Votrient 400 mg film-coated tablets

Votrient is a type of medicine called a protein kinase inhibitor. It is used to treat kidney cancer that is advanced or has spread to other organs. It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.

Don?t take Votrient

• if you are allergic ( hypersensitive) to pazopanib or any of the other ingredients of Votrient (listed in Section 6).
• Check with your doctor if you think this applies to you. Don?t take Votrient.

Take special care with Votrient
Before you take Votrient your doctor needs to know:

• if you have heart disease
• if you have liver disease
• 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).
• 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 heart and liver are working properly.

Votrient is not recommended for people aged under 18. It is not yet known how well it works in this age group.

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 may need to look out for

Votrient can make some conditions worse or cause serious side effects, such as heart conditions, bleeding and thyroid probems. You must look out for certain symptoms while you are taking Votrient to reduce the risk of any problems. See ? Conditions you need to look out for?in Section 4.

Other medicines and Votrient
Tell your doctor or pharmacist if you are taking any other medicines, have taken any recently, or if you start new ones. 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)
• Tell your doctor or pharmacist if you take any of these.

Food and drink with Votrient
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.
Do not drink grapefruit juice while you are being treated with Votrient as this may increase the chance of side effects.

Pregnancy and breast-feeding
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, 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.

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.

Always take Votrient exactly as your doctor has told you. Check with your doctor or pharmacist if you?re not sure.

How much to take
The usual dose is two Votrient 400 mg tablets (800 mg pazopanib) taken once a day. This 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 it affects the way the medicine is absorbed and may increase the chance of side effects.

If you take too much Votrient

If you taketoo many tablets, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet.

If you forget to take Votrient

Don't take the extra tablets to make up for a missed 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, Votrient can cause side effects, although not everybody gets them.

Conditions you need to look out for

Heart conditions

Votrient can affect heart rhythm ( QT prolongation) which in some people can develop into a potentially serious heart condition known as Torsade de Pointes. 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.

• Tell your doctor if you notice any unusual changes in your heart beat, such as beating too fast or too slow.

Bleeding

Votrient can cause severe bleeding in the digestive system (such as stomach, gullet, 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 / vomiting up blood
• Tell your doctor as soon as possible if you get any of these symptoms.

Thyroid problems

Votrient can lower the amount of thyroid hormone produced in your body. You will be checked for this while you are taking Votrient.

Very common side effects

These may affect more than1 in 10 people :

• high blood pressure
• diarrhoea
• feeling or being sick (nausea or vomiting)
• stomach pain
• loss of appetite
• taste disturbance or loss of taste
• lack of energy
• changes in hair colour
• Tell your doctoror pharmacist if any of these side effects becomes troublesome.

Very common side effect that may show up in your blood tests:

• increase in liver enzymes

Common side effects

These may affect up to 1 in 10 people:

• indigestion, bloating, flatulence
• weight loss
• nose bleed
• feeling weak or tired
• abnormal drowsiness
• difficulty in sleeping
• headache
• dizziness
• hot flushes
• swelling caused by fluid of face, hands, ankles, feet or eyelids
• tingling or numbness of the hands, arms, legs or feet
• skin rash, redness, itching, dry skin
• loss of skin pigment
• redness and swelling of the palms of the hands or soles of the feet
• excessive sweating
• muscle or chest pain, muscle spasms
• unusual hair loss or thinning
• hoarseness
• 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:

• under-active thyroid gland
• abnormal liver function
• 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
• 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

These may affect up to 1 in 100 people:

• stroke
• temporary fall in blood supply to the brain (mini-stroke)
• interruption of blood supply to part of the heart ( myocardial infarction)
• heart becomes less effective at pumping blood around the body ( cardiac dysfunction)
• 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, gullet, rectum or intestine), or the lung, kidneys, mouth, vagina and brain
• heart rhythm disturbance ( QT prolongation)
• slow heart beat
• 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
• 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)
• mouth ulcers
• rashes which may be itchy or inflamed (flat or raised spots or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight

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

• low levels of calcium or magnesium in the blood
• changes in the levels of different chemicals / enzymes in the blood. Your doctor will inform you of the results of the blood / urine tests

If you get side effects

Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.

Keep out of the reach and sight of children.

Do not use Votrient 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.

If you have unwanted tablets, don?t put them in waste water or household rubbish. Ask your pharmacist how to dispose of medicines you don?t need. This will help to protect the environment.

What Votrient contains

The active substance in Votrient is pazopanib hydrochloride. Votrient tablets come in different strengths.
Votrient 200 mg: each tablet contains 200 mg pazopanib.
Votrient 400 mg: each 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 (type A), 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
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.

Manufacturer
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom.

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

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

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 6938100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel. 49 089 36044 8701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 022 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK S.R.L. Tel 4021 3028 208 France Laboratoire GlaxoSmithKline Tél. 33 01 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Limited Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 01 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354 530 3700 Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 045 9218 111 SuomiFinland GlaxoSmithKline Oy PuhTel 358 010 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0800 221441 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

This medicine has been given ?conditional approval?.
This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on the medicine every year and this leaflet will be updated as necessary.