belongs to a group of medications known as immunosuppressants. It is used in adults to prevent the body's immune system from rejecting a transplanted kidney, heart, or liver.

Certican is used in combination with other medications, such as ciclosporina for renal and cardiac transplants, tacrolimus for liver transplants, and corticosteroids.

Do not take Certican

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

If any of the above applies to you, inform your doctor and do not take Certican.

Warnings and precautions

Consult your doctor before starting to take Certican:

• Medicines that suppress the immune system, such as Certican, reduce the ability of your body to fight infections. It is advisable that you consult your doctor or transplant centre if you have a fever or feel generally unwell, or present local symptoms such as cough or burning sensation when urinating that may be serious or persistent for several days. Consult your doctor or transplant centre immediately if you feel confused, present difficulty speaking, memory loss, headache, visual disturbances or convulsions, as these may be symptoms of a rare but serious condition called multifocal progressive leukoencephalopathy (LMP).
• If you have recently undergone a major surgical operation or still have an open wound after surgery, Certican may increase the risk of wound healing problems.
• Medicines that suppress the immune system, such as Certican, increase the risk of developing cancer, particularly of the skin and lymphoid system. Therefore, you should limit your exposure to sunlight and UV rays by wearing protective clothing and applying a high-factor sunscreen frequently.
• Your doctor will monitor your kidney function, the amount of fat (lipids) and sugar in your blood, as well as the amount of protein in your urine.
• If you have liver problems or have previously had a condition that may have affected your liver, inform your doctor. Your doctor may need to modify the dose of Certican you are taking.
• If you experience respiratory symptoms (e.g. cough, difficulty breathing and laboured breathing), inform your doctor. Your doctor will decide whether you need to continue and how, with Certican treatment and/or whether you need to receive other medicines to remedy this condition.
• Certican may reduce sperm production in men, thereby reducing their ability to father children. The effect is generally reversible. Male patients who wish to father children should discuss their treatment with their doctor.

Older people (65 years and above)

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

Children and adolescents

Certican should not be used in children and adolescents with a kidney, heart or liver transplant.

Other medicines and Certican

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine, including those obtained without a prescription.

Some medicines may affect the way Certican works in your body. It is very important that you inform 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, 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 heartbeats.
• medicines used to lower cholesterol in the blood, such as atorvastatin, pravastatin or fibrates.
• medicines used to treat acute seizures, or used as sedatives before or during surgery or other medical procedures, such as midazolam.
• cannabidiol (its use includes, among others, the treatment of epilepsy seizures).
• octreotide, a medicine used to treat acromegaly, a rare hormonal disorder that occurs in adults of middle age.
• imatinib, a medicine used to inhibit the growth of abnormal cells.
• St. John's Wort (Hypericum perforatum), a medicinal plant used to treat depression.
• if you need to receive any vaccine, first consult your doctor.

Taking Certican with food and drinks

The presence of food may affect the amount of Certican that is absorbed. In order to maintain constant levels in your body, you should always take Certican in the same way. You should always take it with food or always on an empty stomach.

Do not take Certican with grapefruit or grapefruit juice as they may affect the effect of Certican in your body.

Pregnancy, breastfeeding and fertility

If you are pregnant, do not take Certican unless your doctor thinks it is absolutely necessary. If you are a woman and may become pregnant, you should use an effective contraceptive method during Certican treatment and for 8 weeks after stopping treatment.

If you think you may be pregnant, consult your doctor or pharmacist before taking Certican.

You should not breastfeed while taking Certican. It is unknown whether Certican passes into breast milk.

Certican may affect male fertility.

Driving and operating machinery

The influence of Certican on the ability to drive and operate machinery is negligible or insignificant.

Certican contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Your doctor will decide exactly how much Certican you should take and when you should take it.

Follow exactly the administration instructions for Certican indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount to take

• The usual starting dose is 1.5 mg/day in renal and cardiac transplants and 2.0 mg/day in liver transplants.
• It is usually divided into two separate doses, one in the morning and one at night.

How to take Certican

Certican should be taken only by mouth.

You should take the first dose of this medication as soon as possible after the renal and cardiac transplant and approximately four weeks after the liver transplant.

You should take the tablets along with cyclosporine for microemulsion in renal and cardiac transplants and with tacrolimus in liver transplants.

Do not change from Certican dispersible tablets to Certican tablets without consulting your doctor.

• Place the Certican dispersible tablets in approximately 25 ml of water in a plastic cup.
• The maximum amount of Certican that can be dispersed in 25 ml of water is 1.5 mg.
• Wait for 2 minutes to allow the tablets to dissolve and gently move the cup before drinking the liquid.
• Then, immediately wash the cup with another 25 ml of water and drink completely.

