Pazopanib Glenmark 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pazopanib Glenmark 200 mg film-coated tablets EFG

Pazopanib Glenmark 400 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pazopanib Glenmark 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 taking Pazopanib Glenmark

Do not take Pazopanib Glenmark

• 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

Talk to your doctor before starting pazopanib:

• 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 (a hole) or fistula (abnormal passages that form between parts of the intestine).
• if you have thyroid problems.
• if you have problems with kidney function.
• if you have or have had an aneurysm (a bulge and weakening of a blood vessel wall) 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 Glenmark

Pazopanib can raise your blood pressure. Your doctor will monitor your blood pressure before and during treatment with pazopanib. If you have high blood pressure, you will be given medication to help lower it.

• Inform your doctor if you have high blood pressure.

If you are scheduled for surgery

Your doctor will instruct you to stop taking pazopanib at least 7 days before your surgery, as it may affect wound healing. Your treatment will resume once the wounds have healed adequately.

Conditions requiring your attention

Pazopanib may worsen other medical conditions or cause serious adverse effects. You should be aware of certain symptoms while taking pazopanib to reduce the risk of complications. See section 4.

Children and adolescents

Pazopanib is not recommended for individuals under 18 years of age. Its effectiveness has not been established in this age group. Moreover, it should not be used in children under 2 years of age due to safety concerns.

Other medicines and Pazopanib Glenmark

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

Some medicines may affect how pazopanib works or increase the likelihood of adverse 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 Glenmark with food and drink

Do not take pazopanib with food, as food 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 juice while being treated with pazopanib, as this may increase the risk of adverse effects.

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 immediately.

Do not breastfeed while taking pazopanib. It is not known whether pazopanib passes into breast milk. Inform your doctor about this.

Male patients (including those who have had a vasectomy) who have partners who are either pregnant or could 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 using machines

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

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

Pazopanib Glenmark contains sodium

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

3. How to take Pazopanib Glenmark

Follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

Pazopanib Glenmark 200 mg film-coated tablets EFG

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

Pazopanib Glenmark 400 mg film-coated tablets EFG

The normal dose is two Pazopanib Glenmark 400 mg tablets (800 mg of pazopanib) taken once daily. The 800 mg once-daily dose 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 may 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 the other. 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 Glenmark than you should

If you take more tablets than you should, seek advice from your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Pazopanib Glenmark

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

Do not stop treatment with Pazopanib Glenmark

Take pazopanib for as long as your doctor has recommended. Do not stop 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.

Serious possible adverse effects

Brain inflammation (posterior reversible encephalopathy syndrome).

Rarely, pazopanib may 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 immediate medical attention if 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 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
• seizures
• fainting

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

Heart problems

The risk of developing these problems may be higher in people who already have heart conditions or who are taking other medicines. While you are taking pazopanib, your heart will be monitored for any problems.

Cardiac disorder/heart failure, cardiac arrest

Pazopanib may affect how the heart pumps blood or may increase the likelihood of cardiac arrest. Signs and 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 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 may trigger a potentially serious heart condition known as torsade de pointes. This may cause a rapid heartbeat that could lead to loss of consciousness.

Inform your doctor if you notice any unusual changes in your heartbeat, such as beats that are 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 may 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 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 digestive tract (a fistula). Signs and symptoms may include:

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

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

Liver problems

Pazopanib may cause liver problems that could become serious conditions such as liver failure or hepatic failure, which may be fatal. Your doctor will monitor liver enzymes while you are taking pazopanib. Signs that your liver may not be functioning 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 abdomen (stomach area)
• easy bruising

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

Blood clots

Deep vein thrombosis (DVT) and pulmonary embolism

Pazopanib may 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:

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

Thrombotic microangiopathy (TMA)

Pazopanib may cause blood clots in the small blood vessels of the kidneys and brain, accompanied by a reduction in red blood cells and platelets (thrombotic microangiopathy, TMA). This may damage organs such as the brain and kidneys. 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.

