Pazopanib Zentiva

Package Leaflet: Information for the Patient

Pazopanib Zentiva, 200 mg, Film-Coated Tablets

Pazopanib Zentiva, 400 mg, Film-Coated Tablets

Pazopanib

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms 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 Package Leaflet

• 1. What is Pazopanib Zentiva and What Is It Used For
• 2. Before You Take Pazopanib Zentiva
• 3. How to Take Pazopanib Zentiva
• 4. Possible Side Effects
• 5. How to Store Pazopanib Zentiva
• 6. Contents of the Pack and Other Information

1. What is Pazopanib Zentiva and What Is It Used For

Pazopanib Zentiva 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 Zentiva is used in adults to treat:

• advanced or metastatic renal cell carcinoma.
• certain types of soft tissue sarcoma, which is a type of cancer that affects the supporting tissues of the body, such as muscles, blood vessels, fat, and other tissues that support the internal organs.

2. Before You Take Pazopanib Zentiva

When You Should Not Take Pazopanib Zentiva

• If you are allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6). You should consult your doctorif you think this applies to you.

Warnings and Precautions

Before taking Pazopanib Zentiva, you should discuss with your doctor:

• if you have heart disease
• if you have liver disease
• if you have had heart failure or a heart attack
• if you have had a collapsed lung (pulmonary embolism)
• if you have had bleeding, blood clots, or narrowing of the arteries
• if you have had stomach or intestinal diseasessuch as perforation (a hole in the stomach or intestine) or fistula (an abnormal connection between different parts of the intestine)
• if you have thyroid disease
• if you have kidney problems
• if you have or have had an aneurysm (a bulge or weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel. You should tell your doctorif you have any of these conditions. Your doctor will decide if Pazopanib Zentiva is suitable for you. You may need to have additional tests to check if your kidneys, heart, and liver are working properly.

High Blood Pressure and Taking Pazopanib Zentiva

Pazopanib Zentiva may cause an increase in blood pressure. Before and during treatment with Pazopanib Zentiva, your blood pressure will be checked.

• You should tell your doctorif you have high blood pressure.

If You Are Going to Have Surgery

Your doctor will advise you to stop taking Pazopanib Zentiva at least 7 days before surgery, as it may affect the healing of wounds after surgery. Treatment will be restarted after the wound has healed.

Conditions to Be Aware Of

Pazopanib Zentiva may make some conditions worse or cause serious side effects. During treatment with Pazopanib Zentiva, you should be aware of certain symptoms to reduce the risk of serious side effects. See section 4.

Children and Adolescents

Pazopanib Zentiva should not be used in patients under 18 years of age. The safety and efficacy of Pazopanib Zentiva in this age group have not been established. Additionally, for safety reasons, Pazopanib Zentiva should not be used in children under 2 years of age.

Other Medicines and Pazopanib Zentiva

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and those you plan to take, including:

• herbal preparations and other medicines that you can buy without a prescription.

Some medicines may affect the way Pazopanib Zentiva works or increase the risk of side effects. Pazopanib Zentiva may also affect the way other medicines work. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections)
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infections)
• nefazodone (used to treat depression)
• simvastatin and possibly other statins (used to treat high cholesterol)
• medicines that reduce stomach acid (such as proton pump inhibitors, H2 receptor antagonists, or antacids). Medicines that reduce stomach acid may affect the absorption of Pazopanib Zentiva. Consult your doctor or nurse for advice.

You should tell your doctor or pharmacistif you are taking any of these medicines.

Pazopanib Zentiva with Food and Drink

Do not take Pazopanib Zentiva with food, as it may affect the absorption of the medicine. Take Pazopanib Zentiva at least 2 hours after food or 1 hour before food (see section 3).

Do not drink grapefruit juicewhile taking Pazopanib Zentiva, as it may increase the risk of side effects.

Pregnancy, Breast-Feeding, and Fertility

Pazopanib Zentiva should not be used during pregnancy. It is not known how Pazopanib Zentiva affects pregnancy.

• You should tell your doctor if you are pregnant or planning to become pregnant.
• During treatment with Pazopanib Zentiva and for at least 2 weeks after stopping treatment, you should use effective contraception to prevent pregnancy.
• You should tell your doctor if you become pregnant while taking Pazopanib Zentiva.

Do not breast-feed while taking Pazopanib Zentiva. It is not known if Pazopanib Zentiva passes into breast milk. Consult your doctor.

Men(including those who have had a vasectomy), whose partners are pregnant or are able to become pregnant, should use condoms during sexual intercourse while taking Pazopanib Zentiva and for at least 2 weeks after stopping treatment.

Treatment with Pazopanib Zentiva may affect fertility. Consult your doctor.

Driving and Using Machines

While taking Pazopanib Zentiva, you may experience side effects that affect your ability to drive or use machines.

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

Pazopanib Zentiva Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to Take Pazopanib Zentiva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

How Many Tablets to Take

Pazopanib Zentiva, 200 mg, film-coated tablets:

The usual doseof Pazopanib Zentiva 200 mg is four tablets (800 mg pazopanib) taken once a day. This is the maximum daily dose. Your doctor may reduce the dose if you experience side effects.

Pazopanib Zentiva, 400 mg, film-coated tablets:

The usual doseof Pazopanib Zentiva 400 mg is two tablets (800 mg pazopanib) taken once a day. This is the maximum daily dose. Your doctor may reduce the dose if you experience side effects.

When to Take the Medicine

Do not take Pazopanib Zentiva with food. Take Pazopanib Zentiva at least 2 hours after food or 1 hour before food.

For example, you can take the medicine 2 hours after breakfast or 1 hour before lunch. Take Pazopanib Zentiva at the same time every day.

Swallow the tablets whole with water. Do not crush or break the tablets, as this may affect the absorption of the medicine and increase the risk of side effects.

If You Take More Pazopanib Zentiva Than You Should

If you take too many tablets, consult your doctor or pharmacist. If possible, show them the pack or this leaflet.

If You Forget to Take Pazopanib Zentiva

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

Do Not Stop Taking Pazopanib Zentiva Without Consulting Your Doctor

Take Pazopanib Zentiva for as long as your doctor tells you to. Do not stop taking the medicine unless your doctor tells you to.

4. Possible Side Effects

Like all medicines, Pazopanib Zentiva can cause side effects, although not everybody gets them.

Serious Side Effects

Brain Swelling (Posterior Reversible Encephalopathy Syndrome)

Pazopanib Zentiva may rarely cause brain swelling, which can be life-threatening. Symptoms include:

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

Stop Taking Pazopanib Zentiva and Seek Medical Help Immediately

if you experience any of these symptoms or a headache with any of these symptoms.

Hypertensive Crisis (Sudden and Severe Increase in Blood Pressure)

Pazopanib Zentiva may rarely cause a sudden and severe increase in blood pressure, known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking Pazopanib Zentiva. Symptoms of a hypertensive crisis may include:

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

Stop Taking Pazopanib Zentiva and Seek Medical Help Immediately

if you experience a hypertensive crisis.

Heart Problems

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

Heart Problems, Heart Failure, and Heart Attack

Pazopanib Zentiva may affect the heart's ability to pump blood or increase the risk of a heart attack. Symptoms may include:

• irregular or rapid heartbeat
• rapid palpitations
• fainting
• chest pain or tightness
• arm, back, neck, or jaw pain
• shortness of breath
• swelling of the legs

Seek Medical Help Immediatelyif you experience any of these symptoms.

Stroke

Pazopanib Zentiva may increase the risk of stroke. Symptoms may include:

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

Seek Medical Help Immediatelyif you experience any of these symptoms.

Bleeding

Pazopanib Zentiva may cause serious bleeding, including bleeding from the digestive tract, lungs, kidneys, mouth, vagina, or brain, although this is not common. Symptoms of bleeding may include:

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

Seek Medical Help Immediatelyif you experience any of these symptoms.

Perforation and Fistula

Pazopanib Zentiva may cause a hole in the stomach or intestine (perforation) or an abnormal connection between different parts of the digestive tract (fistula). Symptoms may include:

• severe abdominal pain
• nausea and vomiting
• fever
• a hole in the stomach, intestine, or other parts of the digestive tract, with bleeding or foul-smelling discharge

Seek Medical Help Immediatelyif you experience any of these symptoms.

Liver Problems

Pazopanib Zentiva may cause liver problems, which can lead to serious liver disease and liver failure, which can be life-threatening. Your doctor will monitor your liver function while you are taking Pazopanib Zentiva. Symptoms of liver problems may include:

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

Seek Medical Help Immediatelyif you experience any of these symptoms.

Blood Clots

Deep Vein Thrombosis (DVT) and Pulmonary Embolism

Pazopanib Zentiva may cause blood clots in the veins, especially in the legs (DVT), which can move to the lungs (pulmonary embolism). Symptoms may include:

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

Thrombotic Microangiopathy (TMA)

Pazopanib Zentiva may cause blood clots in small blood vessels in the kidneys and brain, which can damage organs such as the brain and kidneys. Symptoms may include:

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

Seek Medical Help Immediatelyif you experience any of these symptoms.

Tumor Lysis Syndrome

Pazopanib Zentiva may cause rapid breakdown of cancer cells, leading to tumor lysis syndrome, which can be life-threatening. Symptoms may include:

• irregular heartbeat
• seizures
• confusion
• muscle cramps or spasms
• reduced urine output

Seek Medical Help Immediatelyif you experience any of these symptoms.

Infections

Infections that occur while taking Pazopanib Zentiva can become serious. Symptoms of infection may include:

• fever
• flu-like symptoms, such as cough, fatigue, and body aches, that do not go away
• shortness of breath or wheezing
• pain while urinating
• cuts, scratches, or wounds that are red, warm, swollen, or painful

Seek Medical Help Immediatelyif you experience any of these symptoms.

Pneumonitis

Pazopanib Zentiva may rarely cause pneumonitis (inflammation of the lungs), which can be life-threatening. Symptoms may include:

• shortness of breath or cough that does not go away

Seek Medical Help Immediatelyif you experience any of these symptoms.

Thyroid Problems

Pazopanib Zentiva may decrease the production of thyroid hormones in the body, which can cause weight gain and fatigue. Your doctor will monitor your thyroid function while you are taking Pazopanib Zentiva.

Tell your doctorif you notice significant weight gain or fatigue.

Blurred Vision or Vision Problems

Pazopanib Zentiva may cause separation or tears in the layer at the back of the eye (retinal detachment), which can cause blurred vision or vision problems.

Tell your doctorif you notice any changes in your vision.

Common Side Effects

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

• high blood pressure
• diarrhea
• nausea (feeling sick) or vomiting
• abdominal pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth pain
• headache
• cancer pain
• fatigue, weakness, or tiredness
• hair color changes or hair loss
• skin discoloration
• rash or skin peeling
• redness and swelling of the palms of the hands or soles of the feet

Tell your doctor or pharmacistif any of these side effects bother you.

Common Side Effects That May Be Found in Blood or Urine Tests:

• increased liver enzymes
• decreased albumin in the blood
• protein in the urine
• decreased platelet count (a type of blood cell that helps the blood to clot)
• decreased white blood cell count

Less Common Side Effects

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

• indigestion, bloating, gas
• nosebleeds
• dry mouth or mouth sores
• infections
• excessive sleepiness
• sleep disturbances
• chest pain, shortness of breath, leg pain, or swelling of the legs or feet. These may be symptoms of blood clots in the body (thromboembolism). If a blood clot breaks loose, it can travel to the lungs, which can be life-threatening or even fatal.
• reduced heart function (heart failure)
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flushes
• swelling of the face, hands, feet, or ankles due to fluid buildup
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin problems, redness, itching, dryness
• nail problems
• burning, tingling, itching, or numbness of the skin
• feeling cold with chills
• excessive sweating
• dehydration
• muscle, joint, or tendon pain, or chest pain, muscle cramps
• hoarseness
• shortness of breath
• coughing
• coughing up blood
• hiccups

Tell your doctor or pharmacistif any of these side effects bother you.

Less Common Side Effects That May Be Found in Blood or Urine Tests:

• hypothyroidism (underactive thyroid)
• abnormal liver function
• increased bilirubin (a substance produced by the liver)
• increased lipase (an enzyme involved in digestion)
• increased creatinine (a substance produced by the muscles)
• changes in the levels or activity of various substances or enzymes in the blood. Your doctor will tell you about the results of your blood tests.

Rare Side Effects

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

• stroke
• temporary reduction in blood flow to the brain (transient ischemic attack)
• heart attack (myocardial infarction)
• partial blockage of blood flow to the heart (myocardial ischemia)
• blood clots with reduced red blood cell and platelet count (thrombotic microangiopathy). This can damage organs such as the brain and kidneys.
• increased red blood cell count
• sudden shortness of breath, especially if accompanied by chest pain and rapid breathing (pulmonary embolism)
• severe bleeding from the digestive tract, lungs, kidneys, vagina, or brain
• abnormal heart rhythm (QT interval prolongation)
• hole in the stomach or intestine (perforation)
• abnormal connection between different parts of the intestine (fistula)
• excessive or irregular menstrual bleeding
• sudden and severe increase in blood pressure (hypertensive crisis)
• pancreatitis (inflammation of the pancreas)
• inflammation, abnormal function, or damage to the liver
• yellowing of the skin or eyes (jaundice)
• inflammation of the lining of the abdomen (peritonitis)
• runny nose
• rash or skin problems that may be itchy or inflamed (papular or pustular rash)
• diarrhea
• increased sensitivity of the skin to sunlight
• numbness or reduced sensation, especially of the skin
• skin wound that does not heal (skin ulcer)

