200 mg and 400 mg film-coated tablets
pazopanib
What Votrient and what it is used for
Votrient is a type of medicine called a protein kinase inhibitor. It works by preventing the activity of the proteins that participate in the growth and spread of cancer cells.
Votrient is given to adults to treat:
- kidney cancer that is advanced or has spread to other organs
- some forms of soft tissue sarcoma, which is a type of cancer that affects the supporting tissues of the body. This type can appear in muscles, blood vessels, fatty tissue, or in other tissues that support, surround, and protect the organs.
What you need to know before you take Votrient
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 is right for you.
Warnings and precautions
Talk to your doctor before taking Votrient.
- if you have any heart disease
- if you have any liver disease
- if you have had heart failure or a heart attack
- if you have previously had a lung collapse
- if you have had problems with bleeding, blood clots, or artery narrowing
- if you have had stomach or intestinal problems such as perforation (holes) or fistulas (abnormal passages that form between parts of the intestine)
- if you have thyroid problems
- if you have problems with your kidney function
- if you or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a rupture in a blood vessel wall.
Tell your doctor if any of these apply to you. Your doctor will decide if Votrient is right 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. Blood pressure is checked before and while you take Votrient. If you have high blood pressure, you will receive treatment with medicines that lower it.
- Tell the doctor if you have high blood pressure.
If you are going to undergo an operation
The doctor stops treatment with Votrient at least 7 days before surgery, as it can affect wound healing. Your treatment will start again when the wound has healed sufficiently.
Conditions that you need to be observant about
Votrient can make certain conditions worse or cause serious side effects. You need to be aware of certain symptoms when taking Votrient to reduce the risk of problems, see section 4.
Children and young people
Votrient is not recommended for people under 18 years of age. It is not yet known how well it works in this age group. For safety reasons, this medicine should also not be given to children younger than 2 years.
Other medicines and Votrient
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to non-prescription ones, herbal remedies, or other natural products.
Some medicines can affect Votrient or make you more likely to have side effects. Votrient can also affect how certain other medicines work. These include:
- clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, and 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 that reduces stomach acid (eg proton pump inhibitors, H 2 antagonists, or antacids) can affect how Votrient should be taken. Consult your doctor or nurse for advice.
Tell your doctor or pharmacist if you are taking any of these.
Votrient with food and drink
Do not take Votrient with food, as it affects how the medicine is absorbed by the body. 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 Votrient as it may increase the risk of side effects.
Pregnancy, breastfeeding, and fertility
Votrient is not recommended if you are pregnant. The effect of Votrient during pregnancy is not known.
- Tell the doctor if you are pregnant or plan to become pregnant
- Use a reliable method of birth control while taking Votrient and for at least 2 weeks afterward to prevent pregnancy
- If you become pregnant during treatment with Votrient, tell your doctor.
Do not breastfeed while taking Votrient. It is not known whether the ingredients in Votrient pass into breast milk. Talk to your doctor about this.
Men (including those who have undergone sterilization/vasectomy) who have a partner who is, or could become, pregnant (even if they are using other contraceptive methods) should use a condom during intercourse during treatment with Votrient and for at least 2 weeks after the last dose one.
Fertility may be affected by treatment with Votrient. Talk to your doctor about this.
Driving ability and use of machinery
Votrient may 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 you do not have enough energy.
Votrient contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to take Votrient
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much to take
The usual dose is two Votrient 400 mg tablets (800 mg pazopanib) taken once a day. That is the maximum dose of one per day. The doctor may need to reduce the dose if you experience side effects.
When to take it
Do not take Votrient with food. Take it at least two hours after a meal or one hour before a meal. For example, you can take it two hours after breakfast or one hour before lunch. Take Votrient at about the same time each day.
Swallow the tablets whole, one at a time, with water. Do not break or crush the tablets as this affects how the medicine is absorbed by the body and can increase the risk of side effects.
If you have taken too much Votrient
Contact a doctor or pharmacist and ask for advice if you have taken too many tablets. Show the packaging or this leaflet if possible.
If you forget to take Votrient
Do not take a double dose to make up for a missed dose. Just take the next dose at the usual time.
Do not stop taking Votrient without consulting a doctor
Take Votrient for as long as your doctor recommends. Do not stop unless your doctor tells you to.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects are
Swelling of the brain (reversible posterior leukoencephalopathy syndrome).
Votrient can rarely cause swelling of the brain, which can be life-threatening. Symptoms include:
- loss of speech
- vision changes
- convulsions (twitching)
- confusion
- high blood pressure.
Stop taking Votrient and seek medical attention immediately if you experience any of these symptoms, or if you experience a headache followed by any of these symptoms.
Hypertensive crisis (sudden and severe increase in blood pressure)
Votrient can sometimes cause a sudden and severe increase in blood pressure, a so-called hypertensive crisis. The doctor will therefore check your blood pressure during treatment with Votrient. Symptoms of hypertensive crisis may include:
- severe chest pain
- severe headache
- blurred vision
- confusion
- nausea
- vomiting
- severe anxiety
- respiratory distress
- convulsions
- fainting.
