Pazopanib Stada 200 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pazopanib Stada 200 mg film-coated tablets EFG

Pazopanib Stada 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Pazopanib Stada is and what it is used for
2. What you need to know 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 is a type of medicine called a protein kinase inhibitor. It works by blocking the activity of proteins involved in the growth and spread of cancer cells.

Pazopanib is used in adults for the treatment of:

• advanced kidney cancer or cancer that has spread to other organs.
• certain types of soft tissue sarcoma, which is a type of cancer affecting the body's connective tissues. It may occur in muscles, blood vessels, fat tissue, or other tissues that connect, surround, and protect the organs.

2. What you need to know before starting Pazopanib Stada

Do not take Pazopanib Stada

• if you are allergic to pazopanib or to any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if you think this may apply to you.

Warnings and precautions

Consult your doctor before starting to take Pazopanib Stada:

• if you have a heart disease.
• if you have a liver disease.
• if you have had heart failure or a heart attack.
• if you have previously had a pulmonary embolism.
• if you have had problems with bleeding, blood clotting, or narrowing of the arteries.
• if you have had stomach or intestinal problems such as perforation (hole) or fistula (abnormal passages that form between certain parts of the intestine).
• if you have thyroid problems.
• if you have problems with kidney function.
• if you have or have had an aneurysm (bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Consult your doctor if you think you may have any of these conditions. Your doctor will decide whether pazopanib is suitable for you. You may need additional tests to check that your kidneys, heart, and liver are functioning properly.

High blood pressure and pazopanib

Pazopanib may increase your blood pressure. Your doctor will check your blood pressure before you start taking pazopanib and during treatment. If you have high blood pressure, you will be given medication to help lower it.

• Tell your doctor if you have high blood pressure.

If you are going to undergo surgery

Your doctor will tell you to stop taking pazopanib at least 7 days before your surgery, as this may affect wound healing. Your treatment will be resumed once the wounds have healed properly.

Conditions that require your attention

Pazopanib Stada may worsen other conditions or cause serious adverse effects. You should be alert to certain symptoms while taking pazopanib to reduce the risk of any problems. See section 4.

The input is empty. Please provide text to translate.

Children and adolescents

Pazopanib is not recommended for use in individuals under 18 years of age. Its efficacy has not yet been established in this age group. Furthermore, it must not be used in children under 2 years of age due to safety concerns.

Other medicines and Pazopanib Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines and over-the-counter medications.

Some medicines may affect how pazopanib works or increase the likelihood of you experiencing side effects. Pazopanib 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).
• nefazodone (used to treat depression).
• simvastatin and possibly other statins (used for the treatment of high cholesterol levels).
• medicines that reduce stomach acidity. The type of medicine you are taking to reduce stomach acidity (e.g., a proton pump inhibitor, H2-receptor antagonists, or antacids) may affect how you should take pazopanib. Consult your doctor or nurse for further information.

Inform your doctor or pharmacist if you are taking any of these medicines.

Taking Pazopanib Stada with food and drinks

Do not take pazopanib with food, as food affects the absorption of the medicine. Take it at least two hours after eating or one hour before eating (see section 3).

Do not drink grapefruit juice while being treated with pazopanib, as this may increase the likelihood of adverse effects occurring.

Pregnancy, breastfeeding and fertility

Pazopanib is not recommended if you are pregnant. The effect of pazopanib during pregnancy is unknown.

• Inform your doctor if you are pregnant or planning to become pregnant.
• Use a reliable method of contraception while taking pazopanib and for at least 2 weeks after stopping treatment to prevent pregnancy.
• If you become pregnant during treatment with pazopanib, inform your doctor.

Do not breastfeed while taking pazopanib. It is unknown whether pazopanib components pass into breast milk. Inform your doctor about this.

Male patients (including those who have had a vasectomy) who have partners that are pregnant or who may become pregnant (including those using other contraceptive methods) must use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose.

Fertility may be affected by treatment with pazopanib. Discuss this with your doctor.

Driving and operating machines

Pazopanib may cause adverse effects that could affect your ability to drive or operate machinery.

• Avoid driving or operating machinery if you feel dizzy, tired, weak, or if you have low energy.

Pazopanib Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; that is, essentially "sodium-free".

3. How to take Pazopanib Stada

Follow exactly the instructions for using this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much to take

Pazopanib Stada 200 mg film-coated tablets EFG

The normal dose is four 200 mg pazopanib tablets (800 mg of pazopanib) taken once daily. This is the maximum daily dose. Your doctor may need to reduce your dose if you experience adverse effects.

