Pazopanib reddy: detailed information

Package leaflet: Information for the patient

Pazopanib Reddy, 200 mg, coated tablets
Pazopanib Reddy, 400 mg, coated tablets
pazopanib
Please read all of 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, 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, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Pazopanib Reddy is and what it is used for
What you need to know before taking Pazopanib Reddy
How to take Pazopanib Reddy
Possible side effects
How to store Pazopanib Reddy
Contents of the pack and other information

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

Pazopanib Reddy belongs to a group of medicines called protein kinase inhibitors. This medicine works by blocking the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Reddy is used in adults to treat:

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

2. Important information before using Pazopanib Reddy

When not to use Pazopanib Reddy

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 this applies.

Warnings and precautions
Before starting treatment with Pazopanib Reddy, discuss 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 a history of pneumothorax (collapsed lung).
if the patient has bleeding, blood clots, or arterial narrowing.
if the patient has stomach or intestinal disorders, such as perforation (a hole) or fistula (abnormal connections between parts of the intestine).
if the patient has thyroid disorders.
if the patient has kidney function disorders.
if the patient has or has previously had an aneurysm (a weakened and bulging blood vessel wall) or a tear in the wall of a blood vessel. Inform the doctor if any of these conditions apply. The doctor will decide whether Pazopanib Reddy 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 the use of Pazopanib Reddy
Pazopanib Reddy may cause high blood pressure. Blood pressure will be monitored before starting and during treatment with Pazopanib Reddy. If the patient develops high blood pressure, the doctor will prescribe medicines to lower it.

Inform the doctor if the patient has high blood pressure.

If the patient is scheduled for surgery
The doctor will advise stopping Pazopanib Reddy at least 7 days before surgery, as the medicine may affect wound healing after surgery. Treatment will be resumed once the wound has healed.

Conditions requiring special attention
Pazopanib Reddy may worsen certain conditions or cause serious side effects. During treatment with Pazopanib Reddy, it is essential to pay attention to certain symptoms to reduce the risk of adverse effects. See section 4.

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

Pazopanib Reddy and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal preparations and other medicines available without a prescription.
Some medicines may affect the action of pazopanib or increase the likelihood of side effects. Pazopanib may also affect the action of other medicines. These include:

clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (medicines used to treat infections).
atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV infection).
nefazodone (a medicine used to treat depression).
simvastatin and probably other statins (medicines used to treat high blood cholesterol).
medicines that reduce stomach acid secretion. Medicines taken to reduce gastric acid secretion (e.g. proton pump inhibitors, H\ receptor antagonists, or antacids) may affect how Pazopanib Reddy is absorbed. Consult the doctor or nurse for advice.

Tell the doctor or pharmacist if the patient is taking any of these medicines.

Pazopanib Reddy with food and drink
Do not take Pazopanib Reddy 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 Reddy, do not drink grapefruit juice, as this may increase the risk of side effects.

Pregnancy, breastfeeding, and effects on fertility
Pazopanib Reddy is not recommended during pregnancy. It is not known how pazopanib affects pregnancy.

Inform the doctor if the patient is pregnant or planning to become pregnant.
During treatment with Pazopanib Reddy 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 Reddy.

Breastfeeding must not be performed during treatment with Pazopanib Reddy. It is not known whether the ingredients of Pazopanib Reddy pass into human milk. Discuss this with the doctor.

Men (including men who have had a vasectomy), whose partners are pregnant or able to become pregnant (including women using other contraceptive methods), should use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose.

Treatment with pazopanib may affect fertility. Discuss this with the doctor.

Driving and operating machinery
Side effects may occur during treatment with Pazopanib Reddy that may affect the ability to drive and operate machinery.

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

Pazopanib Reddy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Pazopanib Reddy

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
The usual dose is 800 mg taken once daily. This dose can be taken as two tablets of 400 mg or as four tablets of 200 mg. The 800 mg dose 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 Reddy with food. The medicine should be taken at least two hours after a meal or one hour before a meal. For example, the medicine can be taken two hours after breakfast or one hour before lunch. Pazopanib Reddy should be taken at the same time each day.
Tablets should be swallowed whole, one after another, with water. Do not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of adverse reactions.
Taking more Pazopanib Reddy than prescribed
If too many tablets have been swallowed, seek medical advice from your doctor or pharmacist immediately.
If possible, show the medicine package or this leaflet.
Missing a dose of Pazopanib Reddy
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 Reddy without consulting your doctor
Pazopanib Reddy should be taken for as long as your doctor has instructed. Do not discontinue treatment unless advised by your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Possible serious adverse reactions

Brain swelling (reversible posterior leukoencephalopathy syndrome)
In rare cases, pazopanib may cause brain swelling, which may be life-threatening.
Symptoms include:

loss of speech
visual disturbances
seizure (convulsions)
confusion
high blood pressure
Stop taking Pazopanib Reddy and seek immediate medical help if any of these symptoms occur, or if you experience headache accompanied by any of these symptoms.

Hypertensive crisis (sudden and severe increase in blood pressure)
Pazopanib may occasionally cause a sudden and severe rise in blood pressure. This condition is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking Pazopanib Reddy. Symptoms of hypertensive crisis may include:

severe chest pain
severe headache
blurred vision
confusion
nausea
vomiting
severe anxiety
shortness of breath
seizures (convulsions)
fainting
Stop taking Pazopanib Reddy and seek immediate medical help 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. While taking Pazopanib Reddy, you will be monitored for heart problems.

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

irregular or rapid heartbeat
fast fluttering of the heart
fainting
pain or tightness in the chest
pain in the arms, back, neck, or jaw
shortness of breath
swelling of the legs
Seek immediate medical help if any of these symptoms occur.

