Everolimus Viatris 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Everolimus Viatris 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Everolimus is a cancer medicine that contains the active substance everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.

Everolimus is used to treat adult patients with:

• Advanced hormone receptor-positive breast cancer in postmenopausal women, in whom other treatments (called "non-steroidal aromatase inhibitors") are no longer able to control the disease. It is given in combination with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal treatment of breast cancer.
• Advanced tumours known as neuroendocrine tumours originating in the stomach, intestine, lung, or pancreas. It is given when the tumours are inoperable and do not produce excess specific hormones or other related natural substances.
• Advanced renal cell carcinoma (advanced kidney cancer), when other treatments (called anti-VEGF therapy) have not helped to stop the progression of the disease.

2. What you need to know before starting to take Everolimus Viatris

Everolimus will only be prescribed by a doctor experienced in the treatment of cancer. Carefully follow all instructions provided by your doctor. These may differ from the general information contained in this leaflet. If you have any doubts about everolimus or why this medicine has been prescribed for you, consult your doctor.

Do not take Everolimus Viatris:

• If you are allergic to everolimus, to related substances such as sirolimus or temsirolimus, or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take Everolimus Viatris:

• If you have liver problems or have previously had a disease that may have affected your liver. In this case, your doctor may prescribe you a different dose of everolimus.
• If you have diabetes (high blood sugar levels). Everolimus may increase blood sugar levels and worsen diabetes mellitus. This may mean you require treatment with insulin and/or oral antidiabetic medicines. Inform your doctor if you notice excessive thirst or if you need to urinate more frequently.
• If you need to receive a vaccine while taking everolimus.
• If you have high cholesterol levels. Everolimus may increase cholesterol and/or other blood fats.
• If you have recently undergone major surgery or still have an unhealed wound following surgery. Everolimus may increase the risk of wound healing problems.
• If you have an infection. It may be necessary to treat your infection before starting treatment with everolimus.
• If you have previously had hepatitis B, as it may reactivate during treatment with everolimus (see section 4, "Possible side effects").
• If you have received or are about to receive radiotherapy.

Everolimus may also:

• Weaken your immune system. Therefore, you may be at risk of developing an infection while taking everolimus. If you develop fever or other signs of infection, consult your doctor. Some infections may be severe and potentially fatal.
• Affect kidney function. Therefore, your doctor will monitor your kidney function while you are taking everolimus.
• Cause difficulty breathing, cough, and fever.
• Cause mouth ulcers and sores. Your doctor may need to interrupt or stop treatment with Everolimus Viatris. You may require treatment with a mouthwash, gel, or other products. Some mouthwashes and gels may worsen ulcers, so do not use any without first consulting your doctor. Your doctor may restart treatment with Everolimus Viatris at the same dose or at a lower dose.
• Cause complications related to radiotherapy. Serious complications of radiotherapy (such as difficulty breathing, nausea, diarrhea, skin rash, and pain in the mouth, gums, and throat), including fatal cases, have been observed in some patients who were taking everolimus at the same time as receiving radiotherapy or shortly after completing radiotherapy. The so-called radiation recall syndrome (characterized by skin redness or lung inflammation at the site of previous radiotherapy) has also been reported in patients who previously received radiotherapy.

Inform your doctor if you are scheduled to receive radiotherapy soon, or if you have previously received radiotherapy.

Tell your doctor if you experience any of these symptoms.

During treatment, you will have periodic blood tests. These tests will measure your blood cell counts (white blood cells, red blood cells, and platelets) to check whether everolimus is having an unwanted effect on these cells. You will also have blood tests to monitor kidney function (creatinine levels), liver function (transaminase levels), and blood sugar and cholesterol levels. These tests are performed because these parameters may be affected by treatment with everolimus.

Children and adolescents

Everolimus must not be administered to children or adolescents (under 18 years of age).

Other medicines and Everolimus Viatris

Everolimus may affect how other medicines work. If you are taking other medicines at the same time as everolimus, your doctor may adjust the dose of everolimus or of the other medicines.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The following may increase the risk of adverse effects with everolimus:

• 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 infection.
• Verapamil or diltiazem, used to treat heart problems or high blood pressure.
• Dronedarone, a medicine used to help regulate your heartbeat.
• Cyclosporine, a medicine used to prevent the body from rejecting transplanted organs.
• Cannabidiol (used, among others, for the treatment of epileptic seizures).
• Imatinib, used to inhibit the growth of abnormal cells.
• Angiotensin-converting enzyme (ACE) inhibitors (such as ramipril), used to treat high blood pressure or other cardiovascular problems.
• Nefazodone, used to treat depression.

