Certican 0.1 mg dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Certican 0.1 mg dispersible tablets

Certican 0.25 mg dispersible tablets

everolimus

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Certican is and what it is used for
2. What you need to know 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 Certican is and what it is used for

The active substance of Certican is everolimus.

Everolimus belongs to a group of medicines 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 medicines, such as cyclosporine for kidney and heart transplantation, tacrolimus for liver transplantation, and corticosteroids.

2. What you need to know before taking 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 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 your body's ability to fight infections. You should consult your doctor or transplant center if you have a fever or feel generally unwell, or if you develop localized symptoms such as cough or burning sensation when urinating, which may be severe or persist for several days. Contact your doctor or transplant center immediately if you experience confusion, difficulty speaking, memory loss, headache, vision changes, or seizures, as these may be symptoms of a rare but serious condition called progressive multifocal leukoencephalopathy (PML).
• If you have recently undergone major surgery or still have an unhealed surgical wound, Certican may increase the risk of wound healing complications.
• Medicines that suppress the immune system, such as Certican, increase the risk of developing cancer, particularly of the skin and lymphatic system. Therefore, you should limit your exposure to sunlight and UV rays by wearing appropriate protective clothing and frequently applying sunscreen with a high protection factor.
• Your doctor will monitor your kidney function, blood levels of fat (lipids) and sugar, as well as the amount of protein in your urine.
• If you have liver problems or have previously had a disease that may have affected your liver, inform your doctor. Your doctor may need to adjust your Certican dose.
• If you experience respiratory symptoms (e.g., cough, difficulty breathing, or wheezing), inform your doctor. Your doctor will decide whether you should continue Certican treatment and how, and/or whether you need additional medications to manage this condition.
• Certican may reduce sperm production in men, thereby reducing fertility. This effect is generally reversible. Male patients who wish to father children should discuss their treatment with their doctor.

Elderly patients (aged 65 years and over)

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

Children and adolescents

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

Other medicines and Certican

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

Some medicines may affect how 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 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 problems, such as verapamil, nicardipine, or diltiazem.
• dronedarone, a medicine used to help regulate heart rhythm.
• medicines used to lower blood cholesterol, 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 (used, among other things, to treat epileptic 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 you need to receive any vaccine, consult your doctor first.

Taking Certican with food and drinks

Food can affect the amount of Certican that is absorbed. To maintain consistent levels in your body, you should always take Certican the same way—either always with food or always on an empty stomach.

Do not take Certican with grapefruit or grapefruit juice, as they may affect how Certican works in your body.

Pregnancy, breastfeeding, and fertility

Do not take Certican if you are pregnant unless your doctor considers it absolutely necessary. If you are a woman who can become pregnant, you must use an effective method of contraception during treatment with Certican and for 8 weeks after stopping treatment.

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

You must not breastfeed while taking Certican. It is not known whether Certican passes into breast milk.

Certican may affect male fertility.

Driving and using machines

The influence of Certican on the ability to drive and use machines is negligible or none.

Certican contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Certican

Your doctor will decide exactly what dose of Certican you should take and when you should take it.

Always follow exactly the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

How to take Certican

Certican must be taken by mouth only.

You should take the first dose of this medicine as soon as possible after kidney or heart transplantation, and approximately four weeks after liver transplantation.

You must take the tablets together with cyclosporine microemulsion in kidney and heart transplantation, and with tacrolimus in liver transplantation.

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

• Place the Certican dispersible tablets into 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, gently swirl the cup, and then drink the liquid.
• Immediately afterwards, rinse the cup with another 25 ml of water and drink this completely.

Monitoring during treatment with Certican

Your doctor may adjust your dose depending on the level of Certican in your blood and your response to treatment. Your doctor will perform regular blood tests to monitor blood levels of everolimus and cyclosporine. Your doctor will also carefully monitor your kidney function, blood lipids, blood glucose, and the amount of protein in your urine.

If you take more Certican than you should

If you take more tablets 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 continue with your regular dosing schedule. Seek advice from your doctor. Do not take a double dose to make up for a missed dose.

If you stop taking Certican

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

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

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

Because you take Certican together with other medicines, it is not always clear whether adverse effects are caused by Certican or by other medicines.

The following adverse effects require immediate medical attention:

• infections,
• inflammation of the lungs,
• allergic reactions,
• fever and bruising of the skin that may appear as red spots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urine output (thrombotic microangiopathy, haemolytic uraemic syndrome).

If you develop any of the following:

• persistent or worsening respiratory/lung symptoms 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 apparent reason,
• skin rash,
• pain, unusual warmth, swelling or discharge at the surgical site,

you should stop taking Certican and contact your doctor immediately.

