PAZOPANIB DR. REDDYS 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pazopanib Dr. Reddys 200 mg film-coated tablets EFG

Pazopanib Dr. Reddys 400 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pazopanib Dr. Reddys and what is it used for
2. What you need to know before you take Pazopanib Dr. Reddys
3. How to take Pazopanib Dr. Reddys
4. Possible side effects
5. Storage of Pazopanib Dr. Reddys
6. Contents of the pack and other information

1. What is Pazopanib Dr. Reddys and what is it 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 to treat:

• advanced or spreading kidney cancer to other organs.
• certain types of soft tissue sarcoma, which is a type of cancer that affects the connective tissue of the body. It can occur in muscles, blood vessels, fat tissue, or other tissues that connect, surround, and support the organs.

2. What you need to know before you take Pazopanib Dr. Reddys

Do not take pazopanib

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

Consult your doctorif you think this may apply to you.

Warnings and precautions

Consult your doctor before starting to take pazopanib:

• if you have a heart condition.
• ifyou have a liver condition.
• if you have had a heart failure or heart attack.
• if you have had a previous lung collapse.
• if you have had bleeding, blood clotting, or narrowing of the arteries.
• if you have had stomach or intestinal problemssuch as perforation(hole) or fistula(abnormal passages that form between some parts of the intestine).
• if you have thyroid problems.
• if you have kidney problems.
• 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.

Consult your doctorif you think you may have any of these problems. Your doctor will decide if pazopanib is suitable for you. You may need additional teststo check that your kidneys, heart, and liver are working properly.

High blood pressure and pazopanib

Pazopanib may increase your blood pressure. Your doctor will check your blood pressure before you take pazopanib and while you are taking it. If you have high blood pressure, you will receive treatment with medicines that help to lower it.

• Tell your doctorif you have high blood pressure.

If you are going to have an operation

Your doctor will tell you to stop taking pazopanib at least 7 days before your operation, as this can affect wound healing. Your treatment will be restarted when the wounds have healed properly.

Conditions that require your attention

Pazopanib may make other conditions worse or cause serious side effects. You should be aware of certain symptoms while taking Pazopanib Dr. Reddys to reduce the risk of any problems. See section 4.

Children and adolescents

Pazopanib is not recommended for people under 18 years of age. It is not known how pazopanib works in this age group. Additionally, it should not be used in children under 2 years of age due to safety concerns.

Other medicines and Pazopanib Dr. Reddys

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription.

Some medicines may affect how pazopanib works or increase the chance 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 to treat high cholesterol levels).
• medicines that reduce stomach acid. The type of medicine you are taking to reduce stomach acid (e.g., a proton pump inhibitor, H2 receptor antagonists, or antacids) may affect how you take pazopanib.

Consult your doctor or nurse for more information.

Tell your doctoror pharmacist if you are taking any of these medicines.

Taking Pazopanib Dr. Reddys with food and drinks

Do not take pazopanib with food, as this affects the absorption of the medicine. Take it at least 2 hours after a meal or 1 hour before a meal (see section 3).

Do not drink grapefruit juicewhile being treated with pazopanib, as this may increase the chance of side effects.

Pregnancy, breastfeeding, and fertility

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

• Tell your doctor if you are pregnantor are planning to become pregnant.
• Use a reliable method of contraceptionwhile taking pazopanib and for at least 2 weeks after, to prevent pregnancy.
• If you become pregnant during treatmentwith pazopanib, tell your doctor.

Do not breastfeed while taking pazopanib. It is not known if the components of pazopanib pass into breast milk. Tell your doctor about this.

Male patients(including those who have undergone vasectomy) who have partners who are pregnant or 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 affectedby treatment with pazopanib. Consult your doctor about this.

Driving and using machines

Pazopanib may cause side effects that can affect your ability to drive or use machines.

• Avoid driving or using machines if you feel dizzy, tired, or weak, or if you are low on energy.

Pazopanib Dr. Reddys contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Pazopanib Dr. Reddys

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

How much to take

The usual doseis 800 mg taken once a day. The dose can be taken as 2 tablets of 400 mg or as 4 tablets of 200 mg. The dose of 800 mg once a day is the maximum dose per day. Your doctor may need to reduce your dose if you experience side effects.