Stop taking Votrient and seek medical attention immediately if you experience a hypertensive crisis.
Heart problems
The risk of this may be higher for people with an existing heart problem or who are taking other medicines. You will therefore be checked for heart problems while you are taking Votrient.
Cardiac dysfunction/heart failure, heart attack
Votrient can affect the heart’s pumping ability and increase the risk of a heart attack. Symptoms include:
- irregular or fast heartbeat
- heart fibrillation
- fainting
- chest pain or pressure in the chest
- pain in arms, back, neck, or jaw
- respiratory distress
- leg swelling.
Seek medical attention immediately if you experience any of these symptoms.
Change in heart rhythm ( QT prolongation )
Votrient can affect the heart rhythm, which in some people can develop into a heart condition that can be serious and is called torsade de pointes. This can cause a very fast heartbeat which can lead to sudden unconsciousness.
Tell the doctor if you notice any unusual changes in your heart activity, such as your heart beating too fast or too slowly.
Stroke
Votrient increases the risk of stroke. Symptoms may include:
- numbness or weakness on one side of the body
- difficulty speaking
- headache
- dizziness
Seek medical attention immediately if you experience any of these symptoms.
Bleeding
Votrient can cause severe bleeding in the digestive system (eg, stomach, esophagus, rectum, or intestines) or the lungs, kidneys, mouth, vagina, and brain, although this is uncommon. Symptoms are, for example:
- blood in the stool or black stools
- blood in the urine
- stomach ache
- coughing or vomiting blood.
Seek medical attention immediately if you experience any of these symptoms.
Rupture of the intestine and fistula
Votrient can cause a hole (rupture) in the gastrointestinal tract or the formation of an abnormal channel between two parts of the digestive tract ( fistula ). Symptoms may include:
- severe abdominal pain
- nausea and/or vomiting
- fever
- holes (rupture) in the gastrointestinal tract from which bloody or foul-smelling fluid comes out.
Seek medical attention immediately if you experience any of these symptoms.
Liver problems
Votrient can cause liver problems that can develop into serious conditions, e.g. liver dysfunction and liver failure, which can be life-threatening. Doctors will check your liver enzymes while you are taking Votrient. Signs that the liver may not be working normally may include:
- yellow skin or whites of eyes (jaundice)
- dark colored urine
- fatigue
- nausea
- vomiting
- loss of appetite
- pain in the right side of the abdomen
- bruises easily.
Seek medical attention immediately if you experience any of these symptoms.
Blood clot
Deep vein thrombosis and pulmonary embolism
Votrient can cause blood clots, especially in the legs (deep vein thrombosis ), which can also end up in the lungs ( pulmonary embolism ). Symptoms may include:
- severe chest pain
- respiratory distress
- rapid breathing
- pain in the leg
- swelling of the arms and hands or legs and feet.
Thrombotic microangiopathy
Votrient can cause blood clots in the small blood vessels of the kidneys and brain, accompanied by a decrease in red blood cells and cells involved in blood clotting. Symptoms may include:
- bruises easily
- high blood pressure
- fever
- confusion
- drowsiness
- convulsions
- decreased urine output.
Seek medical attention immediately if you experience any of these symptoms.
Tumor lysis syndrome
Votrient can cause a rapid breakdown of cancer cells and lead to tumor lysis syndrome, which can be fatal in some people. Symptoms may include irregular heartbeats, seizures, confusion, muscle cramps or spasms, or decreased urine production. Seek medical attention immediately if you experience any of these symptoms.
Infection you
Infections that occur during treatment with Votrient can be serious. 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, scrapes, or red, hot, swollen, or painful sores.
Seek medical attention immediately if you experience any of these symptoms.
Pneumonia
Votrient can rarely cause lung inflammation ( pneumonitis ), which in some people can be life-threatening. Symptoms include shortness of breath or a cough that does not go away. You will be checked for any lung problems while taking Votrient.
Seek medical attention immediately if you experience any of these symptoms.
Thyroid problems
Votrient can lower the amount of thyroid hormone produced in your body. This can cause weight gain and fatigue. Your thyroid hormone levels will be checked while you are taking Votrient.
Tell your doctor if you gain a lot of weight or feel tired.
Blurred or reduced vision
Votrient can cause separation or tear of the lining of the back of the eye (retinal detachment or rupture ). This can lead to blurred or reduced vision.
Tell your doctor if you experience any vision changes.
Possible side effects (including possible serious side effects are indicated under the relevant frequency range).
Very common side effects ( may affect more than 1 in 10 users):
- high blood pressure
- diarrhea
- nausea, vomiting
- stomach pain
- decreased appetite
- weight loss
- altered taste or loss of taste
- mouth ulcers
- headache
- tumor pain
- lack of energy, feeling weak or tired
- changed hair color
- abnormal hair loss or thinning hair
- reduced skin pigmentation
- skin rash, possibly with flaking
- 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 bother you.
Very common side effects that can show up in blood or urine tests:
- increased liver enzyme values
- decreased levels of albumin in the blood
- protein in the urine
- reduced number of platelets (cells that help the blood to clot)
- reduced number of white blood cells.
Common side effects ( may affect up to 1 in 10 users):
- upset stomach, flatulence, flatulence
- nosebleed
- dry mouth or mouth ulcers
- infection _
- abnormal sleepiness
- sleep difficulties
- chest pain, shortness of breath, leg pain, and leg/feet swelling. This may be a sign of a blood clot in the body ( thromboembolism ). If a blood clot breaks loose, it can travel to the lungs, which can be life-threatening and even cause death.
- the heart becomes less efficient at pumping blood around the body ( heart failure )
- slow pulse
- bleeding in the mouth, rectum, or lungs
- dizziness
- blurred vision
- hot flashes
- swelling caused by fluid accumulation in the face, hands, ankles, feet, or eyelids
- tingling, weakness, or numbness in the hands, arms, legs, or feet
- skin rash, redness, itching, dry skin
- nail diseases
- burning, stinging, itching, or stinging sensation in the skin
- feeling cold with chills
- profuse sweating
- dehydration
- muscle, joint, tendon, or chest pain, muscle cramps
- huskiness
- shortness of breath
- cough
- bloody expectoration
- hiccup
- lung collapse where the air comes down and gets stuck between the lung and the chest, which can often cause shortness of breath (pneumothorax).
Tell your doctor or pharmacist if any of these side effects bother you.
Common side effects that may show up in blood or urine tests:
- interactivity of the thyroid gland
- abnormal liver function
- increased bilirubin (a substance produced in the liver)
- elevated lipase (an enzyme that helps with digestion)
- increased creatinine (a substance produced in muscles)
- altered levels of other chemical substances/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 users):
- stroke
- temporarily reduced blood supply to the brain ( transient ischemic attack, TIA )
- interrupted blood supply to part of the heart or heart attack (myocardial infarction)
- partially interrupted blood supply to part of the heart (cardiac ischemia)
- blood clots are accompanied by a reduction in red blood cells and cells involved in clotting (thrombotic microangiopathy, TMA), which can damage organs such as the brain and kidneys
- increased number of red blood cells
- sudden shortness of breath, especially with simultaneous severe pain in the chest and/or rapid breathing ( pulmonary embolism )
- severe bleeding in the gastrointestinal tract (eg stomach, esophagus, or intestine) or the kidneys, vagina, and brain
- cardiac arrhythmia ( QT prolongation)
- hole ( perforation ) in the stomach or intestine
- formation of an abnormal passage between parts of the intestine ( fistula )
- heavy or irregular menstruation
- sudden high blood pressure (hypertensive crisis)
- inflammation of the pancreas ( pancreatitis )
- inflammation of the liver, impaired liver function, or liver damage
- yellowing of the skin or whites of the eyes (jaundice)
- peritonitis ( peritonitis )
- Runny nose
- rash that may itch or be inflamed (smooth or raised patches or blisters)
- frequent stools
- increased sensitivity of the skin to sunlight
- reduced sensation or sensitivity, especially in the skin
- sores on the skin that do not heal (skin ulcers).
Rare side effects ( may affect up to 1 in 1,000 users).
- inflammation of the lung ( pneumonitis )
- an enlargement and weakening of a blood vessel wall or a rupture in a blood vessel wall ( aneurysms and arterial dissections).
Frequency not known (frequency cannot be estimated from available data):
- tumor lysis syndrome due to a rapid breakdown of cancer cells
- liver failure.
How to store Votrient
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance in Votrient is pazopanib (as hydrochloride). One tablet of Votrient 200 mg contains 200 mg of pazopanib. One tablet of Votrient 400 mg contains 400 mg of pazopanib.
- 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 red iron oxide (E172).
Appearance and package sizes of the medicine
Votrient 200 mg film-coated tablets are capsule-shaped, pink, and marked with GS JT on one side. They are supplied in cans of 30 or 90 tablets.
Votrient 400 mg film-coated tablets are capsule-shaped, white, and marked with GS UHL on one side. They are supplied in cans of 30 or 60 tablets.
Not all pack sizes or tablet strengths may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Lek Pharmaceuticals dd
Verovškova 57
1526 Ljubljana
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Glaxo Wellcome, SA
Abda. Extremadura, 3
09400 Aranda De Duero, Burgos
Spain
Novartis Farmacéutica SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODPhone: +359 2 489 98 28 | Luxembourg/LuxembourgNovartis Pharma NVTél/Tel: +32 2 246 16 11 |
| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 555 |
| EstoniaSIA Novartis Baltics Eesti branch phone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
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| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
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| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland Limited |