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

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 1. What Aderolio is and what it is used for
• 2. Before you take 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 Aderolio is and what it is used for

The active substance of Aderolio is everolimus.
Everolimus belongs to a group of medicines called immunosuppressants. 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 together with other medicines, such as cyclosporin (in patients undergoing kidney or heart transplantation), tacrolimus (in patients undergoing liver transplantation), and corticosteroids.

2. Before you take Aderolio

When not to take Aderolio

• if you are allergic (hypersensitive) to everolimus or 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, tell your doctor and do not take Aderolio.

Warnings and precautions

Before taking Aderolio, discuss this with your doctor.

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

last for several days, you should contact your doctor or the transplant center. You should contact your doctor or the transplant center immediately if you experience symptoms of confusion, speech disorders, memory loss, headache, vision disorders, or seizures, as these may be symptoms of a rare but serious disease called "progressive multifocal leukoencephalopathy" (PML).

• If you have recently undergone major surgery or still have 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, you should limit your exposure to sunlight and ultraviolet (UV) radiation by wearing protective clothing and applying sunscreen with a high sun protection factor frequently.
• Your doctor will monitor your kidney function, lipid levels, and blood sugar levels, as well as the amount of protein in your urine.
• If you have liver function disorders or have had a disease that may have affected liver function, tell your doctor. Your doctor may need to adjust the dose of Aderolio.
• If you experience respiratory symptoms (such as cough, difficulty breathing, and wheezing), contact your doctor. Your doctor may decide whether to continue Aderolio and/or whether to administer other medicines.
• Aderolio may reduce sperm production in men, 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 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription. This includes:
immunosuppressant 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, 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.

If you need to be vaccinated, consult your doctor beforehand.

Aderolio with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, you should not take Aderolio unless your doctor considers it absolutely necessary. Women who may become pregnant should use effective contraception during treatment with Aderolio and for 8 weeks after stopping treatment.
If you think you may be pregnant, consult your doctor or pharmacist before taking Aderolio.
Do 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 or use machines.

Aderolio contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Aderolio

Your doctor will decide what dose and when you should take Aderolio.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

• The usual starting 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 for oral use only.
Do not crush the tablets.
Swallow the tablets whole with a glass of water.
Take the first dose of Aderolio 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 together with cyclosporin in the form of a microemulsion, and patients after liver transplantation should take it together with tacrolimus.
Do not change from Aderolio to everolimus tablets for oral suspension without consulting your doctor first.

Control tests during treatment with Aderolio

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

Taking more Aderolio than prescribed

If you take more Aderolio than prescribed, contact your doctor immediately.

Missing a dose of Aderolio

If you forget to take a dose of Aderolio, take it as soon as you remember, and then take the next dose at the usual time. Consult your doctor. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Aderolio

Do not stop taking Aderolio without your doctor's advice. You should keep taking Aderolio for as long as you need to prevent rejection of your transplanted kidney, heart, or liver. Stopping treatment with Aderolio increases the risk of rejection of the transplanted organ.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aderolio can cause side effects, although not everybody gets them.
Aderolio is taken together with other medicines, so it is not always clear whether the side effects are caused by Aderolio or by the 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 you experience any of the following symptoms, stop taking Aderolio and contact your doctor immediately:

• persistent or worsening respiratory symptoms, such as cough, difficulty breathing, or wheezing,
• fever, general malaise, chest pain, 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 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 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 affect up to 1 in 10 people)

• 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 transplanted kidney, which may result in loss of the transplant, most commonly within the first 30 days after 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 function disorders,
• impotence,
• hernia at the surgical site,
• abnormal liver function test results,
• menstrual disorders (including amenorrhea or heavy menstrual bleeding).

Uncommon(may affect up to 1 in 100 people)

• 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),
• blood vessel inflammation,
• 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 lymphatic vessel obstruction, also known as lymphedema),
• low iron levels in the blood.

If any of the above side effects concern you, contact your doctor.
There may also be side effects that you are not aware of, such as abnormal laboratory test results, including kidney function tests. Therefore, during treatment with Aderolio, 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, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aderolio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
There are no special storage requirements for this medicine.
Store the blisters in the original outer packaging to protect from light and moisture.
Do not use this medicine if you notice damage to the packaging or signs of opening.
Medicines should 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 Aderolio contains

• The active substance 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 "C" engraved 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 "CH" engraved 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 "CL" engraved 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 "CU" engraved 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 Nuremberg, Germany

For more information about this medicine and its authorized names in other EU countries, please contact:

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