AXITINIB TEVA

Patient Information Leaflet

Axitinib Teva 1 mg film-coated tablets, 3 mg film-coated tablets, 5 mg film-coated tablets, 7 mg film-coated tablets

axitinib
Generic medicine
Please read all of 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Axitinib Teva is and what it is used for
2. What you need to know before taking Axitinib Teva
3. How to take Axitinib Teva
4. Possible side effects
5. How to store Axitinib Teva
6. Contents of the pack and other information

1. What Axitinib Teva is and what it is used for

Axitinib Teva is a medicine that contains the active substance axitinib. Axitinib reduces the blood supply to the tumour and slows down its growth.
Axitinib Teva is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, in cases where another medicine (sunitinib or a cytokine) is no longer able to stop the progression of the disease.
If you have any questions about how this medicine works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before taking Axitinib Teva

Do not take Axitinib Teva
If you are allergic to axitinib or to any of the other ingredients of this medicine (listed in
section 6).
If you suspect you may be allergic, consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Axitinib Teva.

• If you have high blood pressure. Axitinib Teva can increase blood pressure. It is important to monitor your blood pressure before starting and regularly during treatment with this medicine. If you have high blood pressure (hypertension), you may be prescribed medications to
  reduce it. Your doctor must ensure that your blood pressure is under control before starting
  treatment with Axitinib Teva and during treatment with this medicine.

• If you have thyroid problems. Axitinib Teva can cause thyroid problems. Inform your doctor if, during treatment with this medicine, you become more easily fatigued, feel colder than usual, or experience a lowering of your voice. Thyroid function should be checked before starting and regularly during treatment with Axitinib Teva. If your thyroid gland does not produce sufficient thyroid hormone before or during treatment with this medicine, thyroid hormone replacement therapy may be required.

• If you have recently experienced a problem due to blood clot formation in veins or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Go immediately to the emergency room and contact your doctor if, during treatment with this medicine, you experience symptoms such as chest pain or pressure, arm, back, neck, or jaw/mouth pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, vision changes, or dizziness.

• If you have or have had bleeding problems. Axitinib Teva may increase the risk of bleeding. Inform your doctor if, during treatment with this medicine, you experience bleeding, coughing up blood, or coughing with blood-streaked sputum.

• If you have or have had an aneurysm (dilation and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

• If you experience severe stomach (abdominal) pain or persistent stomach pain during treatment with this medicine. Axitinib Teva may increase the risk of stomach or intestinal perforation or the formation of a fistula (an abnormal passage connecting two body cavities or a body cavity and the skin). Inform your doctor if you experience severe abdominal pain during treatment with this medicine.

• If you are about to undergo surgery or have an unhealed wound. Your doctor should stop treatment with Axitinib Teva at least 24 hours before surgery, as this medicine may affect wound healing. Treatment with this medicine should be resumed only once the wound has adequately healed.

• If you experience symptoms such as headache, confusion, seizures, or vision changes with or without high blood pressure during treatment with this medicine. Go immediately to the emergency room and contact your doctor. These may be signs of a rare neurological side effect called reversible posterior encephalopathy syndrome.

• If you have liver problems. Your doctor should perform blood tests to check liver function before and during treatment with Axitinib Teva.

• If you experience symptoms such as excessive fatigue, abdominal swelling, swelling of the legs or ankles, shortness of breath, or bulging neck veins during treatment with this medicine. Axitinib Teva may increase the risk of developing heart failure events. Your doctor should monitor you periodically for signs or symptoms of heart failure during treatment with axitinib.

Use in children and adolescents
Axitinib Teva is not recommended for people under 18 years of age. This medicine has not been studied in children and adolescents.

Other medicines and Axitinib Teva
Some medicines may affect Axitinib Teva or may be affected by it. Inform your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take, including over-the-counter medicines, vitamins, and herbal supplements. The medicines listed in this leaflet may not be the only ones that interact with Axitinib Teva.

