Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - votrient

Document Subject

Generated Narrative: MedicinalProductDefinition mpb565284a99d14ce765da70a99bc090d0

identifier: http://ema.europa.eu/identifier/EU/1/10/628/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Votrient 200 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b565284a99d14ce765da70a99bc090d0

identifier: http://ema.europa.eu/identifier/EU/1/10/628/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - votrient

Attesters

What is in this leaflet

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

Votrient 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.

Votrient is used in adults to treat:

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

Do not take Votrient

• if you are allergic to pazopanib or 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 Votrient:

• if you have heart disease.
• if you have liver disease.
• if you have had heart failure or a heart attack.
• if you have had prior collapse of a lung.
• if you have had problems with bleeding, blood clots or narrowing of the arteries.
• if you have had stomach or bowel problems such as perforation (hole) or fistula (abnormal passages forming 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 (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall. Tell your doctor if any of these apply to you. Your doctor will decide whether Votrient is suitable for you. You may need extra tests to check that your kidneys, heart and liver are working properly.

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

• Tell your doctor if you have high blood pressure.

If you are going to have an operation Your doctor will stop Votrient at least 7 days before your operation as it may affect wound healing. Your treatment will be restarted when the wound has adequately healed.

Conditions you need to look out for Votrient can make some conditions worse or cause serious side effects. You must look out for certain symptoms while you are taking Votrient to reduce the risk of any problems. See section 4. Children and adolescents Votrient is not recommended for people aged under 18. It is not yet known how well it works in this age group. Moreover it should not be used in children younger than 2 years of age because of safety concerns.

Other medicines and Votrient 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 ve bought without a prescription.

Some medicines may affect how Votrient works or make it more likely that you ll have side effects. Votrient can also affect how some other medicines work. These include:

• clarithromycin, ketoconazole, itraconazole, rifamicin, telithromycin, voriconazzole (used to treat infection).
• 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 that you are taking to reduce your stomach acid (e.g. proton pump inhibitor, H2 antagonists or antacids) may affect how Votrient is taken. Please consult your doctor or nurse for advice. Tell your doctor or pharmacist if you take any of these.

Votrient with food and drink Don t take Votrient with food, as it affects the way 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 you are being treated with Votrient as this may increase the chance of side effects.

Pregnancy, breast-feeding and fertility Votrient is not recommended if you are pregnant. The effect of Votrient during pregnancy is not known.

• Tell your doctor if you are pregnant or planning to get pregnant.
• Use a reliable method of contraception while you re taking Votrient, and at least for 2 weeks after, to prevent pregnancy.
• If you do become pregnant during treatment with Votrient, tell your doctor.

Don t breast-feed while taking Votrient. It is not known whether the ingredients in Votrient pass into breast milk. Talk to your doctor about this.

Male patients (including those who have had vasectomies) who have partners who are either pregnant or who could become pregnant (including those who use other methods of contraception) should use condoms during sexual intercourse while taking Votrient and for at least 2 weeks after the last dose.

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

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

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

Votrient contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take The usual dose is 800 mg taken once a day. The dose can be taken as 2 tablets of 400 mg or as 4 tablets of 200 mg. The dose of 800 mg once a day is the maximum dose per day. Your doctor may need to reduce your dose if you get side effects.

When to take Don t take Votrient 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 Votrient at about the same time each day.

Swallow the tablets whole with water, one after the other. Do not break or crush the tablets as this affects the way the medicine is absorbed and may increase the chance of side effects.

If you take more Votrient than you should If you take too many tablets, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet.

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

Don t stop Votrient without advice Take Votrient for as long as your doctor recommends. Don t stop unless your doctor advises you to.

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

Possible serious side effects

Swelling of the brain (reversible posterior leukoencephalopathy syndrome) Votrient can, on rare occasions, cause swelling of the brain, which may be life threatening. Symptoms include:

• loss of speech
• change of vision
• seizure (fits)
• confusion
• high blood pressure Stop taking Votrient and seek medical help immediately if you get any of these symptoms, or if you get headache accompanied with any of these symptoms.

