Pazopanib viatris

Package leaflet: Information for the patient

Pazopanib Viatris, 200 mg, film-coated tablets
Pazopanib Viatris, 400 mg, film-coated tablets
pazopanib
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

Pazopanib Viatris belongs to a group of medicines called protein kinase inhibitors. The medicine works by inhibiting the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Viatris is used in adult patients for the treatment of:

• advanced or metastatic renal cell carcinoma (kidney cancer).
• certain types of soft tissue sarcoma, which is a type of tumour affecting the body's connective tissues. It may occur in muscles, blood vessels, fat tissue, or other tissues that support, surround, and protect internal organs.

2. Important information before using Pazopanib Viatris

When not to use Pazopanib Viatris

• if the patient is allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6).

Consult a doctor if the patient thinks any of the above applies.
Warnings and precautions
Before starting treatment with Pazopanib Viatris, discuss with the doctor:

• if the patient has a heart disease.
• if the patient has a liver disease.
• if the patient has had heart failure or heart attack.
• if the patient has a history of lung collapse.
• if the patient has bleeding, blood clots, or narrowing of arteries.
• if the patient has had stomach or intestinal disorders, such as perforation (a hole in the wall) or fistula (abnormal connections between different parts of the intestine).
• if the patient has thyroid disorders.
• if the patient has kidney function disorders.
• if the patient has or has previously had an aneurysm (a weakened and bulging blood vessel wall) or a tear in the blood vessel wall.

Inform the doctor if any of these conditions apply. The doctor will decide whether
Pazopanib Viatris is suitable for the patient. The patient may need to undergo
additional tests to check whether the kidneys, heart, and liver are functioning properly.
High blood pressure and use of Pazopanib Viatris
Pazopanib Viatris may cause increased blood pressure. Blood pressure will be monitored before
starting treatment with Pazopanib Viatris and during treatment.
If the patient develops high blood pressure, the doctor will prescribe medications to lower it.

• Inform the doctor if the patient has high blood pressure.

If the patient is scheduled for surgery
The doctor will advise stopping treatment with Pazopanib Viatris at least 7 days before surgery,
because the medicine may affect wound healing after surgery. Treatment will be resumed
once the wound has healed.
Conditions requiring special attention
Pazopanib Viatris may worsen certain conditions or cause serious adverse effects. During treatment with Pazopanib Viatris, it is essential to pay attention to certain symptoms to reduce the risk of harmful effects. See section 4.
Children and adolescents
Pazopanib Viatris is not recommended for patients under 18 years of age. The effect of the medicine has not been established in this patient group. For safety reasons, the medicine should not be used in children under 2 years of age.
Pazopanib Viatris and other medicines
Tell the doctor or pharmacist about all medicines currently used, recently used, or planned for use, including herbal preparations and other medicines available without a prescription.
Some medicines may affect the action of Pazopanib Viatris or increase the likelihood of adverse effects.
Pazopanib Viatris may also affect the action of other medicines. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used in treatment of infections).
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used in treatment of HIV infection).
• nefazodone (used in treatment of depression).
• simvastatin and possibly other statins (used in treatment of high blood cholesterol).
• medicines that reduce stomach acid secretion. Medicines taken to reduce gastric acid secretion (e.g. proton pump inhibitors, H2-receptor antagonists, or antacids) may affect how Pazopanib Viatris is absorbed. Consult the doctor or nurse for advice. Inform the doctor or pharmacist if the patient is taking any of these medicines.

Pazopanib Viatris with food and drink
Do not take Pazopanib Viatris with food, as this affects absorption of the medicine. The medicine should be taken at least two hours after a meal or one hour before a meal (see section 3).
During treatment with Pazopanib Viatris, do not drink grapefruit juice, as this may increase the risk of adverse effects.
Pregnancy, breastfeeding, and effects on fertility
Pazopanib Viatris is not recommended during pregnancy. It is unknown how Pazopanib Viatris affects pregnancy.

• Inform the doctor if the patient is pregnant or planning to become pregnant.
• During treatment with Pazopanib Viatris and for at least 2 weeks after stopping treatment, an effective method of contraception must be used to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Pazopanib Viatris.

Breastfeeding must not be performed during treatment with Pazopanib Viatris. It is unknown whether components of Pazopanib Viatris pass into human milk. Discuss this with the treating doctor.
Men (including men who have had a vasectomy), whose partners are pregnant or capable of becoming pregnant (including women using other contraceptive methods), should use condoms during sexual intercourse while taking Pazopanib Viatris and for at least 2 weeks after the last dose.
Treatment with Pazopanib Viatris may affect fertility. Discuss this with the treating doctor.
Driving and operating machinery
During treatment with Pazopanib Viatris, adverse effects may occur that could affect the ability to drive or operate machinery.

• Avoid driving and operating machinery if the patient experiences dizziness, fatigue, weakness, or reduced energy levels.

Pazopanib Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to take Pazopanib Viatris

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should
consult your doctor or pharmacist.
How many tablets to take
The usual dose is 800 mg taken once daily. This dose can be taken as two tablets of 400 mg or as four
tablets of 200 mg. The 800 mg dose is the maximum daily dose. Your doctor may recommend reducing
the dose if you experience any adverse effects.
When to take the medicine
Do not take Pazopanib Viatris with food. The medicine should be taken at least two hours after a
meal or one hour before a meal. For example, you may take the medicine two hours after breakfast or
one hour before lunch. Pazopanib Viatris should be taken at the same time each day.
Tablets should be swallowed whole, one after the other, with water. Do not break or crush the tablets,
as this affects the absorption of the medicine and may increase the risk of adverse effects.
Taking more Pazopanib Viatris than prescribed
If you have taken too many tablets, you must seek advice from your doctor or pharmacist immediately.
If possible, show them the packaging or this leaflet.
Missing a dose of Pazopanib Viatris
Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.
Stopping treatment with Pazopanib Viatris
Continue taking Pazopanib Viatris for as long as your doctor recommends. Do not stop taking the
medicine unless your doctor tells you to do so.

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 Viatris can cause brain swelling which may be life-threatening. Symptoms include:

• loss of speech
• vision disturbances
• seizures
• confusion
• high blood pressure

Stop taking Pazopanib Viatris and seek immediate medical help if any of these symptoms occur, or if you experience headache accompanied by any of these symptoms.

Hypertensive crisis (sudden and severe increase in blood pressure)
Pazopanib Viatris may occasionally cause a sudden and severe rise in blood pressure. This condition is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking Pazopanib Viatris. Symptoms of hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe restlessness
• shortness of breath
• seizures
• fainting

Stop taking Pazopanib Viatris and seek immediate medical help if a hypertensive crisis occurs.

Heart problems
The risk of these problems may be higher in people with existing heart disease or those taking other medicines. While taking Pazopanib Viatris, you will be monitored for signs of heart problems.

Heart function disorders/heart failure, heart attack
Pazopanib Viatris may affect the heart's ability to pump blood or may increase the risk of a heart attack. Symptoms include:

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

Seek immediate medical help if any of these symptoms occur.

Changes in heart rhythm (QT interval prolongation)
Pazopanib Viatris may affect heart rhythm, which in some people may lead to a serious heart rhythm disorder called torsade de pointes. This may cause a very rapid heartbeat, which could lead to loss of consciousness.
Tell your doctor if you experience any unusual changes in heart rhythm, such as a heartbeat that is too fast or too slow.

Stroke
Pazopanib Viatris may increase the risk of stroke. Symptoms of stroke may include:

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

Seek immediate medical help if any of these symptoms occur.

Bleeding
Pazopanib Viatris may cause severe bleeding from the gastrointestinal tract (from the stomach, oesophagus, rectum or intestines), from the lungs, kidneys, mouth, vagina, or bleeding into the brain, although this is not common. Symptoms of bleeding include:

• blood in the stool or black stools
• blood in the urine
• abdominal pain
• coughing up blood or vomiting blood

Seek immediate medical help if any of these symptoms occur.

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

• severe abdominal pain
• nausea and (or) vomiting
• fever
• formation of an opening (perforation) in the stomach, large or small intestine, from which blood-stained or foul-smelling pus may discharge

Seek immediate medical help if any of these symptoms occur.

Liver problems
Pazopanib Viatris may cause liver disorders, which may lead to serious conditions such as impaired liver function or liver failure, which may be fatal. Your doctor will monitor your liver enzyme activity while you are taking Pazopanib Viatris. Symptoms indicating impaired liver function may include:

• yellowing of the skin or whites of the eyes (jaundice)
• dark-coloured urine
• feeling tired
• nausea
• vomiting
• loss of appetite
• pain on the right side of the abdomen
• easy bruising

Seek immediate medical help if any of these symptoms occur.

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

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

Thrombotic microangiopathy
Pazopanib Viatris may cause blood clots in small blood vessels in the kidneys and brain, associated with a decrease in red blood cells and platelets (thrombotic microangiopathy). Symptoms include:

• easy bruising
• high blood pressure
• fever
• confusion
• drowsiness
• seizures
• reduced urine output

Seek immediate medical help if any of these symptoms occur.

Tumour lysis syndrome
Pazopanib Viatris 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, confusion, muscle spasms or cramps, or reduced urine output. Seek immediate medical help if any of these symptoms occur.

Infections
Infections occurring during treatment with Pazopanib Viatris 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 during urination
• cuts, scratches or wounds that are red, warm, swollen or painful

Seek immediate medical help if any of these symptoms occur.

Lung inflammation
Pazopanib Viatris may rarely cause lung inflammation (interstitial lung disease, pneumonitis), which may be fatal in some patients. Symptoms include shortness of breath or persistent cough. While taking Pazopanib Viatris, you will be monitored for any lung problems.
Seek immediate medical help if any of these symptoms occur.

Thyroid disorders
Pazopanib Viatris may reduce the production of thyroid hormones in the body. This may lead to weight gain and fatigue. Your doctor will monitor thyroid hormone levels during treatment with Pazopanib Viatris.
Tell your doctor if you notice significant weight gain or fatigue.

Blurred vision or visual disturbances
Pazopanib Viatris may cause detachment or tearing of the membrane at the back of the eye (retinal detachment or tear). This may lead to blurred vision or visual disturbances. Tell your doctor if you notice any changes in vision.

Possible side effects (including potentially serious side effects in the appropriate frequency categories)

Very common side effects (may occur in more than 1 in 10 patients):

• high blood pressure
• diarrhoea
• nausea (feeling sick or vomiting)
• abdominal pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth pain
• headache
• tumour pain
• lack of energy, feeling weak or tired
• hair colour changes
• excessive hair loss or thinning
• skin discolouration
• skin rash, possibly with skin peeling
• redness and swelling of the palms or soles of the feet

Tell your doctor or pharmacist if any of these symptoms become troublesome.

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

• increased liver enzyme activity
• decreased blood albumin levels
• protein in the urine
• decreased platelet count (blood component responsible for clotting)
• decreased white blood cell count

Common side effects (may occur in not more than 1 in 10 patients):

• indigestion, bloating, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• excessive sleepiness
• sleep disturbances
• chest pain, shortness of breath, leg pain and swelling of legs or feet. These may be symptoms of blood clots forming in the body (thrombosis). If a clot detaches, it may travel to the lungs, which may be life-threatening or even fatal.
• reduced ability of the heart to pump blood throughout the body (heart function disorder)
• slow heartbeat
• bleeding from the mouth, rectum or lungs
• dizziness
• blurred vision
• hot flushes
• swelling of the face, hands, legs around the ankles, feet or eyelids due to fluid accumulation
• tingling, weakness or numbness in hands, arms, legs or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, stinging, itching or tingling sensations of the skin
• feeling cold with chills
• excessive sweating
• dehydration
• muscle, joint, tendon or chest pain, muscle cramps
• hoarseness
• shortness of breath
• cough
• coughing up blood
• hiccups
• lung collapse with air trapped between the lung and chest wall, often causing shortness of breath (pneumothorax)

Tell your doctor or pharmacist if any of these symptoms become troublesome.

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

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

Uncommon side effects (may occur in not more than 1 in 100 patients):

• stroke
• transient reduction in 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 associated with reduced red blood cells and platelets (thrombotic microangiopathy). This may damage organs such as the brain and kidneys.
• increased red blood cell count
• sudden shortness of breath, especially if occurring with sudden chest pain and (or) rapid breathing (pulmonary embolism)
• severe gastrointestinal bleeding (from stomach, oesophagus or intestines), kidneys, vagina or bleeding into the brain
• heart rhythm disorders (QT interval prolongation)
• perforation of the stomach or intestine
• formation of abnormal connections between different parts of the intestine (fistula)
• abnormally heavy or irregular menstrual bleeding
• sudden, severe increase in blood pressure (hypertensive crisis)
• pancreatitis
• inflammation, abnormal function or damage to the liver
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the abdominal lining (peritonitis)
• watery nasal discharge
• rashes, which may be itchy or associated with inflammation (flat or raised spots or blisters)
• frequent bowel movements
• increased skin sensitivity to sunlight
• reduced sensation or sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer)

Rare side effects (may occur in not more than 1 in 1000 patients):

• lung inflammation
• enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection)

Frequency not known (frequency cannot be estimated from available data):

• tumour lysis syndrome due to rapid breakdown of tumour cells
• liver failure

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Pazopanib Viatris

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 "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package Contents and Other Information

What Pazopanib Viatris Contains

• The active substance is pazopanib (as hydrochloride). Each 200 mg coated tablet of Pazopanib Viatris contains 200 mg of pazopanib. Each 400 mg coated tablet of Pazopanib Viatris contains 400 mg of pazopanib.
• The other ingredients of the 200 mg and 400 mg tablets are: microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone (K30), magnesium stearate, hypromellose (6 mPas), titanium dioxide (E 171), macrogol 400, polysorbate 80. The 200 mg tablets also contain iron oxide red (E 172).

What Pazopanib Viatris Looks Like and Contents of the Pack
Pazopanib Viatris 200 mg coated tablets are pink, capsule-shaped, film-coated tablets with the inscription "200" embossed on one side. The medicine is available in blister packs containing 30, 60 or 90 tablets, in configurations of 30x1, 60x1 or 90x1 tablets, in multi-packs containing 60 or 60 x 1 (2 cardboard boxes each containing 30 or 2 cardboard boxes each containing 30x1 tablets), 90 or 90x1 (3 cardboard boxes each containing 30 or 3 cardboard boxes each containing 30x1 tablets), as well as in plastic bottles containing 30 or 90 tablets or multi-packs containing 90 tablets (3 bottles of 30 tablets).
Pazopanib Viatris 400 mg coated tablets are white, capsule-shaped, film-coated tablets with the inscription "400" embossed on one side. The medicine is available in blister packs containing 30, 60 or 90 tablets, in configurations of 30x1, 60x1, 90x1 tablets, in multi-packs containing 60 or 60 x 1 (2 cardboard boxes each containing 30 or 2 cardboard boxes each containing 30x1 tablets), 90 or 90x1 (3 cardboard boxes each containing 30 or 3 cardboard boxes each containing 30x1 tablets), as well as in plastic bottles containing 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
(logo of the marketing authorisation holder)

Manufacturer:
Remedica Ltd
Aharnon Street
Limassol Industrial Estate
3056 Limassol
Cyprus
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
Logiters Logistica Portugal S.A.
Estrada Dos Arneiros 4
2050-306 Lisbon
Portugal
Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg
Germany

For further information about this medicine, please contact the local representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Denmark Pazopanib Viatris
Estonia Pazopanib Viatris
France Pazopanib Viatris 200 mg, 400 mg, comprimé pelliculé
Netherlands Pazopanib Viatris 200 mg, 400 mg filmomhulde tabletten
Iceland Pazopanib Viatris
Lithuania Pazopanib Viatris 200 mg, 400 mg plėvele dengtos tabletės
Luxembourg Pazopanib Viatris 200 mg, 400 mg comprimés pelliculés
Latvia Pazopanib Viatris
Germany Pazopanib Viatris 200 mg, 400 mg Filmtabletten
Norway Pazopanib Viatris
Poland Pazopanib Viatris
Portugal Pazopanib Viatris
Czech Republic Pazopanib Viatris
Hungary Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Italy Pazopanib Mylan