Everolimus Avalon 2.5 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Everolimus Avalon 2.5 mg tablets EFG

Everolimus Avalon 5 mg tablets EFG

Everolimus Avalon 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Everolimus Avalon is an anticancer 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") can no longer keep the disease under control. It is given in combination with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal treatment of 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 kidney cancer (advanced renal cell carcinoma), 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 Avalon

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

Do not take Everolimus Avalon

• 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

Talk to your doctor before starting to take everolimus:

• If you have liver problems or have 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 can increase blood sugar levels and worsen diabetes mellitus. This may mean you need 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. Everolimus can increase cholesterol and/or other blood fats.
• If you have recently undergone major surgery, or if you still have an unhealed wound after surgery. Everolimus may increase the risk of problems with wound healing.
• 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 have a fever or other signs of infection, consult your doctor. Some infections may be severe and life-threatening.
• 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. 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 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.

Inform your doctor if you experience these symptoms.

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

Children and adolescents

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

Other medicines and Everolimus Avalon

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, 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.
• 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.
• Cannabidiol (its uses include, among others, the treatment of epileptic seizures).

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 Avalon 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 a harmful level.

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

Breastfeeding

Everolimus may harm the breastfed baby. 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

Absence of menstrual periods (amenorrhea) has been observed in some patients treated with everolimus.

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 Avalon contains lactose

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

3. How to take Everolimus Avalon

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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, at approximately 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 Avalon than you should

• If you have taken too much everolimus, or if someone has accidentally taken your tablets, contact your doctor or pharmacist immediately, go to the hospital immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount taken. Urgent treatment may be necessary.
• Take the packaging and this leaflet with you so the doctor knows what you have taken.

If you forget to take Everolimus Avalon

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

If you stop taking Everolimus Avalon

Do not stop treatment with everolimus unless your doctor tells you to do so.

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 taking 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 skin itching, 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 (hemorrhage), for example in the intestinal wall
• Markedly decreased 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 the feet or legs (signs of heart failure)
• Swelling and/or pain in one leg, usually in the calf, redness or warmth in the skin of the affected area (signs of blockage of a blood vessel (vein) in the legs caused by a blood clot)
• Sudden onset of breathing problems, chest pain, or coughing up blood (possible signs of pulmonary embolism, a condition that occurs when one or more arteries in the lungs become blocked)
• Markedly decreased 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 be life-threatening.

Other possible adverse effects of everolimus include:

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

• High blood sugar level (hyperglycemia)
• Loss of appetite
• Altered taste (dysgeusia)
• Headache
• Nosebleeds (epistaxis)
• Cough
• Mouth ulcers
• Stomach discomfort including nausea or diarrhea
• Skin rash
• Itching (pruritus)
• Feeling weak or fatigued
• Fatigue, difficulty breathing, dizziness, pale skin, signs of low red blood cell count (anemia)
• Swelling of the arms, hands, feet, ankles, or other body parts (signs of edema)
• Weight loss
• High levels of lipids (fats) in the blood (hypercholesterolemia)

Common (may affect up to 1 in 10 people)

• Spontaneous bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• Difficulty breathing (dyspnea)
• Thirst, low urine output, dark urine, dry skin, redness, irritability (signs of dehydration)
• Trouble sleeping (insomnia)
• Headache, dizziness (signs of high blood pressure, also known as hypertension)
• Swelling of part or all of the arm (including fingers) or leg (including toes), feeling of heaviness, limited mobility, discomfort (possible symptoms of lymphedema)
• Fever, sore throat, mouth ulcers due to infections (signs of low white blood cell count, leukopenia, lymphopenia, and/or neutropenia)
• Fever
• Inflammation of the inner mucous membranes of the mouth, stomach, intestine
• Dry mouth
• Heartburn (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 (hyperlipidemia, increased triglycerides)
• 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 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 count, also known as pancytopenia)
• Loss of taste (ageusia)
• Coughing up blood (hemoptysis)
• Menstrual disorders such as absence of periods (amenorrhea)
• Increased frequency of urination during the day
• Chest pain
• Abnormal wound healing
• Hot flushes
• Watery eyes with itching and redness, pink or red eye (conjunctivitis)

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

• Fatigue, difficulty breathing, dizziness, pale skin (signs of low red blood cell count, possibly due to a type of anemia called pure red cell aplasia)
• Swelling of the face, around the eyes, mouth, and inner mucous membranes 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 of previous radiotherapy (e.g., skin redness or lung inflammation) (known as radiation recall syndrome)
• Worsening of adverse effects of 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 Avalon

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. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Open the blister pack immediately before taking the tablets.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Pack contents and other information

Composition of Everolimus Avalon

• The active substance is everolimus.

• Everolimus Avalon 2.5 mg: each tablet contains 2.5 mg of everolimus.

• Everolimus Avalon 5 mg: each tablet contains 5 mg of everolimus.

• Everolimus Avalon 10 mg: each tablet contains 10 mg of everolimus.

• The other components are butylhydroxytoluene (E321), magnesium stearate, hypromellose, crospovidone type A and anhydrous lactose.

Appearance of the product and pack contents

Everolimus Avalon 2.5 mg: elongated tablets, white to slightly yellow in colour, approximately 10 mm long, 4 mm wide and 3 mm high, with the imprint «2.5» on one side.

Everolimus Avalon 5 mg: elongated tablets, white to slightly yellow in colour, approximately 12 mm long, 5 mm wide and 4 mm high, with the imprint «5» on one side.

Everolimus Avalon 10 mg: elongated tablets, white to slightly yellow in colour, approximately 15 mm long, 6 mm wide and 5 mm high, with the imprint «10» on one side.

Everolimus Avalon 2.5 mg is available in packs containing 30x1 or 90x1 tablets.

Everolimus Avalon 5 mg and Everolimus Avalon 10 mg are available in packs containing 10x1, 30x1 or 90x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

AVALON LABORATORIOS S.L.,
C/ La Cora, número 4, Local 1,
18006 Granada, Spain

Manufacturer

Ardena Pamplona, S.L.
Polígono Mocholí. C/ Noáin, 1
31110 Noáin (Navarra), Spain

or

Laboratori Fundació DAU
C/ C, 12-14, Pol. Ind. Zona Franca,
08040 Barcelona, Spain

or

Docuchem, SLU
C/ Pic de Peguera, 11 A.0.07,
17003 Girona, Spain

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

Date of the last review of this leaflet: November 2023

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/