Pazopanib 200 mg Film-Coated Tablets

PAZOPANIB 200 CIPLA contains an active substance pazopanib. It is classified as a cytostatic medicine (medicine that can cause cell death or stop cell growth and cell multiplication) and is used to treat renal cell carcinoma (a form of kidney cancer). PAZOPANIB 200 CIPLA is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (RCC).

Do not take PAZOPANIB 200 CIPLA:

• If you are hypersensitive (allergic) to pazopanib or any of the other ingredients of PAZOPANIB 200 CIPLA (listed in section 6).

Warnings and precautions

Tell your doctor or health care provider before taking PAZOPANIB 200 CIPLA:

• If you have heart disease
• If you have a history of blockage of blood vessels due to blood clots
• If you previously suffered a heart attack or stroke, heart failure, heart palpitations
• If you have a history of aneurysm (weakening of the artery that causes a bulge that can rupture the artery)
• If you have or are developing a condition in which parts of the brain are affected by swelling, this usually results in headaches, changes in vision, confusion, weakness and seizures
• If you have high blood pressure
• If you have liver disease
• If you have a condition whereby there is progressive scarring and inflammation of the lung tissue. Tell your doctor if you experience shortness of breath, dry cough and fatigue
• If you have gastrointestinal problems
• If you have thyroid problems
• If you have problems with wound healing especially if you are going to have surgery, PAZOPANIB 200 CIPLA should be stopped 7 days before the surgery
• If you have problems with your kidneys resulting in protein in the urine
• If you have a rapidly growing tumour or a very large tumour, your doctor will monitor you for a condition called Tumour lysis syndrome (large amounts of cell contents are released into the bloodstream)
• If you have had a history of pneumothorax (collapsing of the lung resulting in difficulty breathing)
• Serious infections can occur during treatment with PAZOPANIB 200 CIPLA. Tell your doctor if you experience fever, chills, fatigue, sore throat
• If you experience bruising, bleeding, fever, fatigue and confusion when taking PAZOPANIB 200 CIPLA, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA)
• If you notice any stroke-like symptoms, such as trouble walking, speaking and understanding, as well as paralysis or numbness of the face, arm or leg, weakness on one side of the body, vision problems and slurred speech
• If you are taking any other medicine including complementary medicine. Check with your doctor if you think any of these may apply to you or if you are unsure. You may need extra tests to check that your heart, liver and thyroid are working properly. Your doctor may decide to adjust your dose or stop treatment based on the results of these tests.

Children and adolescents

Do not give PAZOPANIB 200 CIPLA to children. The safety and efficacy of PAZOPANIB 200 CIPLA in children has not yet been established.

Other medicines and PAZOPANIB 200 CIPLA

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Clarithromycin, telithromycin, voriconazole (used to treat infections) as it may increase the effects of PAZOPANIB 200 CIPLA.
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV) as it may increase the effects of PAZOPANIB 200 CIPLA.
• Nefazodone (used to treat depression) as it may increase the effects of PAZOPANIB 200 CIPLA.
• Lapatinib (used to treat breast cancer), as it may increase the effects of PAZOPANIB 200 CIPLA.
• Paclitaxel (used to treat cancers), as co-administration of PAZOPANIB 200 CIPLA may increase the effects of paclitaxel.
• Cetuximab (used to treat cancers), as co-administration of PAZOPANIB 200 CIPLA may increase the effects of cetuximab.
• Irinotecan (used to treat cancers), as co-administration of PAZOPANIB 200 CIPLA may increase the effects of irinotecan.
• Rifampin (used to treat infections), as the effects of PAZOPANIB 200 CIPLA may be decreased.
• Esomeprazole (used to treat stomach acid), as the effects of PAZOPANIB 200 CIPLA may be decreased.
• Simvastatin or any other ‘statin’ (used to treat high cholesterol levels), as co-administration of PAZOPANIB 200 CIPLA may cause an increase in a certain liver enzyme, which could result in liver failure).
• Midazolam (used to treat anxiety), as co-administration of PAZOPANIB 200 CIPLA may increase the effects of midazolam.
• Dextromethorphan (used to temporarily relieve cough), as co-administration of PAZOPANIB 200 CIPLA may increase the effects of dextromethorphan.

Do not share medicines prescribed for you with any other person. Always take PAZOPANIB 200 CIPLA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. PAZOPANIB 200 CIPLA should be taken orally without food (at least one hour before or two hours after a meal). The usual dose is 800 mg (4 tablets of 200 mg tablet) orally once daily. Your doctor will tell you how long your treatment with PAZOPANIB 200 CIPLA will last. Do not stop treatment early. If you have the impression that the effect of PAZOPANIB 200 CIPLA is too strong or too weak, tell your doctor or pharmacist.

If you take more PAZOPANIB 200 CIPLA than you should

An overdose of PAZOPANIB 200 CIPLA may result in fatigue and hypertension. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take PAZOPANIB 200 CIPLA

Do not take a double dose to make up for forgotten individual doses. If you miss a dose, take it as soon as you remember. Do not take it if it is close (within 12 hours) to your next dose.

PAZOPANIB 200 CIPLA can have side effects. Not all side effects reported for PAZOPANIB 200 CIPLA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PAZOPANIB 200 CIPLA, please consult your health care provider for advice. If any of the following happens, stop taking PAZOPANIB 200 CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to PAZOPANIB 200 CIPLA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain
• Angina - you may experience chest pain, discomfort or a burning sensation
• Changes in the way your heart beats, for example, if you notice it beating faster
• Difficulty breathing.

It is also worth noting that the use of PAZOPANIB 200 CIPLA may increase the risk of the following fatal events:

• Bleeding anywhere in the digestive tract (from the mouth to the rectum),
• Bleeding from the lung,
• Coughing up blood,
• Abnormal liver function,
• Breakage in the intestine which leads to spillage of intestinal contents outside the digestive tract and in the body causing infection,
• Ischaemic stroke (type of stroke caused by a blockage in an artery that supplies blood to the brain).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Infections, you may experience fever, chills, fatigue
• Low levels of blood platelet - you may experience difficulty stopping bleeding
• The thyroid gland does not produce enough thyroid hormone, resulting in fatigue, lethargy, cold sensitivity, constipation, dry skin and unexplained weight gain
• Decreased desire to eat food
• Decrease in body weight
• Low levels of phosphate in the blood, a blood test will be needed to determine this but you may experience muscle or bone pain, weakness, confusion or irritability
• Lack of body water resulting in dehydration
• Not able to sleep efficiently
• Headache, dizziness, lethargy, distortion of the sense of taste
• Tingling or prickling, “pins-and-needles” sensation; usually temporary, often occurs in the arms, hands, legs or feet
• Weakness, numbness and pain from nerve damage, usually in the hands and feet
• Blurred vision
• Increased blood pressure
• Hot flushes
• 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
• Coughing up blood
• Chest pain
• Bleeding from the nose
• Difficulty breathing
• Hoarseness of voice
• Presence of blood in the urine

Store all medicines out of reach of children. Store at or below 25 ºC. Store in the original container. Do not use after the expiry date stated on the label and carton. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).