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 package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 experience any side effects, including those not listed in this leaflet, please inform your 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 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. Important information before taking 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 starting treatment with 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 if you experience symptoms such as coughing or a burning sensation while urinating, and these symptoms are severe or

persist 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 such as 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 radiation (UV) 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, you should inform your doctor. Your doctor may need to adjust the dose of Aderolio.
• If you experience respiratory symptoms (such as coughing, difficulty breathing, or wheezing), you should contact your doctor. Your 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 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

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription. This also applies to herbal medicines.
Some medicines may affect the way Aderolio works in the body.
It is particularly important to inform your doctor about the following medicines:

• immunosuppressants 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 you need to be vaccinated, you should 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 the body, you should always take Aderolio in the same way, either with food or on an empty stomach.
You should not take Aderolio with grapefruit juice or grapefruit. They affect the way Aderolio works in the 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 the end of treatment.
If you suspect that you may be pregnant, you should consult your doctor or pharmacist before taking Aderolio.
You should not breastfeed while taking Aderolio. It is not known whether the medicine passes into breast milk.
Aderolio may affect fertility in men.

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

3. How to take Aderolio

Your doctor will decide what dose and when you should take Aderolio.
This medicine should always be taken 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 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 for oral use only.
Tablets should not be crushed.
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 together with cyclosporin in the form of a microemulsion, and patients after liver transplantation should take it together with tacrolimus.
Without consulting your doctor, you should not switch from Aderolio to everolimus tablets for oral suspension.

Control tests during treatment with Aderolio

Your doctor may adjust the dose of Aderolio based on its level in the blood and your response to treatment. Your doctor will order regular blood tests to monitor the levels of everolimus and cyclosporin in the 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 have taken more Aderolio than prescribed, you should contact your doctor immediately.

Missing a dose of Aderolio

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

Stopping treatment with Aderolio

You should not stop taking Aderolio without your doctor's advice. You should take the medicine 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.
If you have any further questions about 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 this or 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, jaundice, or decreased urine output (thrombotic microangiopathy, hemolytic-uremic syndrome) or without these symptoms.

If you experience any of the following symptoms, you should stop taking Aderolio and contact your doctor immediately:

• persistent or worsening respiratory symptoms, such as coughing, difficulty breathing, or wheezing,
• fever, general malaise, chest pain, or abdominal pain, chills, burning sensation while 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 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 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,
• low 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 cause 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 or throat 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)

• 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, you should consult 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, you should inform 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 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.
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 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 side.
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 side.
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 side.
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 side.
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

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

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