Patient Information Leaflet: Everolimus Dr. Reddys 10 mg Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before taking 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 additional information

Everolimus Dr. Reddys is a cancer medication that contains the active ingredient everolimus. Everolimus reduces blood supply 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 hormone receptor-positive in postmenopausal women, in whom other treatments (designated as "non-steroidal aromatase inhibitors") cannot continue to keep the disease under control. It is administered with a type of medication called exemestane, a steroidal aromatase inhibitor, which is used for hormonal treatment of cancer.
• advanced tumors known as neuroendocrine tumors that originate in the stomach, intestine, lung, or pancreas. It is administered if the tumors are not operable and do not produce specific hormones or other natural substances related to them.
• advanced kidney cancer (advanced renal cell carcinoma), when other treatments (designated as anti-VEGF treatment) have not helped to stop their disease.

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

Do not take Everolimus Dr. Reddys

• if you are allergicto everolimus, related substances such as sirolimus or temserolimus, or 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 haveliver problemsor if you have had anyillnessthat may have affected your 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 drugs. Inform your doctor if you notice excessive thirst or if you need to urinate more frequently.
• if you need to receive avaccinewhile taking Everolimus Dr. Reddys.
• if you have ahigh cholesterol level. Everolimus Dr. Reddys may increase cholesterol and/or other blood fats.
• if you have recently undergone amajor surgical operation, or if you still have anunhealed woundafter a surgical operation. Everolimus Dr. Reddys may increase the risk ofproblems with wound healing.
• if you have aninfection. You may need to treat your infection before starting treatment with Everolimus Dr. Reddys.
• if you have previously hadhepatitis B, because it may reactivate during treatment with Everolimus Dr. Reddys (see section 4 "Possible side effects").
• if you have received or are about to receiveradiation therapy.

Everolimus Dr. Reddys may also:

• weaken your immune system. Therefore, you may be at risk of developing an 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 fatal.
• affect kidney function. Therefore, your doctor will monitor your kidney function while you are taking Everolimus Dr. Reddys.
• cause difficulty breathing, cough, and fever.
• cause ulcers and sores in the mouth. Your doctor may need to interrupt or interrupt your treatment with [product name]. You may need treatment with mouthwash, gel, or other products. Some mouthwashes and gels may worsen ulcers, so do not try anything without first consulting your doctor. Your doctor may restart treatment with everolimus at the same dose or at a lower dose.
• cause complications from radiation therapy. Severe complications from radiation therapy (such as difficulty breathing, nausea, diarrhea, skin rashes, 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 radiation therapy or who were taking everolimus shortly after receiving radiation therapy. Additionally, radiation recall syndrome (which includes skin redness or pulmonary inflammation at the site of previous radiation therapy) has been reported in patients who received radiation therapy in the past.
• Inform your doctor if you plan to receive radiation therapy in the near future or if you have received radiation therapy in the past.

Inform your doctorif you experience these symptoms.

During treatment, you will have blood tests performed periodically. These tests will determine the number of cells in your blood (white blood cells, red blood cells, and platelets) to check if Everolimus Dr. Reddys is having an undesirable 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 these may be affected by treatment with Everolimus Dr. Reddys.

Children and adolescents

Everolimus Dr. Reddys should not be administered to children or adolescents (under 18 years old).

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 of the other medicines.

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medicine.

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

• ketoconazole, itraconazole, voriconazole, orfluconazoleand other antifungal medicines used to treat fungal infections.
• clarithromycin, telithromycinorerythromycin, antibiotics used to treat bacterial infections.
• ritonavirand other medicines used to treat HIV/AIDS.
• verapamilordiltiazem, used to treat heart problems or high blood pressure.
• dronedarone, a medicine used to help regulate your heart rhythm.
• ciclosporin,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 asramipril) 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).
• efavirenzornevirapine, 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 situations, including inflammatory or immune problems.
• phenytoin, carbamazepineorphenobarbitaland other antiepileptic drugs used to control seizures.

