EVEROLIMUS STADA 5 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Everolimus Stada 5 mg tablets EFG

Everolimus Stada 10 mg tablets EFG

Read all of this leaflet carefully before you start 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 experience 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

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

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

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

Everolimus is used to treat adult patients with:

? advanced breast cancer with positive hormonal receptor in postmenopausal women, in whom other treatments (called "non-steroidal aromatase inhibitors") can no longer keep the disease under control. It is given together with a type of medicine called exemestane, a steroidal aromatase inhibitor, which is used for the hormonal treatment of cancer.

? advanced tumors called neuroendocrine tumors that originate in the stomach, intestine, lung, or pancreas. It is given if the tumors are not operable 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 disease.

2. What you need to know before you take Everolimus Stada

Everolimus will only be prescribed by a doctor with experience in the treatment of cancer. Follow carefully all the instructions given by your doctor. They may be different from the general information contained in this leaflet. If you have any questions about everolimus or why you have been prescribed this medicine, ask your doctor.

Do not take everolimus

• if you are allergicto 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

Tell your doctor before you start taking everolimus:

• if you have liver problems or if you have had any disease that may have affected your liver. In this case, your doctor may prescribe a different dose of everolimus.
• if you have diabetes (high blood sugar). Everolimus may increase blood sugar levels and worsen diabetes mellitus. This may require treatment with insulin and/or oral antidiabetic medications. Inform your doctor if you notice that you are excessively thirsty or need to urinate more frequently.
• if you need to be given a vaccine while taking everolimus.
• if you have high cholesterol. Everolimus may 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 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 suffered from 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 getting an infection while taking everolimus. If you have a fever or other signs of infection, consult your doctor. Some infections can be serious and have fatal consequences.
• affect kidney function. Therefore, your doctor will monitor your kidney function while you are taking everolimus.
• cause difficulty breathing, coughing, and fever.
• cause the appearance of ulcers and sores in the mouth. Your doctor may need to interrupt or stop treatment with everolimus. You may need treatment with a mouthwash, gel, or other products. Some mouthwashes and gels can worsen ulcers, so do not try any without consulting your doctor first. Your doctor may restart treatment with everolimus at the same dose or a lower dose.
• cause radiation therapy complications. Serious radiation therapy complications (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 at the same time as receiving radiation therapy or taking everolimus shortly after receiving radiation therapy. Radiation recall syndrome (which occurs with skin redness or lung inflammation at the site of previous radiation therapy) has also been reported in patients who had received radiation therapy in the past.
• Tell your doctor if you are scheduled to receive radiation therapy soon, or if you have received radiation therapy in the past.

Tell your doctorif you experience these symptoms.

During treatment, you will have regular blood tests. These tests will determine the number of cells in the blood (white blood cells, red blood cells, and platelets) to check if everolimus is having an unwanted effect on these cells. You will also have blood tests to monitor kidney function (creatinine level), liver function (transaminase level), and blood sugar and cholesterol levels. These tests are done because they may be affected by treatment with everolimus.

Children and adolescents

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

Other medicines and everolimus

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

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

The following may increase the risk of side 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.
• verapamil or diltiazem, used to treat heart problems or high blood pressure.
• dronedarone, a medicine used to help regulate your heart rhythm.
• 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 (uses include the treatment of seizures).

The following may reduce the effectiveness of everolimus:

• rifampicin, used to treat tuberculosis (TB).
• efavirenz or nevirapine, used to treat HIV/AIDS.
• 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 system problems.
• phenytoin, carbamazepine, or phenobarbital, and other antiepileptics used to control seizures.

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

Taking everolimus with food and drinks

Do not take grapefruit or grapefruit juice while taking everolimus. It may increase the amount of everolimus in the blood, possibly to a harmful level.

Pregnancy, breastfeeding, and fertility

Pregnancy

Everolimus may harm your fetus and should not be used during pregnancy. Tell 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 finishing treatment. If, despite these measures, you think you may be pregnant, consult your doctor beforetaking more everolimus.

Breastfeeding

Everolimus may harm your breastfed baby. Do not breastfeed while taking everolimus and for 2 weeks after the last dose of everolimus. Tell your doctor if you are breastfeeding.

Female fertility

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

Everolimus may have an impact on female fertility. Tell your doctor if you want to have children.

Male fertility

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

Driving and using machines

If you feel abnormally tired (fatigue is a very common side effect), be careful when driving or using machines.

This medicine contains lactose

Everolimus Stada contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Everolimus Stada

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

The recommended dose is 10 mg, once a day. Your doctor will tell you how many everolimus tablets to take.

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

If you experience some side effects while taking everolimus (see section 4), your doctor may reduce the dose you take or interrupt treatment for a short period or permanently.

