PAZOPANIB 200 mg Фильм-Coated Таблетки

Содержание инструкции

1. Pazopanib Zentiva 200 mg film-coated tablets, 400 mg film-coated tablets
   1. What is Pazopanib Zentiva and what it is used for
   2. What you need to know before taking Pazopanib Zentiva
   3. How to take Pazopanib Zentiva
   4. Possible side effects
   5. How to store Pazopanib Zentiva
   6. Package contents and other information

Pazopanib Zentiva 200 mg film-coated tablets, 400 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pazopanib Zentiva is and what it is used for
• 2. What you need to know before you take Pazopanib Zentiva
• 3. How to take Pazopanib Zentiva
• 4. Possible side effects
• 5. How to store Pazopanib Zentiva
• 6. Contents of the pack and other information

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

Pazopanib Zentiva is a type of medicine called a protein kinase inhibitor. It works by preventing
the activity of proteins that are involved in the growth and spread of cancer cells.
Pazopanib Zentiva is used in adults to treat:

• advanced kidney cancer or cancer that has spread to other organs.
• some forms of soft tissue sarcoma, which is a type of cancer that affects the body's supporting tissues. It can occur in muscles, blood vessels, fat tissue, or other tissues that support, surround, and protect organs.

2. What you need to know before taking Pazopanib Zentiva

Do not take Pazopanib Zentiva

• if you are allergicto 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 Zentiva:

• if you have a heart condition.
• if you have a liver condition.
• if you have 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 problems with your stomach or intestines, such as a perforation (hole) or a fistula (abnormal passage that forms between parts of the intestine).
• if you have thyroid problems.
• if you have problems with your kidney function.
• if you have or have had an aneurysm(bulging and weakening of a blood vessel wall) or a

tear in the wall of a blood vessel.

Tell your doctorif any of these apply to you. Your doctor will decide if Pazopanib Zentiva is suitable for
you. Additional testsmay be needed to check that your kidneys, heart and liver are
working correctly.

High blood pressure and Pazopanib Zentiva
Pazopanib Zentiva can raise your blood pressure. Your blood pressure will be checked
before you take Pazopanib Zentiva and while you are taking it. If you have high blood pressure it will
be treated with medicines to lower it.

• Tell your doctorif you have high blood pressure.

If you are going to have surgery
Your doctor will stop Pazopanib Zentiva at least 7 days before your surgery because the
medicine may affect wound healing. Treatment will be restarted when the
wound has healed adequately.

Conditions for which you must be careful
Pazopanib Zentiva can worsen some conditions or cause serious side effects. To reduce
the risk of any problems, you must be careful about some symptoms while taking
Pazopanib Zentiva. See section 4.

Children and adolescents
Pazopanib Zentiva is not recommended in people under the age of 18 years. It is not yet known how
it works in this age group. Also, it should not be used in children under 2 years of age due to safety
concerns.

Other medicines and Pazopanib Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes herbal medicines and any other medicines you can buy
without a prescription.
Some medicines can affect how Pazopanib Zentiva works and can increase the
likelihood of you having side effects. In turn, Pazopanib Zentiva can 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 acid. The type of medicine you are taking to reduce stomach acid (e.g. proton pump inhibitors, H antagonists or antacids) may affect how you take Pazopanib Zentiva. Ask your doctor or nurse for advice.

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

Pazopanib Zentiva with food and drink
Do not take Pazopanib Zentiva 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 juicewhile being treated with Pazopanib Zentiva as this can
increase the possibility of side effects.

Pregnancy, breastfeeding and fertility
Pazopanib Zentiva is not recommended if you are pregnant. The effect of Pazopanib
Zentiva during pregnancy is not known.

• Tell your doctor if you are pregnantor if you are planning to become pregnant.
• Use reliable contraceptionwhile taking Pazopanib Zentiva, and for at least 2 weeks afterwards, to prevent pregnancy.
• If you become pregnant while taking Pazopanib Zentiva, tell your doctor.

Do not breastfeedwith breast milk while taking Pazopanib Zentiva. It is not known if the
components of Pazopanib Zentiva pass into breast milk. Talk to your doctor.
If you are a male patient(even if you have had a vasectomy) and have a pregnant partner
or who could become pregnant (including those using other methods of contraception), you must use
a condom during sexual intercourse while taking Pazopanib Zentiva and for at least 2
weeks after the last dose.

Fertility may be affectedby treatment with Pazopanib Zentiva. Talk to your doctor about this.

Driving and using machines
Pazopanib Zentiva can have side effects that can affect your ability to drive vehicles or
use machines.

• Avoid driving vehicles or using machines if you feel confused, tired or weak, or if your energy levels are low.

Pazopanib Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to take Pazopanib Zentiva

Take this medicine exactly as your doctor has told you.If you have any doubts
ask your doctor or pharmacist.

How much to take

Pazopanib Zentiva 200 mg film-coated tablets:

The recommended doseis four tablets of Pazopanib Zentiva 200 mg tablets (800 mg of
pazopanib) taken once a day. This is the maximum daily dose. Your doctor may need to reduce the dose if you
experience side effects.

Pazopanib Zentiva 400 mg film-coated tablets:

The recommended doseis two tablets of Pazopanib Zentiva 400 mg tablets (800 mg of
pazopanib) taken once a day. This 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 Zentiva 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
Zentiva every day at about the same time.
Swallow the tablets whole with water, one after the other. Do not break or crush the tablets in
as this affects how the medicine is absorbed and may increase the possibility of side
effects.

If you take more Pazopanib Zentiva than you should
If you take too many tablets, contact your doctor or pharmacistfor advice. If possible, show
them the packaging, or this leaflet.

If you forget to take Pazopanib Zentiva
Do not take a double dose to make up for a missed dose. Just take your next dose
at the usual time.

Do not stop taking Pazopanib Zentiva without medical advice
Take Pazopanib Zentiva for as long as your doctor has recommended. Do not stop taking it unless
your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Possible serious side effects
Brain swelling(reversible posterior leukoencephalopathy syndrome)
Pazopanib Zentiva can, in rare cases, cause brain swelling, which can be life-threatening. Symptoms include:

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

Stop taking Pazopanib Zentiva and immediately seek medical adviceif you
experience any of these symptoms, or if you have a headache accompanied by any of these
symptoms

Hypertensive crises(sudden and severe increase in blood pressure)
Pazopanib Zentiva can occasionally cause a sudden and severe increase in blood pressure.
This is known as a hypertensive crisis. Your doctor will monitor your blood pressure
while you are taking Pazopanib Zentiva. Signs and symptoms of a hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe anxiety
• shortness of breath
• convulsions (seizures)
• fainting Stop taking Pazopanib Zentiva and immediately seek medical adviceif you develop a hypertensive crisis.

Heart problems
The risk of these problems may be higher for people with existing heart problems
or who are taking other medicines. You will be monitored for any heart problems while you are
taking Pazopanib Zentiva.

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

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

Immediately seek medical adviceif you experience any of these symptoms.

Changes in heart rhythm (QT prolongation)
Pazopanib Zentiva can have an effect on the heart rhythm which in some people can develop into a
potentially serious heart condition known as torsades de pointes. This can
lead to a very fast heartbeat causing a sudden loss of consciousness.

Inform your doctorif you notice any unusual change in your heartbeat, such as a heartbeat
that is too fast or too slow.

Stroke
Pazopanib Zentiva can increase the likelihood of having a stroke. Signs and symptoms of stroke may
include:

• numbness or weakness on one side of the body
• difficulty speaking
• headache
• dizziness Immediately seek medical adviceif you experience any of these symptoms.

Bleeding
Pazopanib Zentiva can cause serious bleeding from the digestive tract (such as stomach, esophagus,
rectum or intestine), or from lungs, kidneys, mouth, vagina and brain, although this is not common. Symptoms
include:

• passing blood in your stools or passing black, tarry stools
• blood in your urine
• stomach pain
• coughing up or vomiting blood Immediately seek medical adviceif you experience any of these symptoms.

Perforation and fistula
Pazopanib Zentiva can 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 pus mixed with blood and foul-smelling fluid is released Immediately seek medical adviceif you experience any of these symptoms.

Liver problems
Pazopanib Zentiva can cause liver problems that can lead to serious conditions such as liver
dysfunction and liver failure, which can be fatal. Your doctor will check your liver enzymes
while you are taking Pazopanib Zentiva. 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 upper right side of the stomach (abdomen)
• easy bruising Immediately seek medical adviceif you experience any of these symptoms.

Blood clots

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

• sharp chest pain
• shortness of breath
• rapid breathing
• pain in the legs
• swelling of the arms and hands or legs and feet

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

• easy bruising
• high blood pressure
• fever
• confusion
• drowsiness
• convulsions (seizures)
• decreased urination Immediately seek medical adviceif you experience any of these symptoms.

Tumor lysis syndrome
Pazopanib Zentiva can cause a rapid breakdown of cancer cells resulting in
tumor lysis syndrome, which can be fatal in some people. Symptoms may include irregular
heartbeat, convulsions (seizures), confusion, muscle cramps or spasms, or decreased
urine production. Immediately seek medical adviceif you experience any of these
symptoms.

Infections
Infections that occur while you are taking Pazopanib Zentiva can become serious. 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 difficulty breathing
• pain when urinating
• cuts, scrapes, or wounds that are red, warm, swollen, or painful Immediately seek medical adviceif you experience any of these symptoms.

Lung inflammation
In rare cases Pazopanib Zentiva can cause inflammation of the lungs (interstitial lung
disease, pneumonitis), which can be fatal in some people. Symptoms include shortness of breath or cough
that does not go away. While you are taking Pazopanib Zentiva, you will be monitored for
any lung problems.

Immediately seek medical adviceif you experience any of these symptoms.

Thyroid problems
Pazopanib Zentiva can reduce the amount of thyroid hormone produced by the body. This can cause
weight gain and fatigue. While you are taking Pazopanib Zentiva, your thyroid hormone levels will be checked.

Inform your doctorif you notice significant weight gain or fatigue.

Blurred or impaired vision
Pazopanib Zentiva can cause separation or tearing of the inner layer of the back
of the eye (retinal detachment or tear). This can lead to blurred or impaired vision.

Inform your doctorif you notice any change in your vision.

Possible side effects (including possible serious side effects based on the relevant frequency category).
Very common side effects(may affect more than 1 in 10 people):

• high blood pressure
• diarrhea
• nausea or vomiting
• stomach pain
• loss of appetite
• weight loss
• altered taste or loss of taste
• mouth pain
• headache
• pain in the tumor site
• lack of energy, feeling weak or tired
• change in hair color
• hair loss or thinning
• loss of skin pigment
• skin rash, with possible skin peeling
• redness and swelling of the palms of the hands or soles of the feet Inform your doctor or pharmacistif any of these side effects worsen or become bothersome.

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

• increased liver enzymes
• decreased albumin in the blood
• protein in the urine
• decreased number of platelets in the blood (cells that help blood to clot)
• decreased number of white blood cells in the blood

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

• indigestion, bloating, flatulence
• nosebleeds
• dry mouth or mouth sores
• infections
• abnormal drowsiness
• difficulty sleeping
• chest pain, shortness of breath, leg pain, and swelling of legs/feet. These can be signs of a blood clot in the body (thromboembolism). If the clot breaks loose, it can reach the lungs and this can be life-threatening or even fatal.
• the heart becomes less effective at pumping blood around the body (heart failure)
• slowed heartbeat
• bleeding from mouth, rectum or lung
• dizziness
• blurred vision
• hot flashes
• swelling of the face, hands, ankles, feet or eyelids, caused by fluid
• tingling, weakness or numbness in hands, arms, legs or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• skin sensation of burning, prickling, itching or tingling
• feeling cold, with chills
• excessive sweating
• dehydration
• muscle, joint, tendon or chest pain, muscle spasms
• hoarseness
• shortness of breath
• cough
• coughing up blood
• hiccups
• collapsed lung with air trapped in the space between the lung and the chest, often causing shortness of breath (pneumothorax) Inform your doctor or pharmacistif any of these become bothersome.

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

• decreased activity of the thyroid gland
• 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 the levels in the blood of various different chemicals / enzymes. Your doctor will inform you of the results of the blood tests

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

• stroke
• temporary interruption of blood supply to the brain (transient ischemic 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 ischemia)
• blood clots accompanied by a decrease in red blood cells and cells involved in blood clotting (thrombotic microangiopathy, TMA). These can 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 sharp chest pain and / or rapid breathing (pulmonary embolism)
• serious bleeding from the digestive tract (such as stomach, esophagus or intestine), or from kidneys, vagina and brain
• heart rhythm disorders (QT prolongation)
• hole (perforation) in the stomach or intestine
• abnormal passage that forms 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 working properly or damaged
• yellowing of the 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
• decreased sensation, especially of the skin
• skin wound that does not heal (skin ulcer)

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

• inflammation of the lungs (pneumonitis)
• widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)

Not known(frequency cannot be estimated from available data):

• tumor lysis syndrome resulting from rapid disintegration of tumor cells
• hepatic failure

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

5. How to store Pazopanib Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry datewhich is stated on the bottle or blister and on the
box after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 Zentiva contains

Pazopanib Zentiva 200 mg film-coated tablets:

• The active ingredient is pazopanib (as hydrochloride). Each film-coated tablet contains 200 mg of pazopanib.
• The other ingredients are: Tablet core: cellulose, microcrystalline (E460), sodium starch glycolate (type A), povidone K30 (E1201), magnesium stearate (E470b). Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), red iron oxide (E172), polysorbate 80 (E433).

Pazopanib Zentiva 400 mg film-coated tablets:

• The active ingredient is pazopanib (as hydrochloride).

Each film-coated tablet contains 400 mg of pazopanib.

• The other ingredients are: Tablet core: cellulose, microcrystalline (E460), sodium starch glycolate (type A), povidone K30 (E1201), magnesium stearate (E470b). Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433).

Description of the appearance of Pazopanib Zentiva and package contents

Pazopanib Zentiva 200 mg film-coated tablets:
Pazopanib Zentiva 200 mg film-coated tablets are capsule-shaped, pink, with
“200” imprinted on one side, with dimensions approximately 14.3 mm x 5.7 mm.
They are available in bottles of 30, 90, multi-pack of 90 (3 packs of 30) tablets.
They are available in clear/transparent Aluminium-PVC/PE/PVDC blisters of 30, 90, multi-pack
of 90 (3 packs of 30) tablets.
They are available in clear/transparent Aluminium-PVC/PE/PVDC unit-dose divisible blisters
of 30 x 1, 90 x 1, multi-pack of 90 x 1 (3 packs of 30 x 1) tablets.

Pazopanib Zentiva 400 mg film-coated tablets:
Pazopanib Zentiva 400 mg film-coated tablets are capsule-shaped, white, with
“400” imprinted on one side, with dimensions approximately 18.0 mm x 7.1 mm.
They are available in bottles of 30, 60.
They are available in clear/transparent Aluminium-PVC/PE/PVDC blisters of 30, 60, multi-pack
of 60 (2 packs of 30) tablets.
They are available in clear/transparent Aluminium-PVC/PE/PVDC unit-dose divisible blisters
of 30 x 1, 60 x 1, multi-pack of 60 x 1 (2 packs of 30 x 1) tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan

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

This medicinal product is authorised in the member states of the European Economic Area with the
following denominations:
Hungary: Pazopanib Zentiva 200mg filmtabletta
Pazopanib Zentiva 400mg filmtabletta
Bulgaria: Пазопаниб Зентива 200mg филмирани таблетки
Пазопаниб Зентива 200mg филмирани таблетки
Estonia: Pazopanib Zentiva
Croatia: Pazopanib Zentiva 200 mg filmom obložene tablete
Pazopanib Zentiva 400 mg filmom obložene tablete
Lithuania: Pazopanib Zentiva 200 mg plėvele dengtos tabletės
Pazopanib Zentiva 400 mg plėvele dengtos tabletės
Latvia: Pazopanib Zentiva 200 mg apvalkotās tabletes
Pazopanib Zentiva 400 mg apvalkotās tabletes
Romania: PAZOPANIB ZENTIVA 200 mg comprimate filmate
PAZOPANIB ZENTIVA 400 mg comprimate filmate
Slovakia: Pazopanib Zentiva 200 mg
Pazopanib Zentiva 400 mg
Czech Republic: Pazopanib Zentiva
Denmark: Pazopanib Zentiva
Germany: Pazopanib Zentiva 200 mg filmtabletten
Pazopanib Zentiva 400 mg filmtabletten
Finland: Pazopanib Zentiva
France: Pazopanib Zentiva 200 mg comprimé pelliculé
Pazopanib Zentiva 400 mg comprimé pelliculé
Italy: Pazopanib Zentiva
Poland: Pazopanib Zentiva
Spain: Pazopanib Zentiva 200 mg comprimidos recubiertos
con película EFG
Pazopanib Zentiva 400 mg comprimidos recubiertos
con película EFG
Sweden: Pazopanib Zentiva
Norway: Pazopanib Zentiva