When to take it

Do not take pazopanib with food.Take it at least 2 hours after a meal or 1 hour before a meal. For example, you can take it 2 hours after breakfast or 1 hour before lunch. Take pazopanib at the same time every day.

Swallow the tablets whole with water, one after the other. Do not break or crush the tablets, as this can affect how the medicine is absorbed and may increase the chance of side effects.

If you take more Pazopanib Dr. Reddys than you should

If you take more tablets than you should, ask your doctor or pharmacist for advice.If possible, show them the pack or this leaflet.

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

If you forget to take Pazopanib Dr. Reddys

Do not take a double dose to make up for forgotten doses. Just take your next dose at the usual time.

Do not stop taking Pazopanib Dr. Reddys

Take pazopanib for as long as your doctor recommends. Do not stop treatment unless your doctor advises you to.

4. Possible side effects

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

Serious side effects

Brain inflammation(reversible posterior leukoencephalopathy syndrome).

Rarely, pazopanib can cause brain inflammation, which can be life-threatening. Symptoms include:

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

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

Hypertensive crisis(sudden and severe increase in blood pressure)

Pazopanib can 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 can include:

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

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

Heart problems

The risk of these problems may be greater in people who have a heart condition or are taking other medicines. While taking pazopanib, you will be monitored for any heart problems.

Cardiac disorder/heart failure, cardiac arrest

Pazopanib may affect the heart's pumping ability or increase the risk of cardiac arrest.

Symptoms include:

• irregular or rapid heartbeat
• rapid heart palpitations
• fainting
• pain or pressure in the chest
• pain in the arms, back, neck, or jaw
• difficulty breathing
• swelling in the legs

Seek medical attention immediatelyif you experience any of these symptoms.

Changes in heart rhythm (prolonged QT interval)

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

Tell your doctorif you notice any unusual change in heartbeat, such as beats that are too fast or too slow.

Stroke

Pazopanib may increase the risk of stroke. Symptoms of stroke can include:

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

Seek medical attention immediatelyif you experience any of these symptoms.

Bleeding

Pazopanib can cause severe bleeding in the digestive system (in the stomach, esophagus, rectum, or intestine), or in the lungs, kidneys, mouth, vagina, or brain, although this is rare. Symptoms include:

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

Seek medical attention immediatelyif you experience any of these symptoms.

Perforation and fistula

Pazopanib can cause a hole in the stomach or intestinal wall or the formation of an abnormal connection between two parts of the digestive tract (a fistula). Symptoms can include:

• severe stomach pain
• nausea and/or vomiting
• fever
• development of a hole in the stomach or intestine from which bloody pus is released

Seek medical attention immediatelyif you experience any of these symptoms.

Liver problems

Pazopanib can cause liver problems that can become serious diseases such as liver 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 can include:

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

Seek medical attention immediatelyif 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 can move to the lungs (pulmonary embolism). Symptoms can include:

• severe chest pain
• difficulty breathing
• rapid breathing
• pain in the legs
• 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, accompanied by a decrease in red blood cells and cells involved in blood clotting (thrombotic microangiopathy, TMA). Symptoms can include:

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

Seek medical attention immediatelyif you experience any of these symptoms.

Tumor lysis syndrome

Pazopanib can cause rapid destruction of cancer cells, leading to tumor lysis syndrome, which in some people can be fatal. Symptoms can include irregular heartbeat, seizures, confusion, muscle cramps or spasms, or decreased urine output.

Seek medical attention immediatelyif you experience any of these symptoms.

Infections

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

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

Seek medical attention immediatelyif you experience any of these symptoms.

Lung inflammation

Pazopanib can rarely cause lung inflammation (interstitial lung disease, pneumonitis), which in some people can be fatal. Symptoms include difficulty breathing or cough that does not go away. You will be monitored for any lung problems while taking pazopanib.

Seek medical attention immediatelyif you experience any of these symptoms.

Thyroid problems

Pazopanib can 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 doctorif you notice significant weight gain or fatigue.

Blurred Vision or Vision Changes

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

Tell your doctorif you notice any changes in your vision

Possible side effects (including possible serious side effects under the relevant frequency category).

Very Common Side Effects(may affect more than 1 in 10people):

• high blood pressure
• diarrhea
• feeling or being nauseous (nausea or vomiting)
• stomach pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth irritation
• headache
• tumor pain
• lack of energy, feeling of weakness or fatigue
• changes in hair color
• unusual hair loss or fragility
• loss of skin pigmentation
• skin rash, possibly with skin peeling
• redness and inflammation on the palms of the hands and soles of the feet.