The following may reduce the effectiveness of everolimus:

• Rifampicin, used to treat tuberculosis (TB).
• Efavirenz or nevirapine, used to treat HIV/AIDS infection.
• St John’s wort (Hypericum perforatum), a herbal product used to treat depression and other conditions.
• Dexamethasone, a corticosteroid used to treat a wide range of conditions, including inflammatory or immune disorders.
• Phenytoin, carbamazepine, or phenobarbital and other antiepileptic medicines used to control seizures.

The use of these medicines should be avoided during treatment with everolimus. If you are taking any of them, your doctor may prescribe a different medicine or may adjust your dose of everolimus.

Taking Everolimus Viatris with food and drink

Do not eat grapefruit or drink grapefruit juice while taking everolimus. It may increase the amount of everolimus in your blood, possibly to harmful levels.

Pregnancy, breastfeeding, and fertility

Pregnancy

Everolimus may harm the unborn baby and treatment with everolimus is not recommended during pregnancy. Inform your doctor if you are pregnant or think you may be pregnant. Your doctor will discuss with you whether you should take this medicine during pregnancy.

Women who could become pregnant must use a highly effective method of contraception during treatment and for 8 weeks after stopping treatment. If, despite these precautions, you think you may be pregnant, consult your doctor before taking any further doses of everolimus.

Breastfeeding

Everolimus may harm the breastfed infant. You must not breastfeed during treatment and for 2 weeks after the last dose of everolimus. Inform your doctor if you are breastfeeding.

Female fertility

In some patients treated with everolimus, absence of menstrual periods (amenorrhea) has been observed.

Everolimus may affect female fertility. Inform your doctor if you wish to have children.

Male fertility

Everolimus may affect male fertility. Consult your doctor if you wish to father children.

Driving and using machines

If you feel unusually tired (fatigue is a very common side effect), take special care when driving or using machines.

Everolimus Viatris contains lactose

Everolimus Viatris contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Everolimus Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 10 mg once daily. Your doctor will inform you how many everolimus tablets you should take.

If you have liver problems, your doctor may start treatment with a lower dose of everolimus (2.5; 5 or 7.5 mg daily).

If you experience certain adverse effects while taking everolimus (see section 4), your doctor may reduce your dose, temporarily interrupt treatment, or discontinue it permanently.

Take everolimus once daily, approximately at the same time each day, always with food or always without food.

Swallow the tablet(s) whole with a glass of water. Do not chew or crush the tablets.

If you take more Everolimus Viatris than you should

• If you have taken too much everolimus, or if someone accidentally took your tablets, consult your doctor or go immediately to the hospital. Urgent treatment may be necessary.
• Take the packaging and this leaflet with you so the doctor knows what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Everolimus Viatris

If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Everolimus Viatris

Do not stop treatment with everolimus unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

STOP treatment with everolimus and seek immediate medical help 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 red rash or lumps on the skin

Serious adverse effects of everolimus include:

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

• Increased body temperature, chills (signs of infection)
• Fever, cough, difficulty breathing, crackling sounds in the lungs (signs of lung inflammation, also known as pneumonitis)

Common (may affect up to 1 in 10 people)

• Excessive thirst, increased urination, increased appetite with weight loss, fatigue (signs of diabetes)
• Bleeding (haemorrhage), for example, in the intestinal wall
• Marked decrease in urine output (sign of kidney failure)

Uncommon (may affect up to 1 in 100 people)

• Fever, skin rash, joint pain and swelling, 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 signs of reactivation of hepatitis B)
• Feeling short of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure)
• Sudden swelling and/or pain in one leg, usually in the calf, redness or warmth of the skin in the affected area (signs of blockage of a blood vessel (vein) in the legs caused by a blood clot)
• Sudden onset of breathing difficulties, chest pain, or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in the lungs become blocked)
• Marked decrease in urine output, swelling in the legs, 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)

• Difficulty breathing or rapid breathing (signs of respiratory distress syndrome)

If you experience any of these adverse effects, inform your doctor immediately, as they could have life-threatening consequences.