Monitoring during your treatment with Certican

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

If you take more Certican than you should

If you take more tablets than you should, consult 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 continue with your usual treatment schedule. Ask your doctor for advice.Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Certican

Do not stop taking the medication unless your doctor tells you to. You will need to take this medication for as long as you need immunosuppressants to prevent rejection of your transplanted kidney, heart, or liver. If you interrupt the treatment with Certican, you may increase the risk of rejection of your transplanted organ.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Because you are taking Certican with other medicines, it is not always clear if the side effects are caused by Certican or by other medicines.

The following side effects require immediate medical attention:

• infections,
• inflammation of the lungs,
• allergic reactions,
• fever and skin hemorrhages that may appear as red spots, with or without unexplained fatigue, confusion, yellowish skin or eyes, decreased urine output (microangiopathic thrombosis, hemolytic-uremic syndrome),

If you develop any of the following:

• persistent or worsening respiratory symptoms, such as cough, difficulty breathing, or wheezing,
• fever, general feeling of illness, chest or abdominal pain, chills, burning sensation while urinating,
• swelling of the face, lips, tongue, or throat,
• difficulty swallowing,
• spontaneous hemorrhages or bleeding without apparent reason,
• skin rash,
• unusual pain, heat, swelling, or exudate at the surgery site

You should stop taking Certican andinform your doctor immediately.

Other reported side effects include:

Very common(may affect more than1 in 10 patients)

• infections (viral, bacterial, and fungal infections),
• 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 a higher risk of infection, reduced platelet count in blood, which may lead to bleeding and/or skin hematomas,
• high levels of fats (lipids, cholesterol, and triglycerides) in the blood,
• onset of diabetes (elevated blood sugar levels),
• low potassium levels in the blood,
• anxiety,
• difficulty falling asleep (insomnia),
• headache,
• fluid collection in the pericardial sac, which, if severe, may reduce the heart's ability to pump blood,
• high blood pressure,
• deep vein thrombosis (obstruction of a major vein by a blood clot),
• fluid collection in the lungs and thoracic cavity, which, if severe, may impair breathing,
• cough,
• shortness of breath,
• diarrhea,
• nausea,
• vomiting,
• abdominal pain,
• general pain,
• fever,
• fluid accumulation in tissues,
• abnormal wound healing.

Common(may affect up to1 in 10 patients)

• septicemia,
• wound infection,
• cancer and benign tumors,
• skin cancer,
• renal impairment with low platelet count in blood and low red blood cell count, with or without skin rash (thrombotic microangiopathy/hemolytic-uremic syndrome),
• red blood cell breakdown,
• low red blood cell and platelet counts,
• rapid heart rate,
• nasal hemorrhages,
• reduced cell count in the blood (symptoms may include weakness, hematomas, and frequent infections),
• coagulation in the renal blood vessels that may result in graft loss, mainly within the first 30 days after kidney transplantation,
• bleeding disorders,
• fluid-filled lymphatic cyst,
• mouth or throat pain,
• pancreatitis,
• mouth ulcers,
• acne,
• urticaria and other allergic symptoms, such as facial or throat swelling (angioedema),
• skin rash,
• joint pain,
• muscle pain,
• protein in the urine,
• renal disorders,
• impotence,
• hernia at the surgery site,
• abnormal liver function test results,
• menstrual disorders (including absent or intense periods).

Rare(may affect up to1 in 100 patients):

• lymphoma/ post-transplant lymphoproliferative disorder,
• low testosterone levels,
• inflammation of the lungs,
• inflammation of the liver,
• jaundice,
• ovarian cysts.

Other side effects:

Other side effects have been reported in a small number of patients, but their exact frequency is unknown:

• abnormal protein accumulation 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 body parts (this may occur in any part of the body and may indicate abnormal fluid accumulation in soft tissues due to lymphatic obstruction, also known as lymphedema),
• severe skin rash with skin inflammation,
• low iron levels in the blood.

If you have any doubts about any of these side effects,inform your doctor.

Additionally, you may experience side effects that you are not aware of, such as abnormal laboratory test results, including renal function tests. This means that your doctor will perform blood tests to monitor any changes in your kidneys during treatment with Certican.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (www.notificaRAM.es).By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep Certican out of sight and reach of children.
• Do not use Certican after the expiration date that appears on the carton after CAD. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature.
• Store the blister pack in the original packaging to protect it from light and moisture.
• Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.
• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Certican

• The active ingredient is everolimus. Each dispersible tablet contains 0.1 mg or 0.25 mg of everolimus.
• The other components are:

- Certican 0.1 mg dispersible tablets: butylhydroxytoluene (E321), magnesium stearate, lactose monohydrate (1 mg), hypromellose, crospovidone, colloidal anhydrous silica, and anhydrous lactose (72 mg).

- Certican 0.25 mg dispersible tablets: butylhydroxytoluene (E321), magnesium stearate, lactose monohydrate (2 mg), hypromellose, crospovidone, colloidal anhydrous silica, and anhydrous lactose (179 mg).

Appearance of the product and contents of the package

• Certican 0.1 mg dispersible tablets are round, flat tablets of 7 mm, white to yellowish, speckled, with the inscription “I” on one face and “NVR” on the other.
• Certican 0.25 mg dispersible tablets are round, flat tablets of 9 mm, white to yellowish, speckled, with the inscription “JO” on one face and “NVR” on the other.

Certican dispersible tablets are presented in packages containing 50, 60, 100, or 250 dispersible tablets. Only some package sizes may be marketed. Certican is also available in tablet form.

Marketing authorization holder and responsible manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona,

Spain

Responsible manufacturer

NOVARTIS FARMA, S.P.A.

Via Provinciale Schito, 131 (Torre Annunziata) (Naples) - Unknown - Italy

0815354111

NOVARTIS FARMACEUTICA, S.A.

Gran Via de les Corts Catalanes, 764 - 08013 Barcelona- Spain

NOVARTIS PHARMA GMBH

Roonstrasse 25

90429 Nürnberg–

Germany

NOVARTIS PHARMA, S.A.S.

8-10 rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

NOVARTIS SVERIGE AB

Torshamnsgatan 48, 16440 Kista– Sweden

NOVARTIS FINLAND OY

Metsänneidonkujaq (Espoo) - FIN-02130 – Finland

N.V. NOVARTIS PHARMA, S.A.

Medialaan 40, bus 1 (Vilvoorde) - 1800 - Belgium32

2 246 1611

NOVARTIS HELLAS S.A.C.I.

National Road 1 12th Km (Metamorphosi, Athens) - GR-14451 - Greece

302102811712

NOVARTIS PHARMA GMBH

Jakov-Lind-Straße 5, Top 3.05– 1020 Vienna – Austria

NOVARTIS PHARMA BV

Haaksbergweg 16- 1101 BX Amsterdam- Netherlands

NOVARTIS HEALTHCARE A/S

Edvard Thomsens Vej 14,3. (Copenhagen) - DK-2300 – Denmark

NOVARTIS FARMA-PRODUCTOS FARMACEUTICOS, S.A.

Avenida Professor Doutor Cavaco Silva, nº 10E (Taguspark, Porto Salvo) -

2740-255 – Portugal

NOVARTIS HUNGARY LTD.

Bartok Bela út 43-47 (Budapest) - 1114 – Hungary

NOVARTIS POLAND SP.Z.O.O.

Ul. Marynarska, 15 (Warszawa) - 02-674 – Poland

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

NOVARTIS PHARMA GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet:09/2023

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)

THIS INFORMATION IS INTENDED ONLY FOR DOCTORS OR

PROFESSIONALS IN THE HEALTH SECTOR

Instructions for use and handling of dispersible tablets

Administration in a 10 ml syringe via oral route.Place Certican dispersible tablets in a syringe. The maximum amount of Certican that can be dispersed in a 10 ml syringe is 1.25 mg. Add water up to the 5 ml mark. Wait 90 seconds while gently shaking. After dispersion, apply directly to the mouth. Wash the syringe with 5 ml of water and apply again to the mouth. Finally, drink between 10 and 100 ml of water or diluted syrup.

Administration with a plastic cup.Place Certican dispersible tablets in a plastic cup with approximately 25 ml of water. The maximum amount of Certican that can be dispersed in 25 ml of water is 1.5 mg. Wait for approximately 2 minutes to allow the tablets to disintegrate and gently shake before drinking. Immediately wash the cup with an additional 25 ml of water and drink the entire contents.

Administration via nasogastric tube.Place Certican dispersible tablets in a small plastic precipitate vial containing 10 ml of water and wait 90 seconds while gently shaking. Place the dispersion in a syringe and inject slowly (for 40 seconds) into a nasogastric tube. Wash the vial (and syringe) 3 times with 5 ml of water and inject into the tube. Finally, clean the tube with 10 ml of water. The nasogastric tube must be clamped for at least 30 minutes after Certican administration.

If cyclosporine for microemulsion is also administered via nasogastric tube, it should be administered before Certican. The two drugs should not be mixed.