Very Rare Side Effects

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

• pneumonitis (inflammation of the lungs)
• bulge or weakening of the wall of a blood vessel (aneurysm) or tear in the wall of a blood vessel

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

• tumor lysis syndrome due to rapid breakdown of cancer cells
• liver failure

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Pazopanib Zentiva

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

Do not use this medicine after the expiry datestated on the bottle, blister, or carton. The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Pazopanib Zentiva Contains

Pazopanib Zentiva, 200 mg, film-coated tablets:

• The active substance is pazopanib (as pazopanib hydrochloride). Each film-coated tablet contains 200 mg of pazopanib.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), polysorbate 80.

Pazopanib Zentiva, 400 mg, film-coated tablets:

• The active substance is pazopanib (as pazopanib hydrochloride). Each film-coated tablet contains 400 mg of pazopanib.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Pazopanib Zentiva Looks Like and Contents of the Pack

Pazopanib Zentiva, 200 mg, film-coated tablets:

Pazopanib Zentiva, 200 mg, film-coated tablets are capsule-shaped, pink, and marked with "200" on one side, and are approximately 14 mm x 5 mm in size.

They are available in:

• bottles with a child-resistant closure: 30, 90, or 90 (3 packs of 30) film-coated tablets in a carton
• transparent blisters with PVC/PE/PVDC/Aluminum foil: 30, 90, or 90 (3 packs of 30) film-coated tablets in a carton
• transparent single-dose blisters with PVC/PE/PVDC/Aluminum foil: 30 x 1, 90 x 1, or 90 x 1 (3 packs of 30 x 1) film-coated tablets in a carton

Pazopanib Zentiva, 400 mg, film-coated tablets:

Pazopanib Zentiva, 400 mg, film-coated tablets are capsule-shaped, white, and marked with "400" on one side, and are approximately 18 mm x 7 mm in size.

They are available in:

• bottles with a child-resistant closure: 30, 60 film-coated tablets in a carton
• transparent blisters with PVC/PE/PVDC/Aluminum foil: 30, 60, or 60 (2 packs of 30) film-coated tablets in a carton
• transparent single-dose blisters with PVC/PE/PVDC/Aluminum foil: 30 x 1, 60 x 1, or 60 x 1 (2 packs of 30 x 1) film-coated tablets in a carton

Not all pack sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Remedica Ltd., Aharnon Street, Limassol Industrial Estate, 3056 Limassol, 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:

Denmark, Estonia, Finland, Norway, Poland, Czech Republic, Sweden, Italy: Pazopanib Zentiva

Bulgaria: Пазопаниб Зентива 200mg филмирани таблетки, Пазопаниб Зентива 400mg филмирани таблетки

Croatia: Pazopanib Zentiva 200 mg filmom obložene tablete, Pazopanib Zentiva 400 mg filmom obložene tablete

France: Pazopanib Zentiva 200 mg comprimé pelliculé, Pazopanib Zentiva 400 mg comprimé pelliculé

Spain: Pazopanib Zentiva 200 mg comprimidos recubiertos con película EFG, Pazopanib Zentiva 400 mg comprimidos recubiertos con película EFG

Lithuania: Pazopanib Zentiva 200 mg plėvele dengtos tabletės, Pazopanib Zentiva 400 mg plėvele dengtos tabletės

Latvia: Pazopanib Zentiva 200 mg apvalkotās tabletes, Pazopanib Zentiva 400 mg apvalkotās tabletes

Germany: Pazopanib Zentiva 200 mg filmtabletten, Pazopanib Zentiva 400 mg filmtabletten

Slovakia: Pazopanib Zentiva 200 mg, Pazopanib Zentiva 400 mg

Romania: PAZOPANIB ZENTIVA 200 mg comprimate filmate, PAZOPANIB ZENTIVA 400 mg comprimate filmate

Hungary: Pazopanib Zentiva 200mg filmtabletta, Pazopanib Zentiva 400mg filmtabletta

For Further Information on This Medicinal Product, Please Contact the Local Representative of the Marketing Authorization Holder:

Zentiva Polska Sp. z.o.o., ul. Bonifraterska 17, 00-203 Warsaw, Poland, tel.: +48 22 375 92 00

Date of Last Revision of the Leaflet:April 2024