Everolimus Genthon

Leaflet accompanying the packaging: patient information

Everolimus Genthon, 2.5 mg, tablets

Everolimus Genthon, 5 mg, tablets

Everolimus Genthon, 10 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.
• 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 Everolimus Genthon and what is it used for
• 2. Important information before taking Everolimus Genthon
• 3. How to take Everolimus Genthon
• 4. Possible side effects
• 5. How to store Everolimus Genthon
• 6. Contents of the packaging and other information

1. What is Everolimus Genthon and what is it used for

Everolimus Genthon is an anticancer medicine that contains the active substance everolimus.
Everolimus reduces blood flow to the tumor and slows down the growth and spread of cancer cells.
Everolimus Genthon is used to treat adult patients with:

• advanced breast cancer with hormonal receptor expression in postmenopausal women, in whom other medicines (so-called "non-steroidal aromatase inhibitors") have stopped controlling the disease. This medicine is given together with exemestane, a steroid aromatase inhibitor used in hormonal anticancer therapy.
• advanced neuroendocrine tumors that originate from the stomach, intestines, lungs, or pancreas. This medicine is given if the tumors are inoperable and do not secrete excessive amounts of specific hormones or other related natural substances.
• advanced kidney cancer (advanced renal cell carcinoma) when other medicines (called anti-VEGF therapy) have proven ineffective.

2. Important information before taking Everolimus Genthon

Everolimus Genthon may only be prescribed by a doctor experienced in the treatment of cancer. All the doctor's instructions must be followed. They may differ from the general information contained in this leaflet. If additional information about Everolimus Genthon is needed and an explanation of why this medicine was chosen, the doctor should be consulted.

When not to take Everolimus Genthon:

• If the patient is allergicto everolimus, similar substances such as sirolimus or temsirolimus, or any of the other ingredients of this medicine (listed in section 6).

In case of suspected allergy, the doctor should be consulted.

• If the patient suspects an allergy, they should ask their doctor for advice.

Warnings and precautions

Before starting Everolimus Genthon, the following should be discussed with the doctor:

• If the patient has liver problemsor diseases that may have affected liver function. In such cases, the doctor may change the dose of Everolimus Genthon.
• If the patient has diabetes(high blood sugar). Everolimus Genthon may increase blood sugar levels and worsen diabetes. This condition may require the administration of insulin and/or oral anti-diabetic medicines. The doctor should be informed if the patient experiences excessive thirst or frequent urination.
• If the patient needs to receive vaccinationswhile taking Everolimus Genthon.
• If the patient has high cholesterol levels. Everolimus Genthon may increase cholesterol and/or other fats in the blood.
• If the patient has recently undergone major surgeryor has unhealed wounds resulting from surgery. Everolimus Genthon may hinder wound healing.
• If the patient has an infection. Before starting Everolimus Genthon, it may be necessary to cure the existing infection.
• If the patient has had hepatitis B in the past, as the disease may reactivate during treatment with Everolimus Genthon (see section 4, Possible side effects).

Everolimus Genthon may also:

• weaken the immune system. Therefore, the patient may be at risk of infection while taking Everolimus Genthon.
• affect kidney function. Therefore, during treatment with Everolimus Genthon, the doctor will monitor kidney function.
• cause shortness of breath, cough, and fever. The doctor should be informedif the patient experiences these symptoms.

During treatment, the patient will undergo regular blood tests to monitor blood cell count (white blood cells, red blood cells, and platelets) and to check if Everolimus Genthon has a negative effect on blood cells. Blood tests will also be performed to monitor kidney function (creatinine levels), liver function (transaminase activity), and blood sugar and cholesterol levels, as Everolimus Genthon may affect them.

Children and adolescents

Everolimus Genthon is not given to children and adolescents (under 18 years of age).

Everolimus Genthon and other medicines

Everolimus Genthon may affect the action of other medicines. If the patient takes other medicines at the same time as Everolimus Genthon, the doctor may change the dose of Everolimus Genthon or other medicines.
The doctor or pharmacist should be toldabout all medicines the patient is taking, has recently taken, or plans to take.
The following medicines taken with Everolimus Genthon may increase the risk of side effects:

• Ketoconazole, itraconazole, voriconazoleor fluconazole, other antifungal medicinesused to treat fungal infections.
• Clarithromycin, telithromycinor erythromycin, antibioticsused to treat bacterial infections.
• Ritonavirand other medicines used to treat HIV/AIDS.
• Verapamilor diltiazemused to treat heart disease or high blood pressure.
• Dronedarone, a medicine that helps restore a regular heart rhythm.
• Cyclosporine, a medicine used to prevent transplant rejection.
• Imatinib, which inhibits the growth of abnormal cells.
• Angiotensin-converting enzyme inhibitors (ACE)(such as ramipril) used to treat high blood pressure or other heart problems.

The following medicines may reduce the effectiveness of Everolimus Genthon:

• Rifampicinused to treat tuberculosis.
• Efavirenzor nevirapine, used to treat HIV/AIDS.
• St. John's Wort (Hypericum perforatum), a herbal product used to treat depression and other disorders.
• Dexamethasone, a corticosteroid used to treat various diseases, including inflammatory conditions or immune system disorders.
• Phenytoin, carbamazepineor phenobarbitaland other antiepileptic medicinesused to prevent various types of seizures.

These medicines should be avoided during treatment with Everolimus Genthon. If the patient is taking any of these medicines, the doctor may replace them with another medicine or change the dose of Everolimus Genthon.

Pregnancy, breastfeeding, and fertility

Pregnancy
It is not recommended to take Everolimus Genthon during pregnancy, as it may harm the unborn child. The doctor should be informed if the patient is pregnant or thinks they may be pregnant. The doctor will inform the patient whether they can take this medicine during pregnancy.
Women who may become pregnant during treatment should use highly effective contraceptive methods. If, despite these measures, the patient suspects they may be pregnant, they should contact their doctor beforetaking Everolimus Genthon.
Breastfeeding
Everolimus Genthon may harm the breastfed child. Breastfeeding should not be done during treatment and for 2 weeks after the last dose of everolimus. The doctor should be informed about breastfeeding.
Female fertility
In some patients taking Everolimus Genthon, menstrual irregularities (absence of menstruation) have been observed.
Everolimus Genthon may affect female fertility. The doctor should be consulted if the patient wants to have children.
Male fertility
Everolimus Genthon may affect male fertility. The doctor should be informed about the intention to become a father.

Driving and using machines

In case of unexplained fatigue, special caution should be exercised when driving vehicles and operating machines.

Everolimus Genthon contains lactose

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

3. How to take Everolimus Genthon

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor should be consulted.
The recommended dose is 10 mg, taken once a day. The doctor will determine how many tablets to take.
In case of liver problems, the doctor may start treatment with a lower dose of Everolimus Genthon (2.5, 5, or 7.5 mg per day).
In case of certain side effects during treatment with Everolimus Genthon (see section 4), the doctor may reduce the dose or interrupt treatment for a short time or permanently.
Everolimus Genthon should be taken once a day, at the same time, always with or without food.
The Everolimus Genthon tablet(s) should be swallowed whole, with a glass of water. The tablets should not be chewed or crushed.

Taking a higher dose of Everolimus Genthon than recommended

• In case of taking a higher dose of Everolimus Genthon than recommended or if another person accidentally takes the tablets, the doctor or hospital should be consulted immediately. Urgent medical attention may be necessary.
• The doctor should be shown the carton packaging of the medicine and this leaflet, so that it can be determined which medicine was overdosed.

Missing a dose of Everolimus Genthon

In case of missing a dose, the next planned dose should be taken. A double dose should not be taken to make up for the missed tablet.

Stopping Everolimus Genthon

Everolimus Genthon should not be stopped without the doctor's advice.
In case of further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP USINGthe medicinal product Everolimus Genthon and seek medical help immediately if the patient experiences any of the following symptoms of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue, or throat
• Increasing skin itching, with red rash and emerging bumps

The serious side effects of Everolimus Genthon include:

Very common(may occur more often than in 1 in 10 patients)
Increased temperature, chills (infection symptoms) •Fever, cough, difficulty breathing, wheezing (pneumonia symptoms)
Common(may occur less often than in 1 in 10 patients)
Increased thirst, frequent urination, increased appetite with weight loss, fatigue (diabetes symptoms) •Bleeding (e.g., in the intestinal wall) •Severe reduction in urine output (sign of kidney failure)
Uncommon(may occur less often than in 1 in 100 patients)
Fever, skin rash, joint pain, as well as fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools, dark urine (may be symptoms of hepatitis B reactivation) •Shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (signs of heart failure) •Swelling and (or) pain in one leg, usually in the calf, redness or warmth of the skin in the affected area (symptoms of deep vein thrombosis, a blood clot in the legs) •Sudden shortness of breath, chest pain, or coughing up blood (potential symptoms of pulmonary embolism, which occurs when one or more arteries in the lungs become blocked) •Severe reduction in urine output, swelling of the feet, feeling of disorientation, back pain (symptoms of sudden kidney failure) •Rash, itching, hives, difficulty breathing or swallowing, dizziness (symptoms of a severe allergic reaction, also known as hypersensitivity)
Rare(may occur less often than in 1 in 1000 patients)
Shortness of breath or rapid breathing (symptoms of acute respiratory distress syndrome)

The patient should immediately inform their doctor if they experience any of the above side effects, as they may cause life-threatening consequences.

Other possible side effects of Everolimus Genthon include:

Very common(may occur more often than in 1 in 10 patients)
Fatigue, shortness of breath, dizziness, paleness of the skin, symptoms of low red blood cell count (anemia) • High blood sugar levels (hyperglycemia) • Loss of appetite • High levels of fats in the blood (hypercholesterolemia) • Taste disturbances • Headache • Nosebleeds (epistaxis) • Cough • Mouth ulcers • Stomach upset, including nausea (nausea) or diarrhea • Skin rash • Itching (pruritus) • Feeling of weakness or fatigue • Swelling of the arms, hands, feet, ankles, and other body parts (symptoms of edema) • Weight loss •
Common(may occur less often than in 1 in 10 patients)
Sudden bleeding or bruising and frequent infections, with symptoms such as fever, chills, sore throat, or mouth ulcers (symptoms of low platelet count, also known as thrombocytopenia) • Fever, sore throat, mouth ulcers caused by infection (symptoms of low white blood cell count, leukopenia, lymphopenia, and/or neutropenia) • Shortness of breath (dyspnea) • Feeling of thirst, low urine output, dark urine, dry reddened skin, irritability (symptoms of dehydration) • Sleep disturbances (insomnia) • Headaches, dizziness (symptoms of high blood pressure, also known as hypertension) • Fever • Inflammation of the lining of the mouth, stomach, or intestines • Dry mouth • Heartburn (dyspepsia) • Vomiting • Difficulty swallowing (dysphagia) • Abdominal pain • Acne • Skin rash and pain on the palms of the hands and soles of the feet (hand-foot syndrome) • Skin redness (erythema) • Joint pain

• Mouth pain • Menstrual disorders, such as irregular menstrual bleeding • High levels of fats in the blood (hyperlipidemia, increased triglycerides) • Low potassium levels in the blood (hypokalemia) • Low phosphate levels in the blood (hypophosphatemia)
• Low calcium levels in the blood (hypocalcemia) • Dry skin, skin peeling, skin conditions • Nail disorders, nail fragility • Moderate hair loss • Abnormal liver function test results (elevated alanine aminotransferase and aspartate aminotransferase activity) • Abnormal kidney function test results (elevated creatinine levels) • Eye discharge, accompanied by itching, redness, and swelling • Protein in the urine

Uncommon(may occur less often than in 1 in 100 patients)
Weakness, unexpected bleeding or bruising, and frequent infections, with symptoms such as fever, chills, sore throat, or mouth ulcers (symptoms of low blood cell count, also known as pancytopenia) •Loss of taste (ageusia) •Coughing up blood (hemoptysis) •
Menstrual disorders, such as absence of menstruation •Frequent urination during the day •
Chest pain •Wound healing problems •Hot flashes •Conjunctivitis (conjunctival redness)
Rare(may occur less often than in 1 in 1000 patients)
Fatigue, shortness of breath, dizziness, paleness of the skin (symptoms of low red blood cell count, possibly due to pure red cell aplasia) •Swelling of the face, around the eyes, lips, inside the mouth, and (or) throat, as well as difficulty breathing and swallowing (known as angioedema), may be symptoms of an allergic reaction

If the above side effects worsen, the doctor or pharmacist should be informed. Most side effects are mild or moderate and should resolve after stopping treatment for a few days.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Everolimus Genthon

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: {Expiry date (EXP)}. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light
There are no special storage temperature instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Everolimus Genthon contains

• The active substance of the medicine is everolimus. One tablet of Everolimus Genthon contains 2.5 mg, 5 mg, or 10 mg of everolimus
• The other ingredients are: butylhydroxytoluene (E321), hypromellose (E464), lactose, lactose monohydrate, crospovidone (E1202), magnesium stearate (E470b)

What Everolimus Genthon looks like and what the pack contains

Everolimus Genthon tablets are available in three strengths:
Everolimus Genthon 2.5 mg are white or almost white, oval, biconvex tablets (approximately 10 mm x 5 mm) with the inscription E9VS on one side and 2.5 on the other side.
Everolimus Genthon 5 mg are white or almost white, oval, biconvex tablets (approximately 13 mm x 6 mm) with the inscription E9VS 5 on one side.
Everolimus Genthon 10 mg are white or almost white, oval, biconvex tablets (approximately 16 mm x 8 mm) with the inscription E9VS 10 on one side.
Everolimus Genthon 2.5 mg is available in packs containing 30 or 90 tablets.
Everolimus Genthon 5 mg and Everolimus Genthon 10 mg are available in packs containing 10, 30, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Genthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Manufacturer / Importer
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania, S.L.
C/Castelló n°1
Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain

Date of last revision of the leaflet: