Pazopanib Sandoz

Patient Information Leaflet: Information for the User

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Pazopanib Sandoz 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 Sandoz is used in adults to treat:

• advanced kidney cancer or cancer that has spread to other organs.
• certain types of soft tissue sarcoma, which is 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 need to know before taking Pazopanib Sandoz

Do not take Pazopanib Sandoz:

• 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 applies to you.

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

• if you have a heart disease.
• if you have a liver disease.
• if you have previously had heart failure or a heart attack.
• if you have previously had a pulmonary collapse.
• 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 (abnormal passage forming between parts of the intestine).
• if you have thyroid problems.
• if you have problems with kidney function.
• if you have or have had an aneurysm (a bulge and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Tell your doctor if any of these apply to you. Your doctor will decide whether Pazopanib Sandoz is suitable for you.
Additional tests may be needed to check that your kidneys, heart, and liver are functioning properly.

High blood pressure and Pazopanib Sandoz
Pazopanib Sandoz can increase blood pressure. Your blood pressure will be monitored before and during treatment with Pazopanib Sandoz. If you have high blood pressure, you will be treated with medicines to lower it.

• Tell your doctor if you have high blood pressure.

If you are about to undergo surgery
Your doctor will stop Pazopanib Sandoz at least 7 days before surgery, as the medicine may affect wound healing. Treatment will be restarted once the wound has healed adequately.

Conditions you need to monitor
Pazopanib Sandoz may worsen certain conditions or cause serious side effects. To reduce the risk of problems, you should pay attention to certain symptoms while taking Pazopanib Sandoz. See section 4.

Children and adolescents
Pazopanib Sandoz is not recommended for people under 18 years of age. It is not yet known how it works in this age group. Moreover, it must not be used in children under 2 years of age due to safety concerns.

Other medicines and Pazopanib Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and other medicines you can buy without a prescription.

Some medicines can affect how Pazopanib Sandoz works and may increase the likelihood of side effects. Conversely, Pazopanib Sandoz 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 you should take Pazopanib Sandoz. Consult your doctor or nurse for advice. Tell your doctor or pharmacist if you are taking any of these medicines.

Pazopanib Sandoz with food and drink
Do not take Pazopanib Sandoz 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 Sandoz, as this may increase the risk of side effects.

Pregnancy, breastfeeding and fertility
Pazopanib Sandoz is not recommended if you are pregnant. The effects of Pazopanib Sandoz during pregnancy are unknown.

• Tell your doctor if you are pregnant or planning to become pregnant.
• Use a reliable method of contraception while taking Pazopanib Sandoz and for at least 2 weeks after stopping treatment to prevent pregnancy.
• If you become pregnant during treatment with Pazopanib Sandoz, inform your doctor immediately.
• You must not breastfeed while taking Pazopanib Sandoz. It is not known whether the components of Pazopanib Sandoz pass into breast milk. Discuss this with your doctor.

If you are a male patient (even if you have had a vasectomy) and have a partner who is pregnant or could become pregnant (including those using other contraceptive methods), you must use a condom during sexual intercourse while taking Pazopanib Sandoz and for at least 2 weeks after the last dose.
Fertility may be affected by treatment with Pazopanib Sandoz. Talk to your doctor about this.

Driving and using machines
Pazopanib Sandoz may cause side effects that could affect your ability to drive or operate machinery.

• Avoid driving or operating machinery if you feel confused, tired, weak, or if your energy levels are low.

Pazopanib Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Pazopanib Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure,
please consult your doctor or pharmacist.
How much to take
The recommended dose is 800 mg taken once daily. The dose can be taken as 2
tablets of 400 mg or as 4 tablets of 200 mg. The 800 mg once-daily dose 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 Sandoz 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 Sandoz every day at approximately the same time.
Swallow the tablets whole with water, one after the other. Do not break 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 Sandoz than you should
If you take too many tablets, contact your doctor or pharmacist for advice. If possible, show
them the pack or this leaflet.
If you forget to take Pazopanib Sandoz
Do not take a double dose to make up for a forgotten dose. Take only the next dose at the
usual time.
Do not stop taking Pazopanib Sandoz without medical advice
Take Pazopanib Sandoz for as long as your doctor recommends. Do not stop unless your
doctor advises you to do so.

4. Possible side effects

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

• loss of speech
• changes in vision
• seizures (epileptic fits)
• confusion
• high blood pressure

Stop taking Pazopanib Sandoz and seek immediate medical help 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 Sandoz may occasionally cause a sudden and severe rise in blood pressure. This
is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you
are taking Pazopanib Sandoz. Signs and symptoms of a hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe anxiety
• shortness of breath
• seizures (epileptic fits)
• fainting

Stop taking Pazopanib Sandoz and seek immediate medical help if you develop a
hypertensive crisis.
Heart problems
The risk of these problems may be higher in people with existing heart conditions or those
taking other medicines. You will be monitored for heart problems while taking Pazopanib
Sandoz.
Heart dysfunction/heart failure, heart attack
Pazopanib Sandoz may affect the heart's pumping activity and increase the likelihood of a
heart attack. Signs and symptoms include:

• irregular or rapid heartbeat
• fast heart rate
• fainting
• chest pain or pressure
• pain in arms, back, neck, or jaw
• shortness of breath
• swelling in legs

Seek immediate medical help if you experience any of these symptoms.

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

• numbness or weakness on one side of the body
• difficulty speaking
• headache
• dizziness

Seek immediate medical help if you experience any of these symptoms.

Bleeding
Pazopanib Sandoz 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:

• passing blood in stools or black stools
• blood in urine
• stomach pain
• coughing or vomiting blood

Seek immediate medical help if you experience any of these symptoms.

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

• severe stomach pain
• nausea and/or vomiting
• fever
• development of a hole (perforation) in the stomach or intestine, from which pus mixed with blood and with a foul odour is released

Seek immediate medical help if you experience any of these symptoms.

Liver problems
Pazopanib Sandoz may cause liver problems that can lead to serious conditions such as liver
dysfunction and liver failure, which may be fatal. Your doctor will monitor liver enzymes while
you are taking Pazopanib Sandoz.
Signs that the liver may not be working properly 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

Seek immediate medical help if you experience any of these symptoms.

Blood clots
Deep vein thrombosis (DVT) and pulmonary embolism
Pazopanib Sandoz 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 chest pain
• shortness of breath
• rapid breathing
• leg pain
• swelling of arms and hands or legs and feet

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

• easy bruising
• high blood pressure
• fever
• confusion
• drowsiness
• seizures (epileptic fits)
• reduced urine output

Seek immediate medical help if you experience any of these symptoms.

Tumour lysis syndrome
Pazopanib Sandoz may cause rapid breakdown of tumour cells, leading to tumour lysis
syndrome, which may be fatal in some people. Symptoms may include irregular heartbeat,
seizures (epileptic fits), confusion, muscle cramps or spasms, or reduced urine production.
Seek immediate medical help if you experience any of these symptoms.
Infections
Infections occurring while taking Pazopanib Sandoz 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
• cuts, scratches, or wounds that are red, warm, swollen, or painful

Seek immediate medical help if you experience any of these symptoms.

Lung inflammation
Pazopanib Sandoz may rarely cause inflammation of the lungs (interstitial lung disease,
pneumonitis), which may be fatal in some people. Symptoms include shortness of breath or
cough that does not go away. While taking Pazopanib Sandoz, you will be monitored for lung
problems. Seek immediate medical help if you experience any of these symptoms.
Thyroid problems
Pazopanib Sandoz may reduce the amount of thyroid hormone produced by the body. This
may cause weight gain and fatigue. While taking Pazopanib Sandoz, your thyroid hormone
levels will be monitored. Inform your doctor if you notice significant weight gain or fatigue.
Blurred or impaired vision
Pazopanib Sandoz may cause separation or tearing of the inner layer at the back of the eye
(retinal detachment or tear). This may lead to blurred or impaired vision.
Inform your doctor if you notice any changes in vision.

