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«Votrient® 200 mg film-coated tablets Votrient® 400 mg film-coated tablets Pazopanib Read all of this leaflet carefully before you start taking this ...»

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Package leaflet: Information for the patient

Votrient® 200 mg film-coated tablets

Votrient® 400 mg film-coated tablets

Pazopanib

Read all of this leaflet carefully before you start taking this medicine because it contains important

information for you.

- 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 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 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

1. What Votrient is and what it is used for 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 a type of cancer that affects the supportive tissues of the body. It can occur in muscles, blood vessels, fat tissue or in other tissues that support, surround and 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).

- Check with your doctor if you think this applies to you. Don’t 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 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 1

- 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.

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.

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.

–  –  –

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.

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.

–  –  –

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.

3. How to take Votrient 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 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 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, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for Swelling of the brain (reversible posterior leukoencephalopathy syndrome which is a disorder of the brain) Votrient can in rare occasions cause swelling of the brain, which may be life threatening. Symptoms

include:

- loss of speech

- change of vision

- seizure (fits)

–  –  –

- Stop taking Votrient and seek medical advice immediately if you get any of these symptoms, or if you get headache accompanied with any of these symptoms.

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. This can result in a very fast heartbeat causing a sudden loss of consciousness. 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.

Lung Inflammation Votrient can in rare occasions cause lung inflammation (pneumonitis), which in some people can be fatal.

Symptoms include shortness of breath or cough. You will be checked for any lung problems while you are taking Votrient.

-Tell your doctor as soon as possible if you get any of these symptoms.

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.

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.

Very common side effects

These 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 painlack of energy, feeling weak or tired

- changes in hair colour

–  –  –

Very common side effect 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

These may affect up to 1 in 10 people:

- indigestion, bloating, flatulence

- nose bleed

- dry mouth or mouth ulcers

- infections

- abnormal drowsiness

- difficulty in 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

- lung collapses and air gets 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:

- under-active 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) 5

- 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 or heart attack (myocardial infarction)

- blood clots accompanied by a decrease in red blood cells and cells involved in clotting. These may harm organs such as the brain and kidneys

- 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 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

- 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.

Rare side effects

These may affect up to 1 in 1,000 people:

- inflammation of the lung (pneumonitis).

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 (see details below). 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 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.



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