Afinitor 5 mg tablets

Afinitor is an anticancer medicine containing the active substance everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.

Afinitor is used to treat advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called ?VEGF-targeted therapy?) have not helped stop your disease.

Afinitor will only be prescribed for you by a doctor with experience in cancer treatment. Follow all the doctor?s instructions carefully. They may differ from the general information contained in this leaflet. If you have any questions about Afinitor or why it has been prescribed for you, ask your doctor.

Do not take Afinitor

• if you are allergic (hypersensitive) to everolimus, to related substances such as sirolimus or temsirolimus, or to any of the other ingredients of Afinitor (listed in section 6 ?What Afinitor contains?). If you think you may be allergic, ask your doctor for advice.

Take special care with Afinitor

Please tell your doctor before taking Afinitor:

• if you have any problems with your liver or if you have ever had any disease which may have affected your liver. If this is the case, your doctor may need to prescribe a different dose of Afinitor.
• if you have diabetes (high level of sugar in your blood). Afinitor may increase blood sugar levels and worsen diabetes mellitus. This may result in the need for insulin and/or oral antidiabetic agent therapy. Tell your doctor if you experience any excessive thirst or increased frequency of urination.
• if you need to receive a vaccine while taking Afinitor.
• if you have high cholesterol. Afinitor may elevate cholesterol and/or other blood fats.
• if you have had recent major surgery, or if you still have an unhealed wound following surgery. Afinitor may increase the risk of problems with wound healing.
• if you have an infection. It may be necessary to treat your infection before starting Afinitor.
• if you have previously had hepatitis B, because this may be reactivated during treatment with Afinitor (see section 4 Possible side effects).

Afinitor may also:

• weaken your immune system. Therefore, you may be at risk of getting an infection while you are taking Afinitor.
• cause shortness of breath, cough and fever. Tell your doctor if you experience these symptoms.

Afinitor is not to be used in children or adolescents (age below 18 years).

You will have regular blood tests during treatment. These will check the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Afinitor is having an unwanted effect on these cells. Blood tests will also be carried out to check your kidney function (level of creatinine) and liver function (level of transaminases) and your blood sugar and cholesterol levels. This is because these can also be affected by Afinitor.

Taking other medicines
Afinitor may affect the way some other medicines work. If you are taking other medicines at the same time as Afinitor, your doctor may need to change the dose of Afinitor or the other medicines.

Please tell your doctor or pharmacist if you are taking, have recently taken or before you start any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking medicines containing any of the following active substances:
The following 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, efavirenz or nevirapine, used to treat HIV infection/AIDS.
• verapamil or diltiazem, used to treat heart conditions or high blood pressure. The following may reduce the effectiveness of Afinitor:
• rifampicin, used to treat tuberculosis (TB).
• St. John?s wort ( Hypericum perforatum), a herbal product used to treat depression and other conditions.
• phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or fits. These medicines should be avoided during your treatment with Afinitor. If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Afinitor.

Taking Afinitor with food and drink

You should take Afinitor at the same time every day, consistently either with or without food. Avoid grapefruit and grapefruit juice while you are on Afinitor.

Pregnancy and breast-feeding

Afinitor could harm an unborn baby or a breast-fed baby.

Afinitor is not recommended during pregnancy. Tell your doctor if you are pregnant or think that you may be pregnant. Your doctor will discuss with you whether you should take Afinitor during your pregnancy.

Women who could potentially become pregnant should use effective contraception during treatment with Afinitor. If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Afinitor.

You should not breast-feed during treatment with Afinitor. Tell your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Male fertility

Afinitor may affect male fertility. Talk to your doctor if you may wish to father a child.

Driving and using machines

If you feel unusually tired (fatigue is a very common side effect), take special care when driving or using machines.

Important information about some of the ingredients of Afinitor

Afinitor contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Afinitor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is 10 mg, taken once a day. Your doctor will tell you how many tablets of Afinitor to take.

If you have liver problems, your doctor may start you on a lower dose of Afinitor (5 mg per day).

If you experience certain side effects (see section 4) while you are taking Afinitor, your doctor may lower your dose or stop treatment, either for a short time or permanently.

Take Afinitor once a day, at about the same time every day, consistently either 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 too much Afinitor, or if someone else accidentally takes your tablets, see a doctor or go to a hospital immediately. Urgent treatment may be necessary.
• Take the carton and this leaflet, so that the doctor knows what has been taken.

If you forget to take Afinitor

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

If you stop taking Afinitor

Do not stop taking Afinitor unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Afinitor can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data.

Tell your doctor immediately if you experience any serious side effects:

• Lung or breathing problems (very common): new or worsening symptoms, such as cough or shortness of breath.
• Infections (very common) including chest infections, serious infections that are commonly known as blood poisoning and infections that are usually only seen in patients with organ transplants such as fungal infections, with symptoms such as fever, chills or other signs of infection.
• Swelling mainly of the face and throat, causing difficulty in breathing (symptoms of an allergic reaction). You might need urgent treatment.

Other side effects of Afinitor include:

Very common side effects

• Mouth ulcers, pain or discomfort or open sores. Tell your doctor if you experience any of these, since you might need treatment with a mouthwash or gel. Some mouthwashes and gels can make ulcers worse, so always check with your doctor before trying anything.
• Swelling of your arms, hands, feet, ankles or other parts of your body (signs of oedema)
• Feeling sick (nausea), vomiting, diarrhoea, loss of appetite, disturbance of sense of taste
• Feeling weak or tired
• Rash, dry skin, itching
• Nose bleeds
• Decreased number of white cells in the blood, which may increase your risk of infection
• Decreased haemoglobin
• Decreased number of certain cells in the blood that help the blood to clot
• High blood sugar
• High cholesterol and other blood fats

Common side effects

• Rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome), skin exfoliation, breaking of your nails and nail discolouration, redness of the skin, pimples and/or acne
• Dry mouth
• Fever
• Weight loss
• Heartburn or indigestion (dyspepsia), difficulty in swallowing, chest pain, stomach ache
• Headache, trouble sleeping (insomnia)
• High blood pressure (hypertension)
• Dehydration
• Discharge from the eye with itching, redness and swelling
• Coughing up blood

Uncommon side effects

• Loss of sense of taste
• Symptoms of heart failure such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
• New onset of diabetes mellitus
• Problems with wound healing

Hepatitis B reactivation has been observed in some patients taking Afinitor. Tell your doctor if you experience symptoms of hepatitis B during treatment with Afinitor. The first symptoms may include fever, skin rash, joint pain and inflammation. Other symptoms may include fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), and pain in the upper right abdomen. Pale stools or dark urine may also be signs of hepatitis.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use Afinitor after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light and moisture.
• Do not use any pack that is damaged or shows signs of tampering.

What Afinitor contains

• The active substance is everolimus.
• Each tablet of Afinitor 5 mg contains 5 mg everolimus.
• Each tablet of Afinitor 10 mg contains 10 mg everolimus.
• The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.

What Afinitor looks like and contents of the pack

Afinitor 5 mg tablets are white to slightly yellowish, elongated tablets. They are engraved with ?5? on one side and ?NVR? on the other.
Afinitor 10 mg tablets are white to slightly yellowish, elongated tablets. They are engraved with ?UHE? on one side and ?NVR? on the other.

Afinitor is available in packs containing 10, 30, 60 or 90 tablets. Not all pack sizes or strengths may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S.Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

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 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in