Pazopanib Pharmascience

Leaflet accompanying the packaging: patient information

Pazopanib Pharmascience, 200 mg, coated tablets

Pazopanib Pharmascience, 400 mg, coated tablets

Pazopanib

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

• Keep this leaflet, you may need to read it again.
• Consult a doctor or pharmacist if you have any doubts.
• 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 you experience any side effects, including all possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Pazopanib Pharmascience belongs to a group of medicines called protein kinase inhibitors. Its action involves inhibiting the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Pharmascience is used in adult patients to treat:

• 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 Pharmascience

When not to take Pazopanib Pharmascience

• If the patient is allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6). Consult a doctorif the patient thinks the above statement applies to them.

Warnings and precautions

Before starting to take Pazopanib Pharmascience, discuss with your doctor if:

• the patient has heart disease,
• the patient has liver disease,
• the patient has had heart failure or heart attack,
• the patient has a history of lung collapse(pleural effusion),
• the patient has bleeding, blood clots, or narrowing of the arteries,
• the patient has had stomach or intestinal diseases, such as perforation(puncture) or fistula(formation of abnormal connections between different parts of the intestine),
• the patient has thyroid diseases,
• the patient has kidney function disorders,
• the patient has or has had an aneurysm(enlargement and weakening of the wall of a blood vessel) or rupture of a blood vessel. Informyour doctor if you have any of these conditions. The doctor will decide if Pazopanib Pharmascience is suitable for the patient. Additional tests may be necessary to check if the kidneys, heart, and liver are functioning properly.

High blood pressure and taking Pazopanib Pharmascience

Pazopanib Pharmascience may increase blood pressure. Before starting and during treatment, the patient's blood pressure will be monitored. If the patient develops high blood pressure, the doctor will prescribe blood pressure-lowering medications.

• Tell your doctorif you have high blood pressure.

If the patient is scheduled for surgery

The doctor will advise stopping Pazopanib Pharmascience at least 7 days before surgery, as the medicine may affect the healing of the post-operative wound. Treatment will be resumed after the wound has healed.

Conditions to pay special attention to

Pazopanib Pharmascience may exacerbate certain conditions or cause severe side effects. During treatment with Pazopanib Pharmascience, it is essential to pay attention to certain symptoms to minimize the risk of adverse reactions. See section 4.

Children and adolescents

Pazopanib Pharmascience is not recommended for patients under 18 years of age.
So far, it has not been determined how pazopanib works in this patient group. Additionally, for safety reasons, the medicine should not be used in children under 2 years of age.

Pazopanib Pharmascience and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes herbal products and other medicines that are available without a prescription.
Some medicines may affect the action of Pazopanib Pharmascience or increase the likelihood of side effects. Pazopanib Pharmascience 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 secretion (e.g., proton pump inhibitors, H receptor antagonists, or antacids) may affect pazopanib absorption. Consult a doctor or nurse for advice.

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

Pazopanib Pharmascience with food and drink

Do not take Pazopanib Pharmascience with a meal, as it affects the absorption of the medicine. The medicine should be taken at least 2 hours after a meal or 1 hour before a meal (see section 3).
Do not drink grapefruit juicewhile taking Pazopanib Pharmascience, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Pazopanib Pharmascience is not recommended during pregnancy. It is not known how this medicine affects pregnancy.

• Tell your doctor if you are pregnantor plan to become pregnant. While taking Pazopanib Pharmascience and for at least 2 weeks after stopping treatment, use effective contraceptionto prevent pregnancy.
• Tell your doctor if you become pregnantwhile taking Pazopanib Pharmascience.

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

Driving and operating machinery

While taking Pazopanib Pharmascience, side effects may occur that affect the ability to drive and operate machinery.

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

Pazopanib Pharmascience 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 Pharmascience

Always take this medicine as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

How many tablets to take

Pazopanib Pharmascience, 200 mg
The usual doseof Pazopanib Pharmascience, 200 mg is four tablets (800 mg of pazopanib) once a day. This is the maximum daily dose. Your doctor may reduce the dose if you experience side effects.
Pazopanib Pharmascience, 400 mg
The usual doseof Pazopanib Pharmascience, 400 mg is two tablets (800 mg of pazopanib) once a day. This is the maximum daily dose. Your doctor may reduce the dose if you experience side effects.

