Everolimus Accord

Package Leaflet: Information for the Patient

Everolimus Accord, 2.5 mg, tablets

Everolimus Accord, 5 mg, tablets

Everolimus Accord, 10 mg, tablets

Everolimus

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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 signs of illness 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 is Everolimus Accord and what is it used for
• 2. Before you take Everolimus Accord
• 3. How to take Everolimus Accord
• 4. Possible side effects
• 5. How to store Everolimus Accord
• 6. Contents of the pack and other information

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

Everolimus Accord is an anti-cancer medicine that contains the active substance everolimus.
Everolimus reduces the blood supply 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 hormone receptor-positive status in postmenopausal women, where other medicines (so-called "non-steroidal aromatase inhibitors") have stopped keeping the disease under control. This medicine is given in combination with exemestane, a steroid aromatase inhibitor used in hormonal anti-cancer treatment.
• 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 been ineffective.

2. Before you take Everolimus Accord

Everolimus Accord should only be prescribed by a doctor experienced in the treatment of cancer. You must follow all the doctor's instructions. They may differ from the general information contained in this leaflet. If you need more information about Everolimus Accord or want to know why this medicine has been prescribed for you, you should ask your doctor.

When not to take Everolimus Accord:

Warnings and precautions

Before starting treatment with Everolimus Accord, you should discuss with your doctor:

Everolimus Accord may also:

• weaken your immune system. Therefore, you may be at risk of infection while taking Everolimus Accord. If you experience fever or other symptoms of infection, you should consult your doctor. Some infections can be severe and life-threatening.
• affect kidney function. Therefore, during treatment with Everolimus Accord, your doctor will monitor your kidney function.
• cause shortness of breath, cough, and fever.
• cause the development of mouth ulcers and sores. Your doctor may interrupt or discontinue treatment with Everolimus Accord. You may need treatment with mouthwashes, gels, or other products. Some mouthwashes and gels may worsen ulcers, so you should not try anything without consulting your doctor. Your 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 radiation therapy or taking everolimus shortly after radiation therapy. Additionally, in patients who have undergone radiation therapy in the past, a so-called radiation recall syndrome (including skin redness or lung inflammation at the site of previous radiation therapy) has been reported. You should inform your doctor about planned radiation therapy in the near future or previous radiation therapy.

You should inform your doctorif you experience these symptoms.
During treatment, you 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 should not be 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 you are taking other medicines at the same time as Everolimus Accord, your doctor may change the dose of Everolimus Accord or other medicines.
You should tell your doctor or pharmacistabout all the medicines you are taking now or have taken recently, as well as any medicines you plan 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 diseases 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 anti-epileptic medicinesused to prevent various types of seizures.

You should avoid taking these medicines during treatment with Everolimus Accord. If you are taking any of these medicines, your doctor may replace them with another medicine or change the dose of Everolimus Accord.

Taking Everolimus Accord with food and drink

You should avoid eating grapefruits or 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
It is not recommended to take Everolimus Accord during pregnancy, as it may harm the unborn child. You should inform your doctor if you are pregnant or think you may be pregnant. Your doctor will inform you whether you can take this medicine during pregnancy.
Women who may become pregnant during treatment should use highly effective contraceptive methods during treatment and for 8 weeks after treatment ends. If, despite these measures, you suspect you may be pregnant, you should contact your doctor before taking Everolimus Accord.
Breastfeeding
Everolimus Accord may harm the breastfed child. You should not breastfeed during treatment and for 2 weeks after the last dose of everolimus. You should inform your doctor about breastfeeding.
Female fertility
Some female patients taking Everolimus Accord have experienced amenorrhea (absence of menstruation).
Everolimus Accord may affect female fertility. You should discuss this with your doctor if you want to have children.
Male fertility
Everolimus Accord may affect male fertility. You should inform your doctor if you want to become a father.

Driving and using machines

If you experience fatigue of unknown cause (fatigue is a very common side effect), you should be careful when driving or operating machinery.

Everolimus Accord 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 Everolimus Accord

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose is 10 mg, taken once a day. Your doctor will determine how many tablets you should take.
In case of liver problems, your 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), your doctor may reduce the dose of Everolimus Accord 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 prescribed

• If you have taken more Everolimus Accord than prescribed or if someone else has taken your tablets, you should immediately go to your doctor or to the hospital. Emergency medical attention may be necessary.
• You should show your doctor the carton of the medicine and this leaflet so that the doctor can determine which medicine has been overdosed.

Missing a dose of Everolimus Accord

If you miss a dose, you should take the next planned dose. You should not take a double dose to make up for the missed tablet.

Stopping treatment with Everolimus Accord

You should not stop taking Everolimus Accord without your doctor's advice.
If you have any further questions on the use of this product, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOPtaking Everolimus Accord and seek medical help immediately if you experience any of the following symptoms of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue, or throat
• Severe itching of the skin, with redness and bumps

The serious side effects of Everolimus Accord include:

Very common(may affect more than 1 in 10 people)
Increased temperature, chills (infection symptoms), fever, cough, difficulty breathing, wheezing (pneumonia symptoms).
Common(may affect up to 1 in 10 people)
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 affect up to 1 in 100 people)
Fever, skin rash, joint pain, and fatigue, as well as loss of appetite, nausea, yellowing of the skin (jaundice), pain in the upper right part of the abdomen, pale stools, dark urine color (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, confusion, 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 affect up to 1 in 1000 people)
Shortness of breath or rapid breathing (symptoms of acute respiratory distress syndrome).

You should inform your doctor immediately if you experience any of these side effects, as they may be life-threatening.

Other possible side effects of Everolimus Accord include:

Very common(may affect more than 1 in 10 people)
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 disturbance, 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 (edema symptoms), weight loss.
Common(may affect up to 1 in 10 people)
Appearance of sudden 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), shortness of breath (dyspnea), feeling of thirst, low urine output, dark urine color, dry reddened skin, irritability (dehydration symptoms), sleep disturbances (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 (dyspepsia), vomiting, difficulty swallowing (dysphagia), abdominal pain, acne, skin rash, and pain in 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 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 (elevated alanine aminotransferase and aspartate aminotransferase activity), abnormal kidney function test results (elevated creatinine levels), swelling of the eyelids, and protein in the urine.
Uncommon(may affect up to 1 in 100 people)
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, kidney problems, hot flashes, eye discharge with itching, redness, or inflammation of the eye (conjunctivitis).
Rare(may affect up to 1 in 1000 people)
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 syndrome, e.g., skin redness or lung inflammation at the site of previous radiation therapy, exacerbation of radiation therapy side effects

If the above side effects worsen, you should inform your doctor or pharmacist. Most side effects are mild or moderate and should resolve after discontinuation of treatment for a few days.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Everolimus Accord

Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from light.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Everolimus Accord contains

The active substance 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 contents of the pack

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 side.
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 7 Street
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