Take everolimus once a day, more or less at the same time, always with food or always without food.

Swallow the tablet(s) whole with a glass of water. The tablets should not be chewed or crushed.

If you take more Everolimus Stada than you should

If you have taken too much everolimus, or if someone has taken your tablets accidentally, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone: 91 562 04 20. Urgent treatment may be necessary.

Take the pack and this leaflet with you to show the doctor what you have taken.

If you forget to take Everolimus Stada

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

If you stop taking Everolimus Stada

Do not stop taking 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 all people suffer from them.

DISCONTINUE treatment with everolimus and seek immediate medical attention 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

? intense itching of the skin, with a red rash or bumps on the skin

The serious adverse effects of everolimus include:

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

? increased temperature, chills (signs of infection)

? fever, cough, difficulty breathing, wheezing (signs of lung inflammation, also known as pneumonitis)

Common(may affect up to 1 in 10 people)

? excessive thirst, high urine output, increased appetite with weight loss, fatigue (signs of diabetes)

? bleeding (hemorrhage), for example in the intestinal wall

? significant decrease in urine output (sign of kidney failure)

Uncommon(may affect up to 1 in 100 people)

? fever, rash, joint pain and inflammation, as well as fatigue, loss of appetite, nausea, yellowing of the skin (jaundice), pain in the upper right abdomen, pale stools, dark urine (may be signs of hepatitis B reactivation)

? shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)

? swelling and/or pain in one of the legs, 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 problems, chest pain or coughing up blood (potential signs of pulmonary embolism, a situation that occurs when one or more arteries in the lungs are blocked)

? significant decrease in urine output, swelling in the legs, feeling of confusion, back pain (signs of sudden kidney failure)

? rash, itching, acne, 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 fatal consequences.

Other possible adverse effects of everolimus include:

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

? high blood sugar levels (hyperglycemia)

? loss of appetite

? altered taste (dysgeusia)

? headache

? nosebleeds (epistaxis)

? cough

? mouth ulcers

? stomach discomfort including feeling of nausea or diarrhea

? skin rash

? itching (pruritus)

? feeling of weakness or fatigue

? fatigue, difficulty breathing, dizziness, pale skin, signs of low red blood cell count (anemia)

? swelling of the arms, hands, feet, ankles, or other parts of the body (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 red skin, irritability (signs of dehydration)

? sleep problems (insomnia)

? headache, dizziness (sign of high blood pressure, also known as hypertension)

? swelling of a part or all of the arm (including the fingers) or leg (including the 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, leucopenia, lymphopenia, and/or neutropenia)

? fever

? inflammation of the mucous membrane inside 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 (palmar-plantar syndrome)

? skin redness (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 rupture

? mild hair loss

? altered liver function tests (increased alanine and aspartate aminotransferase)

? altered kidney function tests (increased creatinine)

? eyelid swelling

? 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 (hemoptysis)

? menstrual disorders such as absence of periods (amenorrhea)

? frequent urination during the day

? chest pain

? abnormal wound healing

? hot flashes

? tearing 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 mouth and/or throat, as well as difficulty breathing or swallowing (also known as angioedema), may be signs of an allergic reaction

Frequency Not Known(cannot be estimated from the available data)

• reaction at the site of previous radiotherapy (e.g., skin redness or lung inflammation) (called radiation recall syndrome)
• worsening of radiotherapy adverse effects

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Everolimus Stada

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiration date shown on the box and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.Store in the original packaging to protect it from light.

Open the blister just before taking the tablets.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Everolimus Stada

? The active ingredient is everolimus.

? Each 5 mg Everolimus Stada tablet contains 5 mg of everolimus.

Each 10 mg Everolimus Stada tablet contains 10 mg of everolimus.

? The other ingredients are: butylhydroxytoluene (E321), hypromellose type 2910 (E464), lactose, crospovidone type A (E1202), magnesium stearate.

Appearance of the Product and Package Contents

The 5 mg Everolimus Stada tablets are white to off-white, oval, flat, engraved with «EVR» on one side and «5» on the other, approximately 12 mm long and 5 mm wide.

The 10 mg Everolimus Stada tablets are white to off-white, oval, flat, engraved with «EVR» on one side and «NAT» on the other, approximately 15 mm long and 6 mm wide.

Everolimus Stada is available in packages containing 10, 30, or 90 tablets or 10x1, 30x1, 90x1 tablets (unit dose).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Genepharm S.A.

18th Km Marathonos Avenue

153 51 Pallini Athens

Greece

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

PLA 3000 Paola

Malta

or

Pharmacare Premium Ltd

HHF003 Hal Far Industrial Estate, Birzebbugia, BBG3000,

Malta

Date of the Last Revision of this Leaflet:August 2022

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