You should avoid using these medicines 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 your blood, possibly to a harmful level.

Pregnancy, breastfeeding, and fertility

Pregnancy

Everolimus Dr. Reddys may cause harm to the fetus and is not recommended for use 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 may become pregnant should use a highly effective contraceptive method during treatment and for 8 weeks after stopping treatment. If, despite these measures, you think you may be pregnant, consult your doctorbeforetaking more Everolimus Dr. Reddys.

Breastfeeding

Everolimus Dr. Reddys may harm the breastfeeding baby. Do 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 Dr. Reddys, amenorrhea (absence of menstrual periods) has been observed.

Everolimus Dr. Reddys may affect female fertility. Inform 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 operating machines

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

Everolimus Dr. Reddys contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg, once a day. Your doctor will inform you how many tablets of Everolimus Dr. Reddys 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 adverse effects while taking Everolimus Dr. Reddys (see section 4), your doctor may reduce the dose you take or interrupt treatment for a short period of time 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 tablets 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 by accident, consult your doctor or go to the hospital immediately. Urgent treatment may be necessary.
• Bring the packaging and this leaflet so that the doctor knows what you have taken.

If you forget to take Everolimus Dr. Reddys

If you have forgotten a dose, take the next dose at the time it is due. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Everolimus Dr. Reddys

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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

-Intense itching of the skin, with red rash or lumps on the skin

The serious side 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, increased 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 insufficiency)

Uncommon(may affect up to 1 in 100 people)

• Fever, skin rash, joint pain and inflammation, as well as fatigue, loss of appetite, nausea, jaundice (yellow discoloration of the skin), right upper abdominal pain, light stools, dark urine (may be signs of reactivation of hepatitis B)
• 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 heat in the skin in the affected area (signs of venous thrombosis 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)

potentially

• Significant decrease in urine output, swelling in the legs, feeling of confusion, back pain (signs of sudden renal insufficiency)
• Skin rash, itching, acne, difficulty breathing or swallowing, dizziness (signs of 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 side effects, report them to your doctor immediately, as they may be fatal.

Other possible side effects of everolimus include:

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

• High blood sugar (hyperglycemia)
• Loss of appetite
• Alteration of taste (dysgeusia)
• Headache
• Nasal bleeding (epistaxis)
• Cough
• Mouth ulcers
• Stomach discomfort, including 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)

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)

• Bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• Difficulty breathing (dyspnea)
• Excessive thirst, decreased urine output, dark urine, dry, red, and irritated skin (signs of dehydration)
• Insomnia
• Headache, dizziness (signs of high blood pressure, also known as hypertension)
• Swelling of a limb (including fingers or 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
• Mucosal inflammation in the mouth, stomach, intestine
• Dry mouth
• Heartburn (dyspepsia)
• Vomiting
• Difficulty swallowing (dysphagia)
• Abdominal pain
• Acne
• Skin 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
• Irregular menstrual 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 changes, nail breakage
• Mild hair loss
• Abnormal liver function tests (increased alanine and aspartate aminotransferase)
• Abnormal kidney function tests (increased creatinine)
• Excessive tearing, 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 pancitopenia)
• Loss of taste (ageusia)
• Coughing up blood (hemoptysis)
• Irregular menstrual periods (amenorrhea)
• Increased frequency of urination during the day
• Chest pain
• Abnormal wound healing
• Hot flashes
• Red or pink eyes (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 membranes in 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 radiation therapy, p. skin redness or lung inflammation (the so-called radiation recall syndrome)

-Worsening of side effects from radiation therapy

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

Reporting of adverse reactions

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

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

Do not use this medication after the expiration date that appears on the packaging and in the blister. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not require special temperature conditions for storage.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and themedicines that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Everolimus Dr. Reddys

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

Appearance of the product and contents of the package

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

Packaging of 10, 30 or 90 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the Marketing Authorization:

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona

Spain

Telephone: 93 355 49 16

Fax: 93 355 49 61

Responsible 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:

Last review date of this leaflet:March 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).