The following medicines may increase the risk of side effects with Axitinib Teva:

• ketoconazole or itraconazole, used to treat fungal infections;
• clarithromycin, erythromycin, or telithromycin, antibiotics used to treat bacterial infections;
• atazanavir, indinavir, nelfinavir, ritonavir, or saquinavir, used to treat HIV/AIDS infections;
• nefazodone, used to treat depression.

The following medicines may reduce the effectiveness of Axitinib Teva:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a steroid medicine prescribed for various conditions, including serious diseases;
• phenytoin, carbamazepine, or phenobarbital, antiepileptic medicines used to prevent seizures;
• St. John’s wort (Hypericum perforatum), a herbal product used to treat depression.

During treatment with Axitinib Teva, you must not take these medicines. If you are taking any of these medicines, inform your doctor, pharmacist, or nurse. Your doctor may adjust the dose of these medicines or of Axitinib Teva, or switch you to another medicine.

Axitinib Teva may increase the side effects associated with theophylline, used to treat asthma or other lung diseases.

Axitinib Teva with food and drink
Do not take this medicine with grapefruit or grapefruit juice, as they may increase the risk of side effects.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
• Axitinib Teva may harm the unborn baby or the breastfed infant.
• Do not take this medicine during pregnancy. If you are pregnant or may become pregnant, consult your doctor before taking it.
• Use a reliable method of contraception during treatment with Axitinib Teva and for at least 1 week after the last dose of this medicine to prevent pregnancy.
• Do not breastfeed during treatment with Axitinib Teva. If you are breastfeeding, your doctor should discuss with you whether to discontinue breastfeeding or treatment with Axitinib Teva.

Driving and using machines
If you experience dizziness and/or fatigue during treatment with Axitinib Teva, exercise particular caution when driving or operating machinery.

Axitinib Teva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Axitinib Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., it is essentially “sodium-free”.

3. How to take Axitinib Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.
The recommended dose is 5 mg twice daily. Your doctor may later increase or reduce the dose depending on your tolerance to treatment with Axitinib Teva.
Swallow the tablets whole with water, with or without food. Take doses of Axitinib Teva approximately 12 hours apart.
Use in children and adolescents
Axitinib Teva is not recommended for people under 18 years of age. This medicine has not been studied in children and adolescents.
If you take more Axitinib Teva than you should
If you accidentally take too many tablets or a higher dose than required, contact a doctor immediately. If possible, show the doctor the packaging or this leaflet. Medical intervention may be necessary.
If you forget to take Axitinib Teva
Take the next dose at your usual time. Do not take a double dose to make up for forgotten tablets.
If you vomit while being treated with Axitinib Teva
If you vomit, do not take an additional dose. Take the next prescribed dose at the usual time.
If you stop treatment with Axitinib Teva
If you are unable to take this medicine as prescribed by your doctor or if you think you no longer need it, contact your doctor immediately.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious. Contact your doctor immediately if you experience any of
the following serious side effects (see also section 2 “What you need to know before taking
Axitinib Teva”):

• Heart failure events. Inform your doctor if you experience excessive tiredness, swelling of the abdomen, legs or ankles, shortness of breath, or bulging neck veins.
• Blood clots in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Go immediately to the emergency room and call your doctor if you experience symptoms such as chest pain or pressure, pain in the arms, back, neck, or jaw/mandible, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, vision changes, or dizziness.
• Bleeding. Inform your doctor immediately if during treatment with Axitinib Teva you experience any of these symptoms or a serious bleeding problem: black, tarry stools, coughing up blood or bloody sputum, or altered mental status.
• Perforation of the stomach or intestine or formation of a fistula (an abnormal passage connecting two body cavities or between a body cavity and the skin). Inform your doctor if you experience severe abdominal pain.
• Severe increase in blood pressure (hypertensive crisis). Inform your doctor if you experience very high blood pressure, severe headache, or severe chest pain.
• Reversible swelling of the brain (reversible posterior encephalopathy syndrome). Go immediately to the emergency room and contact your doctor if you experience symptoms such as headache, confusion, seizures, or vision changes with or without high blood pressure.