Tell your doctor or pharmacistif any of these side effects become problematic.

Very Common Side Effects that May Appear in Your Blood or Urine Tests:

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

Common Side Effects(may affect up to 1 in 10people):

• indigestion, feeling bloated, flatulence
• nosebleed
• dry mouth or mouth ulcers
• infections
• abnormal numbness
• difficulty sleeping
• chest pain, difficulty breathing, leg pain, swelling of the legs/feet. These may be signs of blood clotting in the body (thromboembolism). If the clot breaks loose, it can travel to the lungs and become a health threat or even cause death.
• reduced heart function to pump blood to the rest of the body (heart failure)
• slow heartbeats
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling caused by fluid retention in the face, hands, ankles, feet, or eyelids
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, itching, itching, or tingling sensation on the skin
• feeling of coldness, with chills
• excessive sweating
• dehydration
• muscle, joint, tendon, or chest pain, muscle spasms
• hoarseness
• difficulty breathing
• cough
• coughing up blood
• hiccups
• collapsed lungs with air trapped in the space between the lungs and chest, often causing difficulty breathing (pneumothorax).

Tell your doctoror pharmacist if any of these side effects become problematic.

Common Side Effects that May Appear in Your Blood or Urine Tests:

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

Uncommon Side Effects(may affect up to 1 in 100people):

• stroke
• temporary reduction in blood supply to the brain (transient ischemic attack)
• interruption of blood supply to a part of the heart or heart attack (myocardial infarction)
• partial interruption of blood supply to a part of the heart (myocardial ischemia)
• thrombi accompanied by a decrease in red blood cells and other cells involved in blood clotting (thrombotic microangiopathy, TMA). These can cause damage to organs such as the brain and kidneys.
• increased red blood cell count
• sudden difficulty breathing, especially when accompanied by acute chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding in the digestive tract (in the stomach, esophagus, or intestine), or in the kidneys, vagina, and brain
• heart rhythm disorders (prolonged QT interval)
• hole (perforation) in the stomach or intestine
• abnormal connections that form between parts of the intestine (fistula)
• heavy or irregular menstrual periods
• sudden increases in blood pressure (hypertensive crisis)
• pancreatitis (inflammation of the pancreas)
• 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
• eruptions that can itch or become inflamed (flat or raised spots, or blisters)
• frequent bowel movements
• increased skin sensitivity to sunlight
• decreased sensitivity, especially in the skin
• non-healing skin wound (skin ulcer)

Rare Side Effects(may affect up to 1 in 1,000people):

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

Frequency Not Known(cannot be estimated from the available data):

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pazopanib Dr. Reddys

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pazopanib Dr. Reddys

• The active substance is pazopanib (as hydrochloride).

Each 200 mg film-coated tablet of Pazopanib Dr. Reddys contains 200 mg of pazopanib.

Each 400 mg film-coated tablet of Pazopanib Dr. Reddys contains 400 mg of pazopanib.

The other ingredients of the 200 mg and 400 mg tablets are: magnesium stearate (E 470b), microcrystalline cellulose (E 460), povidone K30 (E 1201), sodium carboxymethyl starch (type A) of potato or maize, silicified microcrystalline cellulose (composed of microcrystalline cellulose and anhydrous colloidal silica), macrogol/polyvinyl alcohol graft copolymer, and polysorbate 80 (E 433).

Appearance and Package Contents of the Product

Pazopanib Dr. Reddys 200 mg film-coated tablets are white to off-white, modified capsule-shaped, film-coated tablets engraved with "2" on one side and smooth on the other. The tablets are approximately 14 x 6 mm in size. They are supplied in blisters of 30, 60, or 90 film-coated tablets or as single-dose blisters of 30 x 1 film-coated tablets.

Pazopanib Dr. Reddys 400 mg film-coated tablets are white to off-white, modified capsule-shaped, film-coated tablets engraved with "4" on one side and smooth on the other. The tablets are approximately 18 x 7 mm in size. They are supplied in blisters of 30, 60, or 90 film-coated tablets or as single-dose blisters of 60 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

(Spain)

Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of Last Revision of this Leaflet:January 2025

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