SUNITINIB 12.5 mg Kapsułka twarda

Treść ulotki

1. Sunitinib Accord 12.5 mg hard capsules, 25 mg hard capsules, 37.5 mg hard capsules, 50 mg hard capsules
   1. What is Sunitinib Accord and what is it used for
   2. What you need to know before taking Sunitinib Accord
2. Sunitinib Accord may involve an increased risk of bleeding, changes in
   1. How to take Sunitinib Accord
   2. Possible side effects
   3. How to store Sunitinib Accord
   4. Package Contents and Other Information

Sunitinib Accord 12.5 mg hard capsules, 25 mg hard capsules, 37.5 mg hard capsules, 50 mg hard capsules

sunitinib

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Sunitinib Accord contains the active substance sunitinib, which is a protein kinase inhibitor. It is
used to treat cancer by preventing the activity of a specific group of
proteins that are known to be involved in the growth and spread of cancer cells.
Sunitinib Accord is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestinal cancer, in cases where imatinib (another anticancer medicine) is no longer effective or can no longer be taken.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumors (pNET) (tumors of the pancreatic cells that produce hormones) with disease progression or are inoperable.

If you have any doubts about the mechanism of action of Sunitinib Accord or why this
medicine has been prescribed to you, please ask your doctor.

2. What you need to know before taking Sunitinib Accord

Do not take Sunitinib Accord

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

Talk to your doctor or pharmacist before taking Sunitinib Accord:

• If you have high blood pressure.Sunitinib Accord may cause an increase in blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Accord and, if necessary, you may need to take medicines to lower your blood pressure.
• If you have or have had blood disorders, bleeding problems or bruising.Treatment with

Sunitinib Accord may involve an increased risk of bleeding, changes in

the number of certain blood cells whose deficiency determines anemia or affects the blood's ability to coagulate. The risk of bleeding may be greater if you are taking warfarin or acenocoumarol, medications that thin the blood to prevent the formation of blood clots. Tell your doctor if you experience any bleeding while taking Sunitinib Accord.

• If you have heart problems.Sunitinib Accord can cause heart problems. Tell your doctor if you feel very tired, have shortness of breath, or have swelling in your feet and ankles.
• If you experience abnormal changes in heart rate.Sunitinib Accord can cause changes in heart rhythm. During treatment with Sunitinib Accord, your doctor may perform an electrocardiogram to assess the extent of these changes. Tell your doctor if, during treatment with Sunitinib Accord, you feel dizzy, faint, or have irregular heartbeats.
• If you have recently had problems due to the formation of blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism or thrombosis.Contact your doctor immediately if you experience symptoms such as chest tightness or pain, arm pain, back pain, neck pain or jaw/jaw pain, shortness of breath, numbness or weakness on one side of the body, unsteady walking, headache or dizziness during treatment with Sunitinib Accord.
• If you have or have had an aneurysm(dilation 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 damage to the smaller blood vessels called thrombotic microangiopathy (TMA).Tell your doctor if you notice the appearance of fever, fatigue, tiredness, bruising, bleeding, swelling, mental confusion, vision loss, and seizures.
• If you have thyroid problems.Sunitinib Accord can cause thyroid problems. Tell your doctor if you become more tired than usual while taking Sunitinib Accord, generally feel colder than other people, or your voice becomes lower. Thyroid function should be checked before taking Sunitinib Accord and regularly while you are taking the medication. If your thyroid does not produce enough thyroid hormone, you may need to take a thyroid hormone replacement.
• If you have or have had problems with the pancreas or gallbladder.Tell your doctor if you experience any of the following signs and symptoms: stomach pain (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 experience any of the following signs and symptoms of liver problems during treatment with Sunitinib Accord: itching, yellowing of the skin or eyes, dark urine, and pain or discomfort in the upper right area of the stomach. Your doctor should perform blood tests to check liver function before and during treatment with Sunitinib Accord, and as clinically appropriate.
• If you have or have had kidney problems.Your doctor will monitor kidney function.
• If you are about to undergo surgery or if you have had surgery recently.Sunitinib Accord can affect how wounds heal. Usually, if you are about to have surgery, you will need to stop treatment with Sunitinib Accord. Your doctor will decide when to start treatment with Sunitinib Accord again.
• It is advisable to have a dental check-up before starting treatment with Sunitinib Accord
• If you have or have had pain in the mouth, teeth and/or jaw/jaw, swelling or sores in the mouth, numbness or heaviness in the jaw/jaw, or tooth loss, tell your doctor and dentist immediately.
• If you need to undergo invasive dental treatment or dental surgery, tell your doctor that you are being treated with Sunitinib Accord, especially if you are also taking bisphosphonates intravenously or have taken them in the past. Bisphosphonates are medications used to prevent bone complications that may have been prescribed for another clinical problem.
• If you have or have had skin and subcutaneous tissue diseases.During treatment with this medicine, “pyoderma gangrenosum” (painful skin ulceration) or “necrotizing fasciitis” (a skin/soft tissue infection that spreads rapidly and can be fatal) may occur. Contact your doctor immediately if you experience symptoms of infection around a skin wound, including fever, pain, redness, swelling, or drainage of pus or blood. This event is generally reversible after discontinuation of sunitinib. Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, which initially appear on the trunk as reddish spots in the shape of a target or circular patches, often with blisters in the center. The reaction may progress to widespread blistering or skin shedding, and may be fatal. If you develop a skin rash or any of these skin symptoms, see a doctor immediately.
• If you have or have had seizures.Tell your doctor as soon as possible if you have high blood pressure, headache, or vision loss.
• If you have diabetes.Blood sugar levels should be checked regularly in diabetic patients to verify whether doses of diabetes medications need to be adjusted, in order to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you notice signs and symptoms of reduced blood sugar levels (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents
Sunitinib Accord is not indicated for patients under the age of 18 years.

Other medicines and Sunitinib Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those you bought without a prescription.
Some medicines can change the levels of Sunitinib Accord in the body. You should tell your doctor if you are taking medicines that contain the following active ingredients:

• ketoconazole, itraconazole - used to treat fungal infections
• erythromycin, clarithromycin, rifampicin - used to treat infections
• ritonavir - used to treat AIDS
• dexamethasone - a corticosteroid used for various conditions (such as allergic/respiratory 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

Sunitinib Accord with food and drink
Drinking grapefruit juice should be avoided during treatment with Sunitinib Accord.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If pregnancy is possible, you should use reliable contraception during treatment with Sunitinib Accord.
If you are breastfeeding, tell your doctor. You should not breastfeed during treatment with Sunitinib Accord.

Driving and using machines
If you experience dizziness or unusual fatigue, be particularly careful when driving or using machines.

Sunitinib Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium (sodium croscarmellose) per capsule, i.e. essentially “sodium-free”.

3. How to take Sunitinib Accord

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.
The doctor will prescribe the appropriate dose for you, based on the type of cancer to be treated. If you are being
treated for:

• GIST or mRCC, the usual dose is 50 mg once a day to be taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medication), in 6-week cycles.
• pNET the usual dose is 37.5 mg once a day, without a rest period.

The doctor will determine the necessary dose for you and when to stop treatment with Sunitinib
Accord. Sunitinib Accord can be taken with or without food.

If you take more Sunitinib Accord than you should
If you have accidentally taken too many capsules, speak to your doctor immediately. Medical
intervention may be necessary.

If you forget to take Sunitinib Accord
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of these serious side effects (see also section 2 What you need to know before taking Sunitinib Accord):

Heart problems.Tell your doctor if you feel very tired, short of breath, or have swelling in your feet and
ankles. These could be symptoms of heart problems such as heart failure and
problems with the heart muscle (cardiomyopathy).

Lung or breathing problems.Tell your doctor if you experience cough, chest pain,
sudden onset of shortness of breath, or coughing up blood. These could be symptoms of a pulmonary embolism, which occurs when blood clots reach the
lungs.

Kidney problems.Tell your doctor if you experience altered frequency of urination or no
urine output, which could be symptoms of kidney failure.

Bleeding.Tell your doctor if you experience any of the following symptoms or a serious bleeding problem during treatment with Sunitinib Accord: swollen, painful stomach (abdomen);
vomiting blood; dark, sticky stools; blood in your urine; headache or altered mental state, coughing up blood or bloody sputum from the lungs
or airways.

Tumor destruction causing perforation of the intestine.Tell your doctor if you have severe
abdominal pain, fever, nausea, vomiting, blood in your stools, or changes in your bowel habits.
Other side effects that may occur with Sunitinib Accord are:
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.
• Excessive fatigue, loss of strength.
• Swelling caused by fluid retention under the skin and around the eyes, deep allergic rash.
• Mouth pain/irritation, mouth soreness/inflammation/dryness, altered taste, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/bloating, loss/decrease of appetite.
• Reduced thyroid gland activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing of the skin/change in skin color, excessive skin pigmentation, change in hair color, rash on the palms of the hands and soles of the feet, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient blood supply to the heart muscle, due to blockage or constriction of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention also around the lungs.
• Infections.
• Complications of serious infections (infection present in the bloodstream) that can cause tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Protein in the urine, sometimes leading to swelling.
• Flu-like syndrome.
• Abnormal blood tests, including liver and pancreatic enzyme levels.
• High uric acid levels in the blood.
• Hemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning or painful sensation on the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tearing.
• Altered skin sensation, itching, skin peeling and inflammation, blistering, acne, discoloration of nails, hair loss.
• Abnormal sensations in the extremities.
• Excessive reduction/increase in sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Change in urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Soft tissue infections, including in the ano-genital region, potentially life-threatening (see section 2).
• Stroke.
• Heart attack caused by an interrupted or reduced blood supply to the heart.
• Changes in the electrical activity of the heart or altered heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumor destruction causing perforation of the intestine.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• Abnormal communication between two cavities of the body or with the skin.
• Pain in the mouth, teeth and/or jaw/mandible, swelling or irritation in the mouth, numbness or heaviness in the jaw/mandible, or loss of teeth. These could be signs and symptoms of bone damage of the mandible/jaw (osteonecrosis), see section 2.
• Excessive production of thyroid hormones with resulting increased metabolism.
• Problems with wound healing after surgery.
• Increased muscle enzyme in the blood (creatine phosphokinase).
• Inappropriate and excessive reaction to allergens, including hay fever, rash, itchy skin, hives, localized swelling, and difficulty breathing.
• Inflammation of the colon (colitis, ischemic colitis). Rare: may affect up to 1 in 1,000
• Severe skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS) - TLS includes a set of metabolic complications that can occur during cancer treatment. They are caused by the degradation products of cancer cells and can include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue associated with abnormal laboratory results (high levels of potassium, uric acid, and phosphoric acid, and low levels of calcium in the blood) that can lead to changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscles that can cause kidney problems (rhabdomyolysis).
• Changes in brain function that can lead to a variety of symptoms, such as 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 small blood vessels called thrombotic microangiopathy (TMA).

Not known (frequency cannot be estimated based on available data):

• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Accord

• 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 package, bottle and blister after “Scad.” or “EXP”. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Sunitinib Accord Contains
The active ingredient is sunitinib. Each hard capsule contains 12.5 mg, 25 mg, 37.5 mg or 50 mg
of sunitinib. The other components are:

• Capsule Content:microcrystalline cellulose, mannitol (E421), sodium croscarmellose, povidone (E1201), magnesium stearate.
• Capsule Shell:gelatin, titanium dioxide (E171), black iron oxide (E172) (for 25 mg and 50 mg), red iron oxide (E172) (for 12.5 mg, 25 mg, 50 mg), yellow iron oxide (E172) (for 25 mg, 37.5 mg, 50 mg).
• Ink:shellac, titanium dioxide (E171), black iron oxide (E172), propylene glycol, ammonium hydroxide.

Description of the Appearance of Sunitinib Accord and Package Contents
Sunitinib Accord 12.5 mg hard capsules
Gelatin capsules (approximate length 14.3 mm) with a cap and body of
orange color, with the inscription “12.5 mg” in white ink on the body, containing granules
of yellow/orange color.
Sunitinib Accord 25 mg hard capsules
Gelatin capsules (approximate length 15.9 mm) with a caramel-colored cap
and a body of orange color, with the inscription “25 mg” in white ink on the body,
containing granules of yellow/orange color.
Sunitinib Accord 37.5 mg hard capsules
Gelatin capsules (approximate length 18.0 mm) with a cap and body of
yellow color, with the inscription “37.5 mg” in black ink on the body, containing granules of
yellow/orange color.
Sunitinib Accord 50 mg hard capsules
Gelatin capsules (approximate length 19.4 mm) with a cap and body of
caramel color, with the inscription “50 mg” in white ink on the body, containing granules of yellow
/orange color.
Sunitinib Accord is available in bottles of 30 capsules and in blisters containing 28 capsules and
unit dose blisters containing 28 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll De Barcelona s/n,
Edifici Est, 6 Planta,
Barcelona, 08039,
Spain

Manufacturer
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate,
Building 10, 3056 Limassol,
Cyprus
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Birzebbugia, BBG3000
Malta

Other Sources of Information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .