SUNITINIB 12.5 mg Hard capsule

Зміст інструкції

1. Sunitinib Mylan 12.5 mg hard capsules, 25 mg hard capsules, 37.5 mg hard capsules, 50 mg hard capsules
   1. What is Sunitinib Mylan and what is it used for
   2. What you need to know before taking Sunitinib Mylan
   3. How to take Sunitinib Mylan
   4. Possible side effects
   5. How to store Sunitinib Mylan
   6. Contents of the pack and other information

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

Sunitinib

Generic medicine

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

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

Contents of this leaflet:

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

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

Sunitinib Mylan 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 Mylan is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumor (GIST), a type of tumor of the stomach and intestines, 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 Mylan or why this
medicine has been prescribed to you, please ask your doctor.

2. What you need to know before taking Sunitinib Mylan

Do not take Sunitinib Mylan:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Sunitinib Mylan:

• If you have high blood pressure.Sunitinib Mylan can cause an increase in blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Mylan 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 Mylan may involve an increased risk of bleeding, changes in the number of certain blood cells whose deficiency causes anemia or affects the blood's ability to clot. The risk of bleeding may be greater if you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent blood clots from forming. Tell your doctor if you experience any bleeding while taking Sunitinib Mylan.
• If you have heart problems.Sunitinib Mylan 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 your heart rhythm.Sunitinib Mylan can cause changes in heart rhythm. During treatment with Sunitinib Mylan, your doctor may perform an electrocardiogram to assess the extent of these changes. Tell your doctor if, during treatment with Sunitinib Mylan, 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 tightness or pain in the chest, pain in the arms, back, neck or jaw/jawbone, shortness of breath, numbness or weakness on one side of the body, unsteady walking, headache or dizziness during treatment with Sunitinib Mylan.
• If you have been diagnosed with an enlargement or “bulge” of the large blood vesselaorta known as an aortic aneurysm.
• If you have experienced a previous episode of tearing of the aortic wall known asaortic dissection.
• 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 convulsions.
• If you have problems with your thyroid gland.Sunitinib Mylan can cause thyroid problems. Tell your doctor if you feel more tired than usual, generally feel colder than other people or your voice becomes lower while taking Sunitinib Mylan. Thyroid function should be checked before taking Sunitinib Mylan and regularly while you are taking the medicine. 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 your 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 Mylan: 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 Mylan, and as clinically appropriate.
• If you have or have had kidney problems.Your doctor will monitor kidney function.
• If you are about to have surgery or if you have had surgeryrecently.Sunitinib Mylan can affect how wounds heal. Generally, if you are about to have surgery, you will need to stop treatment with Sunitinib Mylan. Your doctor will decide when to start treatment with Sunitinib Mylan again.
• It is advisable to have a dental check-up before starting treatment withSunitinib Mylan.
• If you have or have had pain in the mouth, teeth and/or jaw/jawbone, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw/jawbone, or tooth loss, tell your doctor and dentist immediately.
• If you need to undergo invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sunitinib Mylan, especially if you are taking or have taken bisphosphonates intravenously. Bisphosphonates are medicines 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 rashes (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 rash may progress to widespread blistering or peeling of the skin, and may be fatal. If you develop a rash or any of these skin symptoms, consult 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 if the dosage of diabetes medicines needs 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 Mylan is not indicated for patients under the age of 18 years.

Other medicines and Sunitinib Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can change the levels of Sunitinib Mylan 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 Mylan with food and drink
Taking grapefruit juice should be avoided during treatment with Sunitinib Mylan.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If there is a possibility of becoming pregnant, you should use a reliable contraceptive method during treatment with Sunitinib Mylan.
If you are breastfeeding, tell your doctor. You should not breastfeed during treatment with
Sunitinib Mylan.

Driving and using machines
If you feel dizzy or unusually tired, be particularly careful when driving or using
machines.

Sunitinib Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, which means it is
essentially “sodium-free”.

3. How to take Sunitinib Mylan

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

• Gastrointestinal stromal tumor (GIST) or metastatic renal cell carcinoma (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 (without medicine), in 6-week cycles.
• Pancreatic neuroendocrine tumors (pNET): the usual dose is 37.5 mg once a day, without a rest period. The doctor will determine the necessary dose for you, if and when to interrupt treatment with Sunitinib Mylan.

Sunitinib Mylan can be taken with or without food.

If you take more Sunitinib Mylan 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 Mylan
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 everybody gets them.
You must contact your doctor immediately if you experience any of these serious side effects (see also What you need to know before taking Sunitinib Mylan):

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 condition called 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 have any of the following symptoms or severe bleeding while taking Sunitinib Mylan: swollen, painful stomach (abdomen); vomiting blood;
dark, tarry stools; blood in your urine; headache or altered mental status; coughing up blood or blood-tinged 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 stool or changes in your bowel habits.
Other side effects that may occur with Sunitinib Mylan:
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 under the skin and around the eyes, deep allergic rash.
• Mouth pain/irritation, sore/inflamed/dry mouth, altered taste, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/bloating, loss/decrease of appetite.
• Reduced activity of the thyroid gland (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 sleeping.

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 narrowing of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention even 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 loss 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 in 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, scaling and inflammation of the skin, blisters, 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

• 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 causes a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• Abnormal communication between two cavities of the body or with the skin.
• Mouth, tooth and/or jaw pain, swelling or irritation in the mouth, numbness or feeling of heaviness in the jaw/mandible, or tooth loss. These may be signs and symptoms of bone damage in the jaw/mandible (osteonecrosis), see section 2.
• Excessive production of thyroid hormones with resulting increased metabolism.
• Problems with wound healing after surgery.
• Increase in a muscle enzyme in the blood (creatine phosphokinase).
• Exaggerated 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 affected and can include the following symptoms: nausea, shortness of breath, irregular heartbeat, muscle cramps, convulsions, cloudy urine and fatigue associated with abnormal laboratory results (elevated levels of potassium, uric acid and phosphoric acid and low levels of calcium in the blood) which can lead to changes in kidney function and acute renal 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 smaller blood vessels called thrombotic microangiopathy (TMA).

Not known (frequency cannot be estimated from available data):

• An enlargement or “bulging” of the aorta or a tear in the aortic wall (aortic aneurysms and dissections).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sunitinib Mylan

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 the month.
This medicine does not require any special 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. Contents of the pack and other information

What Sunitinib Mylan contains

• The active substance is sunitinib.

Sunitinib Mylan 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib Mylan 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib Mylan 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitinib Mylan 50 mg hard capsules
Each capsule contains 50 mg of sunitinib.

• Other ingredients are: Capsule contents: microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, povidone (E1201), magnesium stearate (E470b). Sunitinib Mylan 12.5 mg hard capsules
• Capsule shell: red iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520). Sunitinib Mylan 25 mg hard capsules
• Capsule shell: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520). Sunitinib Mylan 37.5 mg hard capsules
• Capsule shell: yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, black: shellac, black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527). Sunitinib Mylan 50 mg hard capsules
• Capsule shell: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).

Description of the appearance of Sunitinib Mylan and contents of the pack
Sunitinib Mylan 12.5 mg hard capsules (capsules)
Gelatin capsules size 4 with orange-colored cap and body, marked with
white ink with the inscription “12.5 mg” on the body and containing yellow/orange granules.
Sunitinib Mylan 25 mg hard capsules (capsules)
Gelatin capsules size 3 with caramel-colored cap and orange-colored body,
marked with white ink with the inscription “25 mg” on the body and containing yellow/orange granules.
Sunitinib Mylan 37.5 mg hard capsules (capsules)
Gelatin capsules size 2 with yellow-colored cap and body, marked with
black ink with the inscription “37.5 mg” on the body and containing yellow/orange granules.
Sunitinib Mylan 50 mg hard capsules (capsules)
Gelatin capsules size 1 with caramel-colored cap and body, marked with
white ink with the inscription “50 mg” on the body and containing yellow/orange granules.

NL/H/4253/001-004/DC:
Sunitinib Mylan hard capsules are available in blisters containing 28 hard capsules, in divisible blisters for unit dose of 28 x 1 hard capsules and in plastic bottles containing 30 hard capsules.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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