Hypertensive crisis (sudden and severe rise in blood pressure) Votrient can on occasion 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 Votrient. 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 (fits)
• fainting Stop taking Votrient and seek medical help immediately if you develop hypertensive crisis.

Heart conditions The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines. You will be checked for any heart problems while you are taking Votrient.

Cardiac dysfunction/heart failure, heart attack Votrient can affect how well your heart pumps or can increase the likelihood of having a heart attack. Signs and symptoms include:

• irregular or fast heartbeat
• rapid fluttering of your heart
• fainting
• chest pain or pressure
• pain in your arms, back, neck or jaw
• shortness of breath
• leg swelling Seek medical help immediately if you get any of these symptoms.

Changes in heart rhythm (QT prolongation) Votrient can affect heart rhythm which in some people can develop into a potentially serious heart condition known as torsade de pointes. This can result in a very fast heartbeat causing a sudden loss of consciousness. Tell your doctor if you notice any unusual changes in your heart beat, such as beating too fast or too slow.

Stroke Votrient can increase your likelihood of having a stroke. Signs and symptoms of stroke may include:

• numbness or weakness on one side of your body
• difficulty talking
• headache
• dizziness Seek medical help immediately if you get any of these symptoms.

Bleeding Votrient can cause severe bleeding in the digestive system (such as stomach, oesophagus, rectum or intestine), or the lungs, kidneys, mouth, vagina and brain, although this is uncommon. Symptoms include:

• passing blood in the stools or passing black stools
• passing blood in the urine
• stomach pain
• coughing or vomiting up blood Seek medical help immediately if you get any of these symptoms.

Perforation and fistula Votrient can cause a tear (perforation) in your stomach or intestinal wall or the development of an abnormal connection between two parts of your 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, intestine or bowel from which bloody or foul smelling pus is released Seek medical help immediately if you get any of these symptoms.

Liver problems Votrient can cause problems with your liver which may develop into serious conditions such as liver dysfunction and liver failure, which may be fatal. Your doctor will be checking your liver enzymes while you are taking Votrient. Signs that your liver may not be working properly may include:

• yellowing of your skin or the whites of your eyes (jaundice)
• dark urine
• tiredness
• nausea
• vomiting
• loss of appetite
• pain on the right side of your stomach area (abdomen)
• bruising easily Seek medical help immediately if you get any of these symptoms.

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

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

Thrombotic microangiopathy (TMA) Votrient may 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 clotting (thrombotic microangiopathy, TMA). Signs and symptoms may include:

• bruising easily
• high blood pressure
• fever
• confusion
• drowsiness
• seizures (fits)
• decrease in urine output Seek medical help immediately if you get any of these symptoms. Tumour lysis syndrome Votrient can cause a fast breakdown of cancer cells resulting in tumour lysis syndrome, which in some people may be fatal. Symptoms may include irregular heartbeat, seizures (fits), confusion, muscle cramps or spasms, or decrease in urine output. Seek medical help immediately if you get any of these symptoms.

Infections Infections occurring while you take Votrient may possibly become serious. Symptoms of infections may include:

• fever
• flu-like symptoms such as cough, tiredness 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 Seek medical help immediately if you get any of these symptoms.

Lung inflammation Votrient can, on rare occasions, cause lung inflammation (interstitial lung disease, pneumonitis), which in some people can be fatal. Symptoms include shortness of breath or cough that will not go away. You will be checked for any lung problems while you are taking Votrient. Seek medical help immediately if you get any of these symptoms.

Thyroid problems Votrient can lower the amount of thyroid hormone produced in your body. This can result in weight increase and tiredness. You will be checked for thyroid hormone levels while you are taking Votrient. Tell your doctor if you notice significant weight gain or tiredness.

Blurry or impaired vision Votrient can cause separation or tear of the lining of the back part of the eye (retinal detachment or tear). This can result in blurry or impaired vision. Tell your doctor if you notice any change in your vision.

Possible side effects (including possible serious side effects under the relevant frequency category).

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

• high blood pressure
• diarrhoea
• feeling or being sick (nausea or vomiting)
• stomach pain
• loss of appetite
• weight loss
• taste disturbance or loss of taste
• sore mouth
• headache
• tumour pain
• lack of energy, feeling weak or tired
• changes in hair colour
• unusual hair loss or thinning
• loss of skin pigment
• skin rash, possibly involving peeling of the skin
• redness and swelling of the palms of the hands or soles of the feet Tell your doctor or pharmacist if any of these side effects becomes troublesome.

Very common side effects that may show up in your blood or urine tests:

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

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

• indigestion, bloating, flatulence
• nose bleed
• dry mouth or mouth ulcers
• infections
• abnormal drowsiness
• difficulty sleeping
• chest pain, shortness of breath, leg pain, and swelling of the legs/feet. These could be signs of a blood clot in your body (thromboembolism). If the clot breaks off, it may travel to your lungs and this may be life threatening or even fatal.
• heart becomes less effective at pumping blood around the body (cardiac dysfunction)
• slow heart beat
• bleeding in the mouth, rectum or lung
• dizziness
• blurred vision
• hot flushes
• swelling caused by fluid of face, hands, ankles, feet or eyelids
• tingling, weakness or numbness of the hands, arms, legs or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, prickling, itching or tingling skin sensation
• sensation of coldness, with shivering
• 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 chest, often causing shortness of breath (pneumothorax) Tell your doctor or pharmacist if any of these effects become troublesome.

Common side effects that may show up in your blood or urine tests:

• underactive thyroid gland
• abnormal liver function
• increase in bilirubin (a substance produced by the liver)
• increase in lipase (an enzyme involved in digestion
• increase in creatinine (a substance produced in muscles)
• changes in the levels of other different chemicals / enzymes in the blood. 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 fall in blood supply to the brain (transient ischaemic attack)
• interruption of blood supply to part of the heart or heart attack (myocardial infarction)
• partial interruption of blood supply to part of the heart (myocardial ischaemia)
• blood clots accompanied by a decrease in red blood cells and cells involved in clotting (thrombotic microangiopathy, TMA). These may harm organs such as the brain and kidneys.
• increase in the number of red blood cells
• sudden shortness of breath, especially when accompanied with sharp pain in the chest and /or rapid breathing (pulmonary embolism)
• severe bleeding in the digestive system (such as stomach, oesophagus or intestine), or the kidneys, vagina and brain
• heart rhythm disturbance (QT prolongation)
• hole (perforation) in stomach or intestine
• abnormal passages 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)
• liver inflamed, not working well or damaged
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• rashes which may be itchy or inflamed (flat or raised spots or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• decreased feeling or sensitivity, especially in the skin
• skin wound which does not heal (skin ulcer)

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

• inflammation of the lung (pneumonitis)
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)

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

• tumour lysis syndrome resulting from a fast breakdown of cancer cells
• liver failure

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date (EXP) which is stated on the bottle and the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Votrient contains

• The active substance is pazopanib (as hydrochloride). Each Votrient 200 mg film-coated tablet contains 200 mg pazopanib. Each Votrient 400 mg film-coated tablet contains 400 mg pazopanib.
• The other ingredients in the 200 mg and 400 mg tablets are: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone (K30), sodium starch glycolate, titanium dioxide (E171). The 200 mg tablets also contain iron oxide red (E172).

What Votrient looks like and contents of the pack Votrient 200 mg film-coated tablets are capsule-shaped, pink with GS JT marked on one side. They are supplied in bottles of 30 or 90 tablets.

Votrient 400 mg film-coated tablets are capsule-shaped, white with GS UHL marked on one side. They are supplied in bottles of 30 or 60 tablets.

Not all pack sizes or tablet strengths may be available in your country.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Lek Pharmaceuticals d.d. Verov kova 1526 Ljubljana Slovenia

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

Glaxo Wellcome, S.A. Avda. Extremadura, 3 09400 Aranda De Duero, Burgos Spain

Novartis Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: