AFINITOR 5 mg Film-Coated Tablets

Зміст інструкції

1. Afinitor 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is Afinitor and what it is used for
   2. What you need to know before you take Afinitor
   3. How to take Afinitor
   4. Possible side effects
   5. How to store Afinitor
   6. Package contents and other information

Afinitor 2.5 mg tablets, 5 mg tablets, 10 mg tablets

everolimus

Read this leaflet carefully before 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 Afinitor is and what it is used for
• 2. What you need to know before you take Afinitor
• 3. How to take Afinitor
• 4. Possible side effects
• 5. How to store Afinitor
• 6. Contents of the pack and other information

1. What is Afinitor and what it is used for

Afinitor 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.
Afinitor is used to treat adult patients with:

• advanced breast cancer with hormone receptor-positive 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.
• advanced tumors called neuroendocrine tumors that originate from the stomach, intestine, lung or pancreas. It is used if the tumors are inoperable and do not overproduce specific hormones or other related natural substances.
• 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 you take Afinitor

Afinitor will only be prescribed to you by a doctor experienced in the treatment of cancer. Follow the doctor's instructions carefully
and all instructions from the doctor. These instructions may differ from the general information
prescribed, consult your doctor.

Do not take Afinitor

• 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 Afinitor:

• 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 Afinitor.
• if you have diabetes (high blood sugar levels). Afinitor may increase blood sugar levels and worsen diabetes mellitus. This may require the use of insulin and/or therapy with 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 Afinitor.
• if you have high cholesterol levels. Afinitor 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. Afinitor may increase the risk of problems related to wound healing.
• if you have an infection. The infection may need to be treated before starting Afinitor.
• if you have previously had hepatitis B, because it may reactivate during treatment with Afinitor (see section 4 ‘Possible side effects’).
• if you have received or are about to receive radiotherapy.

Afinitor may also:

• weaken the immune system. Therefore, you may be exposed to the risk of contracting an infection during treatment with Afinitor. If you have a fever or other signs of an infection, consult your doctor. Some infections can be serious and can be fatal.
• impair kidney function. Therefore, your doctor will check your kidney function during treatment with Afinitor.
• 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 Afinitor. Treatment with a mouthwash, gel or other products may be necessary. Some mouthwashes and gels may worsen ulcers, so do not try anything without first consulting your doctor. Your doctor may resume treatment with Afinitor at the same dose or at a lower dose.
• cause complications from radiotherapy. Serious reactions to radiation (such as shortness of breath, nausea, diarrhea, skin rashes, and irritation of the mouth, gums, and throat), including fatal cases, have been observed in some patients who were taking everolimus at the same time as radiotherapy or who were taking everolimus shortly after radiotherapy. In addition, so-called radiation recall syndrome (including skin redness or lung inflammation at the site of previous radiotherapy) has been reported in patients who have undergone radiotherapy in the past. Tell your doctor if you are planning to receive radiotherapy in the near future or have received radiotherapy in the past.

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
Afinitor 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 may also be affected
by Afinitor.

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

Other medicines and Afinitor
Afinitor can affect the action of some medicines. If you are taking other medicines at the same
time as you are taking Afinitor, your doctor may need to adjust the dose of
Afinitor or the other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The following substances may increase the risk of side effects with Afinitor:

• 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 organ rejection by the body.
• 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.
• cannabidiol (uses include, also, the treatment of seizures).

The following substances may reduce the effectiveness of Afinitor:

• 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 must be avoided during treatment with Afinitor. If you are taking any of these
medicines, your doctor may prescribe different medicines, or may change your dose
of Afinitor.

Afinitor with food and drink
Avoid grapefruit and grapefruit juice while you are being treated with Afinitor. This may increase
the amount of Afinitor in the blood, possibly to harmful levels.

Pregnancy, breastfeeding and fertility
Pregnancy
Afinitor can 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 beforetaking Afinitor again.
Breastfeeding
Afinitor can harm the infant. You must not breastfeed during treatment and for
2 weeks after the last dose of Afinitor. Tell your doctor if you are breastfeeding.
Female fertility
Menstrual cycle disturbances (amenorrhea) have been observed in some patients treated with Afinitor.
Afinitor may affect female fertility. Tell your doctor if you want to become pregnant.
Male fertility
Afinitor 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
especially careful when driving vehicles or using machines.

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

3. How to take Afinitor

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 10 mg, taken once a day. Your doctor will tell you how many Afinitor
tablets you will need to take.
If you have liver problems, your doctor may prescribe you a lower dose of Afinitor (2.5, 5, or
7.5 mg/day).
If certain undesirable events occur while you are taking Afinitor (see section 4), your
doctor may reduce your dose or interrupt the treatment for a short period of time or
permanently.
Take Afinitor once a day, about 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 Afinitor than you should

• If you have taken more Afinitor 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 Afinitor
If you forget to take a dose, take the next dose as scheduled. Do not take a
double dose to make up for missed tablets.

If you stop taking Afinitor
Do not stop treatment with Afinitor unless your doctor tells you to do so.
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 everyone will experience them.
STOP treatment with Afinitor 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 skin rash or skin swellings

Serious side effects of Afinitor 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 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 people)

• Fever, rash, joint pain and inflammation, as well as fatigue, loss of appetite, 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 Afinitor 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 disorders 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 production, dark urine, dry and flushed skin, irritability (signs of dehydration)
• Difficulty sleeping (insomnia)
• Headache, dizziness (signs of high blood pressure, also known as hypertension)
• Swelling of part or all of the arm (including the fingers) or leg (including the toes), feeling of heaviness, limited movement, discomfort (possible symptoms of lymphoedema)
• 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)
• Redness of the skin (erythema)
• Joint pain
• Pain in the mouth
• Menstrual disorders such as irregular periods
• 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, scaling 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)
• Swelling of the eyelids
• 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 blood cells, 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 1000)

• Fatigue, shortness of breath, dizziness, pale skin (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

Not known(the frequency cannot be estimated from the available data)

• Reaction in the site of previous radiotherapy, e.g. skin redness or lung inflammation (so-called radiation recall syndrome)
• Increased side effects of radiation treatment

If these side effects worsen tell your doctor and/or pharmacist. most
side effects are mild or moderate in intensity and usually disappear if the treatment
is interrupted 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 listed in Annex V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Afinitor

• 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.
• Do not store at a temperature above 25°C.
• Store in the original package to protect the medicine from light and moisture.
• Open the blister only at the time of taking 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 Afinitor contains

• The active ingredient is everolimus.
• Each Afinitor 2.5 mg tablet contains 2.5 mg everolimus.
• Each Afinitor 5 mg tablet contains 5 mg everolimus.
• Each Afinitor 10 mg tablet contains 10 mg everolimus.
• The other ingredients are butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and anhydrous lactose.

Description of the appearance of Afinitor and package contents
Afinitor 2.5 mg tablets are off-white to pale yellow, elongated tablets. They are imprinted
“LCL” on one side and “NVR” on the other.
Afinitor 5 mg tablets are off-white to pale yellow, elongated tablets. They are imprinted
“5” on one side and “NVR” on the other.
Afinitor 10 mg tablets are off-white to pale yellow, elongated tablets. They are imprinted
“UHE” on one side and “NVR” on the other.
Afinitor 2.5 mg is available in blister packs containing 30 or 90 tablets.
Afinitor 5 mg and Afinitor 10 mg are available in blister packs containing 10, 30 or
90 tablets.
Not all pack sizes or strengths may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 555

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu