Pazopanib Glenmark

Patient Information Leaflet

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

Pazopanib
Generic medicine
Please read all of this leaflet carefully before you take 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 others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pazopanib Glenmark is a type of medicine called a protein kinase inhibitor. It works by preventing the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Glenmark 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 organs.

2. What you should know before taking Pazopanib Glenmark

Do not take Pazopanib Glenmark

• 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 Glenmark:

• 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 kidney function problems.
• if you have or have had an aneurysm (a bulging and weakening of the wall of a blood vessel) 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 Glenmark 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 Glenmark
Pazopanib Glenmark can increase blood pressure. Your blood pressure will be monitored
before starting and during treatment with Pazopanib Glenmark. 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 Pazopanib Glenmark at least 7 days before surgery,
as the medicine may affect wound healing. Treatment will be restarted once the wound has healed adequately.

Conditions to be aware of
Pazopanib Glenmark 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 Glenmark. See section 4.

Children and adolescents
Pazopanib Glenmark 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 Glenmark
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 Glenmark works and may
increase the likelihood of side effects. Conversely, Pazopanib Glenmark can
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 acidity (e.g. proton pump inhibitors, H2 antagonists, or antacids) may affect how you should take Pazopanib Glenmark. Consult your doctor or nurse for advice.

Inform your doctor or pharmacist if you are taking any of these medicines.

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

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

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

You must not breastfeed while taking Pazopanib Glenmark. It is not known whether the components of Pazopanib Glenmark 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 Glenmark and for at least 2 weeks after the last dose.

Fertility may be affected by treatment with Pazopanib Glenmark. Talk to your doctor about this.

Driving and using machines
Pazopanib Glenmark 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 Glenmark 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 Glenmark

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
How much to take
Pazopanib Glenmark 200 mg film-coated tablets:
The recommended dose is four Pazopanib Glenmark 200 mg tablets (800 mg of
pazopanib) taken once daily. This is the maximum daily dose. Your doctor may need to reduce the dose if you experience adverse effects.
Pazopanib Glenmark 400 mg film-coated tablets:
The recommended dose is two Pazopanib Glenmark 400 mg tablets (800 mg of pazopanib)
taken once daily. This is the maximum daily dose. Your doctor may need to
reduce the dose if you experience adverse effects.
When to take it
Do not take Pazopanib Glenmark 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 Glenmark 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 adverse effects.
If you take more Pazopanib Glenmark 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 Glenmark
Do not take a double dose to make up for the forgotten dose. Take only the next dose at the usual time.
Do not stop taking Pazopanib Glenmark without medical advice
Take Pazopanib Glenmark 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 Glenmark 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 Glenmark 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 Glenmark 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 Glenmark. 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 Glenmark 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 Glenmark.

Cardiac dysfunction/heart failure, heart attack
Pazopanib Glenmark can affect the heart's pumping activity and may 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 the legs

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

Changes in heart rhythm (QT prolongation)
Pazopanib Glenmark may affect heart rhythm, which in some people can 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 one that is too fast or too slow.

Stroke
Pazopanib Glenmark 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 Glenmark may cause serious bleeding in the gastrointestinal tract (such as stomach, esophagus, rectum, or intestine), or in the lungs, kidneys, mouth, vagina, or 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 Glenmark 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 foul-smelling discharge is released

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

Liver problems
Pazopanib Glenmark 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 Glenmark. 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 Glenmark 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 Glenmark 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 blood 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 Glenmark 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 (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 Glenmark 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 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 Glenmark may cause inflammation of the lungs (pulmonary interstitial disease, pneumonia), which may be fatal in some people. Symptoms include shortness of breath or persistent cough. While taking Pazopanib Glenmark, you will be monitored for any lung problems.
Seek immediate medical help if you experience any of these symptoms.

Thyroid problems
Pazopanib Glenmark may reduce the amount of thyroid hormone produced by the body. This may cause weight gain and fatigue. While taking Pazopanib Glenmark, your thyroid hormone levels will be monitored.
Inform your doctor if you notice significant weight gain or fatigue.

Blurred or impaired vision
Pazopanib Glenmark 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 your 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
• 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
• 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 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 in the blood

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

• indigestion, bloating, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• abnormal 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 can be life-threatening or even fatal.
• reduced effectiveness of the heart in 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 sensation, prickling, itching, or tingling 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)
• reduced 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)
• serious gastrointestinal bleeding (such as in stomach, oesophagus, or intestine), or in kidneys, vagina, or 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 rise in blood pressure (hypertensive crisis)
• inflammation of the pancreas (pancreatitis)
• inflamed liver that is not functioning properly or is 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 1000 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 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 Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle or blister pack 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 Glenmark contains
Pazopanib Glenmark 200 mg film-coated tablets:

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

Pazopanib Glenmark 400 mg film-coated tablets:

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

Description of the appearance of Pazopanib Glenmark and package contents
Pazopanib Glenmark 200 mg film-coated tablets:
Pazopanib Glenmark 200 mg film-coated tablets are capsule-shaped, pink, with "200" printed on one side, approximately 14 mm x 6 mm in size.
They are supplied in clear/transparent aluminium-PVC/PE/PVDC blisters containing 30, 90 tablets, and multiple pack containing 90 (3 packs of 30) tablets.
They are also supplied in unit-dose divisible blisters, clear/transparent aluminium-PVC/PE/PVDC, containing 30 x 1, 90 x 1 tablets, and multiple pack containing 90 x 1 (3 packs of 30 x 1) tablets.

Pazopanib Glenmark 400 mg film-coated tablets:
Pazopanib Glenmark 400 mg film-coated tablets are capsule-shaped, white, with "400" printed on one side, approximately 18 mm x 7 mm in size.
They are supplied in clear/transparent aluminium-PVC/PE/PVDC blisters containing 30, 60 tablets, and multiple pack containing 60 (2 packs of 30) tablets.
They are also supplied in unit-dose divisible blisters, clear/transparent aluminium-PVC/PE/PVDC, containing 30 x 1, 60 x 1 tablets, and multiple pack containing 60 x 1 (2 packs of 30 x 1) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Glenmark Arzneimittel GmbH
Industriestrasse 31
82194 Groebenzell
Bavaria
Germany

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate, Limassol 3056, Cyprus
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Pazopanib Glenmark
Hungary: Pazopanib Glenmark 200 mg filmtabletta
Pazopanib Glenmark 400 mg filmtabletta