Pazopanib Sandoz

Package Leaflet: Information for the Patient

Pazopanib Sandoz, 200 mg, Film-Coated Tablets

Pazopanib Sandoz, 400 mg, Film-Coated Tablets

Pazopanib

Read All of This Leaflet Carefully Before 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 Pack and Other Information

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

1. What Pazopanib Sandoz is and What it is Used For

Pazopanib Sandoz belongs to a group of medicines called protein kinase inhibitors. The medicine works by blocking the action of certain proteins involved in cancer cell growth and spread.

Pazopanib Sandoz is used to treat adults with:

• advanced kidney cancer that has spread to other parts of the body
• certain types of soft tissue sarcoma, a type of cancer that affects the supporting tissues of the body, such as muscles, blood vessels, fat, and tendons.

2. Before You Take Pazopanib Sandoz

When You Should Not Take Pazopanib Sandoz

• 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 Sandoz, 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 (pneumothorax) in the past
• if you have bleeding, blood clots, or narrowing of the arteries
• if you have stomach or intestinal problems, such as perforation or fistula
• if you have thyroid problems
• if you have kidney problems
• if you have had an aneurysm (a bulge in the wall of a blood vessel) or a tear in the wall of a blood vessel

You should tell your doctorif any of these conditions apply to you. Your doctor will decide whether Pazopanib Sandoz is suitable for you. You may need to have additional tests to check that your kidneys, heart, and liver are working properly.

High Blood Pressure and Pazopanib Sandoz

Pazopanib Sandoz may cause high blood pressure. Your blood pressure will be checked before and during treatment with Pazopanib Sandoz. If you have high blood pressure, your doctor will treat it with blood pressure-lowering medicines.

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

If You Need to Have Surgery

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

Conditions to Monitor

Pazopanib Sandoz may worsen certain conditions or cause serious side effects. You should be aware of certain symptoms to reduce the risk of serious side effects. See section 4.

Children and Adolescents

Pazopanib Sandoz should not be used in patients under 18 years of age. The medicine has not been studied in this age group, and its use could be harmful.

Pazopanib Sandoz and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription. This includes herbal medicines and other medicines that you can buy without a prescription.

Some medicines may affect how Pazopanib Sandoz works or increase the risk of side effects. Pazopanib Sandoz 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 infections)
• nefazodone (used to treat depression)
• simvastatin and possibly other statins (used to treat high cholesterol)
• medicines that reduce stomach acid

Pazopanib Sandoz with Food and Drink

Do not take Pazopanib Sandoz with food, as this affects how the medicine is absorbed. Take Pazopanib Sandoz at least 2 hours after a meal or 1 hour before a meal (see section 3).

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

Pregnancy, Breast-Feeding, and Fertility

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

• Tell your doctor if you are pregnant or planning to become pregnant
• Use effective contraception during treatment with Pazopanib Sandoz and for at least 2 weeks after stopping treatment to prevent pregnancy.
• Tell your doctor if you become pregnant while taking Pazopanib Sandoz
• Do not breast-feed while taking Pazopanib Sandoz. It is not known whether the ingredients of Pazopanib Sandoz pass into breast milk. Discuss this with your doctor.

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

Treatment with Pazopanib Sandoz may affect fertility. Discuss this with your doctor.

Driving and Using Machines

While taking Pazopanib Sandoz, 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 Sandoz 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 Sandoz

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

Recommended Dose

The usual dose is 800 mg, taken once a day. The dose can be taken as two 400 mg tablets or four 200 mg tablets. The maximum daily dose is 800 mg. Your doctor may reduce the dose if you experience side effects.

When to Take Pazopanib Sandoz

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

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

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

If You Take More Pazopanib Sandoz Than You Should

If you have taken too many tablets, consult your doctor or pharmacist. If possible, show them the packaging or this leaflet.

If You Forget to Take Pazopanib Sandoz

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 Sandoz Without Consulting Your Doctor

Take Pazopanib Sandoz for as long as your doctor recommends. Do not stop taking Pazopanib Sandoz unless your doctor tells you to.

4. Possible Side Effects

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

Serious Side Effects

Brain Swelling (Posterior Reversible Encephalopathy Syndrome)

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

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

Stop Taking Pazopanib Sandoz 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 Sandoz may cause a sudden and severe increase in blood pressure. This is known as a hypertensive crisis. Your doctor will check your blood pressure while you are taking Pazopanib Sandoz. Symptoms of a hypertensive crisis may include:

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

Stop Taking Pazopanib Sandoz and Seek Medical Help Immediately

if you experience a hypertensive crisis.

Heart Problems

The risk of heart problems may be higher in people with existing heart disease or those taking other medicines.

Heart Failure or Heart Attack

Pazopanib Sandoz 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 heartbeat
• fainting
• chest pain or discomfort
• arm, back, neck, or jaw pain
• shortness of breath
• swelling of the legs

Seek Medical Help Immediately

if you experience any of these symptoms.

Changes in Heart Rhythm (Prolonged QT Interval)

Pazopanib Sandoz may affect the heart rhythm, which can lead to serious heart problems. Tell your doctorif you experience any changes in heart rhythm, such as a fast or slow heartbeat.

Stroke

Pazopanib Sandoz 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 Immediately

if you experience any of these symptoms.

