Everolimus Stada

Package Leaflet: Information for the User

Everolimus Stada, 5 mg, tablets

Everolimus Stada, 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 and other information

• 1. What Everolimus Stada is and what it is used for
• 2. What you need to know before you take Everolimus Stada
• 3. How to take Everolimus Stada
• 4. Possible side effects
• 5. How to store Everolimus Stada
• 6. Contents of the pack and other information

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

Everolimus Stada is an anti-cancer 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 Stada 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 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 (so-called "anti-VEGF therapy") have been ineffective.

2. What you need to know before you take Everolimus Stada

Everolimus Stada 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 Stada or want to know why this medicine has been prescribed for you, you should ask your doctor.

When not to take Everolimus Stada

• If you are allergicto everolimus, similar substances such as sirolimus or temsirolimus, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, you should ask your doctor for advice.

Warnings and precautions

Before taking Everolimus Stada, you should tell your doctor if:

• you have liver problems or diseases that may have affected your liver. In this case, your doctor may change the dose of Everolimus Stada.
• you have diabetes (high blood sugar levels). Everolimus Stada may increase blood sugar levels and worsen diabetes. This may require the administration of insulin and/or oral anti-diabetic medicines. You should tell your doctor if you feel excessive thirst or if you urinate more frequently.
• you need to receive vaccinations during treatment with Everolimus Stada.
• you have high cholesterol levels. Everolimus Stada may increase cholesterol levels and/or other fats in the blood.
• you have recently undergone major surgery or have unhealed wounds resulting from surgery. Everolimus Stada may hinder wound healing.
• you have an infection. Before starting treatment with Everolimus Stada, it may be necessary to cure the existing infection.
• you have had hepatitis B in the past, as the disease may reactivate during treatment with Everolimus Stada (see section 4 "Possible side effects").
• you are going to receive or have received radiotherapy.

Everolimus Stada may also:

• weaken your immune system. Therefore, you may be at risk of infection while taking Everolimus Stada. If you have a fever or other signs of infection, you should consult your doctor. Some infections can be severe and life-threatening.
• affect kidney function. Therefore, during treatment with Everolimus Stada, 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 stop treatment with Everolimus Stada. 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 Stada 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. You should inform your doctor about planned radiotherapy in the near future or previous radiotherapy.

You should tell 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 Stada 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 Stada may affect these parameters.

Children and adolescents

Everolimus Stada should not be used in children and adolescents (under 18 years of age).

Everolimus Stada and other medicines

Everolimus Stada may affect the action of other medicines. If you are taking other medicines at the same time as Everolimus Stada, your doctor may change the dose of Everolimus Stada or other medicines.
You should tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
The following medicines taken with Everolimus Stada may increase the risk of side effects:

• ketokonazole, itraconazole, voriconazole, or fluconazole, and other antifungal medicines used to treat fungal infections.
• clarithromycin, telithromycin, or erythromycin, antibiotics used to treat bacterial infections.
• ritonavir and other medicines used to treat HIV/AIDS.
• verapamil or diltiazem used 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 (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 seizure disorders).

The following medicines may reduce the effectiveness of Everolimus Stada:

• rifampicin used to treat tuberculosis.
• efavirenz or 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, carbamazepine, or phenobarbital, and other anti-epileptic medicines used to prevent various types of seizures.

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

Taking Everolimus Stada with food and drink

You should avoid eating grapefruits and drinking grapefruit juice during treatment with Everolimus Stada. This may increase the amount of Everolimus Stada in the blood to a potentially harmful level.

Pregnancy, breastfeeding, and fertility

Pregnancy
Everolimus Stada should not be taken during pregnancy, as it may harm the unborn child.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Your doctor will inform you whether you can take this medicine during pregnancy.
Women who may become pregnant during treatment should use highly effective methods of contraception during treatment and for 8 weeks after the end of treatment. If, despite these measures, you suspect you may have become pregnant, you should consult your doctor beforetaking the next dose of Everolimus Stada.
Breastfeeding
Everolimus Stada may harm the breastfed child. You should not breastfeed during treatment and for 2 weeks after the last dose of Everolimus Stada. If you are breastfeeding, you should inform your doctor.
Female fertility
In some patients taking everolimus, amenorrhea (absence of menstrual periods) has been observed.
Everolimus Stada may affect female fertility. You should discuss this with your doctor if you want to have children.
Male fertility
Everolimus Stada may affect male fertility. You should tell 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 Stada contains lactose

Everolimus Stada contains lactose. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Everolimus Stada

This medicine should always be taken exactly as your doctor or pharmacist 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 Everolimus Stada tablets you should take.
In case of liver problems, your doctor may start treatment with a lower dose of Everolimus Stada (2.5, 5, or 7.5 mg per day).
In case of certain side effects during treatment with Everolimus Stada (see section 4), your doctor may reduce the dose of the medicine or interrupt treatment for a short time or permanently.
Everolimus Stada should be taken once a day, at the same time of day, always in the same way, with or without food.
The tablet(s) should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.

What to do if you take more Everolimus Stada than you should

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

What to do if you forget to take Everolimus Stada

If you forget to take a dose, you should take the next planned dose. You should not take a double dose to make up for forgotten tablets.

What to do if you stop taking Everolimus Stada

You should not stop taking Everolimus Stada unless your doctor tells you to.
If you have any further questions about taking this medicine, 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 Stada and seek medical help immediately if you experience any of the following signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin, with redness and raised bumps

Severe side effects of Everolimus Stada include:

Very common(may affect more than 1 in 10 people)

• increased body temperature, chills (infection symptoms)
• fever, cough, difficulty breathing, wheezing (pneumonia symptoms)

Common(may affect up to 1 in 10 people)

• excessive thirst, excessive urination, increased appetite with weight loss, easy fatigue (diabetes symptoms)
• bleeding (hemorrhage), e.g., in the intestinal wall
• severe reduction in urine production (sign of kidney failure)

Uncommon(may affect up to 1 in 100 people)

• fever, rash, joint pain, and fatigue, as well as easy fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools, dark urine (may be signs 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 the calf, with redness and warmth of the skin in the affected area (signs of blood clot blockage in a leg vein)
• shortness of breath, chest pain, or coughing up blood (potential signs of pulmonary embolism, a condition where one or more arteries in the lungs become blocked)
• reduced urine production, swelling of the feet, confusion, back pain (signs of sudden kidney failure)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of a severe allergic reaction, also known as hypersensitivity)

Rare(may affect up to 1 in 1,000 people)

• shortness of breath or rapid breathing (signs of acute respiratory distress syndrome)

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

Other possible side effects of Everolimus Stada include:

Very common(may affect more than 1 in 10 people)

• high blood sugar levels (hyperglycemia)
• loss of appetite
• taste disturbance
• headache
• nosebleeds
• cough
• mouth ulcers
• stomach upset, including nausea (nausea) and diarrhea
• skin rash
• itching (pruritus)
• feeling weak or tired
• fatigue, shortness of breath, dizziness, pale skin, signs of low red blood cell count (anemia)
• swelling of the arms, hands, feet, ankles, or other parts of the body (signs of edema)
• weight loss
• high levels of fats (lipids) in the blood (hypercholesterolemia)

Common(may affect up to 1 in 10 people)

• sudden bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• shortness of breath (dyspnea)
• feeling thirsty, low urine production, dark urine, dry red skin, irritability (signs of dehydration)
• sleep problems (insomnia)
• headache, dizziness (signs of high blood pressure, also known as hypertension)
• swelling of the hands or feet (including fingers or toes), feeling heavy, limited movement, discomfort (possible signs of lymphedema)
• fever, sore throat, mouth ulcers caused by infection (signs of low white blood cell count, leukopenia, lymphopenia, and/or neutropenia)
• fever
• inflammation of the lining of the mouth, stomach, or intestine
• dry mouth
• heartburn (indigestion)
• 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 (lipids) in the blood (hyperlipidemia, increased triglyceride levels)
• 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, brittle nails
• mild hair loss
• abnormal liver function test results in the blood (increased alanine aminotransferase and aspartate aminotransferase activity)
• abnormal kidney function test results in the blood (increased creatinine levels)
• swelling of the eyelids
• 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 ulcers (signs of low blood cell count, also known as pancytopenia)
• loss of taste (ageusia)
• coughing up blood (hemoptysis)
• menstrual disorders, such as absence of menstruation
• increased urination during the day
• chest pain
• wound healing problems
• hot flashes
• eye discharge with itching and redness, pink eye, or red eye (conjunctivitis)

Rare(may affect up to 1 in 1,000 people)

• fatigue, shortness of breath, dizziness, pale skin (signs of low red blood cell count, possibly due to a condition called 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 signs 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 radiotherapy
• worsening 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 stopping 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, Office for Registration 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Everolimus Stada

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 and blister. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine. Store in the original package to protect from light.
The blister should be opened immediately before taking the tablet.
Do not use this medicine if there are signs of damage or attempted opening.
Medicines should not be disposed of via wastewater or household waste. You should 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 Everolimus Stada contains

• The active substance is everolimus. Each Everolimus Stada 5 mg tablet contains 5 mg of everolimus. Each Everolimus Stada 10 mg tablet contains 10 mg of everolimus.
• The other ingredients are: Butylhydroxytoluene (E321) Hypromellose 3 mPa·s (E464) Lactose Crospovidone Type A (E1202) Magnesium stearate

What Everolimus Stada looks like and contents of the pack

Everolimus Stada 5 mg tablets are oval, flat tablets, white or off-white, with "EVR" engraved on one side and "5" on the other, 12 mm long and 5 mm wide.
Everolimus Stada 10 mg tablets are oval, flat tablets, white or off-white, with "EVR" engraved on one side and "NAT" on the other, 15 mm long and 6 mm wide.
Everolimus Stada 5 mg and 10 mg are available in packs containing 10, 30, 90 tablets or 10x1, 30x1, 90x1 tablets (single-dose blisters).
Not all pack sizes and strengths may be marketed.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Genepharm S.A.
18th Km Marathonos Avenue
153 51 Pallini Attiki
Greece
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta
Pharmacare Premium Ltd
HHF003 Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta

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

Austria:
Everolimus STADA 2.5 mg Tabletten
Everolimus STADA 5 mg Tabletten
Everolimus STADA 10 mg Tabletten
Belgium:
Everolimus EG 2.5 mg tabletten
Everolimus EG 5 mg tabletten
Everolimus EG 10 mg tabletten
Czech Republic:
Everolimus STADA
Germany:
Everolimus AL 2.5 mg Tabletten
Everolimus AL 5 mg Tabletten
Everolimus AL 10 mg Tabletten
Denmark:
Everolimus STADA
Spain:
Everolimus STADA 2.5 mg comprimidos EFG
Everolimus STADA 5 mg comprimidos EFG
Everolimus STADA 10 mg comprimidos EFG
Finland:
Everolimus STADA 2.5 mg/ 5 mg/ 10 mg tabletti
France:
EVEROLIMUS EG 2.5 mg, comprimé
EVEROLIMUS EG 5 mg, comprimé
EVEROLIMUS EG 10 mg, comprimé
Croatia:
Everolimus STADA 2.5/5/10 mg tablete
Italy:
Everolimus EG
Luxembourg:
Everolimus EG 2.5 mg comprimé
Everolimus EG 5 mg comprimé
Everolimus EG 10 mg comprimé
Netherlands:
Everolimus CF 2.5 mg, tabletten
Everolimus CF 5 mg, tabletten
Everolimus CF 10 mg, tabletten
Poland:
Everolimus STADA
Sweden:
Everolimus STADA 2.5 mg/5 mg/10 mg tabletter
Slovakia:
EVEROLIMUS STADA 2.5 mg
EVEROLIMUS STADA 5 mg
EVEROLIMUS STADA 10 mg
Date of last revision of the leaflet:04/2023