Pazopanib Glenmark

Leaflet accompanying the packaging: patient information

Pazopanib Glenmark, 200 mg, coated tablets

Pazopanib Glenmark, 400 mg, coated tablets

Pazopanib

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Pazopanib Glenmark 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 Glenmark is used in adults for the treatment of:

• advanced or metastatic kidney cancer.
• certain types of soft tissue sarcoma, which is a type of tumor that attacks the body's connective tissue. It can occur in muscles, blood vessels, fat tissue, or other tissues that support, surround, and protect internal organs.

2. Important information before taking Pazopanib Glenmark

When not to take Pazopanib Glenmark

Consult a doctorif the patient thinks this applies to them.

Warnings and precautions

Before starting treatment with Pazopanib Glenmark, discuss the following with your doctor:

heart disease.liver disease.heart failure or a heart attack.lung collapse(pneumothorax) in their medical history.bleeding, blood clots, or artery narrowing.stomach or intestinal diseases, such as perforation(puncture) or fistula(formation of abnormal connections between different parts of the intestine).thyroid diseases.kidney function disorders.aneurysm(enlargement and weakening of the blood vessel wall) or rupture of the blood vessel wall. Tell your doctorif any of these situations apply to the patient. The doctor will decide whether Pazopanib Glenmark is suitable for the patient. Additional tests may be necessary to check if the patient's kidneys, heart, and liver are functioning properly.

High blood pressure and Pazopanib Glenmark

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

• Tell your doctorif the patient has high blood pressure.

If the patient is scheduled for surgery

The doctor will advise stopping treatment with Pazopanib Glenmark 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.

Diseases to be aware of

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

Children and adolescents

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

Pazopanib Glenmark and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including herbal medicines and those available without a prescription.
Some medicines may affect the action of Pazopanib Glenmark or increase the risk of side effects in the patient. Pazopanib Glenmark 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. Medicines taken to reduce stomach acid production (e.g., proton pump inhibitors, H2 receptor antagonists, or antacids) may affect the absorption of Pazopanib Glenmark. Consult a doctor or nurse for advice. Tell your doctoror pharmacist if the patient is taking any of these medicines.

Pazopanib Glenmark with food and drink

Do not take Pazopanib Glenmark with food, as it affects the absorption of the medicine.
Take the medicine at least 2 hours after a meal or 1 hour before a meal.
For example, the medicine can be taken 2 hours after breakfast or 1 hour before lunch. Take Pazopanib Glenmark at the same time every day.
Swallow the tablets whole, one after the other, with a glass of water. Do not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of side effects.
Do not drink grapefruit juice during treatment with Pazopanib Glenmark, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

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

• Tell your doctorif the patient is pregnant or plans to become pregnant.
• During treatment with Pazopanib Glenmark and for at least 2 weeks after the end of treatment, use effective contraceptionto prevent pregnancy.
• Tell your doctorif the patient becomes pregnant while taking Pazopanib Glenmark.

Do not breastfeed while taking Pazopanib Glenmark. It is not known whether the ingredients of Pazopanib Glenmark pass into breast milk. Consult the treating doctor.
Men(including men who have had a vasectomy), whose partners are pregnant or may become pregnant (including women using other contraceptive methods) should use condoms during sexual intercourse while taking Pazopanib Glenmark and for at least 2 weeks after the last dose.
Treatment with Pazopanib Glenmark may affect fertility. Consult the treating doctor.

Driving and using machines

While taking Pazopanib Glenmark, side effects may occur that can affect the ability to drive and use machines.

• Avoid driving and using machines if the patient feels dizzy, tired, or weak, or has low energy levels.

Pazopanib Glenmark contains sodium

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

3. How to take Pazopanib Glenmark

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How many tablets to take

Pazopanib Glenmark, 200 mg, coated tablets
Typically, the recommended doseis four Pazopanib Glenmark 200 mg tablets (800 mg of pazopanib) taken once a day. This is the maximum daily dose. The doctor may recommend reducing the dose if the patient experiences side effects.
Pazopanib Glenmark, 400 mg, coated tablets
Typically, the recommended doseis two Pazopanib Glenmark 400 mg tablets (800 mg of pazopanib) taken once a day. This is the maximum daily dose. The doctor may recommend reducing the dose if the patient experiences side effects.

