Everolimus Dr. Reddy's 10 mg tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Everolimus Dr. Reddys is 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. How to store Everolimus Dr. Reddys
6. Contents of the pack and other information

1. What Everolimus Dr. Reddy's is and what it is used for

Everolimus Dr. Reddy's is a cancer 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 Dr. Reddy's 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 keep the disease under control. 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 not surgically removable and do not produce excess specific hormones or other related natural substances.
• advanced renal cell carcinoma (advanced kidney cancer), when other treatments (called anti-VEGF therapy) have not helped to stop the progression of the disease.

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

Everolimus Dr. Reddys will only be prescribed by a physician experienced in the treatment of cancer. 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 Dr. Reddys or why this medicine has been prescribed to you, consult your doctor.

Do not take Everolimus Dr. Reddys

• 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 Dr. Reddys:

• 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 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 medicines. Inform your doctor if you experience excessive thirst or increased frequency of urination.
• if you need to receive a vaccination while 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 still have an unhealed wound following surgery. Everolimus Dr. Reddys may increase the risk of wound healing complications.
• if you have an infection. It may be necessary to treat your infection before starting treatment with Everolimus Dr. Reddys.
• if you have previously had 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 developing an infection while taking Everolimus Dr. Reddys. If you develop fever or other signs of infection, consult your doctor. Some infections may be severe and potentially 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 mouth ulcers and sores. Your doctor may need to interrupt or discontinue your treatment with [product name]. You may require treatment with 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 everolimus treatment at the same or a lower dose.
• cause complications related to radiotherapy. Severe complications of radiotherapy (such as difficulty breathing, nausea, diarrhoea, skin rashes, and pain in the mouth, gums, and throat), including fatal cases, have been observed in some patients taking everolimus concurrently with radiotherapy or shortly after completing radiotherapy. Additionally, a condition called radiation recall syndrome (characterized by skin redness or lung inflammation at the site of previous radiotherapy) has been reported in patients who previously received radiotherapy.
• Inform your doctor if you plan to receive radiotherapy in the near future or if you have previously received radiotherapy.

Tell your doctor if you experience any of these symptoms.

During treatment, you will have periodic blood tests. These tests will measure your blood cell counts (white blood cells, red blood cells, and platelets) to check whether Everolimus Dr. Reddys 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 performed because these parameters may be affected by treatment with Everolimus Dr. Reddys.

Children and adolescents

Everolimus Dr. Reddys must 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 adjust the dose of Everolimus Dr. Reddys or of the other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• 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 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.
• cannabidiol (used, among other things, for the treatment of seizures).
• nefazodone, used for the treatment of depression.
• cannabidiol (used, among other things, for the treatment of seizures).

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

• 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 Dr. Reddys. If you are taking any of them, your doctor may prescribe a different medicine or adjust your dose of Everolimus Dr. Reddys.

Taking Everolimus Dr. Reddys with food and drink

Avoid grapefruit and grapefruit juice while taking everolimus. These can increase the amount of everolimus in your blood, possibly to harmful levels.

Pregnancy, breast-feeding and fertility

Pregnancy

Everolimus Dr. Reddys may harm the unborn baby and treatment with Everolimus Dr. Reddys 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 could become pregnant must use a highly effective method of contraception during treatment and for 8 weeks after stopping treatment. If, despite these precautions, you think you may be pregnant, consult your doctor before taking any further doses of Everolimus Dr. Reddys.

Breast-feeding

Everolimus Dr. Reddys may harm the breastfed infant. You must not breast-feed during treatment and for 2 weeks after the last dose of everolimus. Inform your doctor if you are breast-feeding.

Female fertility

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

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

Male fertility

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

Driving and using machines

If you feel unusually tired (fatigue is a very common side effect), take special care when driving or operating machinery.

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.

3. How to take Everolimus Dr. Reddys

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 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 daily).

If you experience any adverse effects while taking Everolimus Dr. Reddys (see section 4), your doctor may reduce your dose, temporarily interrupt treatment, or discontinue treatment permanently.

Take Everolimus Dr. Reddys once daily, approximately at 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 Dr. Reddys than you should

• If you have taken too much Everolimus Dr. Reddys, or if someone has accidentally taken your tablets, contact your doctor or go to hospital immediately. Urgent treatment may be required.
• Take the container and this leaflet with you so the doctor knows what has been taken.

If you forget to take Everolimus Dr. Reddys

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

If you stop taking Everolimus Dr. Reddys

Do not stop treatment with Everolimus Dr. Reddys unless instructed by your doctor.

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 will experience 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, 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 (haemorrhage), for example in the intestinal wall
• Markedly reduced 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 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 condition that occurs when one or more arteries in the lungs become blocked)
• Markedly reduced urine output, swelling in the legs, 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)

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, paleness of the skin, signs of low red blood cell count (anaemia)
• Swelling of the arms, hands, feet, ankles, or other body parts (signs of oedema)
• Weight loss
• High level 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, restricted movement, discomfort (possible symptoms of lymphoedema)
• Fever, sore throat, mouth ulcers due to infections (signs of low white blood cell counts, 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 level of lipids (fats) in the blood (hyperlipidaemia, increased triglycerides)
• Low potassium level in the blood (hypokalaemia)
• Low phosphate level in the blood (hypophosphataemia)
• Low calcium level 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)
• Watery eyes 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 symptoms such as fever, chills, sore throat, or mouth ulcers (signs of low blood cell counts, 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
• Pink or red eye (conjunctivitis)

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

• Fatigue, difficulty breathing, dizziness, paleness of the 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 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 (so-called radiation recall syndrome)
• Worsening of side effects from radiation therapy

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 Dr. Reddys

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 is 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. Return any unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Everolimus Dr. Reddys

• The active substance 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 pack

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

Packs of 10, 30 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona

Spain

Telephone: 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

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

Date of the most recent review of this leaflet: March 2024

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