PAZOPANIB GLENMARK 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pazopanib Glenmark 200 mg film-coated tablets EFG

Pazopanib Glenmark 400 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Pazopanib 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 is used in adults to treat:

• Advanced or metastatic renal cell cancer.
• Certain types of soft tissue sarcoma, which is a type of cancer that affects the connective tissue of the body. It can occur in muscles, blood vessels, fat tissue, or other tissues that connect, surround, and protect organs.

2. What you need to know before you take Pazopanib Glenmark

Do not take Pazopanib Glenmark

• If you are allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6).

Consult your doctorif you think this may apply to you.

Warnings and precautions

Consult your doctor before starting pazopanib:

• if you have a heart condition.
• if you have a liver condition.
• if you have had heart failure or a heart attack.
• if you have had a previous pulmonary collapse.
• if you have had bleeding, blood clotting, or artery narrowing problems.
• if you have had stomach or intestinal problemssuch as perforation(hole) or fistula(abnormal passages that form between parts of the intestine).
• if you have thyroid problems.
• if you have kidney problems.
• if you have had an aneurysm(enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.

Consult your doctorif you think you may have any of these problems. Your doctor will decide if pazopanib is suitable for you. You may need additional teststo check that your kidneys, heart, and liver are working properly.

High blood pressure and Pazopanib Glenmark

Pazopanib may increase your blood pressure. Your doctor will check your blood pressure before you take pazopanib and while you are taking it. If you have high blood pressure, you will receive treatment with medicines to help lower it.

• Tell your doctor if you have high blood pressure.

If you are going to have an operation

Your doctor will tell you to stop taking pazopanib at least 7 days before your operation, as this may affect wound healing. Your treatment will be restarted when your wounds have healed properly.

Conditions that require your attention

Pazopanib may make other conditions worse or cause serious side effects. You should be aware of certain symptoms while taking pazopanib to reduce the risk of any problems. See section 4.

Children and adolescents

Pazopanib is not recommended for people under 18 years of age. It is not known how pazopanib works in this age group. Additionally, 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, including herbal medicines and medicines obtained without a prescription.

Some medicines may affect how pazopanib works or increase the chance of you experiencing side effects. Pazopanib may also 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., a proton pump inhibitor, H2 receptor antagonists, or antacids) may affect how you take pazopanib. Consult your doctor or nurse for more information.

Tell your doctoror pharmacist if you are taking any of these medicines.

Taking Pazopanib Glenmark with food and drinks

Do not take pazopanib with food, as this affects the absorption of the medicine. Take it at least 2 hours after a meal or 1 hour before a meal (see section 3).

Do not drink grapefruit juicewhile being treated with pazopanib, as this may increase the chance of side effects.

Pregnancy, breast-feeding, and fertility

Pazopanib is not recommended if you are pregnant. The effect of pazopanib during pregnancy is not known.

• Tell your doctor if you are pregnantor planning to become pregnant.
• Use a reliable contraceptive methodwhile taking pazopanib and for at least 2 weeks after, to prevent pregnancy.
• If you become pregnant during treatmentwith pazopanib, tell your doctor.

Do not breast-feed while taking pazopanib. It is not known if the components of pazopanib pass into breast milk. Inform your doctor about this.

Male patients(including those who have undergone vasectomy) who have partners who are pregnant or may become pregnant (including those using other contraceptive methods) must use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose.

Fertility may be affectedby treatment with pazopanib. Consult your doctor about this.

Driving and using machines

Pazopanib may cause side effects that may affect your ability to drive or use machines.

• Avoid driving or using machines if you feel dizzy, tired, or weak, or if you are low on energy.

Pazopanib Glenmark contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Pazopanib Glenmark

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

Pazopanib Glenmark 200 mg film-coated tablets EFG

The normal doseis four Pazopanib Glenmark 200 mg tablets (800 mg of pazopanib) taken once a day. The dose of 800 mg once a day is the maximum daily dose. Your doctor may need to reduce your dose if you experience side effects.

Pazopanib Glenmark 400 mg film-coated tablets EFG

The normal doseis two Pazopanib Glenmark 400 mg tablets (800 mg of pazopanib) taken once a day. The dose of 800 mg once a day is the maximum daily dose. Your doctor may need to reduce your dose if you experience side effects.

When to take it

Do not take pazopanib with food. Take it at least 2 hours after a meal or 1 hour before a meal. For example, you can take it 2 hours after breakfast or 1 hour before lunch. Take pazopanib at the same time every day.

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 chance of side effects.

If you take more Pazopanib Glenmark than you should

If you take more tablets than you should, seek advice from your doctor or pharmacistor call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Pazopanib Glenmark

Do not take a double dose to make up for forgotten doses. Just take your next dose at the usual time.

Do not stop treatment with Pazopanib Glenmark

Take pazopanib for the time your doctor has recommended. Do not stop treatment unless your doctor advises you to.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible Serious Adverse Effects

Brain Inflammation(reversible posterior leukoencephalopathy syndrome).

Rarely, pazopanib can cause brain inflammation, which can put your life at risk. Symptoms include:

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

Stop taking pazopanib and seek medical attention immediatelyif 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 can cause a sudden and severe increase in blood pressure in some cases. This is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking pazopanib. Signs and symptoms of a hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe anxiety
• difficulty breathing
• seizures
• fainting

Stop taking pazopanib and seek medical attention immediatelyif you experience a hypertensive crisis.

Heart Diseases

The risk of experiencing these problems may be higher in people who have a heart problem or are taking other medications. While taking pazopanib, you will be monitored for any heart problems.

Cardiac Alteration/Heart Failure, Cardiac Arrest

Pazopanib can affect the way the heart pumps or increase the likelihood of cardiac arrest. Signs and symptoms include:

• irregular or rapid heartbeat
• rapid heart palpitations
• fainting
• chest pain or pressure
• pain in the arms, back, neck, or jaw
• difficulty breathing
• swelling in the legs

Seek medical attention immediatelyif you experience any of these symptoms.

Changes in Heart Rhythm (QT Interval Prolongation)

Pazopanib can affect the heart rhythm, which in some people can trigger a potentially serious heart disease known as torsades de pointes. This can cause an acceleration of the heart rhythm that can lead to loss of consciousness.

Tell your doctorif you notice any unusual change in your heartbeat, such as beats that are too fast or too slow.

Stroke

Pazopanib can increase the likelihood of experiencing a stroke. Signs and symptoms of a stroke may include:

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

Seek medical attention immediatelyif you experience any of these symptoms.

Bleeding

Pazopanib can cause severe bleeding in the digestive system (in the stomach, esophagus, rectum, or intestine), or in the lungs, kidneys, mouth, vagina, and brain, although this is rare. Symptoms include:

• blood in the stool or black stool
• blood in the urine
• stomach pain
• coughing or vomiting blood

Seek medical attention immediatelyif you experience any of these symptoms.

Perforation and Fistula

Pazopanib can cause a perforation in the stomach or intestinal wall or the formation 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 perforation in the stomach or intestine from which bloody or foul-smelling pus is released

Seek medical attention immediatelyif you experience any of these symptoms.

Liver Problems

Pazopanib can cause liver problems that can become serious diseases such as liver failure or liver damage, which can be fatal. Your doctor will monitor your liver enzymes while you are taking pazopanib. Signs that your liver may not be working properly may include:

• yellowing of the skin or the white part of the eyes (jaundice)
• dark-colored urine
• fatigue
• nausea
• vomiting
• loss of appetite
• pain in the right side of the stomach area (abdomen)
• easy bruising

Seek medical attention immediatelyif you experience any of these symptoms.

Blood Clots

Deep Vein Thrombosis (DVT) and Pulmonary Embolism

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

• sharp chest pain
• difficulty breathing
• rapid breathing
• leg pain
• swelling of the arms and hands or legs and feet

Thrombotic Microangiopathy (TMA)

Pazopanib can cause blood clots in the small blood vessels of the kidneys and brain, accompanied by a reduction 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
• decreased urine output

Seek medical attention immediatelyif you experience any of these symptoms.

Tumor Lysis Syndrome

Pazopanib can cause rapid destruction of cancer cells, leading to tumor lysis syndrome, which in some people can be fatal. Symptoms may include irregular heartbeat, seizures, confusion, muscle cramps or spasms, or decreased urine output. Seek medical attention immediatelyif you experience any of these symptoms.

Infections

Infections that occur while taking pazopanib can become serious. Symptoms of infections may include:

• fever
• flu-like symptoms, such as cough, fatigue, and body aches that do not go away
• difficulty breathing and/or wheezing
• painful urination
• cuts, scratches, or wounds that are red, hot, swollen, or painful

Seek medical attention immediatelyif you experience any of these symptoms.

Lung Inflammation

Pazopanib can rarely cause lung inflammation (interstitial lung disease, pneumonitis), which in some people can be fatal. Symptoms include difficulty breathing or cough that does not go away. You will be monitored for any lung problems while taking pazopanib. Seek medical attention immediatelyif you experience any of these symptoms.

Thyroid Problems

Pazopanib can decrease the amount of thyroid hormone produced in your body. This can cause weight gain and fatigue. Your thyroid hormone levels will be monitored while you are taking pazopanib. Tell your doctorif you notice significant weight gain or fatigue.

Blurred Vision or Vision Changes

Pazopanib can cause separation or tearing of the back of the eye (retinal detachment or tear). This can cause blurred vision or changes in vision. Tell your doctorif you notice any changes in your vision.

Possible Adverse Effects (including possible serious adverse effects under the category of relevant frequency).

