Pazopanib Sandoz

Leaflet accompanying the packaging: patient information

Pazopanib Sandoz, 200 mg, film-coated tablets

Pazopanib Sandoz, 400 mg, film-coated tablets

Pazopanib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pazopanib Sandoz and what is it used for
• 2. Important information before taking Pazopanib Sandoz
• 3. How to take Pazopanib Sandoz
• 4. Possible side effects
• 5. How to store Pazopanib Sandoz
• 6. Contents of the packaging and other information

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

Pazopanib Sandoz belongs to a group of medicines called protein kinase inhibitors. The medicine works by inhibiting the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Sandoz is used in adults to treat:

• advanced or metastatic kidney cancer
• certain types of soft tissue sarcoma, which is a type of tumor that attacks connective tissue in the body. It can occur in muscles, blood vessels, fat tissue, or other tissues that support, surround, and protect internal organs.

2. Important information before taking Pazopanib Sandoz

When not to take Pazopanib Sandoz

• If the patient is allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6). Consult a doctorif the patient thinks this applies to them.

Warnings and precautions

Before starting to take Pazopanib Sandoz, the patient should discuss the following with their doctor:

• heart disease
• liver disease
• heart failure or heart attack
• collapsed lung (pneumothorax) in their medical history
• bleeding, blood clots, or narrowing of the arteries
• stomach or intestinal disorders, such as perforation(hole) or fistula(abnormal connection between different parts of the intestine)
• thyroid disorders
• kidney function disorders
• if the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel

Tell the doctorif any of these conditions occur. The doctor will decide whether Pazopanib Sandoz is suitable for the patient. Additional tests may be necessary to check if the patient's kidneys, heart, and liver are working properly.

High blood pressure and taking Pazopanib Sandoz

Pazopanib Sandoz may cause high blood pressure. Before and during treatment with Pazopanib Sandoz, the patient's blood pressure will be monitored.
Tell the doctorif the patient has high blood pressure.

• Tell the doctorif the patient has high blood pressure.

If the patient is scheduled for surgery

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

Conditions that require special attention

Pazopanib Sandoz may worsen certain disorders or cause severe side effects. While taking Pazopanib Sandoz, the patient should pay special attention to certain symptoms to minimize the risk of adverse effects. See section 4.

Children and adolescents

Pazopanib Sandoz should not be used in patients under 18 years of age. The medicine's effects in this age group have not been established. Additionally, for safety reasons, the medicine should not be used in children under 2 years of age.

Pazopanib Sandoz and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including herbal medicines and medicines available without a prescription.
Some medicines may affect the action of Pazopanib Sandoz or increase the risk of side effects. Pazopanib Sandoz may also affect the action of other medicines. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (medicines used to treat infections)
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV infections)
• nefazodone (a medicine used to treat depression)
• simvastatin and possibly other statins (medicines used to treat high cholesterol)
• medicines that reduce stomach acid production. Medicines taken to reduce stomach acid production (e.g., proton pump inhibitors, H2 receptor antagonists, or antacids) may affect the absorption of Pazopanib Sandoz. Consult a doctor or nurse for advice. Tell the doctor or pharmacistif the patient is taking any of these medicines.

Pazopanib Sandoz with food and drink

Do not take Pazopanib Sandoz with food, as it affects the absorption of the medicine. Take the medicine at least 2 hours after a meal or 1 hour before a meal (see section 3).
Do not drink grapefruit juice during treatment with Pazopanib Sandoz, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

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

• Tell the doctor if the patient is pregnant or planning to become pregnant
• During treatment with Pazopanib Sandoz and for at least 2 weeks after stopping treatment, the patient should use effective contraceptionto prevent pregnancy.
• Tell the doctor if the patient becomes pregnant while taking Pazopanib Sandoz. Do not breastfeed while taking Pazopanib Sandoz. It is not known whether the ingredients of Pazopanib Sandoz pass into human milk. Discuss this with the doctor.

Men(including men who have had a vasectomy), whose partners are pregnant or may become pregnant (including women using other contraceptive methods), should use condoms during sexual intercourse while taking Pazopanib Sandoz and for at least 2 weeks after the last dose.
Treatment with Pazopanib Sandoz may affect fertility. Discuss this with the treating doctor.

Driving and using machines

While taking Pazopanib Sandoz, the patient may experience side effects that can affect their ability to drive or operate machinery.

• Avoid driving or operating machinery if the patient feels dizzy, tired, or weak, or has low energy levels.

Pazopanib Sandoz contains sodium

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

3. How to take Pazopanib Sandoz

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

Recommended dose

The usual doseis 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. The doctor may reduce the dose if the patient experiences side effects.