Tumour lysis syndrome

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

Infections

Infections that occur while taking pazopanib may become severe. 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 may rarely cause inflammation of the lung (interstitial lung disease, pneumonitis), which in some people may be fatal. Symptoms include difficulty breathing or a persistent cough. Your lungs will be monitored while you are taking pazopanib. Seek immediate medical attention if you experience any of these symptoms.

Thyroid problems

Pazopanib may reduce the amount of thyroid hormone produced in your body. This may cause weight gain and fatigue. Your thyroid hormone levels will be monitored while you are taking pazopanib. Inform your doctor if you notice significant weight gain or fatigue.

Blurred vision or visual disturbances

Pazopanib may cause separation or tearing of the back of the eye (retinal detachment or tear). This may result in blurred vision or changes in vision. Inform your doctor if you notice any changes in your vision.

Possible adverse effects (including possible serious adverse effects listed under relevant frequency category).

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

• high blood pressure
• diarrhoea
• dizziness (nausea or vomiting)
• stomach pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth irritation
• headache
• tumour pain
• lack of energy, weakness, or fatigue
• changes in hair colour
• 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 albumin in blood
• protein in 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, bloating, flatulence
• nosebleeds
• dry mouth or mouth ulcers
• infections
• abnormal numbness
• difficulty sleeping
• chest pain, difficulty breathing, leg pain, swelling of 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 pumping efficiency (cardiac dysfunction)
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flushes
• 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, stinging, or tingling sensations on the skin
• feeling cold, with chills
• excessive sweating
• dehydration
• muscle, joint, tendon, or chest pain, muscle spasms
• hoarseness
• difficulty breathing
• cough
• coughing up blood
• hiccups
• collapsed lung with trapped air between the lung and chest wall, often causing difficulty breathing (pneumothorax).

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

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

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

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 may cause organ damage such as in the brain and kidneys.
• increased red blood cell count
• 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, and brain
• changes in heart rhythm (QT interval prolongation)
• hole (perforation) in the stomach or intestine
• abnormal connections 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 abdominal lining (peritonitis)
• runny nose
• rashes that may itch or become inflamed (flat or raised spots, or blisters)
• frequent bowel movements
• increased skin sensitivity to sunlight
• reduced sensitivity, especially in the skin
• non-healing skin wound (skin ulcer)

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

• lung inflammation (pneumonitis)
• weakening or bulging of a blood vessel wall or tearing of a 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pazopanib Glenmark

Store below 30°C. Keep the container in the original outer packaging to protect from light and moisture. Keep out of the reach and sight of children. Do not use after the expiry date stated on the container. Dispose of unused medication according to local regulations to protect the environment.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. In this way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pazopanib Glenmark

Pazopanib Glenmark 200 mg film-coated tablets

• The active substance is pazopanib (as hydrochloride).

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

• The other components are:

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

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

Pazopanib Glenmark 400 mg film-coated tablets

• The active substance is pazopanib (as hydrochloride).

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

• The other components are:

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

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

Appearance of the product and contents of the pack

Pazopanib Glenmark 200 mg film-coated tablets EFG

Oval-shaped, pink-colored tablets, marked with "200" on one side, approximately 14 mm x 6 mm in size.

Supplied in transparent Al-PVC/PE/PVDC blisters containing 30 or 90 tablets, or multiple pack of 90 (3 packs of 30) film-coated tablets.

Supplied in transparent, single-dose perforated Al-PVC/PE/PVDC blisters containing 30 x 1, 90 x 1, or multiple pack of 90 x 1 (3 packs of 30 x 1) film-coated tablets.

Pazopanib Glenmark 400 mg film-coated tablets EFG

Oval-shaped, white-colored tablets, marked with "400" on one side, approximately 18 mm x 7 mm in size.

Supplied in transparent Al-PVC/PE/PVDC blisters containing 30 or 60 tablets, or multiple pack of 60 (2 packs of 30) film-coated tablets.

Supplied in transparent, single-dose perforated Al-PVC/PE/PVDC blisters containing 30 x 1, 60 x 1, or multiple pack of 60 x 1 (2 packs of 30 x 1) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA3000
Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

Date of the most recent revision of this leaflet: May 2024.

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