Changes in heart rhythm (QT interval prolongation)
Pazopanib may affect heart rhythm, which in some people may lead to a serious heart rhythm disorder called torsade de pointes. This may cause a very rapid heartbeat, which could lead to loss of consciousness.
Inform your doctor if you experience changes in heart rhythm, such as a heartbeat that is too fast or too slow.

Stroke
Pazopanib 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 any of these symptoms occur.

Bleeding
Pazopanib may cause severe bleeding from the gastrointestinal tract (from the stomach, oesophagus, 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 stools
blood in the urine
abdominal pain
coughing up blood or vomiting blood
Seek immediate medical help if any of these symptoms occur.

Perforation and fistula
Pazopanib 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 any of these symptoms occur.

Liver problems
Pazopanib may cause liver problems, 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 levels while you are taking Pazopanib Reddy. Symptoms indicating improper liver function 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 immediate medical help if any of these symptoms occur.

Blood clots
Deep vein thrombosis and pulmonary embolism
Pazopanib may cause blood clots in the 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 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). This may damage organs such as the brain and kidneys. Symptoms include:

easy bruising
high blood pressure
fever
confusion
drowsiness
seizures
reduced urine output
Seek immediate medical help if any of these symptoms occur.

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

Infections
Infections occurring during treatment with Pazopanib Reddy may 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 immediate medical help if any of these symptoms occur.

Lung inflammation
Pazopanib may rarely cause lung inflammation (interstitial lung disease, pneumonitis), which may be fatal in some patients. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib Reddy, you will be monitored for any lung problems.
Seek immediate medical help if any of these symptoms occur.

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

Blurred vision or visual disturbances
Pazopanib may cause detachment or tear of the membrane at the back of the eye (retinal detachment or tear). This may cause blurred vision or visual disturbances.
Inform your doctor if you notice any changes in vision.

Possible adverse reactions (including possible serious adverse reactions in the appropriate frequency categories)

Very common adverse reactions (may occur in 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, possibly with skin peeling
redness and swelling of the palms or soles of the feet
Inform your doctor or pharmacist if any of these symptoms become troublesome.

Very common adverse reaction that may be detected in blood or urine tests:

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

Common adverse reactions (may occur in up to 1 in 10 patients):

indigestion, bloating, flatulence
nosebleeds
dry mouth or mouth ulcers
infections
excessive sleepiness
sleep disturbances
chest pain, shortness of breath, leg pain, and swelling of legs or feet. These may be symptoms of blood clots forming in the body (thrombosis). If a clot detaches, 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 the mouth, rectum, or lungs
dizziness
blurred vision
hot flushes
swelling of the face, hands, legs around the 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 cold with 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)
Inform your doctor or pharmacist if any of these symptoms become troublesome.

Common adverse reactions 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 in the muscles)
changes in levels/activity of various other substances/enzymes in the blood. Your doctor will inform you about blood test results.

Uncommon adverse reactions (may occur in up to 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 with sudden chest pain and (or) rapid breathing (pulmonary embolism)
severe gastrointestinal bleeding (from the stomach, oesophagus, or intestines), 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)
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 abdominal lining (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 adverse reactions (may occur in up to 1 in 1,000 patients):

lung inflammation
enlargement and weakening of a 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 adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pazopanib Reddy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Pazopanib Reddy contains

The active substance is pazopanib (as pazopanib hydrochloride). Each 200 mg coated tablet of Pazopanib Reddy contains 200 mg of pazopanib. Each 400 mg coated tablet of Pazopanib Reddy contains 400 mg of pazopanib.
The other ingredients of the 200 mg and 400 mg tablets are: magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone K-30, sodium carboxymethyl starch (type A), grafted copolymer of polyethylene glycol and polyvinyl alcohol, and siliconized microcrystalline cellulose.

What Pazopanib Reddy looks like and contents of the pack
Pazopanib Reddy 200 mg film-coated tablets are white to off-white, film-coated, modified
capsule-shaped tablets, embossed with the code "2" on one side and smooth on the other side. The tablets are approximately 14 x 6 mm in size.
They are supplied in blisters of 30, 60 or 90 tablets or in single-dose blisters of 30x1 film-coated tablets in a cardboard carton.
Pazopanib Reddy 400 mg film-coated tablets are white to off-white, film-coated, modified
capsule-shaped tablets, embossed with the code "4" on one side and smooth on the other side. The tablets are approximately 18 x 7 mm in size.
They are supplied in blisters of 30, 60 or 90 tablets or in single-dose blisters of 60x1 film-coated tablets in a cardboard carton.
Not all pack sizes or tablet strengths may be marketed.

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Telephone: +49 821 74881 0
Fax: +49 0821 74881 20
[email protected]

Manufacturer/Importer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000,
Malta
Rual Laboratories SRL
313 Splaiul Unirii, Building H, 1st floor
Sector 3, 030138, Bucharest,
Romania

This medicinal product is authorised in the European Economic Area under the following names:
Spain: Pazopanib Dr. Reddys 200 mg/400 mg film-coated tablets EFG
Netherlands: Pazopanib Reddy 200 mg/400 mg filmomhulde tabletten
Ireland: Pazopanib Reddy 200 mg/400 mg film-coated tablets
Germany: Pazopanib beta 200 mg/400 mg Filmtabletten
Poland: Pazopanib Reddy
Romania: Pazopanib Dr. Reddy’s 200 mg/400 mg comprimate filmate
Italy: PAZOPANIB DR. REDDY’S