Pazopanib Teva

Patient Information Leaflet

Pazopanib Teva 200 mg film-coated tablets, 400 mg film-coated tablets

pazopanib
Generic medicine
Read this entire 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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Pazopanib Teva is a type of medicine called a protein kinase inhibitor. It works by blocking the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Teva is used in adults to treat:

• advanced kidney cancer or cancer that has spread to other organs;
• certain types of soft tissue sarcoma, a type of tumour affecting the body's supportive tissues. It may occur in muscles, blood vessels, fatty tissue, or other tissues that support, surround, and protect the organs.

2. What you should know before taking Pazopanib Teva

Do not take Pazopanib Teva

• if you are allergic to pazopanib or to any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you think this might apply to you.

Warnings and precautions
Talk to your doctor before taking Pazopanib Teva:

• if you have a heart disease;
• if you have a liver disease;
• if you have previously suffered from heart failure or have had a heart attack;
• if you have previously had a pulmonary embolism;
• if you have had problems related to bleeding, blood clots, or narrowing of the arteries;
• if you have had stomach or intestinal problems, such as a perforation (hole) or a fistula (an abnormal passage forming between parts of the intestine);
• if you have thyroid problems;
• if you have kidney function problems;
• if you have or have had an aneurysm (a bulging and weakening of a blood vessel wall) or a tear in the wall of a blood vessel. Inform your doctor if any of these apply to you. Your doctor will decide whether Pazopanib Teva is suitable for you. You may need additional tests to check that your kidneys, heart, and liver are functioning properly.

High blood pressure and Pazopanib Teva
Pazopanib Teva can increase blood pressure. Your blood pressure will be monitored before starting and during treatment with Pazopanib Teva. If you have high blood pressure, you will be treated with medicines to lower it.
Inform your doctor if you have high blood pressure.
If you are about to undergo surgery
Your doctor will stop treatment with Pazopanib Teva at least 7 days before surgery, as the medicine may affect wound healing. Treatment will be resumed once the wound has healed adequately.
Conditions to which you should pay attention
Pazopanib Teva may worsen certain conditions or cause serious side effects. To reduce the risk of any problems, you should be aware of certain symptoms during treatment with Pazopanib Teva. See section 4.
Children and adolescents
Pazopanib Teva is not recommended for people under 18 years of age. It is not yet known how it works in this age group. Furthermore, it should not be used in children under 2 years of age due to safety concerns.
Other medicines and Pazopanib Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines and other medicines purchased without a prescription.
Some medicines may affect how Pazopanib Teva works or increase the likelihood of side effects. Conversely, Pazopanib Teva may affect how other medicines work. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections);
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV);
• nefazodone (used to treat depression);
• simvastatin and possibly other statins (used to treat high cholesterol levels);
• medicines that reduce stomach acidity. The type of medicine you are taking to reduce stomach acidity (e.g. proton pump inhibitors, H2 antagonists, or antacids) may affect how Pazopanib Teva is absorbed. Ask your doctor or nurse for advice.

Inform your doctor or pharmacist if you are taking any of these medicines.
Pazopanib Teva with food and drinks
Do not take Pazopanib Teva with food, as this affects how the medicine is absorbed. Take it at least two hours after a meal or one hour before a meal (see section 3).
Do not drink grapefruit juice while being treated with Pazopanib Teva, as this may increase the risk of side effects.
Pregnancy, breastfeeding, and fertility
Pazopanib Teva is not recommended during pregnancy. The effect of Pazopanib Teva during pregnancy is unknown.

• Inform your doctor if you are pregnant or planning to become pregnant.
• Use a reliable method of contraception during treatment with Pazopanib Teva and for at least 2 weeks after, to prevent pregnancy.
• If you become pregnant during treatment with Pazopanib Teva, inform your doctor.

