Pazopanib Stada

Leaflet accompanying the packaging: patient information

Pazopanib STADA, 200 mg, coated tablets

Pazopanib STADA, 400 mg, coated tablets

Pazopanib

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including all possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet:

• 1. What is Pazopanib STADA and what is it 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. Package contents and other information

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

Pazopanib STADA belongs to a group of medicines called protein kinase inhibitors. The action of the medicine is based on inhibiting the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib STADA is used in adult patients to treat:

• advanced or metastatic kidney cancer.
• certain types of soft tissue sarcoma, which is a type of tumor that attacks the body's connective tissue. 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 STADA

When not to take Pazopanib STADA

• If the patient is allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6). A doctor should be consultedif the patient thinks the above statement applies to them.

Warnings and precautions

Before starting to take Pazopanib STADA, the following should be discussed with the doctor:

• if the patient has heart disease.
• if the patient has liver disease.
• if the patient has had heart failure or a heart attack.
• if the patient has a history of pneumothorax (fluid accumulation in the lungs).
• if the patient has bleeding, blood clots, or narrowing of the arteries.
• if the patient has had stomach or intestinal diseases, such as perforation(puncture) or fistula(formation of abnormal connections between different parts of the intestines).
• if the patient has thyroid diseases.
• if the patient has 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.

The doctor should be informedif any of these circumstances occur. The doctor will decide whether Pazopanib STADA is suitable for the patient. It may be necessary to perform additional testson the patient to check if the kidneys, heart, and liver are functioning properly.

Hypertension and taking Pazopanib STADA

Pazopanib STADA may cause an increase in blood pressure. Before starting to take Pazopanib STADA and during treatment, the patient's blood pressure will be monitored. If the patient has high blood pressure, the doctor will prescribe blood pressure-lowering medication.

• The doctor should be informedif the patient has high blood pressure.

If the patient is scheduled for surgery

The doctor will recommend stopping Pazopanib STADA at least 7 days before surgery, as the medicine may affect the wound healing process after surgery. Treatment will be resumed after the wound has healed.

Conditions that require special attention

Pazopanib STADA may exacerbate certain disorders or cause severe side effects. During treatment with Pazopanib STADA, attention should be paid to certain symptoms to minimize the risk of adverse reactions. See section 4.

Children and adolescents

Pazopanib STADA is not recommended for patients under 18 years of age.
It has not been established how the medicine works in this group of patients. Additionally, for safety reasons, the medicine should not be used in children under 2 years of age.

Pazopanib STADA and other medicines

The doctor or pharmacist should be told about all medicines currently being taken or recently taken, as well as those that the patient plans to take. This includes herbal products and other medicines that are available without a prescription.
Some medicines may affect the action of Pazopanib STADA or increase the likelihood of side effects in the patient. Pazopanib STADA may also affect the action of other medicines. These medicines 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 production. Medicines taken to reduce stomach acid production (e.g., proton pump inhibitors, H2 receptor antagonists, or antacids) may affect the absorption of Pazopanib STADA. For advice, the doctor or nurse should be consulted. The doctor or pharmacist should be toldif the patient is taking any of these medicines.

Pazopanib STADA with food and drink

Pazopanib STADA should not be taken with food, as it affects the absorption of the medicine. 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, grapefruit juice should not be consumed, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Pazopanib STADA is not recommended during pregnancy.It is not known how Pazopanib STADA affects pregnancy.

• -The doctor should be informed if the patient is pregnantor plans to become pregnant. During treatment with Pazopanib STADA and for at least 2 weeks after the end of treatment, an effective method of contraception should be usedto prevent pregnancy.
• -The doctor should be informed if the patient becomes pregnantwhile taking Pazopanib STADA. Breastfeeding should not be done while taking Pazopanib STADA.It is not known whether the ingredients of Pazopanib STADA pass into breast milk. This should be discussed with the attending doctor.

Men(including men who have had a vasectomy), whose partners are pregnant or are able to become pregnant (including women using other methods of contraception) 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. This should be discussed with the attending doctor.

Driving and operating machinery

While taking Pazopanib STADA, side effects may occur that can affect the ability to drive and operate machinery.

• Driving and operating machinery should be avoided if the patient feels dizzy, tired, or weak, or if they have low energy levels.

Pazopanib STADA contains sodium

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

3. How to take Pazopanib STADA

This medicine should always be taken as directed by the doctor.In case of doubts, the doctor or pharmacist should be consulted.

How many tablets to take

Pazopanib STADA 200 mg coated tablets
The usual doseof Pazopanib STADA is four 200 mg tablets (800 mg of pazopanib) once a day. This is the maximum daily dose. The doctor may recommend reducing the dose if the patient experiences side effects.
Pazopanib STADA 400 mg coated tablets
The usual doseof Pazopanib STADA is two 400 mg tablets (800 mg of pazopanib) once a day. This is the maximum daily dose. The doctor may recommend reducing the dose if the patient experiences side effects.

When to take the medicine

Pazopanib STADA should not be taken with food.The medicine should be taken at least two hours after a meal or one hour before a meal. For example, the medicine can 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 the other, with water. The tablets should not be broken or crushed, as this affects the absorption of the medicine and may increase the risk of side effects.

Taking a higher dose of Pazopanib STADA than recommended

In case of swallowing too many tablets, the doctor or pharmacist should be consulted. If possible, the packaging of the medicine or this leaflet should be shown.

Missing a dose of Pazopanib STADA

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.

Do not stop taking Pazopanib STADA without consulting a doctor

Pazopanib STADA should be taken for as long as the doctor recommends. The medicine should not be stopped without the doctor's advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious side effects

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

• loss of speech
• vision disturbances
• seizures
• disorientation
• high blood pressure.

Stop taking Pazopanib STADA and seek medical help immediately

if any of these symptoms occur or if there is a headache accompanied by any of these symptoms.
Hypertensive crisis(sudden and severe increase in blood pressure)
Pazopanib STADA may occasionally cause a sudden and severe increase in blood pressure. This condition is known as a hypertensive crisis. The doctor will monitor the patient's blood pressure while taking Pazopanib STADA. Symptoms of a hypertensive crisis may include:

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

Stop taking Pazopanib STADA and seek medical help immediately

if a hypertensive crisis occurs.

Heart rhythm disorders

The risk of these disorders may be higher in people with existing heart disease or those taking other medicines.
Heart rhythm disorders/heart failure, heart attack
Pazopanib STADA may affect the heart's pumping efficiency 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. Medical help should be sought immediatelyif any of these symptoms occur.

Changes in heart rhythm (QT interval prolongation)
Pazopanib STADA may affect the heart rhythm, which can lead to heart rhythm disorders called torsades de pointes, which can be severe. They can cause very rapid heartbeats, leading to loss of consciousness.
The doctor should be informedif the patient experiences changes in heart rhythm, such as too fast or too slow heartbeat.

Stroke

Pazopanib STADA 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. Medical help should be sought immediatelyif any of these symptoms occur.

Bleeding

Pazopanib STADA may cause severe bleeding from the digestive tract (stomach, esophagus, colon, or intestines), lungs, kidneys, mouth, vagina, or bleeding into the brain, although this is not common. Symptoms of bleeding include:

• -blood in the stool or black stool color
• -blood in the urine
• -abdominal pain
• -coughing up blood or vomiting blood. Medical help should be sought immediatelyif any of these symptoms occur.

Perforation and fistula

Pazopanib STADA may cause a tear 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/or vomiting
• -fever
• -formation of a hole (perforation) in the stomach, large intestine, or small intestine, from which bloody or foul-smelling pus is discharged. Medical help should be sought immediatelyif any of these symptoms occur.

Liver disease

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

• -yellowing of the skin or whites of the eyes (jaundice)
• -dark urine color
• -feeling tired
• -nausea
• -vomiting
• -loss of appetite
• -pain on the right side of the abdomen
• -easy bruising. Medical help should be sought immediatelyif 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 veins of the legs (deep vein thrombosis), which can also move 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 STADA may cause blood clots in the small blood vessels in the kidneys and brain, accompanied by a decrease in the number of red blood cells and cells involved in blood clotting (microangiopathic hemolytic anemia). Symptoms include:

• -easy bruising
• -high blood pressure
• -fever
• -disorientation
• -drowsiness
• -seizures
• -decreased urine output. Medical help should be sought immediatelyif any of these symptoms occur.

Tumor lysis syndrome

Pazopanib STADA 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, disorientation, muscle cramps, or decreased urine output. Medical help should be sought immediatelyif any of these symptoms occur.

Infections

Infections that occur while taking Pazopanib STADA 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. Medical help should be sought immediatelyif any of these symptoms occur.

Pneumonitis

Pazopanib STADA may rarely cause pneumonitis (interstitial lung disease, pneumonia), which can be fatal in some patients. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib STADA, the patient will be monitored for any lung problems.
Medical help should be sought immediatelyif any of these symptoms occur.

Thyroid diseases

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

Blurred vision or vision disturbances

Pazopanib STADA may cause separation or tearing of the membrane on the back of the eye (retinal detachment or tear). This can cause blurred vision or vision disturbances.
The doctor should be informedif the patient notices any changes in vision.

Possible side effects (including possible severe side effects in the relevant frequency categories). Very common side effects (may occur in more than 1 in 10 patients):

• -high blood pressure
• -diarrhea
• -nausea (vomiting) 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 palms or soles of the feet. The doctor or pharmacist should be informedif any of these symptoms become troublesome.

Very common side effect that may 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 blood component that enables clotting)
• -decreased white blood cell count.

Common side effects(may occur in less than 1 in 10patients) :

• -indigestion, bloating, gas
• -nosebleeds
• -dry mouth or mouth ulcers
• -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 clot breaks loose, it can move to the lungs, which can be life-threatening or fatal.
• -decreased heart function (heart failure)
• -slow heartbeat
• -bleeding from the mouth, rectum, or lungs
• -dizziness
• -blurred vision
• -hot flashes
• -swelling of the face, hands, feet, or ankles due to fluid accumulation
• -tingling, weakness, or numbness of the hands, arms, legs, or feet
• -skin disorders, redness, itching, dryness of the skin
• -nail disorders
• -burning, stinging, itching, or tingling sensation 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 with air entrapment in the space between the lung and the chest cavity, often causing shortness of breath (pneumothorax). The doctor or pharmacist should be informedif any of these symptoms become troublesome.

Common side effects that may 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/activity of various other substances/enzymes in the blood. The doctor will inform the patient about the results of the blood tests.

Uncommon side effects(may occur in less than 1 in 100patients):

• -stroke
• -transient ischemic attack (temporary reduction of blood flow to the brain)
• -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, accompanied by a decrease in the number of red blood cells and cells involved in blood clotting (microangiopathic hemolytic anemia). This can damage organs such as the brain and kidneys.
• -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 intestines), kidneys, vagina, or bleeding into the brain
• -heart rhythm disorders (QT interval prolongation)
• -perforation of the stomach or intestine
• -formation of abnormal connections between different parts of the intestines (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 lining of the abdominal cavity (peritonitis)
• -runny nose
• -rashes, which can be itchy or inflamed (flat or raised spots or blisters)
• -frequent bowel movements
• -increased sensitivity of the skin to sunlight
• -numbness or decreased sensitivity of the skin
• -skin wound that does not heal (skin ulcer).

Rare side effects(may occur in less than 1 in 1000patients):

• -pneumonitis
• -enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and 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 any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Pazopanib STADA

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiration date (EXP) stated on the bottle and carton.
The expiration date refers to the last day of the specified month.
There are no special storage instructions for the medicine.
Medicines should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Pazopanib STADA contains

Pazopanib STADA, 200 mg, coated tablets:

• -The active substance is pazopanib (in the form of hydrochloride). Each coated tablet contains 200 mg of pazopanib.
• -The other ingredients of the medicine are: Tablet core: microcrystalline cellulose type 101, sodium carboxymethylcellulose (type A), povidone K-30, magnesium stearate. Tablet coating: hypromellose 6mPa  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 (in the form of hydrochloride). Each coated tablet contains 400 mg of pazopanib.
• -The other ingredients of the medicine are: Tablet core: microcrystalline cellulose type 101, sodium carboxymethylcellulose (type A), povidone K-30, magnesium stearate. Tablet coating: hypromellose 6mPa  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, measuring approximately 14.3 mm x 5.7 mm.
They are supplied in transparent single-dose blisters made of aluminum/PVC/PE/PVDC, containing 30 x 1 and 90 x 1 coated tablets 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, measuring approximately 18.0 mm x 7.1 mm.
They are supplied in transparent single-dose blisters made of aluminum/PVC/PE/PVDC, containing 30 x 1 and 60 x 1 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

For more detailed information, the representative of the marketing authorization holder should be contacted:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20
Date of last revision of the leaflet:08/2024