Pazopanib stada

Package leaflet: Information for the patient

Pazopanib STADA, 200 mg, film-coated tablets
Pazopanib STADA, 400 mg, film-coated tablets
Pazopanibum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Pazopanib STADA 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 STADA is used in adult patients for the treatment of:

• advanced or metastatic kidney cancer.
• certain types of soft tissue sarcoma, which is a type of tumour affecting the body's connective tissue. It may occur in muscles, blood vessels, fatty tissue, or other tissues that support, surround, and protect internal organs.

2. Important information before using Pazopanib STADA

When not to use Pazopanib STADA

• if the patient is allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6). Consult a doctor if the patient thinks this applies.

Warnings and precautions
Before starting treatment with Pazopanib STADA, discuss the following with the doctor:

• if the patient has a heart disease.
• if the patient has a liver disease.
• if the patient has had heart failure or heart attack.
• if the patient has a history of pneumothorax (collapsed lung).
• if the patient has bleeding, blood clots, or arterial narrowing.
• if the patient has had stomach or intestinal disorders, such as perforation (a hole) or fistula (an abnormal connection between parts of the intestine).
• if the patient has thyroid disorders.
• if the patient has kidney function disorders.
• if the patient has or has had aneurysm (a weakened and enlarged blood vessel wall) or arterial dissection.

Inform the doctor if any of these conditions apply. The doctor will decide whether Pazopanib STADA is suitable for the patient. The patient may need to undergo additional tests to check whether the kidneys, heart, and liver are functioning properly.

High blood pressure and use of Pazopanib STADA
Pazopanib STADA may cause high blood pressure. Blood pressure will be monitored before starting and during treatment with Pazopanib STADA. If the patient develops high blood pressure, the doctor will prescribe antihypertensive medications.

• Inform the doctor if the patient has high blood pressure.

If the patient is scheduled for surgery
The doctor will advise stopping Pazopanib STADA at least 7 days before surgery, as the medicine may affect wound healing after surgery. Treatment will be resumed once the wound has healed.

Conditions requiring special attention
Pazopanib STADA may worsen certain conditions or cause serious side effects. During treatment with Pazopanib STADA, it is essential to pay attention to certain symptoms to reduce the risk of adverse effects. See section 4.

Children and adolescents
Pazopanib STADA is not recommended for patients under 18 years of age. The effect of the medicine in this patient group has not been established. For safety reasons, the medicine should not be used in children under 2 years of age.

Pazopanib STADA and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used, including herbal products and over-the-counter medicines.

Some medicines may affect the action of Pazopanib STADA or increase the risk of side effects. Pazopanib STADA may also affect the action of other medicines. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections).
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection).
• nefazodone (used to treat depression).
• simvastatin and possibly other statins (used to treat high blood cholesterol).
• medicines reducing gastric acid secretion. Medicines taken to reduce stomach acid (e.g. proton pump inhibitors, H-_2 receptor antagonists, or antacids) may affect the absorption of Pazopanib STADA. Consult the doctor or nurse for advice. Inform the doctor or pharmacist if the patient is taking any of these medicines.

Pazopanib STADA with food and drink
Do not take Pazopanib STADA with food, as this affects drug absorption. The medicine should be taken at least two hours after a meal or one hour before a meal (see section 3).
During treatment with Pazopanib STADA, do not drink grapefruit juice, as this may increase the risk of side effects.

Pregnancy, breastfeeding, and effects on fertility
Pazopanib STADA is not recommended during pregnancy. It is unknown how Pazopanib STADA affects pregnancy.

• Inform the doctor if the patient is pregnant or planning to become pregnant. During treatment with Pazopanib STADA and for at least 2 weeks after stopping treatment, an effective method of contraception must be used to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Pazopanib STADA. Do not breastfeed during treatment with Pazopanib STADA. It is unknown whether Pazopanib STADA passes into breast milk. Discuss this with the treating 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 STADA and for at least 2 weeks after the last dose.

Treatment with Pazopanib STADA may affect fertility. Discuss this with the treating doctor.

Driving and using machines
During treatment with Pazopanib STADA, side effects may occur that could affect the ability to drive or operate machinery.