Very Common Adverse Effects(may affect more than 1 in 10people):

• high blood pressure
• diarrhea
• feeling or being nauseous (nausea or vomiting)
• stomach pain
• loss of appetite
• weight loss
• taste changes or loss of taste
• mouth irritation
• headache
• tumor pain
• lack of energy, feeling of weakness or fatigue
• hair color changes
• unusual hair loss or fragility
• skin depigmentation
• skin rash, possibly with skin peeling
• redness and inflammation on the palms of the hands and soles of the feet

Tell your doctor or pharmacistif any of these adverse effects become problematic.

Very Common Adverse Effects that may appear in your blood or urine tests:

• increased liver enzymes
• decrease in blood albumin
• protein in the urine
• decrease in platelet count (blood cells involved in blood clotting)
• decrease in white blood cell count

Common Adverse Effects(may affect up to 1 in 10people):

• indigestion, feeling bloated, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• abnormal numbness
• difficulty sleeping
• chest pain, difficulty breathing, leg pain, leg swelling. These may be signs of blood clotting in the body (thromboembolism). If the clot breaks loose, it can travel to the lungs and become a health threat or even cause death
• reduced heart function (heart failure)
• slow heartbeats
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling caused by fluid retention in the face, hands, ankles, feet, or eyelids
• tingling, weakness, or numbness in the hands, arms, legs, or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, itching, prickling, or tingling sensation on the skin
• feeling of coldness, with chills
• excessive sweating
• dehydration
• muscle, joint, tendon, or chest pain, muscle spasms
• hoarseness
• difficulty breathing
• coughing
• coughing up blood
• hiccups
• collapsed lungs with air trapped in the space between the lungs and the chest, often causing difficulty breathing (pneumothorax)

Tell your doctoror pharmacist if any of these adverse effects become problematic.

Common Adverse Effects that may appear in your blood or urine tests:

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

Uncommon Adverse Effects(may affect up to 1 in 100people):

• stroke
• temporary reduction in blood supply to the brain (transient ischemic attack)
• interruption of blood supply to a part of the heart or heart attack (myocardial infarction)
• partial interruption of blood supply to a part of the heart (myocardial ischemia)
• blood clots accompanied by a decrease in red blood cells and other cells involved in blood clotting (thrombotic microangiopathy, TMA). These can cause damage to organs such as the brain and kidneys
• increase in red blood cell count
• sudden difficulty breathing, especially when accompanied by sharp chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding in the digestive system (in the stomach, esophagus, or intestine), or in the kidneys, vagina, and brain
• heart rhythm changes (QT interval prolongation)
• hole (perforation) in the stomach or intestine
• abnormal connections between parts of the intestine (fistula)
• heavy or irregular menstrual periods
• sudden increases in blood pressure (hypertensive crisis)
• pancreatitis (inflammation of the pancreas)
• inflamed, poorly functioning, or damaged liver
• yellowing of the skin or the white part of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• snoring
• rashes that can itch or become inflamed (flat or raised patches or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• decreased sensitivity, especially in the skin
• skin wound that does not heal (skin ulcer)

Rare Adverse Effects(may affect up to 1 in 1,000people):

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

Frequency Not Known(cannot be estimated from the available data):

• tumor lysis syndrome, resulting from rapid destruction of cancer cells
• liver failure

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online system: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pazopanib Glenmark

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pazopanib Glenmark

Pazopanib Glenmark 200 mg film-coated tablets

• The active ingredient is pazopanib (as hydrochloride).

Each Pazopanib Glenmark 200 mg film-coated tablet contains 200 mg of pazopanib.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (from potato), povidone (E1201), magnesium stearate (E470b).

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172), polysorbate 80 (E433).

Pazopanib Glenmark 400 mg film-coated tablets

• The active ingredient is pazopanib (as hydrochloride).

Each Pazopanib Glenmark 400 mg film-coated tablet contains 400 mg of pazopanib.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (from potato), povidone (E1201), magnesium stearate (E470b).

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), polysorbate 80 (E433).

Appearance and Packaging of the Product

Pazopanib Glenmark 200 mg film-coated tablets EFG

Oval-shaped tablets, pink in color, marked with "200" on one side, with dimensions of approximately 14 mm x 6 mm.

Supplied in transparent aluminum-PVC/PE/PVDC blisters of 30, 90, multiple packaging of 90 (3 packages of 30) film-coated tablets.

Supplied in transparent aluminum-PVC/PE/PVDC single-dose blisters of 30 x 1, 90 x 1, multiple packaging of 90 x 1 (3 packages of 30 x 1) film-coated tablets.

Pazopanib Glenmark 400 mg film-coated tablets EFG

Oval-shaped tablets, white in color, marked with "400" on one side, with dimensions of approximately 18 mm x 7 mm.

Supplied in transparent aluminum-PVC/PE/PVDC blisters of 30, 60, multiple packaging of 60 (2 packages of 30) film-coated tablets.

Supplied in transparent aluminum-PVC/PE/PVDC single-dose blisters of 30 x 1, 60 x 1, multiple packaging of 60 x 1 (2 packages of 30 x 1) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

You can request more information about this medicine from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

Date of the last revision of this leaflet:May 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es).