Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sutent

Document Subject

Generated Narrative: MedicinalProductDefinition mpa3cd214d19f3341c3aa081ac17f909d1

identifier: http://ema.europa.eu/identifier/EU/1/06/347/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Sutent 12.5 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a3cd214d19f3341c3aa081ac17f909d1

identifier: http://ema.europa.eu/identifier/EU/1/06/347/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - sutent

Attesters

What is in this leaflet

1. What Sutent is and what it is used for
2. What you need to know before you take Sutent
3. How to take Sutent
4. Possible side effects
5. How to store Sutent
6. Contents of the pack and other information

Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is 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 is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.

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

Do not take Sutent

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

Warnings and precautions

Talk to your doctor before taking Sutent:

If you have high blood pressure. Sutent can raise blood pressure. Your doctor may check your blood pressure during treatment with Sutent, and you may be treated with medicines to reduce the blood pressure, if needed.

• If you have or have had blood disease, bleeding problems, or bruising. Treatment with Sutent may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot. If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding. Tell your doctor if you have any bleeding while on treatment with Sutent.

• If you have heart problems. Sutent can cause heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.

• If you have abnormal heart rhythm changes. Sutent can cause abnormality of your heart rhythm. Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Sutent. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking Sutent.

• If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sutent.

• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.

• If you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA). Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.

• If you have thyroid glands problems. Sutent can cause thyroid gland problems. Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking Sutent. Your thyroid function should be checked before you take Sutent and regularly while you are taking it. If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.

• If you have or have had pancreatic or gallbladder disorders. Tell your doctor if you develop any of the following signs and symptoms: pain in the area of the stomach (upper abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.

• If you have or have had liver problems. 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.

• If you have or have had kidney problems. Your doctor will monitor your kidney function.

• 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.

• 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 intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.

• If you have or have had skin and subcutaneous tissue disorders. While you are on this medicine "pyoderma gangrenosum" (painful skin ulceration) or necrotising fasciitis (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur. Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood. This event is generally reversible after sunitinib discontinuation. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. The rash may progress to widespread blistering or peeling of the skin and may be life-threatening. If you develop a rash or these skin symptoms, seek immediate advice from a doctor.

• If you have or have had seizures. Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.

• If you have diabetes. Blood sugar levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine s dosage needs to be adjusted to minimise the risk of low blood sugar. Notify your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).

Children and adolescents

Sutent is not recommended for people aged under 18. Other medicines and Sutent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and 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 used to treat infections
• ritonavir used to treat HIV
• dexamethasone a corticosteroid used for various conditions (such as allergic/breathing disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital used to treat epilepsy and other neurological conditions
• herbal preparations containing St. John s Wort (Hypericum perforatum) used to treat depression and anxiety

Sutent with food and drink

You should avoid drinking grapefruit juice while on treatment with Sutent.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you might get pregnant, you should use a reliable method of contraception during treatment with Sutent.

If you are breast-feeding, tell your doctor. You should 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.

Sutent contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per capsule, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

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 MRCC: the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles.
pNET: the usual dose is 37.5 mg once daily without a rest period.

Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sutent.

Sutent can be taken with or without food.

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, this medicine can cause side effects, although not everybody gets them.

You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sutent):

Heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles. These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
Lung or breathing problems. Tell your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.

Kidney disorders. Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.

Bleeding. Tell your doctor if you have any of these symptoms or a serious bleeding problem during treatment with Sutent: painful, swollen stomach (abdomen); vomiting blood; black, sticky stools; bloody urine; headache or change in your mental status; coughing up of blood or bloody sputum from the lungs or airway.

Tumour destruction leading to hole in the intestine. Tell your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.

Other side effects with Sutent may include:

Very common: may affect more than 1 in 10 people

Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).

Shortness of breath.

High blood pressure.

Extreme tiredness, loss of strength.

Swelling caused by fluid under the skin and around the eye, deep allergic rash.

Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.

Decreased activity of thyroid gland (hypothyroidism).

Dizziness.

Headache.

Nose bleeding.

Back pain, joint pain.

Pain in arms and legs.

Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash on the palms of the hands and soles of the feet, rash, dryness of the skin.

Cough.

Fever.

Difficulty in falling asleep.

Common: may affect up to 1 in 10 people

Blood clots in the blood vessels.

Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries.

Chest pain.

Decreased in the amount of blood pumped by the heart.

Fluid retention including around the lungs.

Infections.

Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.

Decreased blood sugar level (see section 2)..

Loss of protein in the urine sometime resulting in swelling.

Influenza-like syndrome.

Abnormal blood tests including pancreatic and liver enzymes.

High level of uric acid in the blood.

Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.

Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.

Weight loss.

Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.

Nasal dryness, congested nose.

Excessive tear flow.

Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss.

Abnormal sensations in extremities.

Abnormally decreased/increased sensitivity, particularly to touch.

Acid heartburn.

Dehydration.

Hot flushes.

Abnormally coloured urine.

Depression.

Chills.

Uncommon: may affect up to 1 in 100 people

Life-threatening infection of the soft tissue including the ano-genital region (see section 2).

Stroke.

Heart attack caused by an interrupted or decreased blood supply to the heart.

Changes in the electrical activity or abnormal rhythm of the heart.

Fluid around the heart (pericardial effusion).

Liver failure.

Pain in the stomach (abdomen) caused by inflammation of the pancreas.

Tumour destruction leading to hole in the intestine (perforation).

Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.

Abnormal tube like passage from one normal body cavity to another body cavity or the skin.

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), see section 2.
Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.

Problems with wound healing after surgery.

Increased blood level of enzyme (creatine phosphokinase) from muscle.

Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.

Inflammation of the colon (colitis, colitis ischaemic).

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

Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Tumour lysis syndrome (TLS) TLS consists of a group of metabolic complications that can occur during treatment of cancer. These complications are caused by the break-down products of dying cancer cells and may include the following: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure.

Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).

Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).

Painful skin ulceration (pyoderma gangrenosum).

Inflammation of the liver (hepatitis).

Inflammation of the thyroid gland.

Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA). Not known (frequency cannot be estimated from available data):

An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections). Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 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 this medicine after the expiry date which is stated on carton, bottle and blister foil after EXP . The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help 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 sunitinib. The other ingredients are:

• Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.

• 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 perforated unit dose blisters containing 28 x 1 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium

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:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. + 370 52 51 4
,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: +36-1-488-37- esk republika Pfizer spol. s.r.o.
Tel.: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer BV Tel: +31 (0)10 406 43 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal
Tel.: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785 Polska Pfizer Polska Sp. z o.o. Tel.:+48 22 335 61 Espa a Pfizer, S.L.
Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer
T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka
Tel.: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh./Tel: +358 (0)9 43 00 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige
Pfizer AB Tel: +46 (0)8 550 520 K
Pfizer A.E. (Cyprus Branch)
T .:+ 357 22 817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel.: + 371 670 35 This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.