SUTENT 25 mg hard capsules

SUTENT is a medicine used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.

SUTENT will only be prescribed to you by a doctor with experienced in the use of anti-cancer medicinal products.

Gastrointestinal stromal tumour (GIST)

SUTENT is indicated for the treatment of unresectable and/or metastatic malignantgastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. GIST is a cancer of the stomach and bowels, originating from uncontrolled cell growth of the supporting tissues of these organs. SUTENT inhibits the growth of these cells.

Metastatic renal cell carcinoma (MRCC)

SUTENT is indicated for the treatment of advanced /metastatic renal cell carcinoma (MRCC) in adults. MRCC is a form of kidney cancer that involves cancerous changes in the cells of the renal tubule.

Pancreatic neuroendocrine tumours (pNET)

SUTENT is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. pNET is a rare cancer originating in the hormone-secreting cells of the pancreas.
Experience with SUTENT as first-line treatment is limited.

If you have any questions about how SUTENT works or why this medicine has been prescribed for you, ask your doctor.

Follow all your doctor?s instructions carefully, even if they differ from the general information contained in this leaflet.

Do not take SUTENT

• If you are allergic to sunitinib or any of the other ingredients of SUTENT.

Before you take SUTENT or while you are being treated with SUTENT:

You may be advised to have a dental check-up before you start treatment with SUTENT.

• if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately.
• if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with SUTENT in particular when you are also receiving or have received i.v. bisphosphonates.

Take special care with SUTENT

• If you have or have had liver or kidney problems.
• If you have high blood pressure.
• If you have an under-active thyroid gland before starting treatment with SUTENT, or if your thyroid gland becomes less active during treatment.
• If you have an abnormality of your heart trace known as Prolonged QT interval.
• If you are pregnant or think you may be (see below).
• If you are breast-feeding (see below).
• If you are going to have surgery or if you had an operation recently. SUTENT may affect the way your wounds heal. You will usually be taken off SUTENT if you are having an operation. Your doctor will decide when to start SUTENT again. If any of those apply to you, tell your doctor before you take SUTENT.

Tell your doctor if you develop any of the following signs and symptoms of liver problems during SUTENT treatment: itching, -yellow eyes or skin, dark urine, and -pain or discomfort in the right upper stomach area.
Your doctor should do blood tests to check your liver function before and during treatment with Sutent, and as clinically indicated.

Before taking SUTENT

Tell your doctor if you need to undergo surgery.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription even those not prescribed.

Some medicines can affect the levels of SUTENT in your body. You should inform your doctor if you are taking medicines containing the following active substances:
ketoconazole, itraconazole ? used to treat fungal infections
erythromycin, clarithromycin, rifampicin ? medicines used to treat infections ritonavir ? medicines used to treat HIV
dexamethasone ? a corticosteroid used for various conditions
phenytoin, carbamazepine phenobarbital ? treatments for epilepsy and other conditions herbal preparations containing St. John?s Wort (Hypericum perforatum) ? used to treat depression and anxiety

Taking SUTENT with food and drink

SUTENT can be taken with or without food; however, you should avoid drinking grapefruit juice while on treatment with SUTENT.

Pregnancy and breast-feeding

If you are pregnant or think you may be, tell your doctor.
SUTENT is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risk of taking SUTENT during pregnancy.
If you might get pregnant, you should use effective contraception during treatment with SUTENT.

If you are breast-feeding, tell your doctor. Do not breast-feed during treatment with SUTENT.

Driving and using machines
If you experience dizziness or you feel unusually tired, take special care when driving or using machines.

Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated. If you are being treated for GIST or renal cancer, the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), given as a 6-weeks cycle. If you are being treated for pNET, the usual dose is 37.5 mg once daily without a rest period. Your doctor will determine how many cycles of treatment you will need as well as the appropriate dose you need to take.
Always take SUTENT exactly as your doctor has told you. You should check with your doctor if you are not sure.

If you take more SUTENT than you should

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention.

If you forget to take SUTENT

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

Like all medicines, SUTENT can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

Very common side effects

• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, burning or painful sensation in the tongue, upset stomach, nausea, vomiting, diarrhoea, inflammation of the digestive tract lining, excessive gas in the stomach or intestine, constipation, abdominal pain, loss/decrease of appetite, loss of strength, weight loss.
• Yellow skin/skin discoloration, hair colour change, hair loss, rash on the palms of the hands and soles of the feet, blisters, rash, dryness of the skin.
• Nose bleeding.
• Extreme tiredness.
• High blood pressure, migraine.
• Reduced/abnormal ability of the heart to pump blood.
• Headache.
• Reduction in the number of platelets, red blood cells and/or neutrophils (type of white blood cells.
• Reduction in the number of white blood cells.
• Decreased activity of the thyroid gland (hypothyroidism).
• Pain in arms and legs.

Common side effects

• Chills, fever, influenza-like syndrome.
• Cough, nasal dryness, congested nose.
• Difficulty in speaking.
• Abnormally coloured urine.
• Haemorrhoids, pain in the rectum, rectal bleeding, gingival bleeding, difficulty in swallowing or inability to swallow, acid heartburn.
• Excessive tear flow.
• Back pain, joint pain, muscle pain.
• Chest pain.
• Abnormal sensations in extremities.
• Swelling of the limbs or around the eyes.
• Abnormal sensation of the skin, dry skin, itching, flaking and inflammation of the skin, blisters, acne, excess pigmentation of the skin.
• Hot flushes.
• Nail discolouration.
• Abnormally decreased/increased sensitivity, particularly to touch.
• Shortness of breath.
• Depression.
• Difficulty in falling asleep.
• Abnormal blood tests including pancreatic and liver enzymes.

Uncommon side effects

• Pain in the stomach (abdomen) caused by inflammation of the pancreas.
• Heart failure.
• Liver failure.

Rareside effect

• Tumour destruction leading to hole in the intestine (perforation).
• Changes in the electrical activity or abnormal rhythm of the heart.

Non Known

• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
• Infections.
• Blood clots in the blood vessels.
• Loss of protein in the urine sometime resulting in swelling.
• Fluid retention including around the lungs.
• Inappropriate and excessive reaction to an allergen.
• Rapid tissue swelling characterized by large circumscribed areas of fluid under the skin.
• Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.
• Abnormal tube like passage from one normal body cavity to another body cavity or the skin.
• Inflammation of the liver (hepatitis).
• Severe disorder of heart muscle that may be associated with an increased risk of death (cardiomyopathy).
• Fluid around the heart (pericardial effusion).
• Kidney failure.
• Problems with wound healing after surgery.
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis). Tell you doctor and dentist immediately if you experience any of them.

If any of the side effect gets serious or if you notice any side effect not listed in this leaflet, please tell your doctor.

• Keep out of reach and sight of children.
• Do not use after the expiry date (EXP) which is stated on the outer pack and label.
• This medicine does not require any special storage conditions.
• Do not use any pack that 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 to protect the environment.

What SUTENT contains

SUTENT 12.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg. The other ingredients are:

• Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25) and magnesiumstearate.
• Capsule shell: gelatin, red iron oxide (E172) and titanium dioxide (E171).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).

SUTENT 25 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg.The other ingredients are:

• Capsule content: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172),black iron oxide (E172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).

SUTENT 37.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 37.5 mg.The other ingredients are:

• Capsule content: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
• Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

SUTENT 50 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg. The other ingredients are:

• Capsule content: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).

What SUTENT looks like and contents of the pack

SUTENT 12.5 mg is supplied as hard gelatin capsules with orange cap and orange body, printed with white ink ?Pfizer? on the cap, ?STN 12.5 mg? on the body, containing yellow to orange granules.

SUTENT 25 mg is supplied as hard gelatin capsules with caramel cap and orange body, printed with white ink ?Pfizer? on the cap, ?STN 25 mg? on the body, containing yellow to orange granules.

SUTENT 37.5 mg is supplied as hard gelatin capsules with yellow cap and yellow body, printed with black ink ?Pfizer? on the cap, ?STN 37.5 mg? on the body, containing yellow to orange granules.

SUTENT 50 mg is supplied as hard gelatin capsules with caramel cap and caramel body, printed with white ink ?Pfizer? on the cap, ?STN 50 mg? on the body, containing yellow to orange granules.

It is available in plastic bottles of 30 capsules and in blister packs of 28 capsules (4x7). Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Limited
Ramsgate Road
Sandwich, Kent CT13 9NJ
United Kingdom

Manufacturer

Pfizer Italia S.r.l.
Via del Commercio ? Zona Industriale
63100 Marino del Tronto (Ascoli Piceno)
Italy

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

Belgique België Belgien Pfizer S.A. N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. TélTel 32 02 554 62 11

, . 359 2 970 4333 Magyarország Pfizer Kft. Tel. 36-1-488-37-00

eská republika Pfizer s.r.o. Tel. 420-283-004-111 Malta V.J. Salomone Pharma Ltd. Tel. 356 21220174

Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer BV Tel 31 010 406 43 01

Deutschland Pfizer Pharma GmbH Tel 49 030 550055 51000 Norge Pfizer AS Tlf 47 67 52 61 00

Eesti Pfizer Luxembourg SARL Eesti filiaal Tel. 372 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. 30 210 6785 800 Polska Pfizer Polska Sp.z.o.o Tel.48 22 335 61 00

España Pfizer S.A. Tél 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 5500

France Pfizer Tél 33 01 58 07 34 40 România Pfizer Romania S.R.L. Tel 40 0 21 207 28 00

Ireland Pfizer Healthcare Ireland Tel 1800 633 363 toll free 44 01304 616161 Slovenija Pfizer Luxembourg SARL Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel. 386 01 52 11 400

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel. 421 2 3355 5500

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy Puh.Tel 358 09 43 00 40

K Geo. Pavlides Araouzos Ltd. T. 357 22 818087 Sverige Pfizer AB Tel 46 08 550-52000

Latvija Pfizer Luxembourg SARL filile Latvij Tel. 371 670 35 775 United Kingdom Pfizer Limited Tel 44 0 1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje
Tel. + 370 52 51 4000

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