Pazopanib Mylan: detailed information

Patient Information Leaflet

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

pazopanib
Generic medicine
Please read all of this leaflet carefully before 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pazopanib Mylan is and what it is used for
What you need to know before taking Pazopanib Mylan
How to take Pazopanib Mylan
Possible side effects
How to store Pazopanib Mylan
Contents of the pack and other information

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

Pazopanib Mylan 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 Mylan 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 can occur in muscles, blood vessels, fatty tissue, or other tissues that support, surround, and protect organs.

2. What you need to know before taking Pazopanib Mylan

Do not take Pazopanib Mylan

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 Mylan

if you have a heart disease.
if you have a liver disease.
if you have had heart failure or a heart attack.
if you have previously had a lung 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 Mylan is suitable for you. You may need additional tests to check that your kidneys, heart, and liver are working properly.

High blood pressure and Pazopanib Mylan
Pazopanib Mylan can increase blood pressure. Your blood pressure will be monitored
before starting and during treatment with Pazopanib Mylan. 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 Mylan at least 7 days before surgery because the
medicine may affect wound healing. Treatment will be restarted once the wound has
healed adequately.
Conditions you should watch for
Pazopanib Mylan may worsen certain conditions or cause serious side effects. To reduce the
risk of any problems, you should pay attention to certain symptoms while taking
Pazopanib Mylan. See section 4.
Children and adolescents
Pazopanib Mylan is not recommended for people under 18 years of age. It is not yet known how
it works in this age group. Moreover, it should not be used in children under 2 years of age
due to safety concerns.
Other medicines and Pazopanib Mylan
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 Mylan works and may increase the likelihood
of you experiencing side effects.
Conversely, Pazopanib Mylan 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 acid. The type of medicine you are taking to reduce stomach acid (e.g. proton pump inhibitors, H\2 antagonists, or antacids) may affect how you should take Pazopanib Mylan. Talk to your doctor or nurse for advice. Tell your doctor or pharmacist if you are taking any of these medicines.

Pazopanib Mylan with food and drink
Do not take Pazopanib Mylan 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 Mylan, as this may
increase the risk of side effects.
Pregnancy, breastfeeding, and fertility
Pazopanib Mylan is not recommended if you are pregnant. The effects of Pazopanib
Mylan 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 Mylan, and for at least 2 weeks after stopping, to prevent pregnancy.
If you become pregnant during treatment with Pazopanib Mylan, tell your doctor.

You must not breastfeed while taking Pazopanib Mylan. It is not known whether the
components of Pazopanib Mylan 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 who could become pregnant (including those using other contraceptive methods), you must use a condom during sexual intercourse while taking Pazopanib Mylan and for at least
2 weeks after the last dose.
Fertility may be affected by treatment with Pazopanib Mylan. Discuss this with your doctor.
Driving and using machines
Pazopanib Mylan may cause side effects that could affect your ability to drive or
operate machinery.

Avoid driving or operating machinery if you feel dizzy, tired, weak, or have low energy levels.

Pazopanib Mylan 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 Mylan

Take this medicine exactly as your doctor has told you. If you are unsure,
ask 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 dose of 800 mg once daily 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 Mylan 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
Mylan 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 may affect how the medicine is absorbed and could increase the risk of side effects.
If you take more Pazopanib Mylan 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 Mylan
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 Mylan without medical advice
Take Pazopanib Mylan for as long as your doctor recommends. Do not stop 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 leucoencephalopathy syndrome)
Pazopanib Mylan 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 Mylan 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 crises (sudden and severe increase in blood pressure)
Pazopanib Mylan 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 Mylan. 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 Mylan 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 any heart problems while taking Pazopanib Mylan.
Heart dysfunction/heart failure, heart attack
Pazopanib Mylan may affect the heart's pumping activity or increase the likelihood of having a heart attack. Signs and symptoms include:

irregular or rapid heartbeat
fast heartbeat
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 Mylan may affect heart rhythm, which in some people can lead to a potentially serious heart condition known as torsade de pointes. This may result in a very rapid heartbeat causing sudden loss of consciousness.
Inform your doctor if you notice any unusual changes in your heartbeat, such as one that is too fast or too slow.
Stroke
Pazopanib Mylan 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 Seek immediate medical help if you experience any of these symptoms.

Bleeding
Pazopanib Mylan may cause severe bleeding in the digestive 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 Mylan 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 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 foul-smelling, bloody pus is released Seek immediate medical help if you experience any of these symptoms.

