Everolimus Ethypharm

Package leaflet: Information for the user

Everolimus Ethypharm, 2.5 mg tablets, 5 mg tablets, 10 mg tablets

everolimus
Generic medicine
Read this entire leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Everolimus Ethypharm is an anticancer medicine containing an active substance called
everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of
cancer cells.
Everolimus Ethypharm is used to treat adult patients with:

• advanced hormone receptor-positive breast cancer in postmenopausal women in whom other treatments (known as “non-steroidal aromatase inhibitors”) are no longer able to control the disease. It is administered in combination with a type of medicine called exemestane, a steroidal aromatase inhibitor, which is used for antitumour hormonal therapy.

2. What you need to know before taking Everolimus Ethypharm

Everolimus Ethypharm will be prescribed to you only by a doctor experienced in the treatment of cancer. Follow carefully all instructions given by your doctor. These instructions may differ from the general information contained in this leaflet. If you have any questions about Everolimus Ethypharm or why it has been prescribed to you, consult your doctor.

Do not take Everolimus Ethypharm

• if you are allergic to everolimus, to similar 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 taking Everolimus Ethypharm:

• if you have liver problems or have had any illness that may have affected your liver. In such cases, your doctor may need to prescribe a different dose of Everolimus Ethypharm.
• if you have diabetes (high blood sugar levels). Everolimus Ethypharm can increase blood sugar levels and worsen diabetes mellitus. This may require the use of insulin and/or oral antidiabetic agents. Inform your doctor if you experience excessive thirst or increased frequency of urination.
• if you need to receive a vaccine while taking Everolimus Ethypharm.
• if you have high cholesterol levels. Everolimus Ethypharm can raise cholesterol levels and/or other blood fats.
• if you have recently undergone surgery, or if you have an unhealed surgical wound. Everolimus Ethypharm may increase the risk of wound healing complications.
• if you have an infection. It may be necessary to treat the infection before starting Everolimus Ethypharm.
• if you have previously had hepatitis B, as it may reactivate during treatment with Everolimus Ethypharm (see section 4 'Possible side effects').

Everolimus Ethypharm may also:

• weaken the immune system. Therefore, you may be at increased risk of developing an infection during treatment with Everolimus Ethypharm.
• impair kidney function. Therefore, your doctor will monitor your kidney function during treatment with Everolimus Ethypharm.
• cause shortness of breath, cough, and fever. Inform your doctor if you experience these symptoms. You will have regular blood tests during treatment. These tests will monitor the number of blood cells in your body (white blood cells, red blood cells, and platelets) to check whether Everolimus Ethypharm is having any unwanted effects on these cells. Blood tests will also be performed to monitor kidney function (creatinine levels), liver function (transaminase levels), and blood sugar and cholesterol levels. These levels may also be affected by Everolimus Ethypharm.

Children and adolescents
Everolimus Ethypharm must not be used in children or adolescents (under 18 years of age).

Other medicines and Everolimus Ethypharm
Everolimus Ethypharm may affect the action of certain medicines. If you are taking other medicines at the same time as Everolimus Ethypharm, your doctor may need to adjust the dose of Everolimus Ethypharm or of the other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following substances may increase the risk of side effects with Everolimus Ethypharm:

• ketoconazole, itraconazole, voriconazole, fluconazole, and other antifungal agents 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 conditions or high blood pressure.
• dronedarone, used to help regulate heart rhythm.
• ciclosporin, a medicine used to prevent rejection of transplanted organs.
• imatinib, used to block the growth of abnormal cells.
• angiotensin-converting enzyme (ACE) inhibitors (such as ramipril), used to treat high blood pressure or other cardiovascular problems.

The following substances may reduce the effectiveness of Everolimus Ethypharm:

• 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 prevent epileptic seizures.

These medicines should be avoided during treatment with Everolimus Ethypharm. If you are taking any of these medicines, your doctor may prescribe alternative medicines, or may adjust your dose of Everolimus Ethypharm.

Everolimus Ethypharm with food and drink
You must take Everolimus Ethypharm at the same time each day, regularly with or without food.
Avoid grapefruit and grapefruit juice while being treated with Everolimus Ethypharm.

Pregnancy, breast-feeding and fertility
Pregnancy
Everolimus Ethypharm may harm the unborn baby and is not recommended during pregnancy. Inform your doctor if you are pregnant or suspect 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 highly effective contraception during treatment. If, despite these precautions, you suspect you are pregnant, consult your doctor before taking any further doses of Everolimus Ethypharm.

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

Female fertility
Menstrual cycle disturbances (amenorrhoea) have been observed in some patients treated with Everolimus Ethypharm.
Everolimus Ethypharm may affect female fertility. Inform your doctor if you wish to have children.

Male fertility
Everolimus Ethypharm may affect male fertility. Talk to your doctor if you wish to father a child.

Driving and using machines
If you feel unusually tired (tiredness is a very common side effect), exercise particular caution when driving or using machines.

Everolimus Ethypharm contains lactose
Everolimus Ethypharm contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Everolimus Ethypharm

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 10 mg, taken once daily. Your doctor will tell you how many tablets of
Everolimus Ethypharm you should take.
If you have liver problems, your doctor may prescribe a lower dose of Everolimus Ethypharm (2.5,
5, or 7.5 mg/day).
If certain side effects occur while you are taking Everolimus Ethypharm (see section 4), your doctor may reduce your dose, or temporarily or permanently stop treatment.
Take Everolimus Ethypharm once daily, approximately at the same time each day, regularly with or
without food.
Swallow the tablet(s) whole with a glass of water. Do not chew or crush the tablets.

If you take more Everolimus Ethypharm than you should

• If you have taken more Everolimus Ethypharm than you should, or if someone else has accidentally taken your tablets, contact a doctor immediately or go to hospital. Emergency treatment may be required.
• Keep the packaging and this leaflet, so the doctor knows what has been taken.

If you forget to take Everolimus Ethypharm
If you forget to take a dose, take the next dose as scheduled. Do not take a double dose to make up for forgotten tablets.

If you stop taking Everolimus Ethypharm
Do not stop treatment with Everolimus Ethypharm unless your doctor tells you to.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop treatment with Everolimus Ethypharm and contact your doctor immediately if you experience any of the following signs of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue, or throat
• Severe itching of the skin, with red rash or skin swellings

Serious side effects of Everolimus Ethypharm include:
Very common (may affect more than 1 in 10 users)

• Increased body 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 users)

• Excessive thirst, increased urine production, increased appetite with weight loss, fatigue (signs of diabetes)
• Bleeding (haemorrhage), for example in the intestinal wall
• Severe decrease in urine production (signs of kidney failure)

Uncommon (may affect up to 1 in 100 users)

• Fever, rash, joint pain and inflammation, as well as fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right part of the abdomen, pale stools, dark urine (may be signs of reactivation of hepatitis B)
• Shortness of breath, difficulty breathing when lying down, swelling of the feet and 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 due to blood clotting)
• Sudden onset of shortness of breath, 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)
• Severe decrease in urine production, swelling of the legs, confusion, back pain (signs of sudden kidney failure)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of severe allergic reactions, also known as hypersensitivity)

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

• Shortness of breath or rapid breathing (signs of acute respiratory distress syndrome)

If you experience any of these side effects, inform your doctor immediately, as they could be life-threatening.
Other possible side effects of Everolimus Ethypharm include:
Very common (may affect more than 1 in 10 users)

• High blood sugar levels (hyperglycaemia)
• Loss of appetite
• Altered sense of taste (dysgeusia)
• Headache
• Nosebleeds (epistaxis)
• Cough
• Mouth ulcers
• Stomach discomfort including nausea or diarrhoea
• Rash
• Itching
• Tiredness or weakness
• Tiredness, shortness of breath, dizziness, pale skin (signs of low red blood cell levels (anaemia))
• Swelling of the arms, hands, feet, ankles, or other parts of the body (signs of oedema)
• Weight loss
• High levels of lipids (fats) in the blood (hypercholesterolaemia)

Common (may affect up to 1 in 10 users)

• Spontaneous bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• Shortness of breath (dyspnoea)
• Thirst, low urine output, dark urine, dry and flushed skin, irritability (signs of dehydration)
• Difficulty sleeping (insomnia)
• Headache, dizziness (signs of high blood pressure, also known as hypertension)
• 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 lining of the mouth, stomach, and intestine
• Dry mouth
• Heartburn (dyspepsia)
• Feeling unwell (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 cycles
• High levels of lipids (fats) in the blood (hyperlipidaemia, increased triglycerides)
• Low potassium levels in the blood (hypokalaemia)
• Low phosphate levels in the blood (hypophosphataemia)
• Low calcium levels in the blood (hypocalcaemia)
• Dryness, peeling, and skin lesions
• Nail problems, nail breakage
• Mild hair loss
• Abnormal blood test results for liver function (increased alanine and aspartate aminotransferase)
• Abnormal blood test results for kidney function (increased creatinine)
• Eye discharge with itching, redness, and swelling
• Protein in the urine

Uncommon (may affect up to 1 in 100 users)

• 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)
• Need to urinate more often during the day
• Chest pain
• Problems with wound healing
• Hot flushes
• Red eyes (conjunctivitis)

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

• Tiredness, shortness of breath, dizziness, paleness (signs of low red blood cell count in the blood, possibly due to a type of anaemia called pure red cell aplasia)
• Swelling of the face, around the eyes, mouth, and inside the mouth and/or throat, as well as of the tongue, and difficulty breathing or swallowing (also known as angioedema), which may be signs of an allergic reaction

If these side effects worsen, inform your doctor and/or pharmacist. Most of the side effects are mild to moderate in severity and usually disappear if treatment is interrupted for a few days.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Everolimus Ethypharm

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. The expiry date refers to the last day of that month.
2.5 mg: Do not store above 25°C.
5 mg and 10 mg: This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light and moisture.
Open the blister pack only when it is time to take the tablets.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Everolimus Ethypharm contains
The active substance is everolimus.

• Each 2.5 mg tablet of Everolimus Ethypharm contains 2.5 mg of everolimus.
• Each 5 mg tablet of Everolimus Ethypharm contains 5 mg of everolimus.
• Each 10 mg tablet of Everolimus Ethypharm contains 10 mg of everolimus.

The other components are butylhydroxytoluene (E321), hypromellose, lactose monohydrate, crospovidone,
lactose and magnesium stearate.
Description of the appearance of Everolimus Ethypharm and the contents of the pack
Everolimus Ethypharm 2.5 mg tablets are white to almost white, oval-shaped tablets measuring
9.6 x 4.5 mm. They are marked with "E" on one side and "2.5" on the other side.
Everolimus Ethypharm 5 mg tablets are white to almost white, oval-shaped tablets measuring
12.5 x 5.0 mm. They are marked with "E" on one side and "5" on the other side.
Everolimus Ethypharm 10 mg tablets are white to almost white, oval-shaped tablets measuring
16.0 x 6.5 mm. They are marked with "E" on one side and "10" on the other side.
Everolimus Ethypharm 2.5 mg is available in packs containing 30 or 90 tablets.
Everolimus Ethypharm 5 mg and Everolimus Ethypharm 10 mg are available in packs containing
10, 30 or 90 tablets.
It is possible that not all pack sizes or strengths are marketed.
Marketing Authorization Holder
Ethypharm
194 Bureaux de la Colline – Bâtiment D
92213 Saint-Cloud cedex
France
Manufacturer:
Ethypharm
Chemin de la Poudrière
76120 Le Grand Quevilly
France
Ethypharm
Z.I. de Saint Arnoult
28170 Châteauneuf en Thymerais
France
This medicinal product is authorized in the European Economic Area countries under the
following names:
Sweden: Everolimus Ethypharm
Germany: Everolimus Ethypharm 2.5 mg, 5 mg, 10 mg, tabletten
Italy: Everolimus Ethypharm
Spain: Everolimus Ethypharm 2.5 mg, 5 mg, 10 mg, comprimidos
United Kingdom: Everolimus Ethypharm 2.5 mg, 5 mg, 10 mg, tablets
More detailed information on this medicinal product is available on the AIFA website.