Pazopanib Accord

Leaflet accompanying the packaging: patient information

Pazopanib Accord, 200 mg, coated tablets

Pazopanib Accord, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, tell the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pazopanib Accord and what is it used for
• 2. Important information before taking Pazopanib Accord
• 3. How to take Pazopanib Accord
• 4. Possible side effects
• 5. How to store Pazopanib Accord
• 6. Package contents and other information

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

Pazopanib Accord 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 Accord 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 Accord

When not to take Pazopanib Accord

• 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 Accord, discuss with your doctor:

• if the patient has heart disease.
• if the patient has liver disease.
• if the patient has had heart failure or a heart attack.
• if the patient has a history of lung collapse(pleural effusion).
• if the patient has bleeding, blood clots, or artery narrowing.
• if the patient has had stomach or intestinal diseases, such as perforation(puncture) or fistula(formation of abnormal connections between different parts of the intestines).
• if the patient has thyroid diseases.
• if the patient has kidney function disorders.
• if the patient has or has had an aneurysm(enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Tell your doctorif any of these circumstances occur. The doctor will decide whether Pazopanib Accord is suitable for the patient. It may be necessary to perform additional testson the patient to check if the kidneys, heart, and liver are functioning properly.

Hypertension and taking Pazopanib Accord

Pazopanib Accord may cause an increase in blood pressure. Before starting to take Pazopanib Accord and during treatment, the patient's blood pressure will be monitored. If the patient has high blood pressure, the doctor will use blood pressure-lowering medications.

• Tell your doctorif the patient has high blood pressure.

If the patient is scheduled for surgery

The doctor will advise to stop taking Pazopanib Accord 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 to pay special attention to

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

Children and adolescents

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

Pazopanib Accord and other medicines

Tell your doctor or pharmacist about all medicines currently being taken or recently taken, as well as those planned to be taken. This includes herbal preparations and other medicines that are available without a prescription.
Some medicines may affect the action of Pazopanib Accord or increase the likelihood of side effects in the patient. Pazopanib Accord 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 secretion. Medicines taken to reduce stomach acid secretion (e.g., proton pump inhibitors, H2 receptor antagonists, or antacids) may affect the way Pazopanib Accord is taken. Consult a doctor or nurse for advice.

Tell your doctoror pharmacist if the patient is taking any of these medicines.

Pazopanib Accord with food and drink

Do not take Pazopanib Accord with food, 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 juiceduring treatment with Pazopanib Accord, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

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

• Tell your doctor if the patient is pregnantor plans to become pregnant. During treatment with Pazopanib Accord and for at least 2 weeks after the end of treatment, the patient should use effective contraceptionto prevent pregnancy.
• Tell your doctor if the patient becomes pregnantwhile taking Pazopanib Accord.

Do not breastfeedwhile taking Pazopanib Accord. It is not known whether the ingredients of Pazopanib Accord pass into breast milk. Consult the attending 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 Accord and for at least 2 weeks after the last dose.
Treatment with Pazopanib Accord may affect fertility. Consult the attending doctor.

Driving and operating machinery

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

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

Pazopanib Accord contains sodium

This 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 Accord

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

How many tablets to take

The usual doseis 800 mg taken once a day. The dose can be taken in two 400 mg tablets or four 200 mg tablets. The 800 mg dose 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 Accord 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 Accord should be taken every day at the same time.
Tablets should be swallowed 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 Accord than recommended

In case of swallowing too many tablets, consult a doctor or pharmacist. If possible, show the medicine packaging or this leaflet.

Missing a dose of Pazopanib Accord

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 Accord without consulting a doctor

Pazopanib Accord should be taken for as long as the doctor recommends. Do not stop taking the medicine unless the doctor advises to do so.

4. Possible side effects

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

Possible serious side effects

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

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

Stop taking Pazopanib Accord and seek medical attention immediately

if any of these symptoms occuror if the patient experiences a headache with any of these symptoms.
Hypertensive crisis(sudden and severe increase in blood pressure)
Pazopanib Accord may occasionally cause a sudden and severe increase in blood pressure, known as a hypertensive crisis. The doctor will monitor the patient's blood pressure while taking Pazopanib Accord. 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 Accord and seek medical attention immediatelyif a hypertensive crisis occurs.

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 Accord, the patient will be monitored for heart rhythm disorders.
Heart rhythm disorders/heart failure, heart attack
Pazopanib Accord may affect the heart's pumping efficiency 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 any of these symptoms occur.
Changes in heart rhythm (QT interval prolongation)
Pazopanib Accord may affect the heart rhythm, which can lead to heart rhythm disorders called torsades de pointesin some people. These can cause very rapid heartbeats, leading to loss of consciousness.
Tell your doctorif the patient experiences changes in heart rhythm, such as too fast or too slow heartbeat.

Stroke

Pazopanib Accord 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 any of these symptoms occur.

Bleeding

Pazopanib Accord may cause severe bleeding from the digestive tract (stomach, esophagus, colon, 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 stools
• -blood in the urine
• -abdominal pain
• -coughing up blood or vomiting blood.

Seek medical attention immediatelyif any of these symptoms occur.

Perforation and fistula

Pazopanib Accord may cause a tear in the wall of the stomach or intestine or the formation of an abnormal connection between different 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.

Seek medical attention immediatelyif any of these symptoms occur.

Liver diseases

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

Seek medical attention immediatelyif any of these symptoms occur.

Blood clots

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

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

Microangiopathic hemolytic anemia
Pazopanib Accord may cause blood clots in the small blood vessels in the kidneys and brain, accompanied by a decrease in red blood cells and platelets (microangiopathic hemolytic anemia, TMA). Symptoms include:

• -easy bruising
• -high blood pressure
• -fever
• -disorientation
• -drowsiness
• -seizures
• -decreased urine output.

Seek medical attention immediatelyif any of these symptoms occur.

Tumor lysis syndrome

Pazopanib Accord 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, disorientation, muscle spasms, or decreased urine output. Seek medical attention immediatelyif any of these symptoms occur.

Infections

Infections that occur while taking Pazopanib Accord can become severe. Symptoms of infections 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 any of these symptoms occur.

Pneumonitis

Pazopanib Accord may rarely cause pneumonitis (interstitial lung disease, lung inflammation), which can be fatal in some patients. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib Accord, the patient will be monitored for any lung problems.
Seek medical attention immediatelyif any of these symptoms occur.

Thyroid diseases

Pazopanib Accord may decrease the production of thyroid hormones in the body. This can cause weight gain and fatigue. While taking Pazopanib Accord, 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 Accord 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 the patient notices any changes in vision.

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

• -high blood pressure
• -diarrhea
• -nausea (vomiting) or vomiting
• -abdominal pain
• -loss of appetite
• -weight loss
• -taste disturbances or loss of taste
• -mouth pain
• -headache
• -tumor 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 hands or soles of the feet.

Tell your doctor or pharmacistif any of these symptoms become troublesome.

Very common side effect 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 helps blood clot)
• -decreased white blood cell count.

Common side effects(may occur in less than 1 in 10 patients):

• -indigestion, bloating, gas
• -nosebleeds
• -dry mouth or mouth sores
• -infections
• -excessive sleepiness
• -sleep disturbances
• -chest pain, shortness of breath, and/or leg pain or swelling. These may be symptoms of blood clots in the body (thromboembolism).
• -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 sensation of the skin
• -feeling cold with chills
• -excessive sweating
• -dehydration
• -muscle, joint, or tendon pain, or chest pain, muscle spasms
• -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 muscles)
• -changes in the levels/activities of various other substances/enzymes in the blood. The doctor will inform the patient about the blood test results.

Uncommon side effects(may occur in less than 1 in 100 patients):

• -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 red blood cells and platelets (microangiopathic hemolytic anemia, TMA). This can damage organs such as the brain and kidneys.
• -increased red blood cell count
• -sudden shortness of breath, especially if accompanied by severe chest pain and/or rapid breathing (pulmonary embolism)

Rare side effects(may occur in less than 1 in 1000 patients):

• -pneumonitis
• -enlargement and weakening of the wall of a blood vessel or tearing of the wall of a blood vessel (aneurysm and arterial dissection).

Frequency not known(frequency cannot be estimated from 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 the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 gather more information on the safety of the medicine.

5. How to store Pazopanib Accord

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister, bottle, and carton. The expiry date refers to the last day of the month.
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. Package contents and other information

What Pazopanib Accord contains

Pazopanib Accord, 200 mg, coated tablets

• -The active substance is pazopanib (as hydrochloride). Each coated tablet contains pazopanib hydrochloride equivalent to 200 mg of pazopanib.
• -The other ingredients are:
• -Tablet core: microcrystalline cellulose (E 460), sodium carboxymethylcellulose (type A), povidone (E 1201), magnesium stearate (E 470b).
• -Tablet coating (Opadry 13B540026 Pink): hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), iron oxide red (E 172), polysorbate 80 (E 433) (see section 2 "Pazopanib Accord contains sodium").

Pazopanib Accord, 400 mg, coated tablets

• -The active substance is pazopanib (as hydrochloride). Each coated tablet contains pazopanib hydrochloride equivalent to 400 mg of pazopanib.
• -The other ingredients are:
• -Tablet core: microcrystalline cellulose (E 460), sodium carboxymethylcellulose (type A), povidone (E 1201), magnesium stearate (E 470b).
• -Tablet coating (Opadry 13B58802 White): hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), polysorbate 80 (E 433) (see section 2 "Pazopanib Accord contains sodium").

What Pazopanib Accord looks like and contents of the pack

Pazopanib Accord, 200 mg, coated tablets
Pazopanib Accord, 200 mg is a pink, capsule-shaped, coated tablet with "200" embossed on one side and approximately 14.3 mm × 5.7 mm in size.
Pazopanib Accord, 200 mg, coated tablets are packaged in cardboard boxes containing 10, 30, 60, or 90 coated tablets in transparent PVC/PE/PVDC/Alu blisters or
cardboard boxes containing 10×1, 30×1, 60×1, or 90×1 coated tablets in transparent, perforated PVC/PE/PVDC/Alu blisters, which can be divided into single doses,
or
white HDPE bottles with child-resistant PP closures containing 30 or 90 coated tablets, in a cardboard box.
Pazopanib Accord, 400 mg, coated tablets
Pazopanib Accord, 400 mg is a white, capsule-shaped, coated tablet with "400" embossed on one side and approximately 18.0 mm × 7.1 mm in size.
Pazopanib Accord, 400 mg, coated tablets are packaged in cardboard boxes containing 10, 30, 60, or 90 coated tablets in transparent PVC/PE/PVDC/Alu blisters or
cardboard boxes containing 10×1, 30×1, 60×1, or 90×1 coated tablets in transparent, perforated PVC/PE/PVDC/Alu blisters, which can be divided into single doses,
or
white HDPE bottles with child-resistant PP closures containing 30 or 60 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer

REMEDICA LTD
Aharnon Street, Limassol Industrial Estate,
3056 Limassol, Cyprus

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

Date of last revision of the leaflet: