Aderolio

Patient Information Leaflet: Patient Information

Aderolio, 0.25 mg, tablets

Aderolio, 0.5 mg, tablets

Aderolio, 0.75 mg, tablets

Aderolio, 1.0 mg, tablets

Everolimus

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet:

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

1. What is Aderolio and what is it used for

The active substance of Aderolio is everolimus.
Everolimus belongs to a group of so-called immunosuppressive medicines. It is used in adult patients
to prevent rejection of a transplanted kidney, heart, or liver by the body's immune system.
Aderolio is used in combination with other medicines, such as cyclosporin (in patients undergoing
kidney or heart transplantation), tacrolimus (in patients undergoing liver transplantation),
and corticosteroids.

2. Important information before taking Aderolio

When not to take Aderolio

• 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 any of the above points apply to the patient, they should tell their doctor and not take Aderolio.

Warnings and precautions

Before starting treatment with Aderolio, the patient should discuss it with their doctor.

• Medicines that suppress the immune system, such as Aderolio, reduce the body's ability to fight infections. If the patient has a fever or feels unwell or has symptoms such as cough or burning sensation when urinating, and these symptoms are severe or

persist for several days, the patient should contact their doctor or the transplant center. The patient should immediately contact their doctor or the transplant center if they 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 the patient has recently undergone major surgery or still has an unhealed surgical wound, Aderolio may increase the risk of wound healing disorders.
• Medicines that suppress the immune system, such as Aderolio, increase the risk of cancer, especially skin and lymphatic system cancer. Therefore, the patient should limit their exposure to sunlight and ultraviolet (UV) radiation by wearing protective clothing and applying sunscreen with a high sun protection factor frequently.
• The doctor will monitor the patient's kidney function, lipid levels, and blood sugar levels, as well as the amount of protein in their urine.
• If the patient has liver function disorders or has had a disease that may have affected liver function, they should inform their doctor. The doctor may need to adjust the dose of Aderolio.
• If the patient experiences respiratory symptoms (such as cough, difficulty breathing, and wheezing), they should consult their doctor. The doctor may decide whether to continue treatment with Aderolio and/or whether to administer other medicines.
• Aderolio may reduce sperm production in men, thereby reducing their fertility. This effect is usually reversible. Men planning to become fathers should discuss their treatment with their doctor.

Elderly patients (65 years and older)

Experience with the use of Aderolio in elderly patients is limited.

Children and adolescents (under 18 years)

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

Aderolio and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription. Some medicines may affect the way Aderolio works in the body.
It is particularly important to inform the doctor about the use of any of the following medicines:

• immunosuppressive medicines other than cyclosporin, 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 disorders, such as verapamil, nicardipine, or diltiazem;
• dronedarone, a medicine used to regulate heart rhythm;
• medicines used to lower cholesterol levels in the blood, such as atorvastatin, pravastatin, or fibrates;
• medicines used to treat acute seizures or as sedatives before or during surgery or other medical procedures, such as midazolam;
• octreotide, a medicine used to treat acromegaly, a rare hormonal disorder that usually occurs in adults of middle age;
• imatinib, a medicine used to inhibit the growth of abnormal cells;
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression.
• Cannabidiol (used, among other things, to treat seizures).

If the patient needs to be vaccinated, they should consult their doctor first.

Aderolio with food and drink

Food may affect the absorption of Aderolio. To maintain a constant level of the medicine in the body, Aderolio should always be taken in the same way, either with food or on an empty stomach.
The patient should not take Aderolio with grapefruit juice or grapefruit. They affect the action of Aderolio in the body.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, they should not take Aderolio, unless their doctor considers it absolutely necessary. Women who may become pregnant should use effective contraception during treatment with Aderolio and for 8 weeks after the end of treatment.
If the patient suspects they may be pregnant, they should consult their doctor or pharmacist before taking Aderolio.
The patient should not breastfeed while taking Aderolio. It is not known whether the medicine passes into breast milk.
Aderolio may affect male fertility.

Driving and using machines

No studies have been conducted on the effects of Aderolio on the ability to drive and use machines.

Aderolio contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Aderolio

The doctor will decide what dose and when the patient should take Aderolio.
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

How much to take

• The usual initial dose for patients after kidney or heart transplantation is 1.5 mg per day, and for patients after liver transplantation, it is 2.0 mg per day.
• The daily dose is usually divided into two doses - one taken in the morning and one taken in the evening.

How to take Aderolio

The medicine is intended for oral use only.
The tablets should not be crushed.
The tablets should be swallowed whole, with a glass of water.
The first dose of Aderolio should be taken as soon as possible after kidney or heart transplantation, and about four weeks after liver transplantation.
Patients after kidney or heart transplantation should take Aderolio at the same time as cyclosporin in the form of a microemulsion, and patients after liver transplantation should take it at the same time as tacrolimus.
Without consulting their doctor first, the patient should not switch from Aderolio to everolimus in tablets for oral suspension.

Control tests during treatment with Aderolio

The doctor may adjust the dose of Aderolio based on its level in the blood and the patient's response to treatment. The doctor will order regular blood tests to monitor the levels of everolimus and cyclosporin in the blood. The doctor will also closely monitor the patient's kidney function, lipid levels, and blood sugar levels, as well as the amount of protein in their urine.

