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.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including all possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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 that participate 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 connective tissue in the body. 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). A doctor should be consultedif the patient thinks the above statement applies to them.

Warnings and precautions

Before starting to take Pazopanib Pharmascience, the doctor should be consulted if:

• the patient has heart disease,
• the patient has liver disease,
• the patient has had heart failure or a heart attack,
• the patient has a history of lung collapse(pulmonary 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 aneurysm(enlargement and weakening of the wall of a blood vessel) or rupture of a blood vessel. The doctor should be informedif any of these disorders occur. The doctor will decide whether 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 to take this medicine 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 medication.

• The doctor should be informedif the patient has high blood pressure.

If the patient is scheduled for surgery

The doctor will recommend stopping Pazopanib Pharmascience 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.

Conditions that require special attention

Pazopanib Pharmascience may exacerbate certain disorders 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 effects. See section 4.

Children and adolescents

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

Pazopanib Pharmascience and other medicines

The doctor or pharmacist should be told about all medicines currently being taken or recently taken, as well as those planned to be taken. This includes herbal products and other medicines 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 production. Medicines taken to reduce stomach acid production (e.g., proton pump inhibitors, H receptor antagonists, or antacids) may affect pazopanib absorption. Consult a doctor or nurse for advice.

The doctor or pharmacist should be informedif the patient is taking any of these medicines.

Pazopanib Pharmascience with food and drink

Pazopanib Pharmascience should not be taken 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).

During treatment with Pazopanib Pharmascience, grapefruit juice should not be consumed, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Pazopanib Pharmascience is not recommended during pregnancy. The effect of this medicine on pregnancy is unknown.

• The doctor should be informed if the patient is pregnantor plans to become pregnant. During treatment with Pazopanib Pharmascience and for at least 2 weeks after the end of treatment, effective contraception should be usedto prevent pregnancy.
• The doctor should be informed if the patient becomes pregnantwhile taking Pazopanib Pharmascience.

Breastfeeding should be avoidedduring treatment with Pazopanib Pharmascience. It is unknown whether the components of this medicine pass into breast milk. The patient should discuss this with their 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 Pharmascience and for at least 2 weeks after the last dose.

Treatment with Pazopanib Pharmascience may affect fertility. The patient should discuss this with their doctor.

Driving and operating machinery

During treatment with Pazopanib Pharmascience, side effects may occur that affect the ability to drive and operate machinery.

• Driving and operating machinery should be avoided if the patient feels dizzy, tired, or weak, or has low energy levels.

Pazopanib Pharmascience contains sodium

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

3. How to take Pazopanib Pharmascience

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

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. The doctor may recommend reducing the dose if the patient experiences 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. The doctor may recommend reducing the dose if the patient experiences side effects.

When to take the medicine

Pazopanib Pharmascience should not be taken with food. The medicine should be taken 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. Pazopanib Pharmascience should be taken every day at the same time.

The tablets should be swallowed whole, one after the other, with a glass of water. The tablets should not be broken or crushed, 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 the patient takes too many tablets, the doctor or pharmacist should be consulted. If possible, the packaging or this leaflet should be shown.

Missing a dose of Pazopanib Pharmascience

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.

Do not stop taking Pazopanib Pharmascience without consulting a doctor

Pazopanib Pharmascience should be taken for as long as the doctor recommends. The medicine should not be stopped unless the doctor advises it.

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 help immediately

if any of these symptoms occur or if there is a headache accompanied by 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. The doctor will monitor the patient's blood pressure during treatment with 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 help immediately

if a hypertensive crisis occurs.

Heart problems

The risk of these problems may be higher in people with existing heart disease or those taking other medicines. During treatment with Pazopanib Pharmascience, the patient will be monitored for heart problems.

Heart function 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. Medical help should be sought immediatelyif any of these symptoms occur.

Changes in heart rhythm (QT interval prolongation)

Pazopanib Pharmascience may affect the heart rhythm, which can lead to severe heart rhythm disorders called torsades de pointesin some people. These can cause very rapid heartbeat, leading to sudden loss of consciousness.

The doctor should be informedif the patient experiences changes in heart rhythm, 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. Medical help should be sought immediatelyif any of these symptoms occur.

Bleeding

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

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

Medical help should be sought immediatelyif any of these symptoms occur.

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 (or) vomiting
• fever
• formation of a hole (perforation) in the stomach, large intestine, or small intestine, from which bloody or foul-smelling pus is discharged. Medical help should be sought immediatelyif any of these symptoms occur.

Liver diseases

Pazopanib Pharmascience may cause liver problems, which can lead to severe symptoms such as liver function disorders or liver failure, which can be fatal. The doctor will monitor the patient's liver enzyme activity during treatment with 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
• pain on the right side of the abdomen
• easy bruising. Medical help should be sought immediatelyif any of these symptoms occur.

Blood clots

Deep vein thrombosis and pulmonary embolism

Pazopanib Pharmascience may cause blood clots in the veins, especially in the veins of 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. Medical help should be sought immediatelyif any of these symptoms occur.

Microangiopathic hemolytic anemia

Pazopanib Pharmascience may cause blood clots in the small blood vessels of the kidneys and brain, which can damage organs such as the brain and kidneys. Symptoms may include:

• easy bruising
• high blood pressure
• fever
• disorientation
• drowsiness
• seizures
• reduced urine output. Medical help should be sought immediatelyif any of these symptoms occur.

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
• reduced urine output. Medical help should be sought immediatelyif any of these symptoms occur.

Infections

Infections that occur during treatment with 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. Medical help should be sought immediatelyif any of these symptoms occur.

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

Medical help should be sought immediatelyif any of these symptoms occur.

Thyroid diseases

Pazopanib Pharmascience may decrease the production of thyroid hormones in the body. This can cause weight gain and fatigue. During treatment with this medicine, the doctor will monitor the patient's thyroid hormone levels.

The doctor should be informedif the patient notices significant weight gain or fatigue.

Blurred vision or vision disturbances

Pazopanib Pharmascience may cause detachment or tearing of the membrane on the back of the eye (retinal detachment or tear), which can cause blurred vision or vision disturbances.

The doctor should be informedif the patient notices any vision disturbances.

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

Very common side effects(may occur in 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
• rash with possible peeling of the skin
• redness and swelling of the palms of the hands or soles of the feet. The doctor or pharmacist should be informedif 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 occur in less than 1 in 10patients):

• 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
• 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, especially of the skin
• skin disorders, redness, itching, dryness of the skin
• nail disorders
• burning, stinging, itching, or tingling 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
• coughing
• hemoptysis
• hiccups
• lung collapse with air trapped in the space between the lung and the chest cavity, often causing shortness of breath (pneumothorax). The doctor or pharmacist should be informedif 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 by the muscles)
• changes in the levels or activity of various other substances or enzymes in the blood. The doctor will inform the patient about the results of the blood tests.

Uncommon side effects(may occur in less than 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 are 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), kidneys, vagina, or 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 inflammatory (flat or raised patches or blisters)
• diarrhea
• increased sensitivity of the skin to sunlight
• numbness or decreased sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer).

Rare side effects(may occur in less than 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug 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 can help gather more information on the safety of the medicine.

5. How to store Pazopanib Pharmascience

The medicine should be stored out of sight and reach of children.

This medicine should not be taken after the expiration date (EXP) stated on the packaging.

The expiration date refers to the last day of the specified month.

There are no special storage instructions for the medicine.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. 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 (in the form of hydrochloride). Each coated tablet contains 200 mg of pazopanib. The other ingredients of the tablets 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 (in the form of hydrochloride). Each coated tablet contains 400 mg of pazopanib. The other ingredients of the tablets 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 packaging

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 the inscription "200" on one side.

Cardboard boxes containing tablets in blisters made of aluminum/PVC/PE/PVDC film.

Packaging of 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 the inscription "400" on one side.

Cardboard boxes containing tablets in blisters made of aluminum/PVC/PE/PVDC film.

Packaging of 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: