EVEROLIMUS 2.5 mg Tabletki powlekane

Treść ulotki

1. Everolimus Ethypharm, 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is Everolimus Ethypharm 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. Package Contents and Other Information

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

everolimus

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Everolimus Ethypharm and what it is used for

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

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

2. What you need to know before taking Everolimus Ethypharm

Everolimus Ethypharm will only be prescribed to you by a doctor experienced in the treatment of cancer. Follow
the doctor's instructions carefully. These instructions may differ from the
Ethypharm or why it has been prescribed to you, consult your doctor.

Do not take Everolimus Ethypharm

• if you are allergicto 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, ask your doctor for advice.

Warnings and precautions
Talk to your doctor before taking Everolimus Ethypharm:

• if you have liver problems or have had any disease that may have affected the liver. If this is the case, your doctor may need to prescribe a different dose of Everolimus Ethypharm.
• if you have diabetes (high blood sugar levels). Everolimus Ethypharm may increase blood sugar levels and worsen diabetes mellitus. This may require the use of insulin and/or oral antidiabetic agents. Tell your doctor if you experience excessive thirst or increased frequency of urination.
• if you need to get a vaccine while taking Everolimus Ethypharm.
• if you have high cholesterol levels. Everolimus Ethypharm may raise cholesterol and/or other fat levels in the blood.
• if you have recently had surgery, or if you have a wound that has not yet healed following surgery. Everolimus Ethypharm may increase the risk of problems related to wound healing.
• if you have an infection. The infection may need to be treated before starting Everolimus Ethypharm.
• if you have previously had hepatitis B, because 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 risk of contracting an infection during treatment with Everolimus Ethypharm.
• impair kidney function. Therefore, your doctor will check your kidney function during treatment with Everolimus Ethypharm.
• cause shortness of breath, cough, and fever. Tell your doctor if you experience these symptoms. You will have regular blood tests during treatment. These tests will check the amount of blood cells in your body (white blood cells, red blood cells, and platelets) to see if Everolimus Ethypharm has an undesirable effect on these cells. You will also have blood tests to check kidney function (creatinine level) and liver function (transaminase levels) and blood sugar and cholesterol levels. These levels can also be affected by Everolimus Ethypharm.

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

Other medicines and Everolimus Ethypharm
Everolimus Ethypharm can affect the action of some medicines. If you are taking other
medicines at the same time as you are taking Everolimus Ethypharm, your doctor may
need to change the dose of Everolimus Ethypharm or the other medicines.
Tell 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, or fluconazole and other antifungals 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 the heartbeat.
• cyclosporine, a medicine used to prevent the body from rejecting 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 problems.
• phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to block seizures.

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

Everolimus Ethypharm with food and drink
You should 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, breastfeeding and fertility
Pregnancy
Everolimus Ethypharm may harm the fetus and is not recommended during pregnancy. Tell
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 should use highly effective contraception during treatment.
If, despite these measures, you suspect you are pregnant, ask your doctor beforetaking Everolimus Ethypharm.
Breastfeeding
Everolimus Ethypharm may harm the infant. Do not breastfeed during treatment and
for 2 weeks after the last dose of Everolimus Ethypharm. Tell your doctor if you are breastfeeding.
Female fertility
Menstrual cycle irregularities (amenorrhea) have been observed in some patients treated with Everolimus Ethypharm.
Everolimus Ethypharm may have an impact on female fertility. Tell your doctor if you want to become
pregnant.
Male fertility
Everolimus Ethypharm may affect male fertility. Talk to your doctor if you want to
become a father.

Driving and using machines
If you feel unusually tired (fatigue is a very common side effect), be
particularly careful when driving vehicles or using machines.

Everolimus Ethypharm contains lactose
Everolimus Ethypharm contains lactose (milk sugar). If your doctor has diagnosed you with
lactose intolerance, contact him/her 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, ask your doctor or pharmacist.
The recommended dose is 10 mg, taken once a day. Your doctor will tell you how many Everolimus Ethypharm tablets you will need to 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 undesirable effects occur while you are taking Everolimus Ethypharm (see section 4), your doctor may reduce your dose or interrupt treatment for a short period of time or permanently.
Take Everolimus Ethypharm once a day, about 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 necessary.

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 a missed dose.