Do not breastfeed while being treated with Pazopanib Teva. It is not known whether the components of Pazopanib Teva pass into breast milk. Discuss this with your doctor.
Male patients (including those who have had a vasectomy) with partners who are pregnant or who may become pregnant (including those using other contraceptive methods) must use a condom during sexual intercourse during treatment with Pazopanib Teva and for at least 2 weeks after the last dose.
Fertility may be affected by treatment with Pazopanib Teva. Discuss this with your doctor.
Driving and using machines
Pazopanib Teva may cause side effects that could affect your ability to drive or operate machinery.
Avoid driving and operating machinery if you experience dizziness, fatigue, weakness, or low energy levels.
Pazopanib 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 Pazopanib Teva

Take this medicine exactly as your doctor has told you. If you are unsure,
please consult your doctor or pharmacist.
How much to take
Pazopanib Teva 200 mg film-coated tablets:
The usual dose is four tablets of Pazopanib Teva 200 mg (800 mg of pazopanib) taken once daily. This is the maximum daily dose. Your doctor may need to reduce the dose if you experience side effects.
Pazopanib Teva 400 mg film-coated tablets:
The usual dose is two tablets of Pazopanib Teva 400 mg (800 mg of pazopanib) taken once daily. This is the maximum daily dose. Your doctor may need to reduce the dose if you experience side effects.
When to take it
Do not take Pazopanib Teva with food. Take it at least two hours after a meal or one hour before a meal.
For example, you could take it two hours after breakfast or one hour before lunch. Take Pazopanib Teva at approximately the same time each day.
Swallow the tablets whole with water, one after the other. Do not split or crush the tablets, as this affects how the medicine is absorbed and may increase the risk of side effects.
If you take more Pazopanib Teva than you should
If you take too many tablets, seek advice from your doctor or pharmacist immediately. If possible, show them the packaging or this leaflet.
If you forget to take Pazopanib Teva
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual time.
Do not stop treatment with Pazopanib Teva without medical advice
Continue taking Pazopanib Teva for as long as your doctor recommends. Do not stop treatment unless instructed by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects
Brain swelling (reversible posterior leukoencephalopathy syndrome)
Rarely, Pazopanib Teva can cause brain swelling, which may be life-threatening. Symptoms include:

• loss of language;
• changes in vision;
• seizure (convulsions);
• confusion;
• high blood pressure. Stop taking Pazopanib Teva and contact a doctor immediately if you experience any of these symptoms or if you have a headache accompanied by any of these symptoms.

Hypertensive crisis (sudden and severe increase in blood pressure)
Pazopanib Teva may occasionally cause a sudden and severe increase in blood pressure, known as a hypertensive crisis. Your doctor will monitor your blood pressure during treatment with Pazopanib Teva. Signs and symptoms of a hypertensive crisis may include:

• severe chest pain;
• severe headache;
• blurred vision;
• confusion;
• nausea;
• vomiting;
• severe anxiety;
• shortness of breath;
• seizure (convulsions);
• fainting. Stop taking Pazopanib Teva and contact a doctor immediately if you develop a hypertensive crisis.

Heart conditions
The risk of these problems may be higher in people with existing heart problems or who are taking other medicines. Any heart problems will be monitored during treatment with Pazopanib Teva.
Heart dysfunction/Heart failure, heart attack
Pazopanib Teva may affect the heart's ability to pump blood or may increase the likelihood of having a heart attack. Signs and symptoms include:

• irregular or rapid heartbeat;
• palpitations;
• fainting;
• pain or pressure in the chest;
• pain in arms, back, neck or jaw;
• shortness of breath;
• swelling of the legs. Contact a doctor immediately if you experience any of these symptoms.

Changes in heart rhythm (QT prolongation)
Pazopanib Teva may affect the heart rhythm, which in some people may lead to a potentially serious heart condition called torsades de pointes. This may cause a very rapid heartbeat leading to sudden loss of consciousness.
Inform your doctor if you notice unusual changes in your heartbeat, such as one that is too fast or too slow.
Stroke
Pazopanib Teva may increase the risk of having a stroke. Signs and symptoms of stroke may include:

• numbness or weakness on one side of the body;
• difficulty speaking;
• headache;
• dizziness. Contact a doctor immediately if you experience any of these symptoms.

Bleeding
Pazopanib Teva may cause serious bleeding in the gastrointestinal tract (such as stomach, oesophagus, rectum or intestine) or in the lungs, kidneys, mouth, vagina and brain, although this is not common. Symptoms include:

• blood in the stools or black stools;
• blood in the urine;
• stomach pain;
• coughing or vomiting blood. Contact a doctor immediately if you experience any of these symptoms.

Perforation and fistula
Pazopanib Teva may cause a tear (perforation) in the wall of the stomach or intestine or the development of an abnormal connection between two parts of the gastrointestinal tract (fistula). Signs and symptoms may include:

• severe stomach pain;
• nausea and/or vomiting;
• fever;
• development of a hole (perforation) in the stomach or intestine with pus mixed with blood or foul-smelling discharge. Contact a doctor immediately if you experience any of these symptoms.

