EVEROLIMUS DR. REDDYS 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Everolimus Dr. Reddys and what is it used for

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

Everolimus Dr. Reddys is used to treat adult patients with:

• advanced breast cancer with positive hormonal receptors 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 an excess of specific hormones or other related natural substances.
• advanced kidney cancer (advanced renal cell carcinoma), when other treatments (called anti-VEGF treatment) have not helped to stop the disease.

2. What you need to know before you take Everolimus Dr. Reddys

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

Do not take Everolimus Dr. Reddys

• if you are allergicto everolimus, to related substances such as sirolimus or temserolimus, 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 Dr. Reddys:

• if you have liver problemsor if you have had any diseasethat may have affectedyour liver. In this case, your doctor may prescribe a different dose of Everolimus Dr. Reddys.
• if you have diabetes(high blood sugar levels). Everolimus Dr. Reddys 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 vaccinewhile taking Everolimus Dr. Reddys.
• if you have high cholesterol levels. Everolimus Dr. Reddys may increase cholesterol and/or other blood fats.
• if you have recently undergone major surgery, or if you still have an unhealed woundafter surgery. Everolimus Dr. Reddys 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 Dr. Reddys.
• if you have previously suffered from hepatitis B, as it may reactivate during treatment with Everolimus Dr. Reddys (see section 4 "Possible side effects").
• if you have received or are about to receive radiotherapy.

Everolimus Dr. Reddys may also:

• weaken your immune system. Therefore, you may be at risk of infection while taking Everolimus Dr. Reddys. 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 Dr. Reddys.
• cause difficulty breathing, coughing, and fever.
• cause ulcers and sores in the mouth. Your doctor may need to interrupt or discontinue your treatment with Everolimus Dr. Reddys. You may need treatment with mouthwash, gel, or other products. Some mouthwashes and gels can worsen ulcers, so do not try anything 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 radiation therapy or taking everolimus shortly after receiving radiation therapy. Additionally, the so-called radiation recall syndrome (which includes skin redness or lung inflammation at the site of previous radiation therapy) has been reported in patients who received radiation therapy in the past.
• Tell your doctor if you plan to receive radiation therapy in the near future 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 Dr. Reddys 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 done because they may be affected by treatment with Everolimus Dr. Reddys.

Children and adolescents

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

Other medicines and Everolimus Dr. Reddys

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

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

The following may increase the risk of side effects with Everolimus Dr. Reddys:

• ketoconazole, itraconazole, voriconazole, or fluconazoleand other antifungal medicinesused to treat fungal infections.
• clarithromycin, telithromycinor erythromycin, antibiotics used to treat bacterial infections.
• ritonavirand other medicines used to treat HIV/AIDS.
• verapamilor 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.
• cannabidiol(uses include treatment of seizures).
• nefazodone, used to treat depression.
• cannabidiol (uses include treatment of seizures).

The following may reduce the effectiveness of Everolimus Dr. Reddys:

• rifampicin, used to treat tuberculosis (TB).
• efavirenzor 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, carbamazepineor phenobarbitaland other antiepilepticsused to control seizures.

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

Taking Everolimus Dr. Reddys with food and drinks

Avoid grapefruit and 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 Dr. Reddys may harm the 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 up to 8 weeks after finishing treatment. If, despite these measures, you think you may be pregnant, consult your doctor before taking more Everolimus Dr. Reddys.

Breastfeeding

Everolimus Dr. Reddys may harm the breastfed baby. Do not breastfeed while taking Everolimus Dr. Reddys 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 Dr. Reddys, absence of menstrual periods (amenorrhea) has been observed.

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

Male fertility

Everolimus Dr. Reddys may affect male fertility. Consult your doctor if you want to be a father.

Driving and using machines

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

Everolimus Dr. Reddys 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 Dr. Reddys

Follow the instructions for administration of this medicine exactly as prescribed 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 Dr. Reddys tablets you should take.

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

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

Take Everolimus Dr. Reddys 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 Dr. Reddys than you should

• If you have taken too much Everolimus Dr. Reddys, or if someone has taken your tablets accidentally, consult your doctor or go to the hospital immediately. You may need urgent treatment.
• Take the pack and this leaflet with you so that the doctor knows what you have taken.

If you forget to take Everolimus Dr. Reddys

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 Dr. Reddys

Do not stop taking Everolimus Dr. Reddys unless your doctor tells you to.

If you have any further questions on 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.

STOP treatment with everolimus and seek medical help immediately 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-colored rash or bumps on the skin

Severe 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 renal failure)

Uncommon(may affect up to 1 in 100 people)

• Fever, skin 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 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 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 renal 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)
• Lack of appetite
• Taste disturbance (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)
• Sleeping problems (insomnia)
• Headache, dizziness (sign of high blood pressure, also known as hypertension)
• Swelling of part or all of the arm (including the fingers) or leg (including the toes), feeling of heaviness, restricted movement, 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, 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)
• 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)
• Excessive tearing with itching, redness, and 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
• Red or pink 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 mucous membrane inside the mouth and/or throat, as well as the tongue and 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 radiation therapy, e.g., skin redness or lung inflammation (so-called radiation recall syndrome)
• Worsening of radiation treatment side 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 interrupted 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 Pharmacovigilance System for Human Use Medicines: 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 Dr. Reddys

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

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

Store in the original packaging to protect from light.

This medicine does not require special temperature storage conditions

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Everolimus Dr. Reddys

• The active ingredient is everolimus. Each tablet contains 10 mg of everolimus.
• The other ingredients are: butylhydroxytoluene (E321), hypromellose (E464), lactose, lactose monohydrate, crospovidone (E1202), and magnesium stearate (E470b).

Appearance of the Product and Package Contents

Everolimus Dr. Reddys 10 mg tablets EFG are oval and biconvex white to off-white tablets (approximately 16 x 8 mm), engraved with E9VS 10 on one side.

Packaging of 10, 30, or 90 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona

Spain

Phone: 93 355 49 16

Fax: 93 355 49 61

Manufacturer:

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Betapharm Arzneimittel GmbH

Kobelweg 95

86156, Augsburg

Germany

or

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley

HU17 0LD, East Yorkshire, United Kingdom

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:March 2024

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