EVEROLIMUS 5 mg Coated Tablet

Зміст інструкції

1. Everolimus Sandoz GmbH 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is Everolimus Sandoz GmbH and what is it used for
   2. What you need to know before taking Everolimus Sandoz GmbH
2. Everolimus Sandoz GmbH will only be prescribed to you by a doctor experienced in the treatment of
   1. How to take Everolimus Sandoz GmbH
   2. Possible side effects
   3. How to store Everolimus Sandoz GmbH
   4. Contents of the pack and other information

Everolimus Sandoz GmbH 2.5 mg tablets, 5 mg tablets, 10 mg tablets

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

1. What is Everolimus Sandoz GmbH and what is it used for

Everolimus Sandoz GmbH is an antineoplastic medicine containing the active substance
called everolimus. Everolimus reduces the blood supply to the tumor and slows the growth
and spread of cancer cells.
Everolimus Sandoz GmbH is used to treat adult patients with:
advanced breast cancer with 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 antineoplastic hormonal therapy.
advanced tumors called neuroendocrine tumors that originate from the
stomach, intestine, lung or pancreas. It is used if the tumors are
unresectable and do not overproduce specific hormones or other natural
substances correlated.
advanced kidney cancer (advanced renal carcinoma) where other treatments
(defined as “anti-VEGF targeted therapies”) have not been helpful in stopping it

2. What you need to know before taking Everolimus Sandoz GmbH

Everolimus Sandoz GmbH will only be prescribed to you by a doctor experienced in the treatment of

cancer. Follow all the doctor's instructions carefully. These instructions may be about questions on Everolimus Sandoz GmbH or why it has been prescribed for you, consult your doctor.

Do not take Everolimus Sandoz GmbH
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 Sandoz GmbH:
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 Sandoz GmbH.
if you have diabetes (high blood sugar levels). Everolimus Sandoz GmbH 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 Sandoz
GmbH.
if you have high cholesterol levels. Everolimus Sandoz GmbH may raise levels of
cholesterol and/or other fats in the blood.
if you have recently had surgery, or if you have a wound that has not yet
healed following surgery. Everolimus Sandoz GmbH may
increase the risk of problems related to wound healing.
if you have an infection. It may be necessary to treat the infection before starting
Everolimus Sandoz GmbH.
if you have previously had hepatitis B, because it may reactivate during
treatment with Everolimus Sandoz GmbH (see section 4 ‘Possible side
effects’).
Everolimus Sandoz GmbH may also:
weaken the immune system. Therefore, you may be at risk of
contracting an infection during treatment with Everolimus Sandoz GmbH. If you have
fever or other signs of an infection, see your doctor. Some infections may be
serious and life-threatening.
affect kidney function. Therefore, your doctor will check your kidney function during treatment with Everolimus Sandoz GmbH.
cause shortness of breath, cough and fever.
cause mouth ulcers and the development of sores. Your doctor may need to
interrupt or suspend treatment with Everolimus Sandoz GmbH. You may
need treatment with a 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 resume treatment with Everolimus
Sandoz GmbH at the same dose or at a lower dose.

Tell your doctorif 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 Sandoz GmbH has an undesirable effect on these
cells. You will also have blood tests to check your kidney function
(creatinine level) and liver function (transaminase levels) and blood glucose and cholesterol levels. These levels can also be affected by Everolimus
Sandoz GmbH.

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

Other medicines and Everolimus Sandoz GmbH
Everolimus Sandoz GmbH can affect the action of some medicines. If you are taking
other medicines at the same time as Everolimus Sandoz GmbH, your
doctor may need to change the dose of Everolimus Sandoz GmbH or of
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
Sandoz GmbH:
ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungals used for the
treatment of fungal infections.
clarithromycin, telithromycin or erythromycin, antibiotics used for the treatment of
bacterial infections.
ritonavir and other medicines used for the treatment of HIV/AIDS.
verapamil or diltiazem used for the treatment of heart conditions or
high blood pressure.
dronedarone, used to help regulate the heartbeat.
cyclosporine, a medicine used to prevent organ rejection by the body
after transplantation.
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.
nefazodone, used in the treatment of depression.
The following substances may reduce the effectiveness of Everolimus Sandoz GmbH:
rifampicin, used for the treatment of tuberculosis (TB).
efavirenz or nevirapine, used for the treatment of HIV/AIDS.
St John's wort ( Hypericum perforatum), a herbal product used for
the treatment of 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 Sandoz
GmbH. If you are taking any of these medicines, your doctor may prescribe
different medicines, or may change your dose of Everolimus Sandoz GmbH.

Everolimus Sandoz GmbH with food and drink
Avoid grapefruit and grapefruit juice while being treated with Everolimus Sandoz
GmbH.