Liver problems
Pazopanib Teva may cause liver problems that may progress to serious conditions such as liver dysfunction and liver failure, which may be fatal. Your doctor will monitor liver enzymes during treatment with Pazopanib Teva. Signs of possible liver malfunction may include:

• yellowing of the skin or whites of the eyes (jaundice);
• dark urine;
• fatigue;
• nausea;
• vomiting;
• loss of appetite;
• pain in the right side of the stomach (abdomen);
• easy bruising. Contact a doctor immediately if you experience any of these symptoms.

Blood clots
Deep vein thrombosis (DVT) and pulmonary embolism
Pazopanib Teva may cause blood clots in the veins, especially in the legs (deep vein thrombosis or DVT), which may travel to the lungs (pulmonary embolism). Signs and symptoms may include:

• sudden sharp chest pain;
• shortness of breath;
• rapid breathing;
• leg pain;
• swelling of arms and hands or legs and feet.

Thrombotic microangiopathy (TMA)
Pazopanib Teva may cause blood clots in the small blood vessels of the kidneys and brain, accompanied by a decrease in red blood cells and platelets involved in blood clotting (thrombotic microangiopathy [TMA]). Signs and symptoms may include:

• easy bruising;
• high blood pressure;
• fever;
• confusion;
• drowsiness;
• seizure (convulsions);
• decreased urine output. Contact a doctor immediately if you experience any of these symptoms.

Tumour lysis syndrome
Pazopanib Teva may cause rapid breakdown of tumour cells, resulting in tumour lysis syndrome, which may be fatal in some people. Symptoms may include irregular heartbeat, seizures (convulsions), confusion, muscle cramps or spasms, or decreased urine output. Contact a doctor immediately if you experience any of these symptoms.
Infections
Infections occurring during treatment with Pazopanib Teva may become severe. Symptoms of infections may include:

• fever;
• flu-like symptoms such as cough, fatigue and body aches that do not go away;
• shortness of breath and/or wheezing;
• pain when urinating;
• red, warm, swollen or painful cuts, scratches or wounds. Contact a doctor immediately if you experience any of these symptoms.

Lung inflammation
Rarely, Pazopanib Teva may cause lung inflammation (interstitial lung disease, pneumonia), which may be fatal in some people. Symptoms include shortness of breath or persistent cough. Any lung problems will be monitored during treatment with Pazopanib Teva.
Contact a doctor immediately if you experience any of these symptoms.
Thyroid problems
Pazopanib Teva may reduce the amount of thyroid hormone produced by the body, which may cause weight gain and fatigue. Thyroid hormone levels will be monitored during treatment with Pazopanib Teva.
Inform your doctor if you notice significant weight gain or fatigue.
Blurred or impaired vision
Pazopanib Teva may cause detachment or tearing of the lining at the back of the eye (retinal detachment or tear), which may lead to blurred or impaired vision.
Inform your doctor if you notice changes in vision.
Possible side effects (including possible serious side effects based on the relevant frequency category)
Very common side effects (may affect more than 1 in 10 people):

• high blood pressure
• diarrhoea
• nausea or vomiting
• stomach pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth pain
• headache
• tumour pain
• lack of energy, feeling weak or tired
• changes in hair colour
• unusual hair loss or thinning
• loss of skin pigment
• skin rash, possibly with skin peeling
• redness and swelling of the palms of the hands or soles of the feet Inform your doctor or pharmacist if any of these side effects become troublesome.

Very common side effects that may be detected in blood or urine tests:

• increased liver enzymes
• decreased albumin in the blood
• protein in the urine
• decreased platelet count (cells that help blood to clot)
• reduced white blood cell count

Common side effects (may affect up to 1 in 10 people):

• indigestion, bloating, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• unusual drowsiness
• difficulty sleeping
• chest pain, shortness of breath, leg pain and swelling of legs/feet. These may be signs of a blood clot in the body (thromboembolism). If the clot breaks loose, it may travel to the lungs with potentially life-threatening or even fatal consequences.
• the heart becomes less effective at pumping blood throughout the body (cardiac dysfunction)
• slow heartbeat
• bleeding from the mouth, rectum or lung
• dizziness
• blurred vision
• hot flushes
• swelling of face, hands, ankles, feet or eyelids due to fluid retention
• tingling, weakness or numbness in hands, arms, legs or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, stinging, itching or tingling sensation on the skin
• feeling cold with chills
• excessive sweating
• dehydration
• muscle, joint, tendon or chest pain, muscle spasms
• hoarseness
• shortness of breath
• cough
• coughing up blood
• hiccups
• lung collapse with trapped air between the lung and chest wall, often causing shortness of breath (pneumothorax) Inform your doctor or pharmacist if any of these side effects become troublesome.

Common side effects that may be detected in blood or urine tests:

• underactive thyroid
• abnormal liver function
• increased bilirubin (a substance produced by the liver)
• increased lipase (an enzyme involved in digestion)
• increased creatinine (a substance produced by muscles)
• changes in levels of various other chemicals/enzymes in the blood. Your doctor will inform you of the results of blood tests

Uncommon side effects (may affect up to 1 in 100 people):

• stroke
• temporary interruption of blood flow to the brain (transient ischaemic attack)
• interruption of blood flow to part of the heart or heart attack (myocardial infarction)
• partial interruption of blood flow to part of the heart (myocardial ischaemia)
• blood clots accompanied by a decrease in red blood cells and platelets involved in blood clotting (thrombotic microangiopathy [TMA]). These may damage organs such as the brain and kidneys.
• increased number of red blood cells
• sudden shortness of breath, especially when accompanied by sharp chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding from the gastrointestinal tract (such as stomach, oesophagus or intestine) or from kidneys, vagina and brain
• heart rhythm disorders (QT prolongation)
• hole (perforation) in the stomach or intestine
• abnormal passage forming between parts of the intestine (fistula)
• heavy or irregular menstrual periods
• sudden sharp increase in blood pressure (hypertensive crisis)
• inflammation of the pancreas (pancreatitis)
• inflamed, malfunctioning or damaged liver
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• skin rashes which may be itchy or inflamed (flat or raised spots or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• decreased sensation, especially in the skin
• skin wound that does not heal (skin ulcer)

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

• lung inflammation (pneumonia)
• dilation and weakening of a blood vessel wall or tear in a blood vessel wall (aneurysms and arterial dissections)

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

• tumour lysis syndrome resulting from rapid breakdown of tumour cells
• liver failure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. 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 Pazopanib Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via 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 Pazopanib Teva contains
Pazopanib Teva 200 mg film-coated tablets:

• The active substance is pazopanib (as hydrochloride). Each film-coated tablet contains pazopanib hydrochloride equivalent to 200 mg of pazopanib.
• The other components are: Tablet core: microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone K30 (E1201), magnesium stearate (E470b). Film coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), red iron oxide (E172), polysorbate 80 (E433).

Pazopanib Teva 400 mg film-coated tablets:

• The active substance is pazopanib (as hydrochloride). Each film-coated tablet contains pazopanib hydrochloride equivalent to 400 mg of pazopanib.
• The other components are: Tablet core: microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone K30 (E1201), magnesium stearate (E470b). Film coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433).

Description of the appearance of Pazopanib Teva and contents of the pack
Pazopanib Teva 200 mg film-coated tablets:
Pazopanib Teva 200 mg film-coated tablets are capsule-shaped, pink in colour, with “200” engraved on one side and measuring approximately 14.3 mm x 5.7 mm.
They are available in clear/transparent aluminium-PVC/PE/PVDC blisters containing 30, 60, multiple pack of 60 (2 packs of 30), 90, multiple pack of 90 (3 packs of 30) tablets.
They are also available in white HDPE bottles with white child-resistant closure, containing 30 tablets.

Pazopanib Teva 400 mg film-coated tablets:
Pazopanib Teva 400 mg film-coated tablets are capsule-shaped, white in colour, with “400” engraved on one side and measuring approximately 18.0 mm x 7.1 mm.
They are available in clear/transparent aluminium-PVC/PE/PVDC blisters containing 30, 60, multiple pack of 60 (2 packs of 30), 90, multiple pack of 90 (3 packs of 30) tablets.
They are also available in white HDPE bottles with white child-resistant closure, containing 30, 60 and multiple pack of 60 (2 packs of 30) tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Remedica Ltd (Building 10-Antineoplastic & Immunomodulating products)
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta