Votrient 400 mg. 60 tablets

What is Votrient and what it is used
 Votrient is a type of drug called protein kinase inhibitors. It works by blocking the activity of proteins involved in the growth and spread of cancer cells.
 Votrient is used in adults to treat:
 -rak kidney that is advanced or has spread to other organs
 Define types of soft tissue sarcoma, this is the kind of cancer that affects the supporting tissues of the body. It can be found in the muscles, blood vessels, fat tissue or other tissues that support, surround or protect the organs.
 2. 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).
 -Obarnete your doctor if you think this applies to you. Do not take
 Votrient.
 Warnings and Precautions
 Before you take Votrient your doctor needs to know:
 • if you have heart disease
 • if you have liver disease
 if you had heart failure or heart attack
 • if you have a lung collapse
 • If you have had problems, bleeding, blood clots or narrowing
 arteries
 • If you have had problems with the stomach or intestines, such as perforation (hole) or fistula (abnormal passages forming between parts of the intestine).
 -Uvedomete your doctor if any of these apply to you. Your doctor will decide whether Votrient is suitable for you. You may need you to do further tests to check whether the 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 start taking Votrient, and while 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 would undergo surgery
 Your doctor will stop Votrient at least 7 days prior to surgery, as the drug can affect wound healing. Your treatment will start again when the wound has healed well.
 Conditions you should track
 Votrient can make some conditions worse or cause serious side effects such as heart problems, bleeding and thyroid problems. While taking Votrient should look out for certain symptoms to reduce the risk of developing problems. look
 'Conditions you need to look' in Section 4.
 Children and adolescents
 Votrient is not recommended for people under the age of 18 years. It is not yet known how well it works in this age group. Also Votrient should not be used in children under 2 years for safety reasons.
 Taking other medicines and Votrient
 Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. This includes herbal medicines and other medicines without a prescription.
 Some drugs may affect the way in Votrient or increase the risk of side effects. Votrient can also affect the way some other medicines. Yeah, they're like that:
 -clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole
 (Used to treat infections)
 -atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat
 HIV infection)
 -nefazodon (used to treat depression)
 -simvastatin and possibly other statins (used to treat high cholesterol levels)
 -Medicinal that reduce gastric acidity. The type of drug that are taking to reduce stomach acidity (ie. An inhibitor of the proton
 pump, H2 antagonists or antacids) may affect how Votrient is accepted. Please consult your doctor or nurse for advice.
 -Uvedomete your doctor or pharmacist if you are taking any of the above mentioned drugs.
 Votrient with food and drink
 Do not take Votrient with food, as it affects the way the medicine is absorbed. Take the medicine at least two hours after a meal or one hour before a meal.
 Do not drink grapefruit juice while being treated with Votrient, as this may increase the risk of side effects.
 Pregnancy, lactation and fertility
 Votrient is not recommended if you are pregnant. The effect of Votrient during pregnancy is not known.
 -Uvedomete your doctor if you are pregnant or planning to become pregnant
 -Use a reliable method of contraception while taking Votrient, to prevent pregnancy
 -If you become pregnant during treatment with Votrient, tell your doctor
 Do not breast-feed while taking Votrient. It is not known whether the ingredients in Votrient pass into breast milk. Discuss this with your doctor.
 Treatment with Votrient can affect fertility. Discuss this with your doctor.
 Driving and using machines
 Votrient can have side effects that could affect method
 When taking Votrient
 Do not 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 tablets whole with water, one after another. Do not break or crush the tablets, since this affects how the medicine is absorbed and may increase the risk of side effects.
 If you take more than the amount of Votrient
 If you take too many tablets, contact your 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 the missed dose. Take your next dose at the usual time.
 Do not stop taking Votrient without the counsel
 Take Votrient for as long as you recommend your doctor. Do not stop unless he has advised.
 4. Possible side effects
 As with all drugs, this drug may cause side effects, although not everyone gets them.
 Conditions you need to track
 Brain edema (syndrome reversible posterior leukoencephalopathy, which is a brain disorder).
 Votrient in rare cases can cause brain swelling, which can be life-threatening. Symptoms include:
 -zaguba speech
 -Change in sight
 -garchove (fits)
 -obarkanost
 -Sprete taking Votrient and seek immediate medical attention if you experience any of these symptoms or if you get a headache accompanied by any of these symptoms.