• Avoid driving and operating machinery if the patient experiences dizziness, fatigue, weakness, or low energy levels.

Pazopanib STADA contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Pazopanib STADA

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should
consult your doctor or pharmacist.
How many tablets to take
Pazopanib STADA 200 mg film-coated tablets
The usual dose of Pazopanib STADA is four 200 mg tablets (800 mg
of pazopanib) once daily. This is the maximum daily dose. Your doctor may recommend reducing
the dose if you experience adverse effects.
Pazopanib STADA 400 mg film-coated tablets
The usual dose of Pazopanib STADA is two 400 mg tablets (800 mg of pazopanib)
once daily. This is the maximum daily dose. Your doctor may recommend reducing the dose if you
experience adverse effects.
When to take the medicine
Do not take Pazopanib STADA with food. The medicine should be taken at least two
hours after a meal or one hour before a meal. For example, the medicine may be taken two hours
after breakfast or one hour before lunch. Pazopanib STADA should be taken every day at the same time.
The tablets should be swallowed whole, one after another, with water. Do not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of adverse effects.
Taking more Pazopanib STADA than recommended
If you have swallowed too many tablets, you must seek advice from your doctor or
pharmacist. If possible, show them the medicine packaging or this leaflet.
Missing a dose of Pazopanib STADA
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 STADA without your doctor's advice
Pazopanib STADA should be taken for as long as your doctor recommends. Do not stop taking the
medicine unless your doctor advises you to do so.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Possible serious adverse reactions
Brain swelling (reversible posterior leukoencephalopathy syndrome)
Rarely, Pazopanib STADA may cause brain swelling, which can be life-threatening. Symptoms include:

• loss of speech
• visual disturbances
• seizures
• disorientation
• high blood pressure. Treatment with Pazopanib STADA should be discontinued and immediate medical help sought if any of these symptoms occur, or if headache is accompanied by any of these symptoms.

Hypertensive crisis (sudden and severe increase in blood pressure)
Pazopanib STADA may occasionally cause a sudden and severe rise in blood pressure. This condition is known as hypertensive crisis. Your doctor will monitor your blood pressure while you are taking Pazopanib STADA. Symptoms of hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• disorientation
• nausea
• vomiting
• severe anxiety
• shortness of breath
• seizures
• fainting. Treatment with Pazopanib STADA should be discontinued and immediate medical help sought if a hypertensive crisis occurs.

Heart problems
The risk of these problems may be higher in people with existing heart disease or those taking other medicines. While taking Pazopanib STADA, you will be monitored for heart problems.
Heart function disorders/heart failure, heart attack
Pazopanib STADA may affect the heart's ability to pump blood or may increase the risk of heart attack. Symptoms include:

• irregular or rapid heartbeat
• fast palpitations
• fainting
• pain or pressure in the chest
• pain in arms, back, neck or jaw
• shortness of breath
• swelling of the legs. Immediate medical help should be sought if any of these symptoms occur.

Changes in heart rhythm (QT interval prolongation)
Pazopanib STADA may affect heart rhythm, which in some people may lead to heart rhythm disorders called torsade de pointes, which can be serious. These may cause very rapid heartbeat, potentially leading to loss of consciousness.
You should inform your doctor if you experience changes in heart rhythm, such as heartbeat that is too fast or too slow.
Stroke
Pazopanib STADA may increase the risk of stroke. Symptoms of stroke may include:

• numbness or weakness on one side of the body
• difficulty speaking
• headache
• dizziness. Immediate medical help should be sought if any of these symptoms occur.

Bleeding
Pazopanib STADA may cause severe bleeding from the gastrointestinal tract (from stomach, oesophagus, rectum or intestines), lungs, kidneys, mouth, vagina or bleeding into the brain, although this is not very common. Symptoms of bleeding include:

• presence of blood in stool or black-coloured stool
• blood in urine
• abdominal pain
• coughing up blood or vomiting blood. Immediate medical help should be sought if any of these symptoms occur.

Perforation and fistula
Pazopanib STADA may cause a tear (perforation) in the wall of the stomach or intestine or the formation of an abnormal connection between two parts of the gastrointestinal tract (fistula). Symptoms of this condition may include:

• severe abdominal pain
• nausea and (or) vomiting
• fever
• formation of an opening (perforation) in the stomach, large or small intestine, from which blood-stained or foul-smelling pus leaks. Immediate medical help should be sought if any of these symptoms occur.

Liver disorders
Pazopanib STADA may cause liver disorders, which may lead to serious conditions such as impaired liver function or liver failure, which may be fatal. Your doctor will monitor your liver enzyme activity while you are taking Pazopanib STADA. Symptoms indicating impaired liver function may include:

• yellowing of the skin or whites of the eyes (jaundice)
• dark-coloured urine
• feeling tired
• nausea
• vomiting
• loss of appetite
• pain on the right side of the abdomen
• easy bruising. Immediate medical help should be sought if any of these symptoms occur.

Blood clots
Deep vein thrombosis and pulmonary embolism
Pazopanib STADA may cause blood clots in the veins, especially in the legs (deep vein thrombosis), which may 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 arms and hands or hands and feet.

Thrombotic microangiopathy
Pazopanib STADA may cause blood clots in small blood vessels in the kidneys and brain, accompanied by a decrease in red blood cells and platelets (thrombotic microangiopathy). Symptoms include:

• easy bruising
• high blood pressure
• fever
• disorientation
• drowsiness
• seizures
• reduced urine output. Immediate medical help should be sought if any of these symptoms occur.

Tumour lysis syndrome
Pazopanib STADA 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, disorientation, muscle cramps or reduced urine output. Immediate medical help should be sought if any of these symptoms occur.
Infections
Infections occurring during treatment with Pazopanib STADA 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 of breath and (or) wheezing
• pain when passing urine
• cuts, scratches or wounds that are red, warm, swollen or painful. Immediate medical help should be sought if any of these symptoms occur.

Pneumonitis
Pazopanib STADA may rarely cause pneumonitis (lung interstitial disease, lung inflammation), which may be fatal in some patients. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib STADA, you will be examined for any lung problems.
Immediate medical help should be sought if any of these symptoms occur.
Thyroid disorders
Pazopanib STADA may reduce the production of thyroid hormones in the body. This may cause weight gain and fatigue. While taking Pazopanib STADA, your doctor will monitor your thyroid hormone levels.
You should tell your doctor if you notice significant weight gain or fatigue.
Blurred vision or visual disturbances
Pazopanib STADA may cause detachment or tear of the membrane at the back of the eye (retinal detachment or tear). This may lead to blurred vision or visual disturbances.
You should inform your doctor if you notice any changes in vision.
Possible adverse reactions (including possible serious adverse reactions in the appropriate frequency categories).
Very common adverse reactions (may affect more than 1 in 10 patients):

• high blood pressure
• diarrhoea
• nausea or vomiting
• abdominal pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth pain
• headache
• tumour pain
• lack of energy, feeling weak or tired
• changes in hair colour
• excessive hair loss or thinning
• skin discolouration
• skin rash with possible peeling of the skin
• redness and swelling of the palms or soles of the feet. Inform your doctor or pharmacist if any of these symptoms become bothersome.

Very common adverse reaction that may be detected in blood or urine tests

• increased liver enzyme activity
• decreased blood albumin levels
• protein in urine
• decreased platelet count (blood component enabling clot formation)
• decreased white blood cell count.

Common adverse reactions (may affect up to 1 in 10 patients):

• indigestion, bloating, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• excessive sleepiness
• sleep disturbances
• chest pain, shortness of breath, leg pain and swelling of legs or feet. These may be symptoms of blood clot formation in the body (thrombosis). If a clot detaches, it may travel to the lungs, which may be life-threatening or even fatal.
• reduced ability of the heart to pump blood to the whole body (heart function disorder)
• slow heartbeat
• bleeding from the mouth, rectum or lungs
• dizziness
• blurred vision
• hot flushes
• swelling of the face, hands, legs around the ankles, feet or eyelids due to fluid accumulation
• tingling, weakness or numbness of hands, arms, legs or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, stinging, itching or tingling sensation of the skin
• feeling of cold accompanied by chills
• excessive sweating
• dehydration
• muscle, joint, tendon or chest pain, muscle cramps
• hoarseness
• shortness of breath
• cough
• coughing up blood
• hiccups
• lung collapse with air trapped between the lung and chest wall, often causing shortness of breath (pneumothorax). Inform your doctor or pharmacist if any of these symptoms become bothersome.

