Novartis

Tablet 2.5 mg 
(white to yellowish, oblong tablets approximately 10.1 mm long and 4.1 mm wide, with beveled edges and without a notch, embossed with “LCL” on one side and “NVR” on the other )

Read all of this leaflet carefully before you start taking this medicine. The

  • contains information that is important to you.
  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What the medicine is and what it is used for 
2. What you need to know before taking Afinitor 
3. How to take Afinitor 
4. Possible side effects 
5. How to store the medicine 
6. Contents of the packaging and other information 

1. What the medicine is and what it is used for

Afinitor is a cancer drug that contains the active substance everolimus. Everolimus reduces the blood supply to the tumor and delays the growth and spread of cancer cells.

Afinitor is used to treat adults with:

  • hormone-receptor-positive advanced breast cancer in postmenopausal women, when other treatments (so-called “non-steroidal aromatase inhibitors”) no longer keep the disease under control. It is given together with a drug called exemestane, a steroidal aromatase inhibitor, which is used as a hormone treatment for cancer.
  • Advanced tumors are called neuroendocrine tumors and come from the stomach, intestines, lungs, or pancreas. It is given if the tumors cannot be operated on and if they do not overproduce specific hormones or other related natural substances.
  • advanced renal cancer (kidney cell carcinoma) when other treatments (so-called “VEGF inhibitors”) have not helped to stop the disease.

2. What you need to know before you take Afinitor

Do not use this medicine

Afinitor is only prescribed by a doctor who has experience in cancer treatment. Follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet. If you have any further questions on the use of Afinitor or why you have been prescribed it, ask your doctor.

Do not take Afinitor

  • if you are allergic to everolimus or related substances, such as sirolimus or temsirolimus, or 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 cautions

Talk to your doctor before taking Afinitor

  • if you have liver problems or if you have ever had a disease that may have affected your liver. In this case, your doctor may need to prescribe another dose of Afinitor.
  • if you have diabetes (high blood sugar). Afinitor may increase blood sugar levels and worsen diabetes mellitus. This may result in the need for insulin and/or oral diabetes medicine. Tell your doctor if you experience any abnormal thirst or that you need to urinate more often.
  • if you need to be vaccinated while you are being treated with Afinitor.
  • if you have high cholesterol. Afinitor may increase cholesterol and/or other blood fats.
  • if you have recently undergone major surgery, or if you still have an unhealed wound after surgery. Afinitor may increase the risk of wound healing problems.
  • if you have an infection. It may be necessary to treat infection one before starting treatment with Afinitor.
  • if you have previously had hepatitis B, as infection may recur during treatment with Afinitor (see section 4 “Possible side effects”).

Afinitor can also:

  • weaken your immune system. There is therefore a risk that you will get an infection while taking Afinitor. If you get a fever or other signs of an infection, talk to your doctor. Some infections can be severe and can lead to death.
  • affect renal function. Therefore, your doctor will check your kidney function while you are taking Afinitor.
  • cause shortness of breath, cough, and fever.
  • cause sores in the mouth to occur. Your doctor may need to stop or stop taking Afinitor. You may need to use a mouthwash, gel, or other product. Some mouthwashes and gels can aggravate sores in the mouth, so do not try anything without first consulting a doctor. Your doctor may resume treatment with Afinitor at the same or lower dose.

Tell your doctor if you experience these symptoms.

Blood samples will be taken from you regularly during treatment. Using these, you can check the number of blood cells in your body ( white blood cells, red blood cells, and platelets ) and see if Afinitor has any unwanted effect on these cells. Blood samples are also taken to check your kidney function (creatinine value), liver function (transaminase value), and blood sugar and cholesterol levels. This is because these can also be affected by Afinitor.

Children and young people

Afinitor should not be given to children or adolescents (under 18 years of age).

Use of 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 one of Afinitor or the other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following may increase the risk of side effects with Afinitor:

  • ketoconazole, itraconazole, voriconazole or fluconazole, and other medicines used to treat fungal infections
  • clarithromycin, telithromycin, or erythromycin – antibiotics used to treat bacterial infections
  • ritonavir, and other medicines used to treat HIV infection / AIDS
  • verapamil or diltiazem is used to treat heart conditions or high blood pressure
  • dronedarone, a drug that regulates heart rhythm
  • cyclosporine, a drug used to prevent the body from rejecting transplanted organs
  • imatinib, a drug that inhibits the growth of tumor cells
  • ACE inhibitors (eg ramipril), used to treat high blood pressure and other cardiovascular diseases.
  • nefazodone, which is used to treat depression.