When to take the medicine

Do not take Pazopanib Sandoz with food. Take the medicine at least 2 hours after a meal or 1 hour before a meal.
For example, the medicine can be taken 2 hours after breakfast or 1 hour before lunch. Take Pazopanib Sandoz at the same time every day.
Swallow the tablets whole, one after the other, with a glass of water. Do not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of side effects.

Taking a higher dose of Pazopanib Sandoz than recommended

If the patient has taken too many tablets, they should consult a doctor or pharmacist. If possible, show the doctor the packaging or this leaflet.

Missing a dose of Pazopanib Sandoz

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

Do not stop taking Pazopanib Sandoz without consulting a doctor

Take Pazopanib Sandoz for as long as the doctor has prescribed. Do not stop taking the medicine unless the doctor advises you to do so.

4. Possible side effects

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

Severe side effects

Brain swelling(reversible posterior leukoencephalopathy syndrome)
Pazopanib Sandoz may rarely cause brain swelling, which can be life-threatening. Symptoms include:

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

Stop taking Pazopanib Sandoz and seek medical help immediately

if the patient experiences any of these symptoms or a headache with any of these symptoms.
Hypertensive crisis(sudden and severe increase in blood pressure)
Pazopanib Sandoz may rarely cause a sudden and severe increase in blood pressure, known as a hypertensive crisis. The doctor will monitor the patient's blood pressure while they are taking Pazopanib Sandoz. 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 Sandoz and seek medical help immediatelyif the patient experiences a hypertensive crisis.

Heart rhythm disorders

The risk of these disorders may be higher in patients with existing heart disease or those taking other medicines. While taking Pazopanib Sandoz, the patient will be monitored for heart rhythm disorders.
Heart rhythm disorders/heart failure, heart attack
Pazopanib Sandoz may affect the heart's ability to pump blood or increase the risk of a heart attack. Symptoms 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 the patient experiences any of these symptoms.

Changes in heart rhythm (QT interval prolongation)
Pazopanib Sandoz may affect the heart rhythm, which can lead to heart rhythm disorders called torsades de pointesin some people. These can cause very rapid heartbeats, leading to loss of consciousness.
Tell the doctorif the patient experiences changes in heart rhythm, such as rapid or slow heartbeat.

Stroke

Pazopanib Sandoz may increase the risk of stroke. Symptoms of a stroke may include:

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

Seek medical help immediatelyif the patient experiences any of these symptoms.

Bleeding

Pazopanib Sandoz may cause severe bleeding from the digestive tract (stomach, esophagus, colon, or intestine), lungs, kidneys, mouth, vagina, or brain, although this is rare. Symptoms of bleeding include:

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

Seek medical help immediatelyif the patient experiences any of these symptoms.

Perforation and fistula

Pazopanib Sandoz may cause a hole in the wall of the stomach or intestine or the formation of an abnormal connection between different parts of the digestive tract (fistula). Symptoms of this condition may include:

• severe abdominal pain
• nausea and vomiting
• fever
• formation of a hole in the stomach, intestine, or colon, with bloody or foul-smelling pus

Seek medical help immediatelyif the patient experiences any of these symptoms.

Liver disorders

Pazopanib Sandoz may cause liver disorders, which can lead to severe liver diseases such as liver dysfunction or liver failure, which can be fatal. The doctor will monitor the patient's liver enzyme levels while they are taking Pazopanib Sandoz.
Symptoms of liver disorders may include:

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

Seek medical help immediatelyif the patient experiences 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 (deep vein thrombosis), which can also travel to the lungs (pulmonary embolism). Symptoms of this condition 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 the small blood vessels in the kidneys and brain, which can damage organs such as the brain and kidneys. Symptoms include:

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

Seek medical help immediatelyif the patient experiences any of these symptoms.

Tumor lysis syndrome

Pazopanib Sandoz may cause rapid breakdown of cancer cells, leading to tumor lysis syndrome, which can be fatal in some people. Symptoms may include irregular heartbeat, seizures, confusion, muscle spasms, or reduced urine output. Seek medical help immediatelyif the patient experiences any of these symptoms.

Infections

Infections that occur while taking Pazopanib Sandoz can 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 wheezing
• pain when urinating
• cuts, scratches, or wounds that are red, warm, swollen, or painful

Seek medical help immediatelyif the patient experiences any of these symptoms.

Pneumonitis

Pazopanib Sandoz may rarely cause inflammation of the lungs (interstitial lung disease or pneumonitis), which can be fatal in some patients. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib Sandoz, the patient will be monitored for any lung problems. Seek medical help immediatelyif the patient experiences any of these symptoms.