 heart problems
 Votrient can affect heart rhythm (QT prolongation) which in some people can develop into a potentially serious heart condition known as Torsade de Pointes. This can lead to very rapid heart rhythm that can cause sudden loss of consciousness. Risks of developing these conditions may be higher in people with existing heart problem, or who are taking other medicines. While taking Votrient will be checked for any heart problems.
 -Uvedomete your doctor if you notice any unusual changes in your heart rate too fast or too slowly beating.
 bleeding
 Votrient can cause severe bleeding in the digestive system (such as the stomach, esophagus, rectum or intestine), or in the lungs, kidneys, mouth, vagina and brain, although this does not happen often. Symptoms include:
 -Blood in the stool or black stools
 -Blood in urine
 -stomachache
 -kashlitsa / vomiting blood
 -Uvedomete your doctor as soon as possible if you experience any of these symptoms.
 Thyroid Problems
 Votrient can lower the amount of thyroid hormone produced by your body. While you are being treated with Votrient will investigate accordingly.
 Very common side effects
 They may affect more than 1 in 10 patients:
 -high blood pressure
 -diariya
 -gadene or vomiting
 -stomachache
 -zaguba appetite
 -zaguba weight
 -narushavane taste or loss of taste
 -vazpalenie mouth
 -headache
 tumors of pain
 Missing energy, feeling weak or tired
 -promeni hair color
 -neobichayna loss or thinning hair
 -zaguba of skin pigment
 -kozhen rash that may have peeling skin
 -zachervyavane and swelling of the palms of the hands or soles of the feet
 -Uvedomete your doctor or pharmacist if any of these side effects becomes troublesome.
 Very common side effects that may occur in blood tests:
 Raising the liver enzymes
 Raising Blood albumin
 -ponizhavane the number of blood platelets (cells that help the blood to clot)
 -ponizhavane the number of white blood cells
 Common side effects
 These may affect up to 1 in 10 patients:
 -losho indigestion, bloating, flatulence
 -karvene nose
 -suhota mouth or mouth ulcers
 -infektsii
 -neobichayna drowsiness
 Harder sleep
 -gradna pain, shortness of breath, pain in the legs and swelling of the legs / feet. These may be signs of a blood clot in your body (thromboembolism). If the blood clot breaks off, it can reach your lungs, which can be life-threatening or even fatal.
 -heart stroke, heart failure
 -baven heartbeat
 -karvene mouth, rectum or lungs
 -zamayanost
 -zamagleno vision
 The hottest waves
 -swelling caused by the retention of fluid in the face, hands, ankles, feet or eyelids
 -mravuchkane, weakness or numbness in the hands, arms, legs or feet
 -kozhni violations, redness, itching, dry skin
 , violations of nails
 -kozhno burning sensation, tingling, itching or tingling
 sensibilities cold, with tremors
 -prekomerno sweating
 -dehidratatsiya
 Muscle pain, joint pain, tendon pain or chest pain, muscle spasms
 -Husky voice
 -zaduh
 -kashlitsa
 -kashlyane blood
 -haltsane
 -chesti bowel movements
 -Increased skin sensitivity to sunlight
 -namalena sensation of the skin
 Rare side effects
 They may affect up to 1 in 1000 patients
 -Blood clots, accompanied by a reduction in red blood cells and cells involved in blood clotting. These blood clots can damage organs such as brain and kidney.

 Adverse event reporting
 If you get any side effects, contact your doctor or pharmacist. This includes any possible 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 do your bit for obtaining more information on the safety of this medicine.
 5. How to store Votrient
 Keep out of reach of children.
 Do not use Votrient after the expiry date stated on the bottle and carton. The expiry date refers to the last day of that month.
 This medicine does not require any special storage conditions.
 If you have any remaining tablets, do not dispose of wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
 6.Sadarzhanie the pack and other information
 What Votrient
 The active substance in Votrient is pazopanib (as hydrochloride). Votrient tablets are supplied with a different amount of the active substance.
 Votrient 200 mg: Each tablet contains 200 mg pazopanib. Votrient 400 mg: Each tablet contains 400 mg pazopanib.
 The other ingredients in the tablets of 200 mg and 400 mg tablets are: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone (K30), sodium starch glycolate (type A), titanium dioxide (E171). The 200 mg tablets also contain red ferric oxide
 (E172).
 Votrient looks like and contents of the pack
 Votrient 200 mg 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 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 may be marketed.

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