Pazopanib Dr. Reddy's

Italy
Brand name Pazopanib Dr. Reddy's
Form tablets, film-coated
Active substance / Dosage
PAZOPANIB HYDROCHLORIDE
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
L01EX03
Registration number 052162
Manufacturer DR. REDDY'S S.R.L.
Pazopanib Dr. Reddy's tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

PAZOPANIB DR. REDDY’S 200 mg film-coated tablets

PAZOPANIB DR. REDDY’S 400 mg film-coated tablets
pazopanib
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What PAZOPANIB DR. REDDY’S is and what it is used for
  2. What you need to know before taking PAZOPANIB DR. REDDY’S
  3. How to take PAZOPANIB DR. REDDY’S
  4. Possible side effects
  5. How to store PAZOPANIB DR. REDDY’S
  6. Contents of the pack and other information

1. What PAZOPANIB DR. REDDY’S is and what it is used for

PAZOPANIB DR. REDDY’S is a type of medicine called a protein kinase inhibitor. It works by
preventing the activity of proteins involved in the growth and spread of cancer cells.
PAZOPANIB DR. REDDY’S is used in adults to treat:

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

2. What you need to know before taking PAZOPANIB DR. REDDY’S

Do not take PAZOPANIB DR. REDDY’S

  • if you are allergic to pazopanib or to any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before taking PAZOPANIB DR. REDDY’S:

  • if you have a heart disease.

  • if you have a liver disease.

  • if you have previously had heart failure or a heart attack.

  • if you have previously had a collapsed lung.

  • if you have had problems related to bleeding, blood clots, or narrowing of the arteries.

  • if you have had stomach or intestinal problems, such as a perforation (hole) or a fistula*
    (abnormal passage forming between parts of the intestine).

  • if you have thyroid problems.

  • if you have problems with kidney function.

  • if you have or have had an aneurysm (a bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel. Tell your doctor if any of these apply to you. Your doctor will decide whether PAZOPANIB DR. REDDY’S is suitable for you. Additional tests may be needed to check that your kidneys, heart, and liver are functioning properly.

High blood pressure and PAZOPANIB DR. REDDY’S
PAZOPANIB DR. REDDY’S can increase blood pressure. Your blood pressure will be monitored before and during treatment with PAZOPANIB DR. REDDY’S. If you have high blood pressure, you will be treated with medicines to lower it.

  • Tell your doctor if you have high blood pressure.

If you are about to undergo surgery
Your doctor will stop PAZOPANIB DR. REDDY’S at least 7 days before surgery, as the medicine may affect wound healing. Treatment will be restarted once the wound has healed adequately.

Conditions to be aware of
PAZOPANIB DR. REDDY’S may worsen certain conditions or cause serious side effects. To reduce the risk of any problems, you should pay attention to certain symptoms while taking PAZOPANIB DR. REDDY’S. See section 4.

Children and adolescents
PAZOPANIB DR. REDDY’S is not recommended for people under 18 years of age. It is not yet known how it works in this age group. It must not be used in children under 2 years of age due to safety concerns.

Other medicines and PAZOPANIB DR. REDDY’S
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and other medicines you can buy without a prescription.

Some medicines can affect how pazopanib works and may increase the likelihood of side effects. In turn, pazopanib may affect how other medicines work. These include:

  • clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections).
  • atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV).
  • nefazodone (used to treat depression).
  • simvastatin and possibly other statins (used to treat high cholesterol levels).
  • medicines that reduce stomach acidity. The type of medicine you are taking to reduce stomach acidity (e.g. proton pump inhibitors, H2 antagonists, or antacids) may affect how you should take PAZOPANIB DR. REDDY’S. Ask your doctor or nurse for advice.

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

PAZOPANIB DR. REDDY’S with food and drink
Do not take PAZOPANIB DR. REDDY’S with food, as this affects how the medicine is absorbed. Take it at least two hours after a meal or one hour before a meal (see section 3).
Do not drink grapefruit juice while being treated with PAZOPANIB DR. REDDY’S, as this may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility
PAZOPANIB DR. REDDY’S is not recommended if you are pregnant. It is not known what effect pazopanib has during pregnancy.
Tell your doctor if you are pregnant or if you are planning to become pregnant.

  • Use a reliable method of contraception while taking PAZOPANIB DR. REDDY’S and for at least 2 weeks after stopping treatment to prevent pregnancy.
  • If you become pregnant during treatment with PAZOPANIB DR. REDDY’S, tell your doctor.

You must not breastfeed while taking PAZOPANIB DR. REDDY’S. It is not known whether the components of PAZOPANIB DR. REDDY’S pass into breast milk. Discuss this with your doctor.

If you are a male patient (even if you have had a vasectomy) and have a partner who is pregnant or who could become pregnant (including those using other contraceptive methods), you must use a condom during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose.

Fertility may be affected by treatment with pazopanib. Talk to your doctor about this.

Driving and using machines
PAZOPANIB DR. REDDY’S may cause side effects that could affect your ability to drive or operate machinery.

  • Avoid driving or operating machinery if you feel confused, tired, or weak, or if your energy levels are low.

PAZOPANIB DR. REDDY’S contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take PAZOPANIB DR. REDDY’S

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose is 800 mg taken once daily. The dose can be taken as 2 tablets of 400 mg or as 4 tablets of 200 mg. The dose of 800 mg once daily is the maximum daily dose. Your doctor may need to reduce the dose if you experience side effects.
When to take it
Do not take PAZOPANIB DR. REDDY’S with food. Take it at least two hours after a meal or one hour before a meal. For example, you could take it two hours after breakfast or one hour before lunch. Take PAZOPANIB DR. REDDY’S every day at approximately the same time.
Swallow the tablets whole with water, one after the other. Do not break or crush the tablets, as this affects how the medicine is absorbed and may increase the risk of side effects.
If you take more PAZOPANIB DR. REDDY’S than you should
If you take too many tablets, contact your doctor or pharmacist for advice. If possible, show them the packaging or this leaflet.
If you forget to take PAZOPANIB DR. REDDY’S
Do not take a double dose to make up for the missed dose. Take only the next dose at the usual time.
Do not stop taking PAZOPANIB DR. REDDY’S without medical advice
Take PAZOPANIB DR. REDDY’S for as long as your doctor recommends. Do not stop unless your doctor tells you to do so.

4. Possible side effects

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

Serious possible side effects

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

  • loss of speech
  • changes in vision
  • seizures (epileptic fits)
  • confusion
  • high blood pressure

Stop taking PAZOPANIB DR. REDDY’S and seek immediate medical help if you experience any of these symptoms, or if you have a 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 is known as a hypertensive crisis. Your doctor will monitor your blood pressure while you are taking PAZOPANIB DR. REDDY’S. Signs and symptoms of a hypertensive crisis may include:

  • severe chest pain
  • severe headache
  • blurred vision
  • confusion
  • nausea
  • vomiting
  • severe anxiety
  • shortness of breath
  • seizures (epileptic fits)
  • fainting

Stop taking PAZOPANIB DR. REDDY’S and seek immediate medical help if you develop a hypertensive crisis.

Heart problems
The risk of these problems may be higher in people with existing heart conditions or who are taking other medicines. You will be monitored for heart problems while taking PAZOPANIB DR. REDDY’S.

Cardiac dysfunction/heart failure, heart attack
Pazopanib can affect the heart's pumping activity and may increase the likelihood of having a heart attack. Signs and symptoms include:

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

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

Changes in heart rhythm (QT prolongation)
Pazopanib can affect the heart rhythm, which in some people may lead to a potentially serious heart condition known as torsade de pointes. This may result in a very rapid heartbeat causing sudden loss of consciousness.
Inform your doctor if you notice any unusual changes in your heartbeat, such as one that is too fast or too slow.

Stroke
Pazopanib may increase the risk of having a stroke. Signs and 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 may cause severe bleeding in the gastrointestinal tract (such as stomach, oesophagus, rectum or intestine), or in the lungs, kidneys, mouth, vagina and brain, although this is not common. Symptoms include:

  • passing blood in stools or black stools
  • blood in urine
  • stomach pain
  • coughing or vomiting blood

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

Perforation and fistula
Pazopanib may cause a tear (perforation) in the stomach or intestine, or the development of an abnormal connection between two parts of the digestive tract (a fistula). Signs and symptoms may include:

  • severe stomach pain
  • nausea and/or vomiting
  • fever
  • development of a hole (perforation) in the stomach or intestine, from which foul-smelling, bloody pus is released

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

Liver problems
Pazopanib may cause liver problems that can lead to serious conditions such as liver dysfunction and liver failure, which may be fatal. Your doctor will monitor your liver enzymes while you are taking PAZOPANIB DR. REDDY’S. Signs that the liver may not be working properly may include:

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

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

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

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

Thrombotic microangiopathy (TMA)
Pazopanib may cause blood clots in the small blood vessels of the kidneys and brain, accompanied by a decrease in red blood cells and platelets (thrombotic microangiopathy, TMA). Signs and symptoms may include:

  • easy bruising
  • high blood pressure
  • fever
  • confusion
  • drowsiness
  • seizures (epileptic fits)
  • reduced urine output

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

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 (fits), confusion, muscle cramps or spasms, or reduced urine production. Seek immediate medical help if you experience any of these symptoms.

Infections
Infections occurring while taking PAZOPANIB DR. REDDY’S 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 you experience any of these symptoms.

Lung inflammation
Rarely, pazopanib may cause inflammation of the lungs (interstitial lung disease, pneumonia), which may be fatal in some people. Symptoms include shortness of breath or persistent cough. While taking PAZOPANIB DR. REDDY’S, you will be monitored for lung problems.
Seek immediate medical help if you experience any of these symptoms.

Thyroid problems
Pazopanib may reduce the amount of thyroid hormone produced by the body. This may cause weight gain and fatigue. While taking PAZOPANIB DR. REDDY’S, your thyroid hormone levels will be monitored.
Inform your doctor if you notice significant weight gain or fatigue.

Blurred or impaired vision
Pazopanib may cause separation or tearing of the inner layer at the back of the eye (retinal detachment or tear). This may lead to blurred or impaired vision.
Inform your doctor if you notice any changes in your vision.

Possible side effects (including possible serious side effects by relevant frequency category)

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

  • high blood pressure
  • diarrhoea
  • nausea or vomiting
  • stomach pain
  • loss of appetite
  • weight loss
  • taste disturbances or loss of taste
  • mouth pain
  • headache
  • tumour site pain
  • lack of energy, feeling weak or tired
  • change in hair colour
  • unusual hair loss or thinning
  • loss of skin pigment
  • skin rash, possibly with skin peeling
  • redness and swelling of the palms of the hands or soles of the feet

Inform your doctor or pharmacist if any of these side effects worsen or become bothersome.

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

  • increased liver enzymes
  • reduced albumin in the blood
  • protein in the urine
  • reduced platelet count in the blood (cells that help blood to clot)
  • reduced white blood cell count

Common side effects (may affect up to 1 in 10 people):

  • indigestion, bloating, flatulence
  • nosebleeds
  • dry mouth or mouth ulcers
  • infections
  • unusual drowsiness
  • difficulty sleeping
  • chest pain, shortness of breath, leg pain, and swelling of legs/feet. These may be signs of a blood clot in the body (thromboembolism). If the clot breaks loose, it may travel to the lungs, which may be life-threatening or fatal.
  • reduced heart pumping efficiency (cardiac dysfunction)
  • slow heartbeat
  • bleeding from mouth, rectum or lung
  • dizziness
  • blurred vision
  • hot flushes
  • swelling of face, hands, ankles, feet or eyelids due to fluid retention
  • tingling, weakness or numbness in hands, arms, legs or feet
  • skin disorders, redness, itching, dry skin
  • nail disorders
  • burning, stinging, itching or tingling sensation on 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
  • collapsed lung with trapped air between the lung and chest wall, often causing shortness of breath (pneumothorax)

Inform your doctor or pharmacist if any of these side effects become bothersome.

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

  • reduced thyroid gland function
  • liver function abnormalities
  • increased bilirubin (a substance produced by the liver)
  • increased lipase (an enzyme involved in digestion)
  • increased creatinine (a substance produced by muscles)
  • changes in blood levels of other various chemicals/enzymes. Your doctor will inform you of blood test results.

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

  • stroke
  • temporary interruption of blood supply to the brain (transient ischaemic attack)
  • interruption of blood supply to part of the heart or heart attack (myocardial infarction)
  • interruption of blood supply to part of the heart (myocardial ischaemia)
  • blood clots accompanied by a decrease in red blood cells and clotting cells (thrombotic microangiopathy, TMA). These may damage organs such as the brain and kidneys
  • increased number of red blood cells in the blood
  • sudden onset of shortness of breath, especially when accompanied by acute chest pain and/or rapid breathing (pulmonary embolism)
  • severe gastrointestinal bleeding (e.g. in stomach, oesophagus or intestine), or in kidneys, vagina and brain
  • heart rhythm disorders (QT prolongation)
  • hole (perforation) in the stomach or intestine
  • abnormal passage forming between parts of the intestine (fistula)
  • heavy or irregular menstrual periods
  • sudden sharp increase in blood pressure (hypertensive crisis)
  • inflammation of the pancreas (pancreatitis)
  • inflamed liver that is not functioning properly or is damaged
  • yellow skin or whites of the eyes (jaundice)
  • inflammation of the lining of the abdominal cavity (peritonitis)
  • runny nose
  • skin rash that may be itchy or inflamed (flat or raised spots or blisters)
  • frequent bowel movements
  • increased sensitivity of the skin to sunlight
  • reduced sensation, especially in the skin
  • skin wound that does not heal (skin ulcer)

Rare side effects (may affect up to 1 in 1,000 people):

  • lung inflammation (pneumonia)
  • dilation and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and arterial dissections)

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 you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PAZOPANIB DR. REDDY’S

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the bottle and the outer carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PAZOPANIB DR. REDDY’S contains

  • The active substance is pazopanib (as hydrochloride). Each PAZOPANIB DR. REDDY’S 200 mg film-coated tablet contains 200 mg of pazopanib. Each PAZOPANIB DR. REDDY’S 400 mg film-coated tablet contains 400 mg of pazopanib.
  • The excipients in the 200 mg and 400 mg tablets are: magnesium stearate (E 470b), microcrystalline cellulose (E 460), polysorbate 80 (E 433), povidone K30 (E 1201), sodium starch glycolate (type A), grafted copolymer of poly(vinyl alcohol)-polyethylene glycol, and silicified microcrystalline cellulose.

Description of the appearance of PAZOPANIB DR. REDDY’S and contents of the pack
PAZOPANIB DR. REDDY’S 200 mg film-coated tablets are film-coated, modified capsule-shaped tablets, white to off-white in colour, with "2" embossed on one side and blank on the other. The tablets are approximately 14 x 6 mm in size. They are available in blisters of 30, 60 or 90 tablets or in unit dose blisters of 30 x 1 film-coated tablets.
PAZOPANIB DR. REDDY’S 400 mg film-coated tablets are film-coated, modified capsule-shaped tablets, white to off-white in colour, with "4" embossed on one side and blank on the other. The tablets are approximately 18 x 7 mm in size. They are available in blisters of 30, 60 or 90 tablets or in unit dose blisters of 60 x 1 film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy

Manufacturer
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 member states under the following names:
Germany: Pazopanib beta 200 mg, 400 mg Filmtabletten
Ireland: Pazopanib Reddy 200 mg, 400 mg film-coated tablets
Italy: PAZOPANIB DR. REDDY’S
Netherlands: Pazopanib Reddy 200 mg, 400 mg filmomhulde tabletten
Poland: Pazopanib Reddy
Romania: PAZOPANIB DR. REDDY’S 200 mg, 400 mg comprimate filmate
Spain: Pazopanib Dr. Reddys 200 mg, 400 mg comprimidos recubiertos con película EFG