Everolimus Accord 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Everolimus Accord 5 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 you should not give it to others, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Everolimus Accord 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") are no longer able to control the disease. It is given in combination with a type of 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 related natural substances.
• advanced renal cell carcinoma (advanced kidney cancer), when other treatments (called anti-VEGF therapies) have not helped to stop the progression of the disease.

2. What you need to know before taking Everolimus Accord

Everolimus Accord will only be prescribed by a physician experienced in cancer treatment. Carefully follow all instructions provided by your doctor, as they may differ from the general information contained in this leaflet. If you have any questions about Everolimus Accord or why it has been prescribed to you, consult your doctor.

Do not take Everolimus Accord

• 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 Accord:

• if you have liver problems or have had any illness that may have affected your liver. In such cases, your doctor may prescribe a different dose of Everolimus Accord.
• if you have diabetes (high blood sugar levels). Everolimus Accord may increase blood sugar levels and worsen diabetes mellitus. This may 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 Accord.
• if you have high cholesterol levels. Everolimus Accord may increase cholesterol and/or other blood fats.
• if you have recently undergone major surgery or still have an unhealed surgical wound. Everolimus Accord may increase the risk of wound healing complications.
• if you have an infection. Your infection may need to be treated before starting Everolimus Accord.
• if you have previously had hepatitis B, as it may reactivate during treatment with Everolimus Accord (see section 4, "Possible side effects").
• if you have received or are about to receive radiotherapy.

Everolimus Accord may also:

• weaken your immune system. Therefore, you may be at risk of developing an infection while taking Everolimus Accord. If you develop fever or other signs of infection, consult your doctor. Some infections may be severe and potentially fatal.
• affect kidney function. Your doctor will monitor your kidney function during treatment with Everolimus Accord.
• cause difficulty breathing, cough, and fever.
• 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 taking everolimus concurrently with or shortly after 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 undergone radiotherapy.
• cause mouth ulcers and sores. Your doctor may need to interrupt or discontinue treatment with Everolimus Accord. 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 Accord at the same or a reduced dose.

Inform your doctor if you experience any of these symptoms.

During treatment, you will have regular blood tests. These tests will measure blood cell counts (white blood cells, red blood cells, and platelets) to check whether Everolimus Accord is having any unwanted effects on these cells. Blood tests will also 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 Accord.

Children and adolescents

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

Other medicines and Everolimus Accord

Everolimus Accord may affect how other medicines work. If you are taking other medicines concurrently with Everolimus Accord, your doctor may adjust the dose of Everolimus Accord or of the other medicines.

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

The following may increase the risk of adverse effects with Everolimus Accord:

• 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 conditions or high blood pressure.
• dronedarone, a medicine used to help regulate heart rhythm.
• cyclosporine, a medicine used to prevent organ transplant rejection.
• 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 conditions.
• nefazodone, used to treat depression.
• Cannabidiol (used, among other things, for the treatment of epileptic seizures).

The following may reduce the effectiveness of Everolimus Accord:

• 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 Accord. If you are taking any of them, your doctor may prescribe an alternative medicine or adjust your dose of Everolimus Accord.

Taking Everolimus Accord with food and drink

Do not consume grapefruit or grapefruit juice while taking Everolimus Accord. It may increase the amount of everolimus in your blood to potentially harmful levels.

Pregnancy, breastfeeding, and fertility

Pregnancy

Everolimus Accord may harm the unborn baby and treatment during pregnancy is not recommended. 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 of childbearing potential must use a highly effective method of contraception during treatment and for 8 weeks after stopping treatment. If, despite these precautions, you suspect you may be pregnant, consult your doctor before taking any further doses of Everolimus Accord.

Breastfeeding

Everolimus Accord 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

Absence of menstrual periods (amenorrhoea) has been observed in some patients treated with Everolimus Accord.

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

Male fertility

Everolimus Accord may affect male fertility. Consult your doctor if you wish to father a child.

Driving and using machines

If you feel abnormally tired (fatigue is a very common side effect), exercise special caution when driving or operating machinery.

Everolimus Accord contains lactose

Everolimus Accord 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 Accord

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 treatment 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. The tablets must not be chewed or crushed.

If you take more Everolimus Accord than you should

• If you have taken too much everolimus, or if someone has accidentally taken your tablets, contact your doctor or go to hospital immediately. 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 Accord

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

If you stop taking Everolimus Accord

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

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 or your child 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, rattling breath sounds (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 (signs 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)
• 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 leg caused by a blood clot)
• Sudden onset of breathing problems, 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, leg swelling, confusion, back pain (signs of sudden kidney failure)
• Rash, itching, pimples, 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)

Frequency not known

• Swelling, feeling of heaviness or tightness, pain, limited mobility in parts of the body (this may occur in any part of the body and could indicate abnormal fluid accumulation in soft tissues due to obstruction of the lymphatic system, also known as lymphoedema)

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

Common (may affect up to 1 in 10 people)

• Spontaneous bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• Difficulty breathing (dyspnoea)
• Thirst, low urine output, dark urine, dry red skin, 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 lymphoedema)
• Fever, sore throat, mouth ulcers due to infections (signs of low white blood cell count, leucopenia, 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)
• Skin redness (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 signs 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 (haemoptysis)
• Menstrual disorders such as absence of periods (amenorrhoea)
• More frequent 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 anaemia called pure red cell aplasia)
• Swelling of the face, around the eyes, mouth and/or throat, including 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 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 Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer packaging and blister. 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 medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Everolimus Accord

• The active substance is everolimus.
• Each tablet contains 5 mg of everolimus.
• The other components are butylhydroxytoluene (E321), hypromellose (E464), lactose, lactose monohydrate, crospovidone (E1202) and magnesium stearate (E470b).

Nature of the product and pack contents

Everolimus Accord 5 mg tablets EFG are white to off-white, oval, biconvex tablets (approximately 13 x 6 mm) with the imprint «E9VS 5» on one side.

Everolimus Accord 5 mg tablets EFG are available in packs containing 10, 30 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

Moll de Barcelona s/n.

World Trade Center. Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Synthon Hispania, S.L.

C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat

08830 Barcelona

Spain

Or

Synthon BV

Microweg, 22

6545 CM Nijmegen

The Netherlands

Date of the most recent review of this leaflet: October 2025

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