Sunitinib Pharmascience

Package Leaflet: Information for the User

Sunitinib Pharmascience,12.5 mg, hard capsules
Sunitinib Pharmascience,25 mg, hard capsules
Sunitinib Pharmascience,37.5 mg, hard capsules
Sunitinib Pharmascience,50 mg, hard capsules
Sunitinibum

Read all of this leaflet carefully before 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 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.

Contents of the pack and other information

• 1. What Sunitinib Pharmascience is and what it is used for
• 2. Before you take Sunitinib Pharmascience
• 3. How to take Sunitinib Pharmascience
• 4. Possible side effects
• 5. How to store Sunitinib Pharmascience
• 6. Contents of the pack and other information

1. What Sunitinib Pharmascience is and what it is used for

Sunitinib Pharmascience contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer. It works by inhibiting the activity of specific proteins involved in the growth and spread of cancer cells.
Sunitinib Pharmascience is used to treat the following types of cancer in adults:

• gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and intestines, when imatinib (another anti-cancer medicine) has stopped working or the patient cannot take it;
• metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• pancreatic neuroendocrine tumours (pNET), tumours that arise from hormone-producing cells in the pancreas, which are in an advanced stage and cannot be removed by surgery.

If you have any questions about how Sunitinib Pharmascience works or why it has been prescribed for you, ask your doctor.

2. Before you take Sunitinib Pharmascience

When you should not take Sunitinib Pharmascience

• If you are allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Sunitinib Pharmascience, tell your doctor:

• If you have high blood pressure. Sunitinib Pharmascience may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Pharmascience and may treat you with medicines that lower blood pressure if necessary.
• If you have or have had bleeding or blood disorders. Treatment with Sunitinib Pharmascience may increase the risk of bleeding or changes in the number of certain blood cells, which can cause anaemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, the risk of bleeding may increase. Tell your doctor about any bleeding during treatment with Sunitinib Pharmascience.
• If you have heart problems. Sunitinib Pharmascience may cause heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling of your feet or ankles.
• If you have heart rhythm problems. Sunitinib Pharmascience may cause abnormal heart rhythms. During treatment with Sunitinib Pharmascience, your doctor may perform an electrocardiogram to check for these problems. Tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms while taking Sunitinib Pharmascience.
• If you have recently had blood clots in your veins or arteries, including stroke, heart attack, embolism, or thrombosis. Tell your doctor immediately if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness.
• If you have or have had an aortic aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have or have had microangiopathic haemolytic anaemia (a condition where small blood vessels are damaged). Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems. Sunitinib Pharmascience may cause thyroid problems. Tell your doctor if you feel very tired, feel cold, or have a hoarse voice while taking Sunitinib Pharmascience. Your doctor should check your thyroid function before starting treatment with Sunitinib Pharmascience and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take replacement thyroid hormone.
• If you have or have had pancreas or gallbladder problems. Tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If you have or have had liver problems. Tell your doctor if you experience any of the following symptoms of liver problems: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check your liver function before starting treatment with Sunitinib Pharmascience, during treatment, and if you experience any symptoms.
• If you have or have had kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery. Sunitinib Pharmascience may affect wound healing. This medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitinib Pharmascience.
• Dental examination before starting Sunitinib Pharmascience treatment is recommended:
  • If you experience pain in your mouth, tooth, or jaw, swelling, or ulcers in your mouth, numbness or heaviness in your jaw, or tooth mobility, tell your doctor and dentist immediately.
  • If you need to have invasive dental procedures or dental surgery, tell your dentist that you are taking Sunitinib Pharmascience, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems and may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, you may experience pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and soft tissues that can be life-threatening). Tell your doctor immediately if you experience symptoms of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after stopping treatment with Sunitinib Pharmascience. During treatment with this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches with a target-like shape or round patches, often with centrally located blisters. The rash may progress to widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned skin symptoms, tell your doctor immediately.
• If you have or have had seizures. Tell your doctor as soon as possible if you experience high blood pressure, headache, or loss of vision.
• If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you experience symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, or loss of consciousness).

Children and adolescents

Sunitinib Pharmascience is not recommended for patients under 18 years of age.

Sunitinib Pharmascience and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription and those you plan to take.
Some medicines may affect the levels of Sunitinib Pharmascience in your body. Tell your doctor if you are taking medicines containing the following active substances:

• ketokonazole, itraconazole - used to treat fungal infections
• erythromycin, clarithromycin, rifampicin - used to treat infections
• ritonavir - used to treat HIV infections
• dexamethasone - a corticosteroid used in various diseases (such as allergic disorders and/or respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions
• herbal products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Taking Sunitinib Pharmascience with food and drink

Do not drink grapefruit juice while taking Sunitinib Pharmascience.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitinib Pharmascience.
Women who are breastfeeding should tell their doctor. Do not breastfeed while taking Sunitinib Pharmascience.

Driving and using machines

If you experience dizziness or feel very tired, be careful when driving or using machines.

Sunitinib Pharmascience contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, which is essentially 'sodium-free'.

