Everolimus Accord

Leaflet accompanying the packaging: patient information

Everolimus Accord, 2.5 mg, tablets

Everolimus Accord, 5 mg, tablets

Everolimus Accord, 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Everolimus Accord 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 Accord 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, 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 Accord

Everolimus Accord may only be prescribed by a doctor experienced in treating 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 Accord is needed and an explanation of why this medicine was chosen, the doctor should be consulted.

When not to take Everolimus Accord:

allergic to everolimus, similar substances such as sirolimus or temsirolimus, or any of the other ingredientsof this medicine (listed in section 6). In case of suspected allergy, the doctor should be consulted.

Warnings and precautions

Before starting treatment with Everolimus Accord, the doctor should be consulted:

liver problems or diseases that may have affected liver function. In such cases, the doctor may change the dose of Everolimus Accord.diabetes(high blood sugar). Everolimus Accord may increase blood sugar levels and worsen diabetes. This condition may require insulin and/or oral antidiabetic drugs. The doctor should be informed if the patient experiences excessive thirst or frequent urination.vaccinationsduring treatment with Everolimus Accord.high cholesterol levels. Everolimus Accord may increase cholesterol and/or other fats in the blood.major surgeryor has unhealed woundsresulting from surgery. Everolimus Accord may hinder wound healing.infection. Before starting treatment with Everolimus Accord, it may be necessary to cure the existing infection.hepatitis B, as the disease may reactivate during treatment with Everolimus Accord (see section 4 "Possible side effects").

Everolimus Accord may also:

• weaken the immune system. Therefore, the patient may be at risk of infection while taking Everolimus Accord. If the patient experiences fever or other symptoms of infection, they should consult their doctor. Some infections can be severe and life-threatening.
• affect kidney function. Therefore, during treatment with Everolimus Accord, the doctor will monitor kidney function.
• cause shortness of breath, cough, and fever.
• cause the development of mouth ulcers and sores. The doctor may interrupt or discontinue treatment with Everolimus Accord. The patient may need treatment with mouthwashes, gels, or other products. Some mouthwashes and gels may worsen ulcers, so the patient should not try anything without consulting their doctor. The doctor may restart treatment with Everolimus Accord at the same or lower dose.
• cause radiation therapy complications. Severe radiation reactions (such as shortness of breath, nausea, diarrhea, skin rash, and mouth pain, throat pain), including fatal cases, have been observed in some patients taking everolimus at the same time as radiotherapy or taking everolimus shortly after radiotherapy. Additionally, in patients who have undergone radiotherapy in the past, a so-called radiation recall syndrome (including skin redness or lung inflammation at the site of previous radiotherapy) has been reported. The doctor should be informed about planned radiotherapy in the near future or previous radiotherapy.

The doctor should be informedif the patient experiences these symptoms.
During treatment, the patient will undergo regular blood tests to monitor the number of blood cells (white blood cells, red blood cells, and platelets) and to check if Everolimus Accord 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 Accord may affect them.

Children and adolescents

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

Everolimus Accord and other medicines

Everolimus Accord may affect the action of other medicines. If the patient takes other medicines at the same time as Everolimus Accord, the doctor may change the dose of Everolimus Accord or other medicines.
The doctor or pharmacist should be toldabout all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The following medicines taken with Everolimus Accord 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 inhibitors)(such as ramipril) used to treat high blood pressure or other heart problems.
• nefazodone, used to treat depression.
• Cannabidiol (used, among other things, to treat seizures)

The following medicines may reduce the effectiveness of Everolimus Accord:

• 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 disorders.
• phenytoin, carbamazepineor phenobarbitaland other antiepileptic medicinesused to prevent various types of seizures.

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

Taking Everolimus Accord with food and drink

The patient should avoid eating grapefruits and drinking grapefruit juiceduring treatment with Everolimus Accord. This may increase the amount of Everolimus Accord in the blood to a potentially harmful level.

Pregnancy, breastfeeding, and fertility

Pregnancy
Everolimus Accord should not be taken during pregnancy, as it may harm the unborn child. The patient should inform their doctor if they are pregnant or think 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 contraception during treatment and for 8 weeks after its completion. If, despite these measures, the patient suspects they may be pregnant, they should consult their doctor before taking Everolimus Accord.
Breastfeeding
Everolimus Accord may harm the breastfed child. Breastfeeding should be avoided during treatment and for 2 weeks after the last dose of everolimus. The patient should inform their doctor about breastfeeding.
Female fertility
Some patients taking Everolimus Accord have experienced a lack of menstrual periods (amenorrhea).
Everolimus Accord may affect female fertility. The patient should discuss this with their doctor if they want to have children.
Male fertility
Everolimus Accord may affect male fertility. The patient should tell their doctor if they want to become a father.

Driving and using machines

If the patient experiences fatigue of unknown cause (fatigue is a very common side effect), they should be careful when driving vehicles and operating machines.

Everolimus Accord contains lactose

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

3. How to take Everolimus Accord

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist 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 Accord (2.5, 5, or 7.5 mg per day).
In case of certain side effects during treatment with Everolimus Accord (see section 4), the doctor may reduce the dose of the medicine or interrupt treatment for a short time or permanently.
Everolimus Accord should be taken once a day, at the same time of day, always in the same way, with or without food.
The Everolimus Accord 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 Accord than recommended

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

Missing a dose of Everolimus Accord

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

Stopping treatment with Everolimus Accord

Treatment with Everolimus Accord 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 Accord 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 itching of the skin, with red rash and emerging bumps

The serious side effects of Everolimus Accord 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, excessive urination, increased appetite with weight loss, fatigue (diabetes symptoms), bleeding (e.g., in the intestinal wall), significantly reduced urine output (kidney failure symptom).
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 (heart failure symptoms), 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), sudden shortness of breath, chest pain, or coughing up blood (potential symptoms of pulmonary embolism), significantly reduced urine output, swelling of the feet, feeling of disorientation, back pain (symptoms of acute kidney failure), rash, itching, hives, difficulty breathing or swallowing, dizziness (symptoms of 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 these side effects, as they may cause life-threatening consequences.

Other possible side effects of Everolimus Accord include:

Very common(may occur more often than in 1 in 10 patients)
Fatigue, shortness of breath, dizziness, paleness, symptoms of low red blood cell count (anemia), high blood sugar levels (hyperglycemia), loss of appetite, high lipid levels (hypercholesterolemia), taste disorders, headache, nosebleeds (nosebleeds), cough, mouth sores, stomach upset, including nausea (nausea), diarrhea, skin rash, itching (pruritus), feeling of weakness or fatigue, swelling of the arms, hands, feet, ankles, and other parts of the body (symptoms of edema), weight loss.
Common(may occur less often than in 1 in 10 patients)
Appearance of sudden bleeding or bruising and frequent infections, with symptoms such as fever, chills, sore throat, or mouth sores (symptoms of low platelet count, also known as thrombocytopenia), fever, sore throat, mouth sores 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 disorders (insomnia), headaches, dizziness (symptoms of high blood pressure, also known as hypertension), swelling of parts or all of the hand (including fingers) or foot (including toes), feeling of heaviness, limited mobility, discomfort (possible symptoms of lymphedema), inflammation of the tissue lining the mouth, stomach, intestine, dry mouth, heartburn (indigestion), vomiting, difficulty swallowing (dysphagia), abdominal pain, acne, skin rash, and pain in the hands and soles of the feet (hand-foot syndrome), skin redness (flushing), joint pain, mouth pain, menstrual disorders, such as irregular menstrual bleeding, high lipid levels (hyperlipidemia, increased triglyceride levels), low potassium levels (hypokalemia), low phosphate levels (hypophosphatemia), low calcium levels (hypocalcemia), dry skin, skin peeling, skin conditions, nail disorders, nail brittleness, moderate hair loss, abnormal liver function test results (increased alanine aminotransferase and aspartate aminotransferase activity), abnormal kidney function test results (increased creatinine levels), swelling of the eyelids, and 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 sores (symptoms of low blood cell count, also known as pancytopenia), loss of taste (ageusia), coughing up blood (hemoptysis), menstrual disorders, such as amenorrhea, frequent urination during the day, chest pain, problems with wound healing, hot flashes, eye discharge accompanied by itching, redness, or eye redness (conjunctivitis).
Rare(may occur less often than in 1 in 1000 patients)
Fatigue, shortness of breath, dizziness, paleness (symptoms of low red blood cell count, possibly due to selective 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.
Frequency not known(cannot be estimated from the available data)
Radiation recall reaction, e.g., skin redness or lung inflammation at the site of previous radiotherapy, exacerbation of radiation therapy side effects

If the above side effects worsen, the doctor or pharmacist should be informed. Most side effects are mild or moderate and should resolve after discontinuing 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 gather more information on the safety of this medicine.

5. How to store Everolimus Accord

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 or blister.
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 requirements for this 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 does Everolimus Accord contain

The active substance of the medicine is everolimus.
Each Everolimus Accord tablet contains 2.5 mg, 5 mg, or 10 mg of everolimus.
The other ingredients are: butylhydroxytoluene (E321), hypromellose (2910) (3 mPa·s), lactose, lactose monohydrate, crospovidone (type A), and magnesium stearate.

What Everolimus Accord looks like and what the pack contains

Everolimus Accord 2.5 mg is a white or almost white, oval, biconvex tablet (approximately 10 x 5 mm in size), with the imprint E9VS on one side and 2.5 on the other.
Everolimus Accord 5 mg is a white or almost white, oval, biconvex tablet (approximately 13 x 6 mm in size), with the imprint E9VS 5 on one side.
Everolimus Accord 10 mg is a white or almost white, oval, biconvex tablet (approximately 16 x 8 mm in size), with the imprint E9VS 10 on one side.
Pack sizes:
Everolimus Accord 2.5 mg - OPA/Al/PVC/Al blisters containing 30 or 90 tablets.
Everolimus Accord 5 mg and 10 mg - OPA/Al/PVC/Al blisters containing 10, 30, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer

Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat
Barcelona, 08830
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: May 2022