Taking a higher dose of Aderolio than recommended

If the patient has taken a higher dose of Aderolio than recommended, they should immediately consult their doctor.

Missing a dose of Aderolio

If the patient forgets to take a dose of Aderolio, they should take it as soon as they remember, and then take the next dose at the usual time. The patient should consult their doctor. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Aderolio

The patient should not stop taking Aderolio without their doctor's advice. The medicine should be taken for as long as it is necessary to suppress the immune system to prevent rejection of the transplanted kidney, heart, or liver. Stopping treatment with Aderolio increases the risk of rejection of the transplanted organ by the body.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aderolio can cause side effects, although not everybody gets them.
Aderolio is taken with other medicines, so it is not always clear whether the side effects are caused by Aderolio or by other medicines.

The following side effects require immediate medical attention:

• infections,
• pneumonia,
• allergic reactions,
• fever and the formation of bruises under the skin, which may look like 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 the patient experiences any of the following symptoms, they should stop taking Aderolio and immediately consult their doctor:

• persistent or worsening symptoms related to the lungs/breathing, such as cough, difficulty breathing, or wheezing,
• fever, general malaise, chest pain, 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, unusual sensation of heat, swelling, or discharge from the surgical wound.

Other reported side effects include:

Very common(may occur more frequently than in 1 in 10 patients)

• 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 an increased risk of infection, low platelet count, which may cause bleeding and/or bruising under the skin,
• high levels of lipids (cholesterol and triglycerides) in the blood,
• onset of diabetes (high blood sugar levels),
• low potassium levels in the blood,
• anxiety,
• difficulty sleeping (insomnia),
• headache,
• fluid accumulation in the sac around the heart, which (if significant) may reduce the heart's ability to pump blood,
• high blood pressure,
• venous thrombosis (blockage of a large vein by a blood clot),
• fluid accumulation in the lungs and chest cavity, which (if significant) may cause shortness of breath,
• cough,
• shortness of breath,
• diarrhea,
• nausea,
• vomiting,
• stomach pain (abdominal pain),
• generalized pain,
• fever,
• fluid accumulation in tissues,
• wound healing disorders.

Common(may occur less frequently than in 1 in 10 patients)

• blood infection,
• wound infection,
• 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 blood cell and platelet count,
• rapid heartbeat,
• nosebleeds,
• reduced blood cell count (symptoms may include: weakness, bruising, and frequent infections),
• formation of a blood clot in a blood vessel of the transplanted kidney, which may result in loss of the transplant, most often within the first 30 days after transplantation,
• bleeding disorders,
• lymphatic 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 function disorders,
• impotence,
• hernia at the site of surgery,
• abnormal liver function test results,
• menstrual disorders (including amenorrhea or heavy menstrual bleeding).

Uncommon(may occur less frequently than in 1 in 100 patients)

• lymph tissue cancer (lymphoma/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 their exact frequency is not known:

• abnormal protein accumulation in the lungs (symptoms may include: persistent dry cough, feeling of fatigue, and difficulty breathing),
• inflammation of blood vessels,
• severe rash with skin swelling,
• swelling, feeling of heaviness or pressure, pain, limited mobility of a body part (may affect any area of the body and may be a sign of abnormal fluid accumulation in soft tissues due to blockage of lymphatic vessels, also known as lymphedema)
• low iron levels in the blood.

If any of the above side effects concern the patient, they should consult their doctor.
There may also be side effects that the patient is not aware of, such as abnormal laboratory test results, including kidney function tests. Therefore, during treatment with Aderolio, the doctor will perform blood tests to monitor changes in the kidneys.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 Aderolio

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of the month.
There are no special storage requirements for the medicine.
Store the blisters in the original outer packaging to protect them from light and moisture.
Do not use this medicine if the packaging is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Aderolio contains

• The active substance of Aderolio is everolimus. Aderolio 0.25 mg:Each tablet contains 0.25 mg of everolimus. Aderolio 0.5 mg:Each tablet contains 0.5 mg of everolimus. Aderolio 0.75 mg:Each tablet contains 0.75 mg of everolimus. Aderolio 1.0 mg:Each tablet contains 1 mg of everolimus.
• The other ingredients are: butylhydroxytoluene (E 321), magnesium stearate, lactose monohydrate, hypromellose (type 2910), crospovidone (type A), and lactose.

What Aderolio looks like and contents of the pack

Aderolio, 0.25 mg: White to yellowish, marbled, round, flat tablets with beveled edges, 6 mm in diameter, with the inscription "C" on one side and "NVR" on the other.
Aderolio, 0.5 mg: White to yellowish, marbled, round, flat tablets with beveled edges, 7 mm in diameter, with the inscription "CH" on one side and "NVR" on the other.
Aderolio, 0.75 mg: White to yellowish, marbled, round, flat tablets with beveled edges, 8.5 mm in diameter, with the inscription "CL" on one side and "NVR" on the other.
Aderolio, 1.0 mg: White to yellowish, marbled, round, flat tablets with beveled edges, 9 mm in diameter, with the inscription "CU" on one side and "NVR" on the other.
Pack sizes: 50, 60, 100, or 250 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg, Germany

To obtain more detailed information about the medicine and its names in other European Economic Area member states, the patient should contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:07/2022
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