3. How to take Sunitinib Pharmascience

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will prescribe the dose that is right for you, depending on the type of cancer you have. If you are being treated for GIST or MRCC, the usual dose is 50 mg taken once a day for 28 days (4 weeks), followed by a 14-day (2-week) break (without the medicine), in 6-week cycles of treatment.
If you are being treated for pNET, the usual dose is 37.5 mg taken once a day continuously.
Your doctor will determine the right dose for you and when to stop taking Sunitinib Pharmascience.
Sunitinib Pharmascience can be taken with or without food.

If you take more Sunitinib Pharmascience than you should

If you accidentally take more capsules than you should, tell your doctor immediately. You may need urgent medical attention.

If you forget to take Sunitinib Pharmascience

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects (see also 'Before you take Sunitinib Pharmascience'):
Heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling of your feet and ankles. These may be symptoms of heart problems, including heart failure and heart muscle problems (cardiomyopathy).
Lung problems or breathing difficulties. Tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney problems. Tell your doctor if you experience changes in urination or lack of urination, which may be symptoms of kidney failure.
Bleeding. Tell your doctor if you experience any of the following symptoms or heavy bleeding during treatment with Sunitinib Pharmascience: stomach pain or swelling; vomiting blood; black or tarry stools; blood in urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumour rupture leading to perforation of the intestine. Tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.
Other side effects of Sunitinib Pharmascience may include:

• Very common: may affect more than 1 in 10 people
• decreased number of platelets, red blood cells, and/or white blood cells (e.g. neutrophils)
• shortness of breath
• high blood pressure
• extreme tiredness, weakness
• swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep
• mouth pain or irritation, painful mouth ulcers, and/or inflammation, and/or dryness of the mouth, taste disturbances, stomach upset, nausea, vomiting, diarrhoea, constipation, stomach pain or swelling, loss of or decreased appetite
• decreased thyroid activity (hypothyroidism)
• dizziness
• headache
• nosebleeds
• back pain, joint pain
• arm and leg pain
• discoloration of the skin and/or pigmentation, excessive skin pigmentation, hair colour changes, palmar-plantar erythrodysesthesia syndrome (redness, swelling, and sometimes peeling of the skin on the palms of the hands and soles of the feet), rash, dry skin
• cough
• fever
• difficulty sleeping

Common: may affect up to 1 in 10 people

• blood clots in blood vessels
• insufficient blood supply to the heart due to a blockage or narrowing of the coronary arteries
• chest pain
• decreased amount of blood pumped by the heart
• fluid accumulation, including in the lungs
• infections
• complication after severe infection (sepsis), which can lead to tissue damage, organ failure, and death
• decreased blood sugar levels (see section 2)
• protein loss in urine, sometimes causing swelling
• flu-like syndrome
• abnormal blood test results, including pancreatic and liver enzymes
• high levels of uric acid in the blood
• haemorrhoids, anal pain, gum bleeding, difficulty swallowing, or loss of swallowing ability
• burning or painful sensation of the tongue, inflammation of the mucous membranes, excessive gas in the stomach or intestines
• weight loss
• musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle spasms
• dryness of the nasal mucosa, feeling of nasal congestion
• excessive tearing
• skin sensitivity disorders, itching, skin peeling, and/or inflammation, blisters, acne, skin discoloration, nail disorders, hair loss
• skin sensation disorders
• sensitivity disorders, especially to touch
• heartburn
• dehydration
• hot flushes
• abnormal urine colour
• depression
• chills

Uncommon: may affect up to 1 in 100 people

• life-threatening infection of soft tissues, including the perineal area (see section 2)
• stroke
• heart attack due to interruption or reduction of blood flow to the heart
• changes in heart rhythm or conduction
• fluid accumulation around the heart (pericardial effusion)
• liver failure
• stomach pain due to pancreatitis
• tumour rupture leading to perforation of the intestine
• inflammation of the gallbladder (with or without gallstones)
• formation of abnormal connections between one body cavity and another or with the skin
• mouth pain, tooth pain, and/or jaw pain, swelling, or ulcers in the mouth, numbness or heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2
• excessive production of thyroid hormones leading to increased resting metabolism
• impaired wound healing after surgery
• increased activity of a muscle enzyme (creatine phosphokinase) in the blood
• excessive allergic reaction, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing
• inflammation of the large intestine (colitis, ischaemic colitis)

Rare: may affect up to 1 in 1000 people

• severe skin reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• tumour lysis syndrome, a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, and fatigue, which are related to abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to kidney damage and acute kidney failure
• abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis)
• abnormal changes in the brain, which can cause a syndrome of symptoms including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome)
• painful skin ulcers (pyoderma gangrenosum)
• liver inflammation
• thyroid gland inflammation
• damage to the smallest blood vessels (microangiopathic haemolytic anaemia)

Frequency not known (frequency cannot be estimated from the available data)

• expansion or 'bulging' of the aorta or tear in the aortic wall (aortic aneurysm or aortic dissection)

Reporting of side effects

If you experience 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 to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Pharmascience

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of that month.
• There are no special storage requirements for this medicine.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Pharmascience contains

Sunitinib Pharmascience,12.5 mg, hard capsules
The active substance is sunitinib. Each capsule contains sunitinib hydrochloride equivalent to 12.5 mg of sunitinib. The other ingredients are:
Capsule content: mannitol, croscarmellose sodium, povidone (K25), and magnesium stearate.
Capsule shell: gelatin, iron oxide red (E 172), and titanium dioxide (E 171).
Black ink: shellac, propylene glycol, iron oxide black (E 172), concentrated ammonia solution, and potassium hydroxide.
Sunitinib Pharmascience,25 mg, hard capsules
The active substance is sunitinib. Each capsule contains sunitinib hydrochloride equivalent to 25 mg of sunitinib. The other ingredients are:
Capsule content: mannitol, croscarmellose sodium, povidone (K25), and magnesium stearate.
Capsule shell: gelatin, iron oxide red (E 172), titanium dioxide (E 171), and iron oxide yellow (E 172).
Black ink: shellac, propylene glycol, iron oxide black (E 172), concentrated ammonia solution, and potassium hydroxide.
Sunitinib Pharmascience,37.5 mg, hard capsules
The active substance is sunitinib. Each capsule contains sunitinib hydrochloride equivalent to 37.5 mg of sunitinib. The other ingredients are:
Capsule content: mannitol, croscarmellose sodium, povidone (K25), and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171), and iron oxide yellow (E 172).
Black ink: shellac, propylene glycol (E1520), iron oxide black (E 172), concentrated ammonia solution, and potassium hydroxide.
Sunitinib Pharmascience,50 mg, hard capsules
The active substance is sunitinib. Each capsule contains sunitinib hydrochloride equivalent to 50 mg of sunitinib. The other ingredients are:
Capsule content: mannitol, croscarmellose sodium, povidone (K25), and magnesium stearate.
Capsule shell: gelatin, iron oxide red (E 172), titanium dioxide (E 171), and iron oxide yellow (E 172).
Black ink: shellac, propylene glycol, iron oxide black (E 172), concentrated ammonia solution, and potassium hydroxide.

What Sunitinib Pharmascience looks like and contents of the pack

Sunitinib Pharmascience, 12.5 mg is available as hard gelatin capsules, size 4, with an orange cap and body, with a radial black imprint "SUN 12.5 mg" on the body, which contain orange powder.
Sunitinib Pharmascience, 25 mg is available as hard gelatin capsules, size 3, with an orange cap and orange body, with a radial black imprint "SUN 25 mg" on the body, which contain orange powder.
Sunitinib Pharmascience, 37.5 mg is available as hard gelatin capsules, size 3, with a cap and body of ivory colour, with a radial black imprint "SUN 37.5 mg" on the body, which contain orange powder.
Sunitinib Pharmascience, 50 mg is available as hard gelatin capsules, size 2, with an orange cap and body, with a radial black imprint "SUN 50 mg" on the body, which contain orange powder.
Sunitinib Pharmascience is available in cardboard boxes containing 28 capsules packed in PVC/PVAC (PVC/PCTFE)/Aluminium blisters.
Sunitinib Pharmascience, 50 mg is also available in cardboard boxes containing 28 capsules packed in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pharmascience International Limited.
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

• S. Martinho do Bispo 3045-016 Coimbra Portugal

This medicinal product is authorised in the Member States of the EEA under the following names:

Portugal
Sunitinib Bluepharma
Cyprus
Sunitinib Pharmascience 12.5 mg καψάκια σκληρά
Sunitinib Pharmascience 25 mg καψάκια σκληρά
Sunitinib Pharmascience 37.5 mg καψάκια σκληρά
Sunitinib Pharmascience 50 mg καψάκια σκληρά
Bulgaria
Сунитиниб Фармасайънс 12.5 mg твърди капсули
Сунитиниб Фармасайънс 25 mg твърди капсули
Сунитиниб Фармасайънс 37.5 mg твърди капсули
Сунитиниб Фармасайънс 50 mg твърди капсули
Croatia
Sunitinib Pharmascience 12.5 mg tvrde kapsule
Sunitinib Pharmascience 25 mg tvrde kapsule
Sunitinib Pharmascience 37.5 mg tvrde kapsule
Sunitinib Pharmascience 50 mg tvrde kapsule
Hungary
Sunitinib Pharmascience 12.5 mg kemény kapszula
Sunitinib Pharmascience 25 mg kemény kapszula
Sunitinib Pharmascience 37.5 mg kemény kapszula
Sunitinib Pharmascience 50 mg kemény kapszula
Poland
Sunitinib Pharmascience
Slovenia
Sunitinib Pharmascience 12.5 mg trde kapsule
Sunitinib Pharmascience 25 mg trde kapsule
Sunitinib Pharmascience 37.5 mg trde kapsule
Sunitinib Pharmascience 50 mg trde kapsule

Date of last revision of the leaflet: