Everolimus Vipharm

Leaflet accompanying the packaging: patient information

Everolimus Vipharm, 2.5 mg, tablets

Everolimus Vipharm, 5 mg, tablets

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

Everolimus Vipharm may only be prescribed by a doctor experienced in cancer treatment. All the doctor's instructions must be followed. They may differ from the general information contained in this leaflet. If additional information about Everolimus Vipharm and why this medicine was chosen is needed, the doctor should be consulted.
When not to take Everolimus Vipharm:

section 6).
In case of suspected allergy, the doctor should be consulted.

Warnings and precautions

Before starting Everolimus Vipharm, discuss with your doctor:

Everolimus Vipharm may also:

• weaken the immune system. Therefore, the patient may be at risk of infection while taking Everolimus Vipharm. 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 Vipharm, 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 Vipharm. 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 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, gum, and 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.

Tell your doctorif you experience 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 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 is not 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 the patient is taking other medicines at the same time as Everolimus Vipharm, the doctor may change the dose of Everolimus Vipharm or other medicines.
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:

• 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 epileptic seizures).

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 system disorders.
• phenytoin, carbamazepine, or phenobarbital, and other anti-epileptic medicines used to prevent various types of seizures.

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

Taking Everolimus Vipharm with food and drink

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
Everolimus Vipharm should not be taken during pregnancy, as it may harm the unborn child. The doctor should be informed if the patient is pregnant or thinks she may be pregnant. The doctor will inform the patient whether she 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 the end of treatment. If, despite these measures, the patient suspects she may be pregnant, she should consult her doctor beforetaking Everolimus Vipharm.
Breastfeeding
Everolimus Vipharm may harm the breastfed child. Breastfeeding should be avoided during treatment and for 2 weeks after the last dose of Everolimus Vipharm. The doctor should be informed about breastfeeding.
Female fertility
Some patients taking everolimus have experienced menstrual disorders (amenorrhea).
Everolimus Vipharm may affect female fertility. The patient should discuss this with her doctor if she wants to have children.
Male fertility
Everolimus Vipharm may affect male fertility. The patient should tell her doctor if she wants 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 or operating machines.

Everolimus Vipharm contains lactose

Everolimus Vipharm contains lactose (milk sugar). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Everolimus Vipharm

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
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 Vipharm (2.5, 5, or 7.5 mg daily).
In case of certain side effects during treatment with Everolimus Vipharm (see section 4), the doctor may reduce the dose 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 recommended

• In case of taking a higher dose of Everolimus Vipharm than recommended or if someone else 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 has been overdosed.

Missing a dose of Everolimus Vipharm

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 treatment with Everolimus Vipharm

Treatment with Everolimus Vipharm should not be stopped without the doctor's advice.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Everolimus Vipharm and seek medical help immediatelyif 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

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, frequent 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, skin rash, joint pain, and fatigue, as well as 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, which occurs when one or more pulmonary arteries are 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 1000 people)

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

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

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 (bleeding)
• Cough
• Mouth ulcers
• Stomach upset, 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, likely caused by anemia called selective red cell aplasia)
• Swelling of the arms, hands, feet, ankles, and other parts of the body (symptoms of edema)
• 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, dry reddened skin, irritability (symptoms of dehydration)
• Sleep disorders (insomnia)
• Headaches, dizziness (symptoms of high blood pressure, also known as hypertension)
• Swelling of the hands or feet (including fingers or toes), feeling of heaviness, limited movement, discomfort (possible symptoms of lymphedema)
• Fever, sore throat, mouth ulcers caused by infection (symptoms of low white blood cell count, leukopenia, lymphopenia, and/or neutropenia)
• Fever
• Inflammations of the lining of the mouth, stomach, 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)
• Redness of the skin (flushing)
• 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, peeling skin, skin lesions
• Nail disorders, brittle nails
• 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
• 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)
• Lack of taste (ageusia)
• Coughing up blood (hemoptysis)
• Menstrual disorders, such as amenorrhea
• Frequent 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 1000 people)
• Fatigue, shortness of breath, dizziness, pale skin (symptoms of low red blood cell count, likely caused by anemia called 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
• Increased 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 you experience any side effects, including those not listed in this leaflet, 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

Keep the medicine 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 the medicine. Store in the original packaging 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. Ask your pharmacist 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 Vipharm contains

• The active substance of the medicine is everolimus. Each Everolimus Vipharm 2.5 mg tablet contains 2.5 mg of everolimus. Each Everolimus Vipharm 5 mg tablet contains 5 mg of everolimus. Each Everolimus Vipharm 10 mg tablet 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.
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.
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.
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