Everolimus Vipharm

Package Leaflet: Information for the Patient

Everolimus Vipharm, 2.5 mg, tablets

Everolimus Vipharm, 5 mg, tablets

Everolimus Vipharm, 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 is Everolimus Vipharm and what is it used for
• 2. Before you take Everolimus Vipharm
• 3. How to take Everolimus Vipharm
• 4. Possible side effects
• 5. How to store Everolimus Vipharm
• 6. Contents of the pack and other information

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

Everolimus Vipharm 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 Vipharm is used to treat adults 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 together with exemestane, a steroid aromatase inhibitor used in hormonal anti-cancer treatment.
• 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. Before you take Everolimus Vipharm

Everolimus Vipharm 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 Vipharm and why it has been prescribed for you, you should ask your doctor.
When not to take Everolimus Vipharm:

In case of suspected allergy, you should ask your doctor for advice.

Warnings and precautions

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

Everolimus Vipharm may also:

• weaken your immune system. Therefore, you may be at risk of infection while taking Everolimus Vipharm. 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 Vipharm, 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 Vipharm. 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 Vipharm 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 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 Vipharm 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 Vipharm may affect them.

Children and adolescents

Everolimus Vipharm should not be given to children and adolescents (under 18 years of age).

Everolimus Vipharm and other medicines

Everolimus Vipharm may affect the action of other medicines. If you are taking other medicines at the same time as Everolimus Vipharm, your doctor may change the dose of Everolimus Vipharm or other medicines.
You should tell your doctor or pharmacist about 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 Vipharm may increase the risk of side effects:

• ketoconazole, 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.
• cyclosporin, 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 seizure disorders).

The following medicines may reduce the effectiveness of Everolimus Vipharm:

• 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 Vipharm. If you are taking any of these medicines, your doctor may replace them with another medicine or change the dose of Everolimus Vipharm.

Taking Everolimus Vipharm with food and drink

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

Pregnancy, breastfeeding, and fertility

Pregnancy
It is not recommended to take Everolimus Vipharm 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 the end of treatment. If, despite these measures, you suspect you may be pregnant, you should contact your doctor beforetaking Everolimus Vipharm.
Breastfeeding
Everolimus Vipharm may harm the breastfed child. You should not breastfeed during treatment and for 2 weeks after the last dose of Everolimus Vipharm. You should inform your doctor about breastfeeding.
Female fertility
In some patients taking everolimus, menstrual disorders (amenorrhea) have been observed.
Everolimus Vipharm may affect female fertility. You should discuss with your doctor if you want to have children.
Male fertility
Everolimus Vipharm 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 vehicles and operating machines.

Everolimus Vipharm contains lactose

Everolimus Vipharm contains lactose (milk sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Everolimus Vipharm

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

Taking a higher dose of Everolimus Vipharm than prescribed

• In case of taking a higher dose of Everolimus Vipharm than prescribed or if someone else has taken the tablets by mistake, you should immediately go to a doctor or hospital. Emergency medical attention may be necessary.
• You should show your doctor the carton packaging of the medicine and this leaflet so that it can be determined which medicine has been overdosed.

Missing a dose of Everolimus Vipharm

In case of missing 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 Vipharm

You should not stop taking Everolimus Vipharm without your doctor's advice.
If you have any further questions about the use of 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 Vipharm 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
• Increasing skin itching, with red rash and emerging bumps

The serious side effects of Everolimus Vipharm include:

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

• High 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)
• Significant reduction in urine output (kidney failure symptom)

Uncommon(may affect up to 1 in 100 people)

• Fever, rash, joint pain, and fatigue, as well as loss of appetite, nausea, yellowing of the skin (jaundice), pain in the upper right 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, which occurs when one or more arteries in the lungs become blocked)
• Significant reduction in 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 a severe allergic reaction, also known as hypersensitivity)

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

• Shortness of breath or rapid breathing (symptoms of acute respiratory distress syndrome)

You should immediately inform your doctor if you experience any of the above side effects, as they may cause life-threatening consequences.

Other possible side effects of Everolimus Vipharm include:

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

• High blood sugar levels (hyperglycemia)
• Lack of appetite
• Taste disorders
• Headache
• Nosebleeds (epistaxis)
• Cough
• Mouth ulcers
• Upset stomach, including nausea (nausea) and diarrhea
• Skin rash
• Itching (pruritus)
• Feeling of weakness or fatigue
• Fatigue, shortness of breath, dizziness, pale skin, symptoms of low red blood cell count (anemia)
• Swelling of the arms, hands, feet, ankles, and other parts of the body (edema symptoms)
• Weight loss
• High levels of fats (lipids) in the blood (hypercholesterolemia)

Common(may affect up to 1 in 10 people)

• Appearance of sudden bleeding or bruising (symptoms of low platelet count, also known as thrombocytopenia)
• Shortness of breath (dyspnea)
• Feeling of thirst, low urine output, dark urine color, dry reddened skin, irritability (symptoms of dehydration)
• Sleep disorders (insomnia)
• Headaches, dizziness (symptoms of high blood pressure, also known as hypertension)
• Swelling of the eyelids
• Presence of 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 (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
• Difficulty breathing
• Problems with wound healing
• Hot flashes
• Eye discharge, accompanied by 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 (symptoms of low red blood cell count, likely caused by 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(frequency cannot be estimated from the available data)
• Radiation recall syndrome, 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, you should inform your doctor or pharmacist. Most side effects are mild or moderate and should improve 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, pharmacist, or nurse. 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:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 Vipharm

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.
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 Vipharm contains

• The active substance of the medicine is everolimus. Each tablet of Everolimus Vipharm 2.5 mg contains 2.5 mg of everolimus. Each tablet of Everolimus Vipharm 5 mg contains 5 mg of everolimus. Each tablet of Everolimus Vipharm 10 mg contains 10 mg of everolimus.
• The other ingredients are: butylhydroxytoluene (E 321), hypromellose (type 2910), lactose, crospovidone (type A), magnesium stearate.

What Everolimus Vipharm looks like and contents of the pack

Everolimus Vipharm 2.5 mg tablets are white or almost white, oval, flat tablets with the inscription "EVR" on one side and "2.5" on the other side.
Everolimus Vipharm 5 mg tablets are white or almost white, oval, flat tablets with the inscription "EVR" on one side and "5" on the other side.
Everolimus Vipharm 10 mg tablets are white or almost white, oval, flat tablets with the inscription "EVR" on one side and "NAT" on the other side.
Everolimus Vipharm 2.5 mg is available in packs of 30 or 90 tablets.
Everolimus Vipharm 5 mg and Everolimus Vipharm 10 mg are available in packs of 10, 30, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
phone: (+48 22) 679 51 35
fax: (+48 22) 678 92 87
e-mail: vipharm@vipharm.com.pl
Manufacturer / Importer:

Genepharm S.A
18 km Marathonos Avenue
153 51 Pallini Attiki
Greece
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

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

Hungary:
Everolimus Vipharm 2.5 mg tablet
Everolimus Vipharm 5 mg tablet
Everolimus Vipharm 10 mg tablet
Czech Republic:
Everolimus Vipharm
Poland:
Everolimus Vipharm
Slovakia: Everolimus Vipharm 2.5 mg tablets
Everolimus Vipharm 5 mg tablets
Everolimus Vipharm 10 mg tablets
Date of last revision of the leaflet: 11.2022