Pregnancy, breastfeeding and fertility
Pregnancy
Everolimus Sandoz GmbH 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 must use highly effective contraception during treatment and for 8 weeks after the end of treatment.
If, despite these measures, you suspect you are pregnant, ask your doctor for advice before
taking Everolimus Sandoz GmbH again.
Breastfeeding
Everolimus Sandoz GmbH may harm the infant. Do not breastfeed during
treatment and for 2 weeks after the last dose of Everolimus Sandoz GmbH. Tell your
doctor if you are breastfeeding.
Female fertility
Menstrual cycle disturbances (amenorrhoea) have been observed in some patients treated with Everolimus Sandoz GmbH.
Everolimus Sandoz GmbH may have an impact on female fertility. Tell your doctor if
you want to become pregnant.
Male fertility
Everolimus Sandoz GmbH may affect male fertility. Talk to your doctor if
you wish 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 or using machines.

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

3. How to take Everolimus Sandoz GmbH

Take this medicine following exactly the instructions of your doctor or pharmacist. 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
tablets of Everolimus Sandoz GmbH you will need to take.
If you have liver problems, your doctor may prescribe you a lower dose of Everolimus
Sandoz GmbH (2.5, 5, or 7.5 mg/day).
If certain undesirable events occur while you are taking Everolimus Sandoz GmbH
(see section 4), your doctor may reduce your dose or interrupt treatment for a
short period of time or permanently.
Take Everolimus Sandoz GmbH once a day, 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 Sandoz GmbH than you should
If you have taken more Everolimus Sandoz GmbH than you should, or if someone else has
accidentally taken your tablets, contact a doctor or go to hospital
immediately. Emergency treatment may be necessary.

If you forget to take Everolimus Sandoz GmbH
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 Sandoz GmbH
Do not stop treatment with Everolimus Sandoz GmbH 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 Sandoz GmbH and seek immediate medical attention 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 swellings

Serious side effects of Everolimus Sandoz GmbH 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, pain and inflammation of the joints, 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 or 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 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 of
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 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 Sandoz GmbH 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
Nose bleeding (epistaxis)
Cough
Mouth ulcers
Stomach discomfort 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 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)
Redness of the skin (erythema)
Joint pain
Oral 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, 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 aminotransferase)
Altered results in blood tests for kidney function (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 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
Eye discharge with itching and redness, red eyes (conjunctivitis)

Rare(may affect up to 1 in 1,000)
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 and usually disappear if the
treatment is stopped for a few days.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 Sandoz GmbH

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 package and on the blister
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
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 you notice that 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. Contents of the pack and other information

What Everolimus Sandoz GmbH contains

• The active ingredient is everolimus.

Everolimus Sandoz GmbH 2.5 mg tablets

• Each tablet contains 2.5 mg of everolimus

Everolimus Sandoz GmbH 5 mg tablets

• Each tablet contains 5 mg of everolimus

Everolimus Sandoz GmbH 10 mg tablets

• Each tablet contains 10 mg of everolimus
• The other ingredients are: butylhydroxytoluene (E321), magnesium stearate, lactose, hypromellose, crospovidone Type A. See paragraph 2 “Everolimus Sandoz GmbH contains lactose”

Description of the appearance of Everolimus Sandoz GmbH and contents of the pack
Everolimus Sandoz GmbH 2.5 mg tablets
White-yellowish, elongated tablets, approximately 10.1 x 4.1 mm with a
bevelled edge and without a fracture line, with “LCL“ imprinted on one side and “NVR“ on the other.

Everolimus Sandoz GmbH 5 mg tablets
White-yellowish, elongated tablets, approximately 12.1 x 4.9 mm with a
bevelled edge and without a fracture line, with “5“ imprinted on one side and “NVR“ on the other.

Everolimus Sandoz GmbH 10 mg tablets
White-yellowish, elongated tablets, approximately 15.1 x 6.0 mm with a
bevelled edge and without a fracture line, with “UHE“ imprinted on one side and “NVR“ on the other.
The tablets are packaged in an Aluminium/polyamide/aluminium/PVC blister and
contained in a carton
Pack sizes
Blisters: 10, 30 or 90 tablets
Not all pack sizes or strengths may be marketed.

Marketing Authorisation Holder

Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria
Legal Representative in Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA),
Italy

Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Germany Everolimus - 1 A Pharma 2.5 mg Tablets
Everolimus - 1 A Pharma 5 mg Tablets
Everolimus - 1 A Pharma 10 mg Tablets
Italy Everolimus Sandoz GmbH
Netherlands Everolimus Sandoz 2.5 mg, tablets
Everolimus Sandoz 5 mg, tablets
Everolimus Sandoz 10 mg, tablets