Common adverse reactions that may be detected in blood or urine tests:

• hypothyroidism
• abnormal liver function
• increased bilirubin levels (substance produced by the liver)
• increased lipase activity (enzyme involved in digestion)
• increased creatinine levels (substance produced in muscles)
• changes in levels/activity of various other substances/enzymes in blood. Your doctor will inform you about blood test results.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• stroke
• transient reduction in blood flow to the brain (transient ischaemic attack)
• interruption of blood flow to part of the heart or heart attack (myocardial infarction)
• partial interruption of blood flow to part of the heart (myocardial ischaemia)
• blood clots, accompanied by reduced red blood cells and platelets (thrombotic microangiopathy). This may damage organs such as the brain and kidneys.
• increased red blood cell count
• sudden shortness of breath, especially if occurring simultaneously with acute chest pain and (or) rapid breathing (pulmonary embolism)
• severe bleeding from the gastrointestinal tract (from stomach, oesophagus or intestines), kidneys, vagina or bleeding into the brain
• heart rhythm disorders (QT interval prolongation)
• perforation of stomach or intestine
• formation of abnormal connections between different parts of the intestine (fistula)
• excessive or irregular menstrual bleeding
• sudden, severe increase in blood pressure (hypertensive crisis)
• pancreatitis
• inflammation, abnormal function or damage to the liver
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the abdominal lining (peritonitis)
• watery nasal discharge
• rashes, which may be itchy or associated with inflammation (flat or raised spots or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• reduced sensation or sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer).

Rare adverse reactions (may affect up to 1 in 1000 patients):

• pneumonitis
• enlargement and weakening of blood vessel wall or tear in blood vessel wall (aneurysm and arterial dissection).

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

• tumour lysis syndrome due to rapid breakdown of tumour cells
• liver failure.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Pazopanib STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the bottle and carton.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the Package and Other Information

What Pazopanib STADA contains
Pazopanib STADA, 200 mg, coated tablets:

• The active substance is pazopanib (as hydrochloride). Each coated tablet contains 200 mg of pazopanib.
• Other ingredients are:
  Tablet core: microcrystalline cellulose type 101, sodium carboxymethyl starch (type A), povidone K-30, magnesium stearate.
  Tablet coating: hypromellose 6 mPa·s, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), polysorbate 80.

Pazopanib STADA, 400 mg, coated tablets:

• The active substance is pazopanib (as hydrochloride). Each coated tablet contains 400 mg of pazopanib.
• Other ingredients are:
  Tablet core: microcrystalline cellulose type 101, sodium carboxymethyl starch (type A), povidone K-30, magnesium stearate.
  Tablet coating: hypromellose 6 mPa·s, titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Pazopanib STADA looks like and contents of the pack
Pazopanib STADA, 200 mg, coated tablets
Pazopanib STADA 200 mg coated tablets are pink, capsule-shaped coated tablets,
with "200" embossed on one side, approximately 14.3 mm x 5.7 mm in size.
They are supplied in transparent unit dose blisters made of Aluminium/PVC/PE/PVDC foil,
containing 30 x 1 and 90 x 1 coated tablet in a cardboard box.
Pazopanib STADA, 400 mg, coated tablets
Pazopanib STADA 400 mg coated tablets are white, capsule-shaped coated tablets,
with "400" embossed on one side, approximately 18.0 mm x 7.1 mm in size.
They are supplied in transparent unit dose blisters made of Aluminium/PVC/PE/PVDC foil,
containing 30 x 1 and 60 x 1 coated tablet in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
Limassol 3056
Cyprus

STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further information, please contact the representative of the marketing authorisation holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20