Other side effects of Axitinib Teva may include:
Very common: may affect more than 1 in 10 people

• High blood pressure or increases in blood pressure
• Diarrhoea, nausea or vomiting, stomach ache, indigestion, pain in the mouth, tongue or throat, constipation
• Shortness of breath, cough, hoarseness
• Lack of energy, feeling weak or tired
• Reduced thyroid activity (can be detected in blood tests)
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome), skin rash, dry skin
• Joint pain, pain in the hands or feet
• Loss of appetite
• Presence of protein in the urine (can be detected in blood tests)
• Weight loss
• Headache, taste disturbances or loss of taste

Common: may affect up to 1 in 10 people

• Dehydration (loss of body fluids)
• Kidney failure
• Flatulence (excess intestinal gas), haemorrhoids, bleeding gums, rectal bleeding, burning or irritation in the mouth
• Overactivity of the thyroid (can be detected in blood tests)
• Sore throat or irritation of nose and throat
• Muscle pain
• Nosebleeds
• Itchy skin, skin redness, hair loss
• Ringing or buzzing in the ears (tinnitus)
• Decrease in red blood cell count (can be detected in blood tests)
• Decrease in platelet count (cells that help blood to clot) (can be detected in blood tests)
• Presence of red blood cells in the urine (can be detected in urine tests)
• Changes in levels of various chemicals/enzymes in the blood (can be detected in blood tests)
• Increase in red blood cell count (can be detected in blood tests)
• Swelling of the abdomen, legs or ankles, bulging neck veins, excessive tiredness, shortness of breath (signs of heart failure events)
• Fistula (an abnormal passage connecting two body cavities or between a body cavity and the skin)
• Dizziness
• Inflammation of the gallbladder

Uncommon: may affect up to 1 in 100 people

• Decrease in white blood cell count (can be detected in blood tests)

Not known: frequency cannot be estimated from the available data

• Widening and weakening of the wall of a blood vessel or tearing of the wall of a blood vessel (aneurysms and arterial dissections)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
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 Axitinib Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp." and on the
blister after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging, protected from moisture.
This medicine does not require any special storage temperature conditions.
Do not use packages that are damaged or show signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Axitinib Teva contains

• The active substance is axitinib. Axitinib Teva 1 mg: each film-coated tablet contains 1 mg of axitinib. Axitinib Teva 3 mg: each film-coated tablet contains 3 mg of axitinib. Axitinib Teva 5 mg: each film-coated tablet contains 5 mg of axitinib. Axitinib Teva 7 mg: each film-coated tablet contains 7 mg of axitinib.
• The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2 “Axitinib Teva contains lactose”), sodium croscarmellose (see section 2 “Axitinib Teva contains sodium”), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin (E1518), red iron oxide (E172).

Description of the appearance of Axitinib Teva and contents of the pack
Axitinib Teva 1 mg film-coated tablets are round, biconvex, red film-coated tablets, approximately 6 mm in diameter, with “A7TI” engraved on one side and “1” on the other side.
Axitinib Teva 3 mg film-coated tablets are oval, biconvex, red film-coated tablets, approximately 12 mm long and 7 mm wide, with “A7TI” engraved on one side and “3” on the other side.
Axitinib Teva 5 mg film-coated tablets are oval, biconvex, red film-coated tablets, approximately 15 mm long and 8 mm wide, with “A7TI” engraved on one side and “5” on the other side.
Axitinib Teva 7 mg film-coated tablets are oval, biconvex, red film-coated tablets, approximately 17 mm long and 9 mm wide, with “A7TI” engraved on one side and “7” on the other side.
Unit dose blister packs and perforated divisible blisters in OPA/Al/PVC/Al (Al/Al), packed in cardboard boxes.
Pack sizes: 56, 60, 56 x 1 or 120 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturer
Synthon Hispania, S.L.
c/ Castelló, 1
Sant Boi de Llobregat
08830 Barcelona, Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen, The Netherlands
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa, Bulgaria