The following may reduce the effectiveness of Afinitor:

  • rifampicin – used to treat tuberculosis ( TB )
  • efavirenz or nevirapine used to treat HIV infection / AIDS
  • St. John’s wort (Hypericum perforatum), a traditional herbal medicine used to treat mild depression and other conditions
  • dexamethasone, a corticosteroid used to treat several conditions, including inflammation and immune disorders
  • phenytoin, carbamazepine or phenobarbital and other antiepileptic drugs – used to stop seizures or seizures

These medicines should be avoided during treatment with Afinitor. If you are taking any of these medicines, your doctor may switch you to another medicine or change the dose of Afinitor.

Afinitor with food and drink

Avoid grapefruit and grapefruit juice while you are being treated with Afinitor.

Pregnancy, breastfeeding, and fertility

Pregnancy

Afinitor can have harmful effects on the fetus and is not recommended during pregnancy. Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will discuss whether you should take this medicine during pregnancy.

Women who could become pregnant should use a very effective method of contraception during treatment and up to 8 weeks after the end of treatment. If, despite these measures, you think you may be pregnant, talk to your doctor before taking any more Afinitor.

Breast-feeding

Afinitor can have harmful effects on breastfed babies. You should not breast-feed during treatment and up to 2 weeks after the last dose of Afinitor. Tell your doctor if you are breast-feeding.

Female fertility

Missed menstruation ( amenorrhea ) has occurred in some women who have used Afinitor.

Afinitor may affect female fertility. Talk to your doctor if you wish 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 or using machines.

Afinitor contains lactose

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.

3. How to take Afinitor

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 10 mg once daily. Your doctor will tell you how many tablets of Afinitor to take.

If you have liver problems, your doctor may give you a lower dose of Afinitor (2.5, 5, or 7.5 mg daily) at the beginning of treatment.

If you experience any special side effects while taking Afinitor (see section 4), your doctor may reduce your dose or discontinue treatment, either for a short time or permanently.

Take Afinitor once daily, at about the same time each day, consistently with or without food.

Swallow the tablets whole with a glass of water. Do not chew or crush the tablets.

If you take more Afinitor than you should

  • If you take more Afinitor than you should, or if someone else accidentally takes your tablets, contact a doctor or hospital immediately. Urgent medical treatment may be necessary.
  • Bring the tablet pack and this leaflet so that your doctor knows what you have taken.

If you forget to take Afinitor

If you miss a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten tablet.

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.

4. Possible side effects

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

STOP taking Afinitor and seek medical help 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 (signs of angioedema )
  • severe skin itching with red or raised rash.

Serious side effects of Afinitor can be:

Very common (may affect more than 1 in 10 people)

  • fever, chills (signs of infection )
  • fever, cough, difficulty breathing, wheezing (signs of pneumonia, pneumonitis ).

Common (may affect up to 1 in 10 people)

  • pronounced thirst, large urine production, increased appetite with weight loss, fatigue (signs of diabetes )
  • bleeding, eg in the intestinal wall
  • sharply reduced urine production (signs of renal 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 (yellowish 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 lying down, swollen feet or legs (signs of heart failure )
  • swelling and/or pain in one of the legs, usually in the calf, redness or hot skin in the affected area (signs of a blood clot in a blood vessel (vein) in the legs)
  • sudden shortness of breath, chest pain, or bloody cough (possible signs of pulmonary embolism, a condition that occurs when one or more arteries in the lungs are blocked)
  • sharply reduced urine output, swelling of the legs, confusion, back pain (signs of sudden renal failure )
  • skin rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of a severe allergic reaction or so-called hypersensitivity reaction ).

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

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

If you get any of these side effects, talk to your doctor immediately as they can have life-threatening consequences.

Other possible side effects of Afinitor may be:

Very common (may affect more than 1 in 10 people)

  • high blood sugar levels (hyperglycemia)
  • decreased appetite
  • taste change
  • headache
  • nosebleeds
  • cough
  • cold sores
  • upset stomach including nausea or diarrhea
  • rash
  • itching
  • feeling weak or tired
  • fatigue, shortness of breath, dizziness, pale skin (signs of low red blood cell count, anemia )
  • swollen arms, hands, feet, ankles, or another body part (signs of edema )
  • weight loss
  • elevated blood fats ( hypercholesterolemia ).

Common (may affect up to 1 in 10 people)

  • spontaneous bleeding or bruising (signs of low platelet count ie thrombocytopenia )
  • shortness of breath ( dyspnoea )
  • thirst, low urine output, dark urine, dry skin, redness, irritability (signs of dehydration)
  • difficulty sleeping
  • headache, dizziness (signs of high blood pressure )
  • fever, sore throat, cold sores due to infection (signs of low white blood cell count, ie leukopenia, lymphopenia, and/or neutropenia )
  • fever
  • inflammation inside the mouth, stomach, or intestines
  • dry mouth
  • heartburn ( dyspepsia )
  • vomiting
  • difficulty swallowing
  • abdominal pain
  • acne
  • rash and pain in palms or soles of the feet (hand-foot syndrome)
  • reddening of the skin
  • joint pain
  • pain in the mouth
  • menstrual disorders such as irregular menstruation
  • elevated blood lipids ( hyperlipidemia, hypertriglyceridemia )
  • low potassium levels in the blood
  • low phosphate level in the blood
  • low calcium levels in the blood
  • dry skin, skin peeling, skin damage
  • nail problems, broken nails
  • light hair loss
  • abnormal liver values ​​(elevated AST or ALT )
  • abnormal kidney values ​​(elevated creatinine )
  • swollen eyelids
  • protein in the urine.

Uncommon (may affect up to 1 in 100 people)

  • weakness, spontaneous bleeding or bruising and frequent infection with symptoms such as fever, chills, sore throat, or cold sores (signs of low levels of certain blood cells, pancytopenia)
  • loss of taste
  • bloody vomiting
  • menstrual disorders such as the absence of menstruation ( amenorrhea )
  • frequent urination during the day
  • chest pain
  • abnormal wound healing
  • hot flashes
  • watery eyes with itching and redness, red eyes ( conjunctivitis ).

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

  • fatigue, shortness of breath, dizziness, pale skin (signs of the low level of red blood cells, possibly due to a type of anemia called erythroblastopenia)
  • swelling of the face, around the eyes, mouth, and inside the mouth and/or throat and tongue as well as difficulty breathing or swallowing ( angioedema, which may be a sign of an allergic reaction ).

If these side effects become severe, consult a doctor and/or pharmacist. Most side effects are mild to moderate and generally, go away if treatment is stopped for a few days.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store the medicine

  • 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 expiration date is the last day of the specified month.
  • Do not store above 25 ° C.
  • Store in the original package. Sensitive to light. Moisture sensitive.
  • Do not open the blister until the tablets are to be taken.
  • Do not use this medicine if you notice that the package is damaged or appears to have been opened earlier.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is everolimus.

  • Each Afinitor 2.5 mg tablet contains 2.5 mg everolimus.
  • Each tablet of Afinitor 5 mg contains 5 mg of everolimus.
  • Each tablet of Afinitor 10 mg contains 10 mg of everolimus.

The other ingredients are butylhydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A, and anhydrous lactose.

What the medicine looks like and the contents of the pack

Afinitor 2.5 mg tablets are white to yellowish, oblong tablets. They are marked with “LCL” on one side and “NVR” on the other.

Afinitor 5 mg tablets are white to yellowish, oblong tablets. They are marked with “5” on one side and “NVR” on the other.

Afinitor 10 mg tablets are white to yellowish, oblong tablets. They are marked with “UHE” on one side and “NVR” on the other.

Afinitor 2.5 mg is available in blister packs of 30 or 90 tablets. Afinitor 5 mg and Afinitor 10 mg are available in blister packs of 10, 30, or 90 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharmacéutica SA

Ronda de Santa Maria 158

08210 Barberà del Vallès, Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 Luxembourg / LuxemburgNovartis Pharma NV:Tel: +32 2 246 16 11
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
Czech RepublicNovartis sroTel: +420 225 775 111 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 555
GermanyNovartis Pharma GmbHTel: +49 911 273 0 NorwayNovartis Norge ASTel: +47 23 05 20 00
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PortugalNovartis Pharma-Pharmaceutical Products, Satel: +351 21 000 8600
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
IcelandVistor hf.Phone: +354 535 7000 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ItalyNovartis Farma SpATel: +39 02 96 54 1
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370
LatviaSIA Novartis BalticsTel: +371 67 887 070  
LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50  

Muhammad Nadeem

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