Other reported adverse 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 pharyngitis and common cold,
• urinary tract infections,
• anaemia (reduced red blood cell count),
• low white blood cell count leading to increased risk of infection, reduced platelet count in blood which may lead to bleeding and/or bruising under the skin,
• elevated levels of fats (lipids, cholesterol and triglycerides) in the blood,
• onset of diabetes (high blood sugar level),
• low potassium levels in the blood,
• anxiety,
• difficulty sleeping (insomnia),
• headache,
• fluid accumulation in the sac surrounding the heart, which, if severe, may reduce the heart's ability to pump blood,
• venous thrombosis (blockage of a major vein by a blood clot),
• fluid accumulation in the lungs and in the chest cavity, which, if severe, may make breathing difficult,
• cough,
• shortness of breath,
• diarrhoea,
• discomfort (nausea),
• discomfort (vomiting),
• stomach (abdominal) pain,
• general pain,
• fever,
• fluid accumulation in tissues,
• abnormal wound healing.

Common (may affect up to 1 in 10 patients)

• sepsis,
• wound infection,
• cancer and benign tumours,
• skin cancer,
• kidney disorder with low platelet count and low red blood cell count, with or without skin rash (thrombotic purpura/haemolytic uraemic syndrome),
• breakdown of red blood cells,
• low red blood cell and platelet counts,
• rapid heartbeat,
• nosebleeds,
• reduced number of blood cells (symptoms may include weakness, bruising and frequent infections),
• blood clotting in blood vessels of the kidney, which may result in graft loss, mostly within the first 30 days after kidney transplantation,
• bleeding disorders,
• cyst containing lymphatic fluid,
• pain in mouth or throat,
• inflammation of the pancreas,
• mouth ulcers,
• acne,
• hives 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 surgical site,
• abnormal liver function test results,
• menstrual disorders (including absent or heavy periods).

Uncommon (may affect up to 1 in 100 patients)

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

Other adverse effects:

Other adverse effects have occurred in a small number of patients, 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 in certain parts of the body (this may occur anywhere in the body and could indicate abnormal fluid accumulation in soft tissues due to obstruction of the lymphatic system, also known as lymphoedema),
• severe skin rash with skin inflammation,
• low iron levels in blood.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month indicated.
• This medicine does not require any special storage temperature.
• Keep the blister pack in the original outer packaging to protect it from light and moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Certican

• The active substance 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, monohydrate lactose (1 mg), hypromellose, crospovidone, colloidal anhydrous silica and anhydrous lactose (72 mg).

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

Appearance of the product and contents of the pack

• Certican 0.1 mg dispersible tablets are round, flat, 7 mm in diameter, white to yellowish-white, mottled tablets, marked with “I” on one side and “NVR” on the other.
• Certican 0.25 mg dispersible tablets are round, flat, 9 mm in diameter, white to yellowish-white, mottled tablets, marked with “JO” on one side and “NVR” on the other.

Certican dispersible tablets are available in packs containing 50, 60, 100 or 250 dispersible tablets. Only certain pack sizes may be marketed. Certican is also available in the form of tablets.

Marketing Authorization Holder and Manufacturer Responsible

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona,

Spain

Manufacturer Responsible

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, S.A.S.

8-10 rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

NOVARTIS SVERIGE AB

Torshamnsgatan 48, 16440 Kista – Sweden

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 Wien – Austria

NOVARTIS PHARMA BV

Haaksbergweg 16 - 1101 BX Amsterdam - The Netherlands

NOVARTIS FARMA-PRODUCTOS FARMACÉUTICOS, S.A.

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

2740-255 – Portugal

NOVARTIS HUNGARY LTD.

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

NOVARTIS FARMA, S.P.A.

Viale Luigi Sturzo 43, 20154 - Milano (MI) – Italy

NOVARTIS PHARMACEUTICALS S.R.L.

Livezeni Street Nr. 7A, Targu Mures, 540472 – Romania

NOVARTIS PHARMA GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

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 the most recent review of this summary: 09/2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

THIS INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Instructions for use and handling of dispersible tablets

Oral administration using a 10 ml syringe. Place Certican dispersible tablets into a 10 ml 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, gently shaking during this time. After dispersion, administer directly into the mouth. Rinse the syringe with 5 ml of water and administer again into the mouth. Afterwards, drink between 10 and 100 ml of water or diluted syrup.

Administration using a plastic cup. Place Certican dispersible tablets into 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 approximately 2 minutes to allow the tablets to disintegrate, gently shaking before drinking. Immediately rinse the cup with an additional 25 ml of water and drink all the contents.

Administration via nasogastric tube. Place Certican dispersible tablets into a small plastic beaker containing 10 ml of water and wait 90 seconds, gently shaking during this time. Transfer the dispersion into a syringe and slowly inject (over 40 seconds) through the nasogastric tube. Rinse the beaker (and syringe) three times with 5 ml of water each time, injecting each rinse into the tube. Finally, flush the tube with 10 ml of water. The nasogastric tube should remain clamped for at least 30 minutes after administration of Certican.

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