Liver problems
Pazopanib Mylan 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 your liver enzymes while you are taking Pazopanib Mylan. 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 Mylan 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 Mylan may cause blood clots in small blood vessels in the kidneys and brain, accompanied by a decrease in red blood cells and platelets (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 Mylan may cause rapid breakdown of tumour cells leading to tumour lysis syndrome, which in some people may be fatal. Symptoms may include irregular heartbeat, seizures (fits), confusion, muscle cramps or spasms, or reduced urine output. Seek immediate medical help if you experience any of these symptoms.
Infections
Infections occurring while taking Pazopanib Mylan 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 laboured breathing
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
Rarely, Pazopanib Mylan may cause inflammation of the lungs (interstitial lung disease, pneumonia), which in some people may be fatal. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib Mylan, you will be monitored for any lung problems. Seek immediate medical help if you experience any of these symptoms.
Thyroid problems
Pazopanib Mylan may reduce the amount of thyroid hormone produced by the body. This may cause weight gain and fatigue. While taking Pazopanib Mylan, your thyroid hormone levels will be monitored. Inform your doctor if you notice significant weight gain or fatigue.
Blurred or impaired vision
Pazopanib Mylan 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 according to the relevant frequency category).
Very common side effects (may affect more than 1 in 10 people):

high blood pressure
diarrhoea
feeling unwell (nausea or vomiting)
stomach pain
loss of appetite
weight loss
taste disturbances or loss of taste
mouth pain
headache
pain at tumour site
lack of energy, feeling weak or tired
change 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 worsen or become bothersome.

Very common side effects that may be evident from blood or urine tests:

increased liver enzymes
reduced albumin in the blood
protein in the urine
reduced number of platelets in the blood (cells that help blood to clot)
reduced number of white blood cells in the blood

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, which may be life-threatening or even fatal.
the heart becomes less effective at pumping blood around the body (cardiac dysfunction)
slow 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, stinging, 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 air trapped 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 evident from 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 the 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)
partial 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 number of red blood cells in the blood
sudden onset of shortness of breath, especially when accompanied by sharp chest pain and/or rapid breathing (pulmonary embolism)
severe bleeding in the digestive tract (such as 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, poorly functioning 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 rash which 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 (pneumonia)
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 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, 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 Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the blister, bottle, and 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. Package contents and other information

What Pazopanib Mylan contains

The active substance is pazopanib (as hydrochloride). Each film-coated tablet of Pazopanib Mylan 200 mg contains 200 mg of pazopanib. Each film-coated tablet of Pazopanib Mylan 400 mg contains 400 mg of pazopanib.
The other ingredients in the 200 mg and 400 mg tablets are: microcrystalline cellulose, sodium starch glycolate (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 Mylan and contents of the pack
The film-coated tablets of Pazopanib Mylan 200 mg are capsule-shaped, pink, with '200' engraved on one side.
They are available in blisters of 30, 60 or 90 tablets, 30×1, 60×1 or 90×1 tablets, multiple packs of 60 or 60×1 (2 packs of 30 or 2 packs of 30×1), 90 or 90×1 (3 packs of 30 or 3 packs of 30×1) tablets, and in plastic bottles containing 30 or 90 tablets or multiple packs of 90 (3 bottles of 30) tablets.
The film-coated tablets of Pazopanib Mylan 400 mg are capsule-shaped, white, with '400' engraved on one side.
They are available in blisters of 30, 60 or 90 tablets, 30×1, 60×1 or 90×1 tablets, multiple packs of 60 or 60×1 (2 packs of 30 or 2 packs of 30×1), 90 or 90×1 (3 packs of 30 or 3 packs of 30×1) tablets, and in plastic bottles containing 30 or 60 tablets.
Not all pack sizes or tablet strengths may be available in your country.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Logiters Logistica Portugal SA
Estrada Dos Arneiros 4
Azumbuja
Lisbon, 2050-306
Portugal
Mylan Germany GmbH
Benzstrasse 1
Bad Homburg, 61352
Germany
Pharos MT Limited
Hf62x, Qasam Industrijali Hal Far
Birzebbuga
BBG3000
Malta
Pharos Pharmaceutical Oriented Services Ltd.
Lesvou Street End,
Thesi Loggos Industrial Zone,
Metamorfossi, 14452,
Greece
Remedica Limited
Aharnon Street,
Limassol Industrial Estate,
Limassol, 3056,
Cyprus

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