Bleeding

Pazopanib Sandoz may cause serious bleeding, including bleeding in the gut, lungs, kidneys, vagina, or brain. Symptoms may include:

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

Seek Medical Help Immediately

if you experience any of these symptoms.

Perforation and Fistula

Pazopanib Sandoz may cause a hole in the wall of the stomach or intestine or an abnormal connection between two parts of the gut. Symptoms may include:

• severe abdominal pain
• nausea and vomiting
• fever
• a hole in the stomach, intestine, or other parts of the gut, with leakage of contents

Seek Medical Help Immediately

if you experience any of these symptoms.

Liver Problems

Pazopanib Sandoz may cause liver problems, which can lead to serious liver damage or liver failure. Your doctor will check your liver function while you are taking Pazopanib Sandoz. Symptoms may include:

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

Seek Medical Help Immediately

if you experience any of these symptoms.

Blood Clots

Deep Vein Thrombosis and Pulmonary Embolism

Pazopanib Sandoz may cause blood clots in the veins, especially in the legs, which can travel to the lungs. Symptoms may include:

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

Microangiopathic Hemolytic Anemia

Pazopanib Sandoz 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 Immediately

if you experience any of these symptoms.

Tumor Lysis Syndrome

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

• irregular heartbeat
• seizures
• confusion
• muscle spasms

Seek Medical Help Immediately

if you experience any of these symptoms.

Infections

Infections that occur while taking Pazopanib Sandoz can become serious.

Symptoms of infection may include:

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

Seek Medical Help Immediately

if you experience any of these symptoms.

Pneumonitis

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

• shortness of breath or cough that does not go away

Seek Medical Help Immediately

if you experience any of these symptoms.

Thyroid Problems

Pazopanib Sandoz may reduce the production of thyroid hormones in the body, which can cause weight gain and tiredness. Your doctor will check your thyroid function while you are taking Pazopanib Sandoz.

Tell your doctorif you notice any significant weight gain or tiredness.

Blurred Vision or Changes in Vision

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

Other 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
• lack of energy, feeling weak or tired
• changes in hair color 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 Pharmacist

if any of these side effects bother you.

Very 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

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 and feet. These may be symptoms of blood clots in the lungs (pulmonary embolism).
• decreased heart function
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flushes
• swelling of the face, hands, ankles, or feet 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 spasms
• hoarseness
• shortness of breath
• coughing
• coughing up blood
• hiccups
• pneumothorax (collapsed lung)

Tell Your Doctor or Pharmacist

if any of these side effects bother you.

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 of other substances or enzymes in the blood

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 or interruption of blood flow to the heart (myocardial infarction)
• partial interruption of blood flow to the heart (myocardial ischemia)
• blood clots in the small blood vessels, which 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 in the gut, lungs, kidneys, vagina, or brain
• abnormal heart rhythm (prolonged QT interval)
• hole in the wall of the stomach or intestine (perforation) or abnormal connection between two parts of the gut (fistula)
• excessive or irregular menstrual bleeding
• sudden and severe increase in blood pressure (hypertensive crisis)
• inflammation of the pancreas (pancreatitis)
• 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
• diarrhea
• increased sensitivity of the skin to sunlight
• numbness, weakness, or tingling of the skin
• skin wound that does not heal (skin ulcer)

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

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

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

• tumor lysis syndrome (rapid breakdown of cancer cells)
• liver failure

Reporting Side Effects

If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

You can also report side effects directly via the national reporting system.

5. How to Store Pazopanib Sandoz

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

Do not use this medicine after the expiry date which is stated on the bottle, blister, and carton after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

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 Sandoz Contains

• The active substance is pazopanib (as pazopanib hydrochloride). Each film-coated tablet contains 200 mg or 400 mg of pazopanib.
• The other ingredients are microcrystalline cellulose, sodium starch glycolate (Type A), povidone (K 30), magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 400, and polysorbate 80. The 200 mg tablets also contain iron oxide red (E 172).

What Pazopanib Sandoz Looks Like and Contents of the Pack

The 200 mg film-coated tablets are pink, capsule-shaped, and marked with "200" on one side.

The 400 mg film-coated tablets are white, capsule-shaped, and marked with "400" on one side.

Pazopanib Sandoz is available in blister packs containing 30, 60, or 90 film-coated tablets, or in plastic bottles containing 30 or 90 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warszawa

Polska

Tel. 22 209 70 00

Manufacturer:

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

Birzebbugia, BBG 3000

Malta

Pharos Pharmaceutical Oriented Services Ltd.

Lesvou Street End, Thesi Loggos Industrial Zone

14452 Metamorfossi

Greece

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Croatia:

Pazopanib Sandoz 200 mg filmom obložene tablete

Pazopanib Sandoz 400 mg filmom obložene tablete

Czech Republic:

Pazopanib Sandoz

Ireland:

Pazopanib Rowex 200 mg film-coated tablets

Pazopanib Rowex 400 mg film-coated tablets

Malta:

Pazopanib Sandoz 200 mg film-coated tablets

Pazopanib Sandoz 400 mg film-coated tablets

Poland:

Pazopanib Sandoz

Slovakia:

Pazopanib Sandoz 200 mg

Pazopanib Sandoz 400 mg

Hungary:

Pazopanib Sandoz 200 mg filmtabletta

Pazopanib Sandoz 400 mg filmtabletta

Italy:

Pazopanib Sandoz

Date of Last Revision of the Leaflet:

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