Everolimus STADA 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Everolimus Stada 5 mg tablets EFG

Everolimus Stada 10 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; do 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 Stada is and what it is used for
2. What you need to know before taking Everolimus Stada
3. How to take Everolimus Stada
4. Possible side effects
5. How to store Everolimus Stada
6. Contents of the pack and other information

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

Everolimus 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 breast cancer.

? advanced tumours called 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 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 starting Everolimus Stada

Everolimus will only be prescribed by a doctor experienced in cancer treatment. Carefully follow all instructions given by your doctor, as they may differ from the general information contained in this leaflet. If you have any doubts about everolimus or why you have been prescribed this medicine, consult your doctor.

Do not take everolimus

• 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 everolimus:

• if you have liver problems or have had a 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 levels). Everolimus can increase blood sugar levels and worsen diabetes mellitus. This may mean you need 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.
• if you have high cholesterol. Everolimus can increase cholesterol and/or other blood fats.
• if you have recently had 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. You may need to be treated for your infection before starting treatment with everolimus.
• if you have previously had 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 developing an infection while taking everolimus. 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.
• cause difficulty breathing, cough, and fever.
• cause mouth ulcers and sores. Your doctor may need to interrupt or stop treatment with everolimus. 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 everolimus treatment at the same dose or at a lower dose.
• cause complications related to radiotherapy. Severe complications of radiotherapy (such as difficulty breathing, nausea, diarrhoea, skin rash, 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 receiving radiotherapy or shortly after completing 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 had previously received radiotherapy.
• Inform your doctor if you are scheduled to receive radiotherapy soon, or if you have previously received radiotherapy.

Tell your doctor if you experience any of these symptoms.

During treatment, you will have regular blood tests. These tests will measure the number of blood cells (white blood cells, red blood cells, and platelets) to check whether everolimus 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 performed because these parameters may be affected by treatment with everolimus.

Children and adolescents

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

Other medicines and everolimus

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

Tell your doctor or pharmacist if you are using, have recently used, or might need to 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 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.
• nefazodone, used to treat depression.
• cannabidiol (uses include, among others, 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 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. If you are taking any of them, your doctor may prescribe a different medicine or may adjust your dose of everolimus.

Taking everolimus with food and drink

Do not eat grapefruit or drink 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 may harm your unborn baby and treatment with everolimus 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 can 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.

Breastfeeding

Everolimus may harm your breastfed baby. You must not breastfeed during treatment and for 2 weeks after your 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.

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

Male fertility

Everolimus may affect male fertility. Consult your doctor if you wish to father children.

Driving and using machines

If you feel unusually tired (fatigue is a very common side effect), take special care 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 certain sugars, consult him before taking this medicine.

3. How to take Everolimus Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, 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 any adverse effects while taking everolimus (see section 4), your doctor may reduce your dose, temporarily interrupt treatment, or discontinue it permanently.

Take everolimus 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. Do not chew or crush the tablets.

If you take more Everolimus Stada than you should

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

Take the packaging and this leaflet along so the doctor knows what you have taken.

If you forget to take Everolimus Stada

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

If you stop taking Everolimus Stada

Do not stop treatment with everolimus 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 skin lumps

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 (hemorrhage), for example in the intestinal wall
• Markedly reduced urine output (sign 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)
• Markedly reduced urine output, swelling in the legs, confusion, back pain (signs of sudden kidney failure)
• Rash, itching, hives, 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
• Taste disturbance (dysgeusia)
• Headache
• Nosebleeds (epistaxis)
• Cough
• Mouth ulcers
• Stomach discomfort including nausea or diarrhoea
• Skin rash
• Itching (pruritus)
• Feeling of weakness or fatigue
• 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 (sign 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 lining 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
• Increased frequency of urination during the day
• High levels of lipids (fats) in the blood (hyperlipidaemia, increased triglycerides)
• Low blood potassium level (hypokalaemia)
• Low blood phosphate level (hypophosphataemia)
• Low blood calcium level (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 symptoms 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)
• Increased frequency of urination during the day
• Chest pain
• Abnormal wound healing
• Hot flushes
• Watery eyes with itching and redness, 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 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 of 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 Stada

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Open the blister pack immediately before taking the tablets.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Everolimus Stada

• The active substance is everolimus.

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

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

• The other components are: butylated hydroxytoluene (E321), hypromellose type 2910 (E464), lactose, crospovidone type A (E1202), magnesium stearate.

Appearance of the medicine and contents of the pack

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: August 2022

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