When to take the medicine

Do not take Pazopanib Pharmascience with food. Take the medicine at least 2 hours after a meal or 1 hour before a meal. For example, you can take the medicine 2 hours after breakfast or 1 hour before lunch. Take Pazopanib Pharmascience every day at the same time.
Swallow the tablets whole, one after the other, with 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 Pharmascience than recommended

If you take too many tablets, consult your doctor or pharmacist.
If possible, show them the packaging or this leaflet.

Missing a dose of Pazopanib Pharmascience

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

Do not stop taking Pazopanib Pharmascience without consulting your doctor

Take Pazopanib Pharmascience for as long as your doctor recommends. Do not stop taking the medicine unless your doctor advises you to do so.

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)
Rarely, Pazopanib Pharmascience may cause brain swelling, which can be life-threatening.
Symptoms include:

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

Stop taking Pazopanib Pharmascience and seek medical attention immediately

if you experience any of these symptoms or a headache with any of these symptoms.
Hypertensive crisis(sudden and severe increase in blood pressure)
Pazopanib Pharmascience may rarely cause a sudden and severe increase in blood pressure.
This condition is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking Pazopanib Pharmascience. Symptoms of a hypertensive crisis may include:

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

Stop taking Pazopanib Pharmascience and seek medical attention immediately

if you experience a hypertensive crisis.

Heart rhythm disorders

The risk of these disorders may be higher in people with existing heart disease or those taking other medicines. While taking Pazopanib Pharmascience, you will be monitored for heart rhythm disorders.
Heart rhythm disorders/heart failure, heart attack
Pazopanib Pharmascience 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 you experience any of these symptoms.

QT interval prolongation (change in heart rhythm)
Pazopanib Pharmascience may affect the heart rhythm, which can lead to heart rhythm disorders called torsades de pointesin some people. These can cause very rapid heartbeat, leading to sudden loss of consciousness.
Tell your doctorif you experience heart rhythm changes, such as too fast or too slow heartbeat.

Stroke

Pazopanib Pharmascience 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 you experience any of these symptoms.

Bleeding

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

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

Seek medical attention immediatelyif you experience any of these symptoms.

Perforation and fistula

Pazopanib Pharmascience 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 of this condition may include:

• severe abdominal pain
• nausea and vomiting
• fever
• formation of a hole (perforation) in the stomach, intestine, or rectum, with discharge of blood-stained or foul-smelling pus. Seek medical attention immediatelyif you experience any of these symptoms.

Liver disease

Pazopanib Pharmascience may cause liver problems, which can lead to severe symptoms such as liver dysfunction or liver failure, which can be fatal. Your doctor will monitor your liver enzyme activity while you are taking this medicine.
Symptoms of liver dysfunction may include:

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

Blood clots

Deep vein thrombosis and pulmonary embolism
Pazopanib Pharmascience may cause blood clots in the veins, especially in the legs (deep vein thrombosis), which can also move to the lungs (pulmonary embolism). A symptom of this condition may be:

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

Microangiopathic hemolytic anemia
Pazopanib Pharmascience may cause blood clots in the small blood vessels of 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
• disorientation
• drowsiness
• seizures
• decreased urine output. Seek medical attention immediatelyif you experience any of these symptoms.

Tumor lysis syndrome

Pazopanib Pharmascience may cause rapid breakdown of cancer cells, leading to tumor lysis syndrome, which can be fatal in some people. Symptoms may include:

• irregular heartbeat
• seizures
• confusion
• muscle spasms
• decreased urine output. Seek medical attention immediatelyif you experience any of these symptoms.

Infections

Infections that occur while taking Pazopanib Pharmascience can become severe.
Symptoms of infections that may occur 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 you experience any of these symptoms.

Pneumonitis

Pazopanib Pharmascience may rarely cause inflammation of the lungs (interstitial lung disease, pneumonitis), which can be fatal in some patients. Symptoms include:

• shortness of breath or cough that does not go away

Seek medical attention immediatelyif you experience any of these symptoms.

Thyroid diseases

Pazopanib Pharmascience may decrease the production of thyroid hormones in the body.
This can cause weight gain and fatigue. While taking this medicine, your doctor will monitor your thyroid hormone levels.
Tell your doctorif you notice significant weight gain or fatigue.

Blurred vision or vision disturbances

Pazopanib Pharmascience may cause separation or tearing of the membrane on the back of the eye (retinal detachment or tear). This can cause blurred vision or vision disturbances.
Tell your doctorif you experience any vision disturbances.

Possible side effects (including possible severe side effects in the relevant frequency categories).

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

• 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
• skin rash with possible peeling
• 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 may 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 10patients):

• indigestion, bloating, gas
• nosebleeds
• dry mouth or mouth sores
• infections
• excessive sleepiness
• sleep disturbances
• chest pain, shortness of breath, leg pain, or swelling of the legs or feet. These may be symptoms of blood clots in the body (thromboembolism). If the clot breaks loose, it can move to the lungs, which can be life-threatening or fatal
• decreased heart function (heart failure)
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling of the face, hands, feet, or ankles due to fluid accumulation
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin disorders, redness, itching, dryness
• nail disorders
• burning, stinging, itching, or tingling of the skin
• feeling cold with chills
• excessive sweating
• dehydration
• muscle, joint, or tendon pain, or chest pain, muscle cramps
• hoarseness
• shortness of breath
• coughing
• coughing up blood
• 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 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 the muscles)
• changes in the levels/activity of various other substances/enzymes in the blood. Your doctor will inform you about the results of your blood tests.

Uncommon side effects(may affect up to 1 in 100patients):

• 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 infarction)
• blood clots, which can lead to 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 (stomach, esophagus, or intestine), 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 sensation, especially of the skin
• skin wound that does not heal (skin ulcer).

Rare side effects(may affect up to 1 in 1000patients):

• pneumonitis
• enlargement and weakening of the wall of a blood vessel or rupture of a blood vessel (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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Pazopanib Pharmascience

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton.
The expiry date refers to the last day of the month.
There are no special storage instructions for this 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 Pharmascience contains

Pazopanib Pharmascience, 200 mg, coated tablets:

• The active substance is pazopanib (as hydrochloride). Each coated tablet contains 200 mg of pazopanib. The other ingredients are: Tablet core: microcrystalline cellulose type 101, sodium carboxymethylcellulose (type A), povidone (K-30), magnesium stearate. Tablet coating: hypromellose 6 mPa*s, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), polysorbate 80.

Pazopanib Pharmascience, 400 mg, coated tablets:

• The active substance is pazopanib (as hydrochloride). Each coated tablet contains 400 mg of pazopanib. The other ingredients are: Tablet core: microcrystalline cellulose type 101, sodium carboxymethylcellulose (type A), povidone (K-30), magnesium stearate. Tablet coating: hypromellose (6 mPa*s), titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Pazopanib Pharmascience looks like and contents of the pack

Pazopanib Pharmascience, 200 mg, coated tablets: pink coated tablet in the shape of a capsule, 14.3 mm x 5.7 mm ± 5% in size, with "200" embossed on one side.
Cartons containing tablets in blisters made of aluminum/PVC/PE/PVDC film.
Pack sizes: 30, 60, and 90 tablets.
Pazopanib Pharmascience, 400 mg, coated tablets: white coated tablet in the shape of a capsule, 18.0 mm x 7.1 mm ± 5% in size, with "400" embossed on one side.
Cartons containing tablets in blisters made of aluminum/PVC/PE/PVDC film.
Pack sizes: 30, 60, and 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer

Remedica Ltd.
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta

This medicinal product is authorized in the Member States of the EEA under the following names:

Date of last revision of the leaflet: