Pazopanib glenmark

Package leaflet: Information for the patient

Pazopanib Glenmark, 200 mg, coated tablets
Pazopanib Glenmark, 400 mg, coated tablets
Pazopanibum
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. 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 Glenmark belongs to a group of medicines called protein kinase inhibitors. The medicine works by inhibiting the activity of proteins involved in the growth and spread of cancer cells.

Pazopanib Glenmark is used in adults to treat:

• advanced or metastatic renal cell carcinoma (a type of kidney cancer).
• certain types of soft tissue sarcoma, which is a type of tumour affecting the body's connective tissues. It may occur in muscles, blood vessels, fat tissue, or other tissues that support, surround, and protect internal organs.

2. Important information before using Pazopanib Glenmark

When not to use Pazopanib Glenmark

• if the patient is allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6). Consult a doctor if the patient thinks any of the above situations apply.

Warnings and precautions
Before starting treatment with Pazopanib Glenmark, discuss the following with the doctor:

• if the patient has heart disease.
• if the patient has liver disease.
• if the patient has had heart failure or heart attack.
• if the patient has had pneumothorax (collapsed lung) in the past.
• if the patient has had bleeding, blood clots, or narrowing of arteries.
• if the patient has stomach or intestinal disorders, such as perforation (a hole) or fistula (abnormal connections between different parts of the intestine).
• if the patient has thyroid disorders.
• if the patient has kidney function disorders.
• if the patient has or has had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in the wall of a blood vessel. Inform the doctor if any of these situations apply. The doctor will decide whether Pazopanib Glenmark is suitable for the patient. The patient may need to undergo additional tests to check whether the kidneys, heart, and liver are functioning properly.

High blood pressure and Pazopanib Glenmark
Pazopanib Glenmark may cause high blood pressure. Blood pressure will be monitored before starting treatment with Pazopanib Glenmark and during treatment. If the patient develops high blood pressure, the doctor will prescribe medications to lower it.

• Inform the doctor if the patient has high blood pressure.

If surgery is planned
The doctor will advise stopping Pazopanib Glenmark at least 7 days before surgery, as the medicine may affect wound healing after surgery. Treatment will be restarted once the wound has healed.

Conditions requiring attention
Pazopanib Glenmark may worsen certain conditions or cause serious side effects. During treatment with Pazopanib Glenmark, certain symptoms should be monitored to reduce 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 patient group has not been established. Moreover, for safety reasons, the medicine should not be used in children under 2 years of age.

Pazopanib Glenmark and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal medicines and those available without a prescription.

Some medicines may affect the action of Pazopanib Glenmark or increase the likelihood of side effects. Pazopanib Glenmark may also affect the action of other medicines. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections).
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection).
• nefazodone (used to treat depression).
• simvastatin and possibly other statins (used to treat high blood cholesterol levels).
• medicines reducing gastric acid secretion. Medicines taken to reduce stomach acid (e.g. proton pump inhibitors, H\2-receptor antagonists, or antacids) may affect how Pazopanib Glenmark is absorbed. Consult the doctor or nurse for advice. Tell the doctor or pharmacist if the patient is taking any of these medicines.

Pazopanib Glenmark with food and drink
Do not take Pazopanib Glenmark with food, as this affects the absorption of the medicine. The medicine should be taken at least two hours after a meal or one hour before a meal (see section 3).
During treatment with Pazopanib Glenmark, do not drink grapefruit juice, as this may increase the risk of side effects.

Pregnancy, breastfeeding and effects on fertility

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

• Inform the doctor if the patient is pregnant or planning to become pregnant.
• During treatment with Pazopanib Glenmark and for at least 2 weeks after stopping treatment, an effective method of contraception must be used to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Pazopanib Glenmark.

Breastfeeding is not recommended during treatment with Pazopanib Glenmark. It is unknown whether the active substances of Pazopanib Glenmark pass into breast milk. Discuss this with the treating doctor.

Men (including men who have had a vasectomy), whose partners are pregnant or could 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. Discuss this with the treating doctor.

Driving and using machines
Side effects may occur during treatment with Pazopanib Glenmark that could affect the ability to drive or operate machinery.

• Avoid driving and operating machinery if the patient experiences dizziness, fatigue, weakness, or low energy levels.

Pazopanib Glenmark contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Pazopanib Glenmark

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
How many tablets to take
Pazopanib Glenmark, 200 mg, coated tablets
The usual dose is four tablets of Pazopanib Glenmark, 200 mg (800 mg of pazopanib) taken once daily. This is the maximum daily dose. Your doctor may recommend reducing the dose if you experience adverse effects.
Pazopanib Glenmark, 400 mg, coated tablets
The usual dose is two tablets of Pazopanib Glenmark, 400 mg (800 mg of pazopanib) taken once daily. This is the maximum daily dose. Your doctor may recommend reducing the dose if you experience adverse effects.
When to take the medicine
Do not take Pazopanib Glenmark with food. The medicine should be taken at least two hours after a meal or one hour before a meal.
For example, the medicine may be taken two hours after breakfast or one hour before lunch. Pazopanib Glenmark should be taken at the same time each day.
The tablets should be swallowed whole, one at a time, with water. Do not break or crush the tablets, as this affects drug absorption and may increase the risk of adverse effects.
Taking more Pazopanib Glenmark than prescribed
If you have taken more tablets than recommended, contact your doctor or pharmacist immediately.
If possible, show the medicine packaging or this leaflet.
If you miss a dose of Pazopanib Glenmark
Do not take a double dose to make up for a missed tablet. Take the next dose according to your regular dosing schedule.
Stopping treatment with Pazopanib Glenmark
Continue taking Pazopanib Glenmark for as long as your doctor prescribes. Do not stop taking Pazopanib Glenmark without first consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will get them.

Possible serious side effects

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

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

Stop taking Pazopanib Glenmark and seek immediate medical help if any of these symptoms occur, or if headache occurs together with any of these symptoms.

Hypertensive crisis (sudden and severe increase in blood pressure)
Pazopanib Glenmark may occasionally cause a sudden and severe rise in blood pressure, known as a hypertensive crisis. Your doctor will monitor your blood pressure during treatment with Pazopanib Glenmark. Symptoms of hypertensive crisis include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe restlessness
• shortness of breath
• seizures
• fainting

Stop taking Pazopanib Glenmark and seek immediate medical help if a hypertensive crisis occurs.

Heart problems
The risk of these conditions may be higher in patients with existing heart disease or those taking other medicines.
While taking Pazopanib Glenmark, you will be monitored for any heart problems.

Heart rhythm disorders or heart failure, heart attack
Pazopanib Glenmark may affect the heart's ability to pump blood or may increase the risk of heart attack. Symptoms include:

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

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

Changes in heart rhythm (QT interval prolongation)
Pazopanib Glenmark may affect heart rhythm, which in some people may lead to potentially serious rhythm disturbances called torsade de pointes. These may cause very rapid heartbeat, possibly leading to loss of consciousness.
Tell your doctor if you experience unusual changes in heart rhythm, such as heartbeat that is too fast or too slow.

Stroke
Pazopanib Glenmark may increase the risk of stroke. Symptoms of stroke may include:

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

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

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

• presence of blood in stool or black-coloured stool
• blood in urine
• abdominal pain
• coughing up blood or vomiting blood

Seek immediate medical help if you experience 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 gastrointestinal tract (fistula). Symptoms may include:

• severe abdominal pain
• nausea and (or) vomiting
• fever
• formation of an opening (perforation) in the stomach, large or small intestine, from which blood-stained or foul-smelling pus leaks

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

Liver problems
Pazopanib Glenmark may cause liver disorders, which may lead to serious conditions such as impaired liver function or liver failure, which may be fatal. Your doctor will monitor your liver enzyme activity during treatment with Pazopanib Glenmark. Symptoms that may indicate impaired liver function include:

• yellowing of the skin or whites of the eyes (jaundice)
• dark-coloured urine
• feeling tired
• nausea
• vomiting
• loss of appetite
• pain in the right side of the abdomen
• easy bruising

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

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

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

Thrombotic microangiopathy
Pazopanib Glenmark may cause blood clots in small blood vessels in the kidneys and brain, associated with a decrease in red blood cells and platelets (thrombotic microangiopathy). Symptoms may include:

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

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

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

Infections
Infections occurring during treatment with Pazopanib Glenmark may potentially become severe.
Symptoms of infection may include:

• fever
• flu-like symptoms such as cough, fatigue and body aches that do not resolve
• shortness of breath and (or) wheezing
• pain when urinating
• cuts, scratches or wounds that are red, warm, swollen or painful

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

Lung inflammation
Pazopanib Glenmark may rarely cause lung inflammation (interstitial lung disease, pneumonia), which may be fatal in some patients. Symptoms include shortness of breath or cough that does not resolve. During treatment with Pazopanib Glenmark, your doctor will perform tests to detect any lung problems.
Seek immediate medical help if you experience any of these symptoms.

Thyroid disorders
Pazopanib Glenmark may reduce the production of thyroid hormones in the body. This may cause weight gain and fatigue. While you are taking Pazopanib Glenmark, your doctor will monitor your thyroid hormone levels.
Tell your doctor if you notice significant weight gain or fatigue.

Blurred or disturbed vision
Pazopanib Glenmark may cause detachment or damage to the membrane at the back of the eye (retinal detachment or tear). This may cause blurred or disturbed vision.
Tell your doctor if you notice any changes in vision.

Possible side effects (including possible serious side effects in appropriate frequency categories)

Very common side effects (may affect more than 1 in 10 patients):

• high blood pressure
• diarrhoea
• nausea or vomiting
• abdominal pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth pain
• headache
• tumour pain
• lack of energy, feeling weak or tired
• changes in hair colour
• excessive hair loss or thinning
• skin discolouration
• skin rash with possible peeling of the skin
• redness and swelling of the palms or soles of the feet

Tell your doctor or pharmacist if any of these symptoms become troublesome.

Very common side effects that may be detected in blood or urine tests:

• increased liver enzyme activity
• decreased blood albumin levels
• protein in urine
• decreased platelet count (blood component responsible for clotting)
• decreased white blood cell count

Common side effects (may affect not more than 1 in 10 patients):

• indigestion, bloating, gas
• nosebleeds
• dry mouth or mouth ulcers
• infections
• excessive drowsiness
• sleep disturbances
• chest pain, shortness of breath, leg pain and swelling of legs or feet. These may be symptoms of blood clot formation in the body (thrombosis). If a clot breaks loose, it may travel to the lungs, which may be life-threatening or even fatal.
• reduced ability of the heart to pump blood to the whole body (heart dysfunction)
• slow heartbeat
• bleeding from mouth, rectum or lungs
• dizziness
• blurred vision
• hot flushes
• swelling of the face, hands, legs around ankles, feet or eyelids due to fluid accumulation
• tingling, weakness or numbness in hands, arms, legs or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, stinging, itching or tingling sensation of the skin
• feeling of cold accompanied by chills
• excessive sweating
• dehydration
• muscle, joint, tendon or chest pain, muscle cramps
• hoarseness
• shortness of breath
• cough
• coughing up blood
• hiccups
• lung collapse with air trapped between the lung and chest wall, often causing shortness of breath (pneumothorax)

Tell your doctor or pharmacist if any of these symptoms become troublesome.

Common side effects that may be detected in blood or urine tests:

• hypothyroidism
• abnormal liver function
• increased bilirubin levels (a substance produced by the liver)
• increased lipase activity (an enzyme involved in digestion)
• increased creatinine levels (a substance produced by muscles)
• changes in concentration/activity of various other substances/enzymes in blood. Your doctor will inform you about the blood test results.

Uncommon side effects (may affect not more than 1 in 100 patients):

• stroke
• transient reduction in blood flow to the brain (transient ischaemic attack)
• interruption of blood flow to part of the heart or heart attack (myocardial infarction)
• partial interruption of blood flow to part of the heart (myocardial ischaemia)
• blood clots associated with reduced red blood cells and platelets (thrombotic microangiopathy). This may damage organs such as the brain and kidneys.
• increased red blood cell count
• sudden shortness of breath, especially if occurring together with sudden chest pain and (or) rapid breathing (pulmonary embolism)
• severe gastrointestinal bleeding (from stomach, oesophagus or intestines) or from kidneys, vagina, or bleeding into the brain
• heart rhythm disorders (QT interval prolongation)
• perforation of stomach or intestine
• formation of abnormal connections between different parts of the intestine (fistula)
• abnormally heavy 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)
• watery nasal discharge
• rashes, which may be itchy or associated with inflammation (flat or raised spots or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• reduced sensation or sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer)

Rare side effects (may affect not more than 1 in 1,000 patients):

• lung inflammation
• enlargement and weakening of the blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection)

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

• tumour lysis syndrome due to rapid breakdown of tumour cells
• liver failure

Reporting of side effects
If any side effects occur, including any unlisted side effects not mentioned in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +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 authorisation holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Pazopanib Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
blister indicated by EXP, which refers to the expiry date. The expiry date refers to the last day
of the stated month.
There are no special storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Pazopanib Glenmark contains:
Pazopanib Glenmark, 200 mg, film-coated tablets

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

Pazopanib Glenmark, 400 mg, film-coated tablets

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

What Pazopanib Glenmark looks like and contents of the pack
Pazopanib Glenmark, 200 mg, film-coated tablets
Pazopanib Glenmark, 200 mg are pink, film-coated, capsule-shaped tablets marked with "200" on one side, approximately 14 mm x 6 mm in size.
Pack sizes:
Transparent blisters made of Aluminium/PVC/PE/PVDC in cardboard packaging containing 30,
90 tablets; collective pack of 90 tablets (3 packs of 30 tablets).
Single-dose perforated transparent blisters made of Aluminium/PVC/PE/PVDC in cardboard
packaging containing 30x1, 90x1 tablet; collective pack of 90x1 tablet (3 packs of 30x1 tablet).

Pazopanib Glenmark, 400 mg, film-coated tablets
Pazopanib Glenmark, 400 mg are white, film-coated, capsule-shaped tablets marked with "400" on one side, approximately 18 mm x 7 mm in size.
Pack sizes:
Transparent blisters made of Aluminium/PVC/PE/PVDC in cardboard packaging containing 30,
60 tablets; collective pack of 60 tablets (2 packs of 30 tablets).
Single-dose perforated transparent blisters made of Aluminium/PVC/PE/PVDC in cardboard
packaging containing 30x1, 60x1 film-coated tablet; collective pack of 60x1 tablet (2 packs of
30x1 tablet).
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:

For further information about the medicinal product, please contact the local representative of the marketing authorization holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego Street 3
00-728 Warsaw
Email: [email protected]