Other possible adverse effects of everolimus include:

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

• Fatigue, shortness of breath, dizziness, paleness of the skin, signs of low red blood cell levels (anaemia)
• High blood sugar levels (hyperglycaemia)
• Loss of appetite
• High levels of lipids (fats) in the blood (hypercholesterolaemia)
• Altered taste (dysgeusia)
• Headache
• Nosebleeds (epistaxis)
• Cough
• Mouth ulcers
• Stomach discomfort, including nausea or diarrhoea
• Skin rash
• Itching (pruritus)
• Feeling weak or tired
• Swelling of the arms, hands, feet, ankles, or other parts of the body (signs of oedema)
• Weight loss

Common (may affect up to 1 in 10 people)

• Spontaneous bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• Fever, sore throat, mouth ulcers due to infections (signs of low white blood cell count, leucopenia, lymphopenia and/or neutropenia)
• Lymphoedema (swelling of body tissues, usually in the arms or legs)
• Difficulty breathing (dyspnoea)
• Thirst, low urine output, dark urine, dry red skin, irritability (signs of dehydration)
• Trouble sleeping (insomnia)
• Headache, dizziness (sign of high blood pressure, also known as hypertension)
• Fever
• Inflammation of the mucous lining of the mouth, stomach, or intestine
• Dry mouth
• Stomach burning (dyspepsia)
• Vomiting
• Difficulty swallowing (dysphagia)
• Abdominal pain
• Acne
• Rash and pain on the palms of the hands or soles of the feet (hand-foot syndrome)
• Redness of the skin (erythema)
• Joint pain
• Mouth pain
• Menstrual disorders such as irregular periods
• High levels of lipids (fats) in the blood (hyperlipidaemia, increased triglycerides)
• Low potassium levels in the blood (hypokalaemia)
• Low phosphate levels in the blood (hypophosphataemia)
• Low calcium levels in the blood (hypocalcaemia)
• Dry skin, skin peeling, skin lesions
• Nail disorders, nail breakage
• Mild hair loss
• Abnormal liver function tests (increased alanine and aspartate aminotransferase)
• Abnormal kidney function tests (increased creatinine)
• Swelling of the eyelid
• Protein in the urine

Uncommon (may affect up to 1 in 100 people)

• Weakness, spontaneous bleeding or bruising, and frequent infections with symptoms such as fever, chills, sore throat, or mouth ulcers (signs of low blood cell counts, also known as pancytopenia)
• Loss of taste (ageusia)
• Coughing up blood (haemoptysis)
• Menstrual disorders such as absence of periods (amenorrhoea)
• Increased frequency of urination during the day
• Chest pain
• Abnormal wound healing
• Hot flushes
• Watery, itchy eyes with redness, or pink eye (conjunctivitis)

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

• Fatigue, difficulty breathing, dizziness, paleness of the skin (signs of low red blood cell count, possibly due to a type of anaemia called pure red cell aplasia)
• Swelling of the face, around the eyes, mouth, and the inner mucous lining of the mouth and/or throat, as well as the tongue, and difficulty breathing or swallowing (also known as angioedema), which may be signs of an allergic reaction

Frequency not known (cannot be estimated from available data)

• Reaction at the site where you previously received radiotherapy (e.g., skin redness or lung inflammation) (known as radiation recall syndrome)
• Worsening of adverse effects from radiotherapy

If these adverse reactions worsen, inform your doctor and/or pharmacist. Most adverse effects are mild to moderate and usually resolve if treatment is interrupted for a few days.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Everolimus Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the
blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

This medicine does not require special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Everolimus Viatris

• The active substance is everolimus. Each tablet contains 10 mg of everolimus.
• The other components are butylated hydroxytoluene (E-321), hypromellose (E-464), lactose, lactose monohydrate, crospovidone (E-1202), and magnesium stearate (E-470b). See section 2: Everolimus Viatris contains lactose.

Appearance of Everolimus Viatris and contents of the pack

Everolimus Viatris are biconvex, oval, white or almost white tablets, engraved with E9VS 10 on one side.

Everolimus Viatris is supplied in blister packs containing 30 or 90 tablets, or in packs containing 30 tablets in single-dose perforated blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Synthon Hispania S.L.
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain

Or

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Germany Everolimus Mylan 10 mg Tabletten
Bulgaria Everolimus Viatris 10 mg tablets
Croatia Everolimus Viatris 10 mg tablete
Denmark Everolimus Viatris, 10 mg tabletter
Spain Everolimus Viatris 10 mg comprimidos EFG
Finland Everolimus Viatris, 10 mg tabletti
France Everolimus Mylan 10 mg comprimés
Italy Everolimus Mylan 10 mg compresse
Norway Everolimus Viatris, 10 mg tabletter
The Netherlands Everolimus Viatris 10 mg, tabletten
Portugal Everolimus Mylan
United Kingdom (Northern Ireland) Everolimus Mylan 10 mg tablets
Sweden Everolimus Viatris, 10 mg tabletter

Date of the most recent revision of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/