Pazopanib Stada 400 mg film-coated tablets EFG

The normal dose is two 400 mg pazopanib tablets (800 mg of pazopanib) taken once daily. This is the maximum daily dose. Your doctor may need to reduce your dose if you experience adverse effects.

When to take it

Do not take pazopanib with food. Take it at least two hours after a meal or one hour before a meal.

For example, you can take it two hours after breakfast or one hour before lunch. Take pazopanib at the same time each day.

Swallow the tablets whole with water, one after another. Do not break or crush the tablets, as this affects how the medicine is absorbed and may increase the risk of adverse effects.

If you take more Pazopanib Stada than you should

If you take more tablets than you should, seek advice from your doctor or pharmacist. If possible, show them the container or this leaflet.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pazopanib Stada

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

Do not interrupt treatment with Pazopanib Stada

Take pazopanib for as long as your doctor has recommended. Do not stop the treatment unless advised by your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Possible serious side effects

Inflammation of the brain (posterior reversible encephalopathy syndrome).

On rare occasions, pazopanib may cause inflammation of the brain, which can be life-threatening. Symptoms include:

• loss of speech
• changes in vision
• seizures (epileptic attacks)
• confusion
• high blood pressure

Stop taking pazopanib and seek immediate medical attention if you experience any of these symptoms, or if you have a headache accompanied by any of these symptoms.

Hypertensive crises (sudden and severe increase in blood pressure)

Pazopanib may occasionally cause a sudden and severe increase in blood pressure. This is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking pazopanib. Signs and symptoms of a hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe anxiety
• difficulty breathing
• fainting

Stop taking pazopanib and seek immediate medical attention if you experience a hypertensive crisis.

Heart problems

The risk of these problems may be higher in people who have a heart condition or who are taking other medicines. While you are taking pazopanib, your doctor will monitor you for any heart-related issues.

Cardiac dysfunction/heart failure, cardiac arrest

Pazopanib can affect the heart's ability to pump or may increase the risk of cardiac arrest.

Signs and symptoms include:

• irregular or rapid heartbeat
• fast heart palpitations
• fainting or feeling lightheaded
• chest pain or pressure
• pain in the arms, back, neck, or jaw
• shortness of breath
• swelling in the legs

Seek immediate medical attention if you experience any of these symptoms.

Changes in heart rhythm (QT interval prolongation)

Pazopanib may affect heart rhythm, which in some people can trigger a potentially serious heart condition known as torsade de pointes. This can cause a rapid heartbeat that may lead to loss of consciousness.

Tell your doctor if you notice any unusual changes in your heartbeat, such as a heartbeat that is too fast or too slow.

Stroke

Pazopanib may increase the risk of having a stroke. Signs and symptoms of stroke may include:

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

Seek immediate medical attention if you experience any of these symptoms.

Bleeding

Pazopanib can cause serious bleeding in the gastrointestinal tract (in the stomach, esophagus, rectum, or intestine), or in the lungs, kidneys, mouth, vagina, and brain, although this is uncommon. Symptoms include:

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

Seek immediate medical attention if you experience any of these symptoms.

Perforation and Fistula

Pazopanib may cause a perforation in the stomach or intestinal wall, or the development of an abnormal connection between two parts of the gastrointestinal tract (a fistula). Signs and symptoms may include:

• severe abdominal pain
• nausea and/or vomiting
• fever
• development of a perforation in the stomach or intestine from which foul-smelling, bloody pus is released

Seek immediate medical attention if you experience any of these symptoms.

Liver problems

Pazopanib can cause liver problems that may become serious conditions such as liver failure or hepatic failure, which can be fatal. Your doctor will monitor your liver enzymes while you are taking pazopanib. Signs that your liver may not be working properly may include:

• yellowing of the skin or the whites of the eyes (jaundice)
• dark-colored urine
• fatigue
• nausea
• vomiting
• loss of appetite
• pain in the right side of the stomach area (abdomen)
• easy bruising

Seek immediate medical attention if you experience any of these symptoms.

Blood clots

Deep vein thrombosis (DVT) and pulmonary embolism

Pazopanib can cause blood clots in the veins, especially in the legs (deep vein thrombosis or DVT), which may travel to the lungs (pulmonary embolism). Signs and symptoms may include:

• sharp chest pain
• difficulty breathing
• rapid breathing
• leg pain
• swelling of the arms and hands or legs and feet

Thrombotic microangiopathy (TMA)

Pazopanib can cause blood clots in the small blood vessels of the kidneys and brain, along with a reduction in red blood cells and platelets (thrombotic microangiopathy, TMA). Signs and symptoms may include:

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

Seek immediate medical attention if you experience any of these symptoms.