When to take the medicine

Do not take Pazopanib Glenmark with food. Take the medicine at least 2 hours after a meal or 1 hour before a meal.
For example, the medicine can be taken 2 hours after breakfast or 1 hour before lunch. Take Pazopanib Glenmark at the same time every day.
Swallow the tablets whole, one after the other, with a glass of water. Do not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of side effects.

Taking a higher dose of Pazopanib Glenmark than recommended

If the patient has taken too many tablets, contact a doctor or pharmacist.
If possible, show the packaging or this leaflet.

Missing a dose of Pazopanib Glenmark

Do not take a double dose to make up for a missed tablet. Take the next dose as scheduled.

Stopping treatment with Pazopanib Glenmark

Take Pazopanib Glenmark for as long as your doctor has prescribed. Do not stop taking Pazopanib Glenmark without consulting your doctor first.

4. Possible side effects

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

Severe side effects

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

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

Stop taking Pazopanib Glenmark and seek medical attention immediately

if any of these symptoms occur, or if the patient experiences a headache with any of these symptoms.

Hypertensive crisis (sudden and severe increase in blood pressure)

Pazopanib Glenmark can occasionally cause a sudden and severe increase in blood pressure.
This is known as a hypertensive crisis. The patient's doctor will monitor their blood pressure while taking Pazopanib Glenmark. Symptoms of a hypertensive crisis include:

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

Stop taking Pazopanib Glenmark and seek medical attention immediately

if a hypertensive crisis occurs.

Heart disease

The risk of these diseases may be higher in people with existing heart disease or those taking other medicines.
During treatment with Pazopanib Glenmark, the patient will be monitored for any heart disease.
Heart function disorders or heart failure, heart attack
Pazopanib Glenmark may affect the heart's ability to pump blood 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 Seek medical attention immediatelyif the patient experiences any of these symptoms.

Changes in heart rhythm (QT interval prolongation)
Pazopanib Glenmark may affect the heart rhythm, which can lead to potentially serious heart rhythm disorders called torsades de pointes. These can cause very rapid heartbeats, leading to loss of consciousness.
Tell your doctorif the patient experiences abnormal heart rhythm changes, such as too fast or too slow a heartbeat.

Stroke

Pazopanib Glenmark 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 Seek medical attention immediatelyif the patient experiences any of these symptoms.

Bleeding

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

• blood in the stool or black stool
• blood in the urine
• abdominal pain
• coughing up blood or vomiting blood Seek medical attention immediatelyif the patient experiences any of these symptoms.

Perforation and fistula

Pazopanib Glenmark may cause a tear (perforation) in the wall of the stomach or intestine or the formation of an abnormal connection between two parts of the digestive tract (fistula).
Symptoms may include:

• severe abdominal pain
• nausea and (or) vomiting
• fever
• formation of a hole (perforation) in the stomach, large intestine, or small intestine, with bloody or foul-smelling pus Seek medical attention immediatelyif the patient experiences any of these symptoms.

Liver disease

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

• yellowing of the skin or whites of the eyes (jaundice)
• dark urine
• fatigue
• nausea
• vomiting
• loss of appetite
• abdominal pain on the right side
• easy bruising Seek medical attention immediatelyif the patient experiences any of these symptoms.

Blood clots

Deep vein thrombosis and pulmonary embolism
Pazopanib Glenmark may cause blood clots in the veins, especially in the legs (deep vein thrombosis), which can also move to the lungs (pulmonary embolism). Symptoms may include:

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

Microangiopathic hemolytic anemia
Pazopanib Glenmark 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 blood cells involved in clotting (microangiopathic hemolytic anemia). Symptoms may include:

• easy bruising
• high blood pressure
• fever
• confusion
• drowsiness
• seizures
• decreased urine output Seek medical attention immediatelyif the patient experiences any of these symptoms.

Tumor lysis syndrome

Pazopanib Glenmark may cause rapid breakdown of cancer cells, leading to tumor lysis syndrome, which can be fatal in some patients. Symptoms may include irregular heartbeat, seizures, confusion, muscle spasms, or decreased urine output. Seek medical attention immediatelyif the patient experiences any of these symptoms.

Infections

Infections that occur during treatment with Pazopanib Glenmark can potentially become severe.
Symptoms of infection 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 Seek medical attention immediatelyif the patient experiences any of these symptoms.

Pneumonitis

Pazopanib Glenmark 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. During treatment with Pazopanib Glenmark, the doctor will perform tests to detect any lung problems in the patient.
Seek medical attention immediatelyif the patient experiences any of these symptoms.

Thyroid disease

Pazopanib Glenmark may decrease the production of thyroid hormones in the body. This can cause weight gain and fatigue. During treatment with Pazopanib Glenmark, the doctor will monitor the patient's thyroid hormone levels.
Tell your doctorif the patient notices significant weight gain or fatigue.

Blurred vision or vision disturbances

Pazopanib Glenmark may cause separation or damage to the membrane at the back of the eye (retinal detachment or tear). This can cause blurred vision or vision disturbances.
Tell your doctorif the patient notices any changes in 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
• cancer pain
• lack of energy, feeling weak or tired
• hair color changes
• excessive hair loss or thinning
• skin discoloration
• rash with possible peeling of the skin
• redness and swelling of the palms of the hands or soles of the feet Tell your doctor or pharmacistif any of these symptoms become troublesome.

Very common side effects 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, and swelling of the legs or feet. These may be symptoms of blood clots in the body (thromboembolism). If a clot breaks loose, it can move to the lungs, which can be life-threatening or even fatal.
• decreased heart function (heart function disorder)
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling of the face, hands, legs, or feet due to fluid accumulation
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, tingling, itching, or numbness of the skin
• feeling cold with accompanying chills
• excessive sweating
• dehydration
• muscle, joint, or tendon pain, or chest pain, muscle spasms
• hoarseness
• shortness of breath
• cough
• hemoptysis
• hiccups
• lung collapse with air trapped in the space between the lung and chest cavity, often causing shortness of breath (pneumothorax) Tell 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 in the muscles)
• changes in the levels or activity of various substances or enzymes in the blood. The doctor will inform the patient about the results of the 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 blood cells involved in 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 intestines) or 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
• rashes, which can be itchy or inflamed (flat or raised patches or blisters)
• diarrhea
• increased sensitivity of the skin to sunlight
• weakness or decreased sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer)

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

• pneumonitis
• enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial 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 side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pazopanib Glenmark

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry datestated on the carton or blister after EXP. The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pazopanib Glenmark contains:

Pazopanib Glenmark, 200 mg, coated tablets

• The active substance is pazopanib (as hydrochloride). Each coated tablet contains 200 mg of pazopanib.
• Other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol, iron oxide red (E 172), polysorbate 80.

Pazopanib Glenmark, 400 mg, coated tablets

• The active substance is pazopanib (as hydrochloride). Each coated tablet contains 400 mg of pazopanib.
• Other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol, polysorbate 80.

What Pazopanib Glenmark looks like and contents of the pack

Pazopanib Glenmark, 200 mg, coated tablets
Pazopanib Glenmark, 200 mg are pink, capsule-shaped, coated tablets with the marking "200" on one side, approximately 14 mm x 6 mm in size.
Available pack sizes:
Transparent blisters of aluminum/PVC/PE/PVDC in a cardboard box containing 30, 90 tablets, a collective pack of 90 tablets (3 packs of 30 tablets).
Transparent, single-dose, perforated blisters of aluminum/PVC/PE/PVDC in a cardboard box containing 30x1, 90x1 tablets, a collective pack of 90x1 tablets (3 packs of 30x1 tablets).
Pazopanib Glenmark, 400 mg, coated tablets
Pazopanib Glenmark, 400 mg are white, capsule-shaped, coated tablets with the marking "400" on one side, approximately 18 mm x 7 mm in size.
Available pack sizes:
Transparent blisters of aluminum/PVC/PE/PVDC in a cardboard box containing 30, 60 tablets, a collective pack of 60 tablets (2 packs of 30 tablets).
Transparent, single-dose, perforated blisters of aluminum/PVC/PE/PVDC in a cardboard box containing 30x1, 60x1 tablets, a collective pack of 60x1 tablets (2 packs of 30x1 tablets).
Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer

Remedica Limited
Aharnon Street
Limassol Industrial Estate
3056 Limassol
Cyprus
Pharos MT Limited
Hf62x
Qasam Industrijali Hal Far
Hal Far, Birzebbuga
BBG 3000
Malta

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

For more information about this medicine, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com
Date of last revision of the leaflet:September 2024