Votrient
pazopanib
pazopanib
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Votrient is and what it is used for
What you need to know before you take Votrient
How to take Votrient
Possible side effects
How to store Votrient
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.
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.
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.
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.
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.
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.
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
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.
hours after a meal or one hour before a meal (see section 3).
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.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
maximum dose per day. Your doctor may need to reduce your dose if you get side effects.
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 too many tablets, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet.
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
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.
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
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
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
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.
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
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
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
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
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
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 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
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.
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.
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.
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
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
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)
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
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)
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)
tumour lysis syndrome resulting from a fast breakdown of cancer cells
liver failure
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.
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).
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.
Novartis Europharm Limited Vista Building
Elm Park, Merrion Road
Dublin 4 Ireland
Lek Pharmaceuticals d.d. Verovškova 57
1526 Ljubljana
Slovenia
Novartis Pharma GmbH Roonstraße 25
D-90429 Nuremberg
Germany
Glaxo Wellcome, S.A. | |
Avda. Extremadura, 3 | |
09400 Aranda De Duero, Burgos | |
Spain |
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 555
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810
Novartis Norge AS
Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12
Novartis Pharma GmbH
Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited
Tel: +353 1 260 12 55
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370