Tumor lysis syndrome

Pazopanib may cause rapid destruction of cancer cells, leading to tumor lysis syndrome, which can be fatal in some people. Symptoms may include irregular heartbeat, seizures, confusion, muscle cramps or spasms, or decreased urine output. Seek immediate medical attention if you experience any of these symptoms.

Infections

Infections that occur while you are taking pazopanib can become serious. Symptoms of infections may include:

• fever
• flu-like symptoms, such as cough, fatigue, and body aches that do not go away
• difficulty breathing and/or wheezing
• pain when urinating
• cuts, scratches, or wounds that are red, warm, swollen, or painful

Seek immediate medical attention if you experience any of these symptoms.

Lung inflammation

Pazopanib Stada may, in rare cases, cause lung inflammation (interstitial lung disease, pneumonitis), which in some people may be fatal. Symptoms include shortness of breath or cough that does not go away. Your doctor will monitor you for any lung problems while you are taking pazopanib.

Seek immediate medical attention if you experience any of these symptoms.

Thyroid problems

Pazopanib may decrease the amount of thyroid hormone produced in your body. This can cause weight gain and fatigue. Your thyroid hormone levels will be monitored while you are taking pazopanib.

Tell your doctor if you notice significant weight gain or fatigue.

Blurred or altered vision

Pazopanib may cause separation or tearing of the back of the eye (retinal detachment or tear). This may lead to blurred vision or changes in vision.

Inform your doctor if you notice any changes in vision

Possible adverse effects (including potentially serious adverse effects under the relevant frequency category).

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

• elevated blood pressure
• diarrhea
• feeling dizzy or being nauseous or vomiting
• stomach pain
• loss of appetite
• weight loss
• altered or loss of taste
• mouth irritation
• headache
• tumor pain
• lack of energy, feeling weak or tired
• changes in hair color
• unusual hair loss or hair fragility
• loss of skin pigmentation
• skin rash, possibly with skin peeling
• redness and inflammation of the palms of the hands and soles of the feet.

Inform your doctor or pharmacist if any of these adverse effects become troublesome.

Very common adverse effects that may appear in your blood or urine tests:

• increased liver enzymes
• decreased blood albumin
• protein in the urine
• decreased platelet count (blood cells involved in blood clotting)
• decreased white blood cell count

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

• indigestion, feeling bloated, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• abnormal numbness
• difficulty sleeping
• chest pain, shortness of breath, leg pain, swelling of the legs/feet. These may be signs of blood clotting in the body (thromboembolism). If the clot dislodges, it may travel to the lungs and may become life-threatening or even fatal.
• reduced heart ability to pump blood to the rest of the body (cardiac dysfunction)
• slow heart rate
• bleeding from mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling due to fluid retention in the face, hands, ankles, feet, or eyelids
• tingling, weakness, or numbness in the hands, arms, legs, or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, itching, pruritus, or tingling sensation on the skin
• feeling cold, with chills
• excessive sweating
• dehydration
• muscle, joint, tendon pain, or chest pain, muscle spasms
• hoarseness
• difficulty breathing
• cough
• coughing up blood
• hiccups
• collapsed lung with air trapped between the lung and chest wall, often causing difficulty breathing (pneumothorax)

Inform your doctor or pharmacist if any of these adverse effects become troublesome.

Frequent adverse effects that may appear in your blood or urine tests:

• reduced activity of the thyroid gland
• altered liver function
• increased bilirubin (a substance produced by the liver)
• increased lipase levels (an enzyme involved in digestion)
• increased creatinine (a substance produced in the muscles)
• changes in the levels of other chemicals/enzymes in the blood. Your doctor will inform you of the results of your blood tests.

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

• stroke
• temporary reduction in blood supply to the brain (transient ischaemic attack)
• interruption of blood supply to part of the heart or heart attack (myocardial infarction)
• partial interruption of blood supply to part of the heart (myocardial ischaemia)
• blood clots accompanied by a decrease in red blood cells and other cells involved in blood clotting (thrombotic microangiopathy, TMA). These can cause organ damage, such as in the brain and kidneys.
• increased number of red blood cells
• sudden difficulty breathing, especially when accompanied by sharp chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding in the gastrointestinal tract (in the stomach, oesophagus, or intestine), or in the kidneys, vagina, or brain
• disturbances in heart rhythm (QT interval prolongation)
• hole (perforation) in the stomach or intestine
• abnormal passages forming between parts of the intestine (fistula)
• heavy or irregular menstrual periods
• sudden increases in blood pressure (hypertensive crisis)
• inflammation of the pancreas (pancreatitis)
• inflamed, poorly functioning, or damaged liver
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• skin rashes that may itch or become inflamed (flat or raised spots, or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• reduced sensation, especially in the skin
• skin wound that does not heal (skin ulcer)

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

• inflammation of the lung (pneumonitis)
• enlargement and weakening of the wall of a blood vessel or tear in the blood vessel wall (aneurysms and arterial dissections)

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

• tumour lysis syndrome, resulting from rapid destruction of cancer cells
• liver failure

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pazopanib Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and carton after EXP and CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Pazopanib Stada

Pazopanib Stada 200 mg film-coated tablets EFG

• The active substance is pazopanib (as hydrochloride). Each tablet contains 200 mg of pazopanib.
• The other components are:

Tablet core: microcrystalline cellulose (E460), sodium carboxymethylstarch (type A) (from potato), povidone K30 (E1201), magnesium stearate (E470b).

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), iron oxide red (E172), polysorbate 80 (E433).

Pazopanib Stada 400 mg film-coated tablets EFG

• The active substance is pazopanib (as hydrochloride). Each tablet contains 400 mg of pazopanib.
• The other components are:

Tablet core: microcrystalline cellulose (E460), sodium carboxymethylstarch (type A) (from potato), povidone K30 (E1201), magnesium stearate (E470b).

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433).

Appearance of the product and contents of the pack

Pazopanib Stada 200 mg film-coated tablets

Pazopanib Stada 200 mg are film-coated, capsule-shaped, pink tablets, marked with "200" on one side, and measuring approximately 14.3 mm x 5.7 mm.

Supplied in white HDPE bottles with child-resistant caps containing 30, 90 tablets; multiple pack of 90 (3 packs of 30) tablets.

Supplied in clear/transparent Aluminio-PVC/PE/PVDC blisters containing 30, 60 tablets; multiple pack of 60 (2 packs of 30), 90 tablets; multiple pack of 90 (3 packs of 30) tablets.

Supplied in perforated unit-dose Aluminio-PVC/PE/PVDC clear/transparent blisters containing 30x1, 60x1 tablets; multiple pack of 60x1 (2 packs of 30x1), 90x1 tablets; multiple pack of 90x1 (3 packs of 30x1) tablets.

Pazopanib Stada 400 mg film-coated tablets

Pazopanib Stada 400 mg are film-coated, capsule-shaped, white tablets, marked with "400" on one side, and measuring approximately 18.0 mm x 7.1 mm.

Available in white HDPE bottles with child-resistant caps containing 30, 60 tablets.

Supplied in clear/transparent Aluminio-PVC/PE/PVDC blisters containing 30, 60 tablets; multiple pack of 60 (2 packs of 30), 90 tablets; multiple pack of 90 (3 packs of 30) tablets.

Supplied in perforated unit-dose Aluminio-PVC/PE/PVDC clear/transparent blisters containing 30x1, 60x1 tablets; multiple pack of 60x1 (2 packs of 30x1), 90x1 tablets; multiple pack of 90x1 (3 packs of 30x1) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

or

PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000,
Malta

or

STADA Arzneimittel AG
Stadastrasse 2 – 18,
61118 Bad Vilbel,
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Hungary: Pazopanib Stada 200 mg/400 mg filmtabletta
Belgium: Pazopanib EG 200 mg/400 mg filmomhulde tabletten
Germany: Pazopanib STADA 200 mg/400 mg Filmtabletten
Denmark: Pazopanib STADA
Greece: Pazopanib/Stada 200 mg/400 mg επικαλυμμένα με λεπτό υμένιο δισκία
Spain: Pazopanib STADA 200 mg/400 mg comprimidos recubiertos con película EFG
Finland: Pazopanib STADA 200 mg/400 mg kalvopäällysteiset tabletit
France: PAZOPANIB STADA 200 mg/400 mg, comprimé pelliculé
Iceland: Pazopanib STADA 200 mg/400 mg filmuhúðaðar töflur
Luxembourg: Pazopanib EG 200 mg/400 mg comprimé pelliculé
Netherlands: Pazopanib CF 200 mg/400 mg, filmomhulde tabletten
Norway: Pazopanib STADA
Poland: Pazopanib STADA
Portugal: Pazopanib STADA
Sweden: Pazopanib STADA 200 mg/400 mg filmdragerade tabletter
Slovakia: Pazopanib STADA 200 mg/400 mg

Date of the most recent review of this leaflet: December 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)