Possible side effects (including possible serious side effects by 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 site pain
• lack of energy, feeling weak or tired
• change in hair colour
• unusual hair loss or thinning
• loss of skin pigment
• 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 worsen or become bothersome.

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

• increased liver enzymes
• reduced albumin in the blood
• protein in the urine
• reduced platelet count in the blood (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 and this can be life-threatening or fatal.
• the heart becomes less effective at pumping blood around the body (cardiac dysfunction)
• slowed heartbeat
• bleeding from 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, prickling, itching, or tingling sensations 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
• collapsed lung 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 bothersome.
Common side effects that may be detected by blood or urine tests:

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

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

• stroke
• temporary interruption of blood supply to the brain (transient ischaemic attack)
• interruption of blood supply to part of the heart or heart attack (myocardial infarction)
• interruption of blood supply to part of the heart (myocardial ischaemia)
• blood clots accompanied by a decrease in red blood cells and clotting cells (thrombotic microangiopathy, TMA). These may damage organs such as the brain and kidneys
• increased red blood cell count in the blood
• sudden onset of shortness of breath, especially when accompanied by sudden chest pain and/or rapid breathing (pulmonary embolism)
• serious gastrointestinal bleeding (such as in stomach, oesophagus, or intestine), or in 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 liver that is not working properly or damaged
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• skin rash that may be itchy or inflamed (flat or raised spots or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• reduced sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer)

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

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

Not known (frequency cannot be estimated from 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, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting
system at https://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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the bottle and outer carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pazopanib Sandoz contains

• The active substance is pazopanib (as hydrochloride). Each Pazopanib Sandoz 200 mg film-coated tablet contains 200 mg of pazopanib. Each Pazopanib Sandoz 400 mg film-coated tablet contains 400 mg of pazopanib.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone (K30), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80. The 200 mg tablets also contain red iron oxide (E172).

Description of the appearance of Pazopanib Sandoz and contents of the pack
Pazopanib Sandoz 200 mg film-coated tablets are capsule-shaped, pink in colour, with ‘200’ printed on one side, available in blister packs of 30, 60 or 90 tablets, multi-packs of 60 or 60x1 (2 packs of 30 or 2 packs of 30x1), 90 or 90x1 (3 packs of 30 or 3 packs of 30x1) tablets, and in plastic bottles containing 30 or 90 tablets or multi-packs of 90 (3 bottles of 30) tablets.
Pazopanib Sandoz 400 mg film-coated tablets are capsule-shaped, white in colour, with ‘400’ printed on one side, available in blister packs of 30, 60 or 90 tablets, multi-packs of 60 or 60x1 (2 packs of 30 or 2 packs of 30x1), 90 or 90x1 (3 packs of 30 or 3 packs of 30x1) tablets, and in plastic bottles containing 30 or 90 tablets or multi-packs of 90 (3 bottles of 30) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone
Metamorfossi, 14452, Greece
Remedica Ltd,
Aharnon Street, Limassol Industrial Estate,
3056 Limassol, Cyprus

This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia: Pazopanib Sandoz 200 mg filmom obložene tablete
Pazopanib Sandoz 400 mg filmom obložene tablete
Ireland: Pazopanib Rowex 200 mg film-coated tablets
Pazopanib Rowex 400 mg film-coated tablets
Italy: Pazopanib Sandoz
Malta: Pazopanib Sandoz 200 mg film-coated tablets
Pazopanib Sandoz 400 mg film-coated tablets
Norway: Pazopanib Sandoz
Poland: Pazopanib Sandoz
Slovak Republic: Pazopanib Sandoz 200 mg
Pazopanib Sandoz 400 mg
Hungary: Pazopanib Sandoz 200 mg filmtabletta
Pazopanib Sandoz 400 mg filmtabletta