PAZOPANIB 200 мг Фильм-coated таблетки

Содержание инструкции

1. Pazopanib Sandoz 200 mg film-coated tablets, 400 mg film-coated tablets
   1. What is Pazopanib Sandoz and what it is used for
   2. What you need to know before taking Pazopanib Sandoz
   3. How to take Pazopanib Sandoz
   4. How to store Pazopanib Sandoz
   5. Package Contents and Other Information

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

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

Pazopanib Sandoz 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 Sandoz 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 the organs.

2. What you need to know before taking Pazopanib Sandoz

Do not take Pazopanib Sandoz:

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

Warnings and precautions
Talk to your doctor before taking Pazopanib Sandoz:

• 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 with bleeding, blood clots or narrowing of thearteries.
• 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 kidney function.
• if you have or have had an aneurysm(bulging and weakening of a blood vessel wall) or a tear in a blood vessel wall.

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

High blood pressure and Pazopanib Sandoz
Pazopanib Sandoz can raise your blood pressure. Your blood pressure will be checked
before you take Pazopanib Sandoz 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 Sandoz at least 7 days before your surgery because
the medicine can affect wound healing. Treatment will be restarted when the
wound has healed properly.

Conditions for which you must be careful
Pazopanib Sandoz can worsen certain conditions or cause serious side effects. To reduce
the risk of any problems, you must be careful about certain symptoms while taking
Pazopanib Sandoz. See section 4.
Children and adolescents
Pazopanib Sandoz 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 Sandoz
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 Sandoz works and can increase
the chance that you have side effects. In turn, Pazopanib Sandoz 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) can affect how you take Pazopanib Sandoz. Ask your doctor or nurse for advice. Tell your doctoror pharmacist if you are taking any of these medicines.

Pazopanib Sandoz with food and drink
Do not take Pazopanib Sandoz 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 Sandoz as this can
increase the chance of side effects.

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

• Tell your doctor if you are pregnantor if you are planning to become pregnant.
• Use reliable contraceptionwhile taking Pazopanib Sandoz, and for at least 2 weeks afterwards, to prevent pregnancy.
• If you become pregnant during treatmentwith Pazopanib Sandoz, tell your doctor.
• Do not breastfeed while taking Pazopanib Sandoz.It is not known whether the ingredients of Pazopanib Sandoz pass into breast milk. Talk to 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 methods of contraception), you must
use a condom during sexual intercourse while taking Pazopanib Sandoz and for at least
2 weeks after the last dose.

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

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

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

Pazopanib Sandoz 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 Sandoz

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

How much to take
The recommended doseis 800 mg taken once a day. The dose can be taken as 2
400 mg tablets or as 4 200 mg tablets. The 800 mg once daily dose 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 Sandoz 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 Sandoz 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
because this affects how the medicine is absorbed and may increase the possibility of
side effects.

If you take more Pazopanib Sandoz 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 Sandoz
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 Pazopanib Sandoz without medical advice
Take Pazopanib Sandoz for the whole time recommended by your doctor. Do not stop it unless
your doctor tells you to.

• 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 Sandoz can rarely cause swelling of the brain, which can be life-threatening.
Symptoms include:

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

Stop taking Pazopanib Sandoz and immediately seek medical helpif 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 Sandoz 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 Sandoz. Signs and symptoms of a hypertensive crisis can include:

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

Stop taking Pazopanib Sandoz and immediately seek medical helpif
you develop a hypertensive crisis.

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

Heart failure/cardiac failure, heart attack
Pazopanib Sandoz 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
• racing heart
• fainting
• chest pain or pressure
• pain in arms, back, neck or jaw
• shortness of breath
• swelling in the legs Immediately seek medical helpif you experience any of these symptoms.

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

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

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

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

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

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

Perforation and fistula
Pazopanib Sandoz 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 helpif you experience any of these symptoms.

Liver problems
Pazopanib Sandoz 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 Sandoz.
Signs that your liver may not be working properly can include:

• yellowing of the skin or the white of your eyes (jaundice)
• dark urine
• fatigue
• nausea
• vomiting
• loss of appetite
• pain in the upper right area of your stomach (abdomen)
• easy bruising Immediately seek medical helpif you experience any of these symptoms.

Blood clots

Deep vein thrombosis (DVT) and pulmonary embolism
Pazopanib Sandoz 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
can 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 Sandoz 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 can include:

• easy bruising
• high blood pressure
• fever
• confusion
• drowsiness
• seizures (fits)
• decreased urine production Immediately seek medical helpif you experience any of these symptoms.

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

Infections
Infections that occur while you are taking Pazopanib Sandoz can become serious. Symptoms
of infections can include:

• fever
• flu-like symptoms such as cough, fatigue and body aches that do not go away
• shortness of breath and/or wheezing
• pain while urinating
• cuts, scrapes or wounds that are red, warm, swollen or painful Immediately seek medical helpif you experience any of these symptoms.

Lung inflammation
Pazopanib Sandoz can rarely 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 Sandoz, you will be monitored for
any lung problems. Immediately seek medical helpif you experience any of
these symptoms.

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

Blurred or impaired vision
Pazopanib Sandoz 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.

Tell your doctorif you notice any changes in your vision.

Possible side effects (including possible serious side effects according to the 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
• altered taste or loss of taste
• mouth pain
• headache
• pain in the tumor site
• lack of energy, feeling weak or tired
• change in hair colour
• hair loss or thinning
• loss of skin pigment
• skin rash, with possible peeling of the skin
• redness and swelling of the palms of the hands or soles of the feet Tell your doctor or pharmacistif any of these side effects get worse 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 number of platelets in the blood (cells that help the blood to clot)
• reduced 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 sleepiness
• 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 flushes
• swelling of 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)

Tell your doctoror pharmacist if any of these become bothersome.

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

• reduced activity of the thyroid gland
• abnormal liver function
• 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 undesirable 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 coagulation (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 acute chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding of the digestive tract (such as stomach, esophagus or intestine), or of 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, which does not work properly or is 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
• reduced sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer)

Rare undesirable effects (may affect up to 1 in 1000

• inflammation of the lungs (pneumonia)
• dilation 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 based on available data):

• tumor lysis syndrome resulting from rapid breakdown of cancer cells
• liver failure

Reporting of undesirable effects
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.
By reporting side effects, you can help provide more information on the safety
of this medicine.

5. How to store Pazopanib Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) that is stated on the bottle and on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any particular 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 Sandoz contains

• The active ingredient is pazopanib (as hydrochloride). Each film-coated tablet of Pazopanib Sandoz 200 mg contains 200 mg of pazopanib. Each film-coated tablet of Pazopanib Sandoz 400 mg contains 400 mg of pazopanib.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A) povidone (K30), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80. The 200 mg tablets also contain red iron oxide (E172).

Description of the appearance of Pazopanib Sandoz and package contents
Pazopanib Sandoz 200 mg film-coated tablets are capsule-shaped, pink in color, with
‘200’ imprinted on one side, available in blister packs of 30, 60 or 90 tablets, multi-pack of
60 or 60x1 (2 packs of 30 or 2 packs of 30x1), 90 or 90 x 1 (3 packs of 30 or 3 packs of 30x1)
tablets and in plastic bottles of 30 or 90 tablets or multi-pack of 90 (3 bottles of 30)
tablets.
Pazopanib Sandoz 400 mg film-coated tablets are capsule-shaped, white in color, with
‘400’ imprinted on one side, available in blister packs of 30, 60 or 90 tablets, multi-pack of
60 or 60x1 (2 packs of 30 or 2 packs of 30x1), 90 or 90 x 1 (3 packs of 30 or 3 packs of 30x1)
tablets and in plastic bottles of 30 or 90 tablets or multi-pack of 90 (3 bottles of 30)
tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone
Metamorfossi, 14452, Greece
Remedica Ltd,
Aharnon Street, Limassol Industrial Estate,
3056 Limassol, Cyprus

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations
Croatia Pazopanib Sandoz 200 mg filmom obložene tablete
Pazopanib Sandoz 400 mg filmom obložene tablete
Ireland Pazopanib Rowex 200 mg film-coated tablets
Pazopanib Rowex 400 mg film-coated tablets
Italy Pazopanib Sandoz
Malta Pazopanib Sandoz 200 mg film-coated tablets
Pazopanib Sandoz 400 mg film-coated tablets
Norway Pazopanib Sandoz
Poland Pazopanib Sandoz
Slovakia Pazopanib Sandoz 200 mg
Pazopanib Sandoz 400 mg
Hungary Pazopanib Sandoz 200 mg filmtabletta
Pazopanib Sandoz 400 mg filmtabletta