If you stop taking Everolimus Ethypharm
Do not stop taking Everolimus Ethypharm 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Everolimus Ethypharm and see 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 a red rash or skin bumps

Serious side effects of Everolimus Ethypharm 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 pneumonia)

Common(may affect up to 1 in 10 people )

• Excessive thirst, high urine output, 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 people )

• Fever, rash, joint pain and inflammation, as well as fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right side of the abdomen, pale stools, dark urine (may be signs of hepatitis B reactivation)
• 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 a blocked blood vessel (vein) in the legs caused by blood clotting)
• Sudden 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, feeling confused, back pain (signs of sudden kidney failure)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of severe allergic reactions, also called hypersensitivity)

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

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

If any of these side effects occur, tell your doctor immediately, as this could be life-threatening.

Other possible side effects of Everolimus Ethypharm include:
Very common(may affect more than 1 in 10 people )

• High blood sugar levels (hyperglycaemia)
• Loss of appetite
• Altered sense of taste (dysgeusia)
• Headache
• Nosebleed (epistaxis)
• Cough
• Mouth ulcers
• Stomach problems including feeling unwell (nausea) or diarrhoea
• Rash
• Itching
• Fatigue or weakness
• Fatigue, shortness of breath, dizziness, pale skin, signs of low red blood cells (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 people )
• Spontaneous bleeding or bruising (signs of a low level of platelets, 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 caused by infections (signs of a low level of white blood cells, leucopenia, lymphopenia and/or neutropenia)
• Fever
• Inflammation of the lining of the mouth, stomach and intestines
• Dry mouth
• Heartburn (dyspepsia)
• Feeling sick (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
• Pain in the mouth
• Menstrual disorders such as irregular periods
• High levels of lipids (fats) in the blood (hyperlipidemia, increased triglycerides)
• Low level of potassium in the blood (hypokalaemia)
• Low level of phosphates in the blood (hypophosphataemia)
• Low level of calcium in the blood (hypocalcaemia)
• Dryness, flaking and lesions of the skin
• Nail problems, nail breakage
• Mild hair loss
• Altered results in blood tests for liver function (increased alanine and aspartate aminotransferases)
• Altered results in blood tests for kidney function (increased creatinine)
• Eye discharge with itching, redness and swelling
• Protein in the urine

Uncommon(may affect up to 1 in 100 )

• Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever, chills, sore throat or mouth ulcers (signs of a low level of cells in the blood, 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 1000)

• Fatigue, shortness of breath, dizziness, paleness (signs of a low level of red blood cells 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 the tongue and difficulty breathing or swallowing (also known as angioedema), may be signs of an allergic reaction

If these side effects worsen, tell your doctor and/or pharmacist. most side effects are mild or moderate in intensity and usually disappear if treatment is stopped for a few days.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at
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 which is stated on the carton and blister. The expiry date refers to the last day of that month.

• 2.5 mg: Do not store at a temperature above 25°C. 5 mg and 10 mg: This medicine does not require any particular storage temperature. Store in the original package to protect the medicine from light and moisture.

Only open the blister when you are ready to take the tablets.
Do not use this medicine if the package is damaged or shows signs of tampering.
Do not dispose of any medicine in 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 ingredient is everolimus.

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

The other ingredients are butylhydroxytoluene (E321), hypromellose, lactose monohydrate, crospovidone,
lactose and magnesium stearate.

Description of the appearance of Everolimus Ethypharm and package contents
Everolimus Ethypharm 2.5 mg tablets are oblong tablets of white to almost white color

• 9.6 x 4.5 mm. They have "E" imprinted on one side and "2.5" on the other side.

Everolimus Ethypharm 5 mg tablets are oblong tablets of white to almost white color ,

• 12.5 x 5.0 mm. They have "E" imprinted on one side and "5" on the other side.

Everolimus Ethypharm 10 mg tablets are oblong tablets of white to almost white color
, 16.0 x 6.5 mm. They have "E" imprinted 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.
Not all pack sizes or strengths may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Sweden: Everolimus Ethypharm
Germany: Everolimus Ethypharm 2.5 mg, 5 mg, 10 mg, tablets
Italy: Everolimus Ethypharm
Spain: Everolimus Ethypharm 2.5 mg, 5 mg, 10 mg, tablets
United Kingdom: Everolimus Ethypharm 2.5 mg, 5 mg, 10 mg, tablets
More detailed information on this medicine is available on the AIFA website.