Thyroid disorders

Pazopanib Sandoz may decrease the production of thyroid hormones in the body. This can cause weight gain and fatigue. While taking Pazopanib Sandoz, the doctor will monitor the patient's thyroid hormone levels. Tell the doctorif the patient notices significant weight gain or fatigue.

Blurred vision or vision disturbances

Pazopanib Sandoz may cause separation or tearing of the membrane at the back of the eye (retinal detachment or retinal tear), which can cause blurred vision or vision disturbances. Tell the doctorif the patient notices any changes in their vision.

Possible side effects (including possible severe side effects in the relevant frequency categories)

Very common side effects(may affect more than 1 in 10 people):

• high blood pressure
• diarrhea
• nausea (nausea) 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
• hair color changes
• excessive hair loss or thinning
• skin discoloration
• skin rash with possible peeling
• redness and swelling of the hands or soles of the feet

Very common side effect that can be detected in blood or urine tests:

• increased liver enzyme activity
• decreased albumin levels in the blood
• protein in the urine
• decreased platelet count (a component of blood that helps it 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 or feet. These may be symptoms of blood clots in the body (thromboembolism), which can be life-threatening or fatal.
• reduced heart function (heart failure)
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling of the face, hands, ankles, or feet due to fluid accumulation
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin disorders, redness, itching, dryness, or peeling of the skin
• nail disorders
• 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
• hemoptysis
• hiccups
• pneumothorax (collapsed lung with air trapped between the lung and chest cavity), often causing shortness of breath

Common side effects that can be detected in blood or urine tests:

• hypothyroidism
• abnormal liver function
• increased bilirubin levels (a substance produced by the liver)
• increased lipase activity (an enzyme involved in digestion)
• increased creatinine levels (a substance produced by the muscles)
• changes in the levels or activity of various substances or enzymes in the blood. The doctor will inform the patient about the results of their blood tests.

Uncommon side effects(may affect up to 1 in 100 people):

• stroke
• transient reduction in blood flow to the brain (transient ischemic attack)
• interruption of blood flow to a part of the heart or heart attack (myocardial infarction)
• partial interruption of blood flow to a part of the heart (myocardial ischemia)
• blood clots, which can damage organs such as the brain and kidneys (microangiopathic hemolytic anemia)
• increased red blood cell count
• sudden shortness of breath, especially if accompanied by sudden chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding from the digestive tract (stomach, esophagus, or intestine), lungs, kidneys, mouth, vagina, or brain
• heart rhythm disorders (QT interval prolongation)
• perforation of the stomach or intestine
• formation of an 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, abnormal function, or damage to the liver
• yellowing of the skin or eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• rashes, which can be itchy or inflamed (flat or raised patches or blisters)
• diarrhea
• increased sensitivity of the skin to sunlight
• weakness or numbness of the skin
• skin ulcers that do not heal

Rare side effects(may affect up to 1 in 1,000 people):

• pneumonitis
• enlargement and weakening of the wall of a blood vessel or tearing of the wall of a blood vessel (aneurysm and arterial dissection)

Frequency not known(frequency cannot be estimated from the available data)

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Pazopanib Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle, blister, or carton after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pazopanib Sandoz contains

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

What Pazopanib Sandoz looks like and contents of the pack

Pazopanib Sandoz 200 mg film-coated tablets are pink, capsule-shaped, and engraved with "200" on one side.
They are available in blisters containing 30, 60, or 90 film-coated tablets, or in multipacks containing 60 or 60 x 1 (2 packs of 30 or 2 packs of 30 x 1 single-dose blisters), 90 or 90 x 1 (3 packs of 30 or 3 packs of 30 x 1 single-dose blisters) film-coated tablets, or in plastic bottles containing 30 or 90 tablets, or in multipacks containing 90 (3 bottles of 30) tablets.
Pazopanib Sandoz 400 mg film-coated tablets are white, capsule-shaped, and engraved with "400" on one side.
They are available in blisters containing 30, 60, or 90 film-coated tablets, or in multipacks containing 60 or 60 x 1 (2 packs of 30 or 2 packs of 30 x 1 single-dose blisters), 90 or 90 x 1 (3 packs of 30 or 3 packs of 30 x 1 single-dose blisters) film-coated tablets, or in plastic bottles containing 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Poland
Phone: 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Croatia
Pazopanib Sandoz 200 mg film-coated tablets
Pazopanib Sandoz 400 mg film-coated tablets
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 film-coated tablets
Pazopanib Sandoz 400 mg film-coated tablets
Italy
Pazopanib Sandoz

Date of last revision of the leaflet:

{logo of the marketing authorization holder}