Pazopanib Stada

Leaflet attached to the packaging: patient information

Pazopanib STADA, 200 mg, coated tablets

Pazopanib STADA, 400 mg, coated tablets

Pazopanib

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• 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 you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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. Contents of the pack 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, fatty 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 you are allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6). You should consult a doctorif you think the above statement applies to you.

Warnings and precautions

Before starting to take Pazopanib STADA, 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 effusion) in the past.
• if you have bleeding, blood clots, or narrowing of the arteries.
• if you have had stomach or intestinal diseases, such as perforation(puncture) or fistula(formation of abnormal connections between different parts of the intestine).
• if you have thyroid diseases.
• if you have kidney function disorders.
• if you have or have had an aneurysm(enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

You should inform your doctorif any of these circumstances occur. The doctor will decide whether Pazopanib STADA is suitable for you. It may be necessary to perform additional testson you to check if your kidneys, heart, and liver are working properly.

Hypertension and taking Pazopanib STADA

Pazopanib STADA may cause an increase in blood pressure. Before starting to take Pazopanib STADA and during treatment, your blood pressure will be monitored. If you have high blood pressure, your doctor will prescribe blood pressure-lowering medications.

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

If you are scheduled for surgery

Your doctor will advise you to stop taking 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 to pay special attention to

Pazopanib STADA may exacerbate certain disorders or cause severe side effects. While taking Pazopanib STADA, you should pay attention to certain symptoms to minimize the risk of adverse effects. 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as those you plan 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 you. 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, H receptor antagonists, or antacids) may affect the way Pazopanib STADA is absorbed. For advice, you should consult a doctor or nurse. You should tell your doctoror pharmacist if you are taking any of these medicines.

Pazopanib STADA with food and drink

You should not take Pazopanib STADA 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, you should not drink grapefruit juice, 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.

• -You should inform your doctor if you are pregnantor planning to become pregnant. During treatment with Pazopanib STADA and for at least 2 weeks after the end of treatment, you should use effective contraceptionto prevent pregnancy.
• -You should inform your doctor if you become pregnantwhile taking Pazopanib STADA. You should not breastfeedwhile taking Pazopanib STADA. It is not known whether the ingredients of Pazopanib STADA pass into breast milk. You should discuss this with your doctor.

Men(including men who have had a vasectomy), whose partners are pregnant or are able to 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. You should discuss this with your doctor.

Driving and using machines

While taking Pazopanib STADA, you may experience side effects that can affect your ability to drive and use machines.

• You should avoid driving and using machines if you feel dizzy, tired, or weak, or if you 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 your doctor.If you are unsure, you should consult a doctor or pharmacist.

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. Your doctor may prescribe a lower dose if you experience 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. Your doctor may prescribe a lower dose if you experience side effects.

When to take the medicine

You should 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, you can take the medicine two hours after breakfast or one hour before lunch. You should take Pazopanib STADA every day at the same time.
The tablets should be swallowed whole, one after the other, with a glass of water. You should not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of side effects.

Taking more than the recommended dose of Pazopanib STADA

If you have swallowed too many tablets, you should consult a doctor or pharmacist. If possible, you should show the medicine packaging or this leaflet.

Missing a dose of Pazopanib STADA

You should not take a double dose to make up for a missed dose. You should take the next dose of the medicine at the usual time.

Do not stop taking Pazopanib STADA without consulting your doctor

You should take Pazopanib STADA for as long as your doctor has prescribed. You should not stop taking the medicine unless your doctor advises you to do so.

4. Possible side effects

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

Severe 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.

You should stop taking Pazopanib STADA and seek medical attention 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 STADA may occasionally 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 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.

You should stop taking Pazopanib STADA and seek medical attention 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 STADA, you will be monitored for heart problems.
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. You should seek medical attention immediatelyif you experience any of these symptoms.

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 heartbeat, leading to loss of consciousness.
You should inform your doctorif you experience changes in heart rhythm, such as a heartbeat that is too fast or too slow.

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. You should seek medical attention immediatelyif you experience any of these symptoms.

Bleeding

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

• -blood in the stool or black stools
• -blood in the urine
• -abdominal pain
• -coughing up blood or vomiting blood. You should seek medical attention immediatelyif you experience any of these symptoms.

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 two 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. You should seek medical attention immediatelyif you experience any of these symptoms.

Liver disease

Pazopanib STADA may cause liver disorders, which can lead to severe diseases such as liver dysfunction or liver failure, which can be fatal. Your doctor will monitor your liver enzyme activity while you are taking Pazopanib STADA. Symptoms of liver dysfunction may include:

• -yellowing of the skin or whites of the eyes (jaundice)
• -dark urine
• -feeling tired
• -nausea
• -vomiting
• -loss of appetite
• -pain on the right side of the abdomen
• -easy bruising. You should seek medical attention immediatelyif you experience any of these symptoms.

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 feet and ankles.

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 You should seek medical attention immediatelyif you experience any of these symptoms.

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. You should seek medical attention immediatelyif you experience any of these symptoms.

Infections

Infections that occur while taking Pazopanib STADA can become severe infections. 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 You should seek medical attention immediatelyif you experience any of these symptoms.

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, you will be monitored for any lung problems.
You should seek medical attention immediatelyif you experience any of these symptoms.

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, your doctor will monitor your thyroid hormone levels.
You should tell your doctorif you notice significant weight gain or fatigue.

Blurred vision or vision disturbances

Pazopanib STADA may cause separation or tearing of the membrane on the back surface of the eye (detachment or tear of the retina). This can cause blurred vision or vision disturbances.
You should inform your doctorif you notice any changes in your vision.

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
• -tumor 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. You should inform your doctor or pharmacistif any of these symptoms become troublesome.

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 blood component that enables clotting)
• -decreased white blood cell count.

Common side effects(may affect up to 1 in 10 people):

• -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 blood 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, tingling, itching, or numbness of the skin
• -feeling cold with accompanying 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 in the space between the lung and the chest cavity, often causing shortness of breath (pneumothorax). You should inform your doctoror pharmacist if any of these symptoms become troublesome.

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 other substances or enzymes in the blood. Your doctor will inform you about the results of your 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, 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 (from the stomach, esophagus, or intestine), 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 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 lining of the abdominal cavity (peritonitis)
• -runny nose
• -skin rashes, which can be itchy or inflamed (flat or raised patches or blisters)
• -frequent bowel movements
• -increased sensitivity of the skin to sunlight
• -numbness or decreased sensitivity, especially of the skin
• -a skin wound that does not heal (skin ulcer).

Rare side effects(may affect up to 1 in 1000 people):

• -pneumonitis
• -enlargement and weakening of the wall of a blood vessel or tearing of 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 you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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.
By reporting side effects, you can help provide 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.
You should 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.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, you should consult the representative of the marketing authorization holder:
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