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SUTENT. 12.5 mg. 30 capsules View full size

SUTENT. 12.5 mg. 30 capsules

Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is used for treating cancer by preventing activation of a specific group of proteins known to be involved in the growth and spread of cancer cells

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1 599.00 €

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SUTENT. 12.5 mg. 30 capsules

SUTENT. 12.5 mg. 30 capsules

 

 

What is Sutent and what it is used?
Sutent contains the active substance sunitinib , which is a protein kinase inhibitor . It is used for treating cancer by preventing activation of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sutent will only be prescribed by a physician experienced in the use of anticancer drugs.
Sutent is used in adults to treat the following types of cancer:
- Gastrointestinal stromal tumor ( GIST ) , a type of cancer of the stomach and intestines, in which imatinib ( another anticancer medicine ) is no longer effective or are unable to tolerate imatinib.
- Metastatic renal cell carcinoma ( mRCC ) , a type of cancer of the kidney that has spread to other parts of the body.
- Neuroendocrine tumor of the pancreas ( pNET ) ( tumors of hormone -producing cells of the pancreas ), which are advanced and can not be surgically removed .
If you have any questions about how or why Sutent prescribed this medicine, ask your doctor.

2 . What you should know before taking Sutent?
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 increase blood pressure . Your doctor may check your blood pressure during treatment with Sutent and can be treated with drugs to lower blood pressure , if necessary.
- If you have or have had blood disease , problems with bleeding or bruising . Treatment with Sutent may lead to an increased bleeding risk , or result in changes in the numbers of certain blood cells, which may lead to anemia , or to interfere with the ability of your blood to clot. If taking warfarin or acenocoumarol - medications that thin the blood to prevent clot formation , the risk of bleeding can be larger . Tell your doctor if you have any bleeding while taking Sutent.
- If you have heart problems. Sutent may cause heart problems. Tell your doctor if you feel fatigued , have shortness of breath or swollen feet and ankles.
- If you have heart rhythm disorders . Sutent may cause abnormalities in your heart rate . Your doctor may do electrocardiograms to evaluate these problems during your treatment with Sutent. Tell your doctor if you feel dizzy , faint or have your heartbeat while taking Sutent.
- If you have had problems with blood clots in the veins and / or arteries ( types of blood vessels ) recently , including stroke , heart attack, embolism or thrombosis. Call your doctor immediately if during treatment with Sutent have symptoms such as pain or pressure in the chest, pain in the arms, back, neck or jaw , shortness of breath , numbness or weakness on one side of the body, difficulty speaking , headache or dizziness .
- If you have thyroid problems . Sutent can cause thyroid problems . Tell your doctor if you during treatment with Sutent tired easier colder you compared to others, or your voice becomes hoarse . The function of your thyroid should be checked before treatment and regularly during treatment. If your thyroid gland does not produce enough thyroid hormone , you may be supplied with thyroid hormone replacement therapy.
- If you have or have had pancreatic or biliary disorders . Tell your doctor if you experience any of the following symptoms: pain in the stomach ( upper abdomen ), nausea , vomiting and fever. This may be due to inflammation of the pancreas or gallbladder .
- If you have or have had liver problems. Tell your doctor if you develop any of the following symptoms of liver problems during treatment with Sutent: itching , yellowing of skin and eyes, dark urine , and pain or discomfort in the right upper abdomen . Your doctor should do blood tests to check your liver function before and during treatment with Sutent and, if necessary , according to your condition.
- If you have or have had kidney problems. Your doctor will monitor your kidney function.
- If you operate or rather you operate. Sutent may affect the way your wounds heal . Usually your treatment with Sutent will be stopped if you have an operation . Your doctor will decide when to resume treatment with Sutent.
- You may be advised to make a dental examination before starting treatment with Sutent.
- If you have or have had pain in the mouth, teeth and / or jaw , swelling or sores in the mouth , numbness or a feeling of heaviness in the jaw or loosening of a tooth , immediately tell your doctor and dentist.
- If you have to undergo a bleeding dental treatment or dental surgery , tell your dentist that you are being treated with Sutent, especially if you apply more or you intravenously administered bisphosphonates . Bisphosphonates are drugs used to prevent bone complications , which may be applied to another medical condition.
- If you have or have had any of the skin and subcutaneous tissue. While this medicine may occur " pyoderma gangrenosum " ( painful ulceration of the skin). This event is usually reversible after discontinuation of treatment. Use with sunitinib reported severe skin reactions (Stevens -Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) , which appear initially as red , similar to target points or circular spots , often centrally located blisters on the body. rash may progress to widespread straddling blistering or peeling of the skin and can be life-threatening . If you develop a rash or those skin symptoms , seek medical advice.
- If you have or have had seizures. Immediately tell your doctor if you have high blood pressure, headaches and loss of vision.

Children and adolescents
Sutent is not recommended under the age of 18 years . Sutent has not been studied in children and adolescents.

Sutent and other drugs
Tell your doctor or pharmacist if you are taking , have recently taken or to take other medicines , including medicines obtained without a prescription , even those not prescribed .
Some medicines may affect the levels of Sutent in your body. You should tell your doctor if you are taking medicines containing the following active ingredients:
• ketoconazole , itraconazole - drugs used for the treatment of fungal infections
• erythromycin , clarithromycin , rifampicin , used to treat infection
• ritonavir , used to treat HIV
• dexamethasone - a corticosteroid used in the treatment of various diseases
• phenytoin , carbamazepine , phenobarbital - used to treat epilepsy and other neurological disorders
• herbal products containing St. John's wort (Hypericum perforatum) - used to treat depression and anxiety

Sutent with food and drink
You should avoid intake of grapefruit juice during treatment with Sutent.
Pregnancy and lactation
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 could become pregnant should use a reliable method of contraception during treatment with Sutent.
If you are breastfeeding , tell your doctor. Do not breast-feed during treatment with Sutent. Driving and using machines
If you experience dizziness or feel unusually tired , be especially careful when driving or operating machinery.

3 . How to take Sutent?
Always take this medicine exactly as your doctor tells you . If you are not sure, ask your doctor.
Your doctor will prescribe the right dose for you , depending on the type of tumor. If you are undergoing treatment for GIST or MRCC, the usual dose is 50 mg once daily for 28 days ( 4 weeks) followed by 14 days (2 weeks ) pause (no drug ) in 6- week cycles . If you are undergoing treatment for pNET, the usual dose is 37,5 mg once daily without a rest period .
Your doctor will decide the right dose , you should take , and whether and when to stop treatment with Sutent.
Sutent can be taken with or without food.
If you take more than the amount of Sutent
If you accidentally take too many capsules , tell your doctor immediately . You may need medical attention .

If you forget to take Sutent
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 should contact your doctor if you experience any of these serious side effects (see also What you should know before taking Sutent):
Heart problems. Tell your doctor if you feel very tired , have shortness of breath or swollen feet and ankles. These may be symptoms of heart problems , including heart failure and problems with the heart muscle ( cardiomyopathy ) .
Problems with the lungs and breathing. Tell your doctor if you have a cough, chest pain, sudden shortness of breath or cough up blood. These may be symptoms of a condition known as pulmonary embolism which occurs when a blood clot reaches your lungs .
Renal disorders. Tell your doctor if you urinate with altered frequency or urinate , it may be symptoms of kidney failure.
Bleeding. Tell your doctor immediately if you experience any of these symptoms or problems with serious bleeding events during treatment with Sutent: painful swollen abdomen , vomiting of blood, black , sticky stools, bloody urine , headache or change in your mental state , coughing up blood or bloody sputum from the lungs or respiratory tract .
Disintegration of the tumor, leading to a breakthrough in the gut. Tell your doctor if you have severe abdominal pain, fever , nausea , vomiting, blood in the stool or changes in bowel habits.

Other side effects may include:
Very common side effects (likely to affect more than 1 user in 10)
• Low platelet count , red blood cells and / or white blood cells (e.g., neutrophils ) .
• High blood pressure
• Infections .
• Pain / mouth irritation , redness / inflammation / dry mouth, changes in taste , burning or painful sensation in the tongue, stomach upset , nausea, vomiting , diarrhea, inflammation of the lining of the digestive system more gas in the stomach or intestines, constipation , abdominal pain , loss / decrease in appetite, loss of strength , loss of weight.
• Yellowing of the skin / discoloration of the skin, change in hair color , hair loss, rash on palms and soles , blisters, rash , dry skin ;
• Excessive fatigue.
• Headache .
• Nosebleeds
• Pain in the arms and legs.
• Fast swelling of the tissues due to the fluid under the skin

Common side effects (likely to affect 1 to 10 users in 100)
• Reduced activity of the thyroid ( hypothyroidism ) .
• retention of fluids , including around the lungs .
• Fever , fever, flu-like syndrome.
• Pain in the chest.
• Shortness of breath .
• Depression .
• Hemorrhoids , pain in the rectum, bleeding gums , difficulty in swallowing or inability to swallow , heartburn .
• Difficulty in speaking .
• Cough, dry nose , stuffy nose.
• Excessive lacrimation .
• Back pain , joint pain, muscle pain .
• Swelling of the legs and around the eyes.
• Change the sensitivity of the skin, dry skin, itching, scaling and inflammation of the skin , blisters, acne , excessive coloring of the skin.
• sensation in the extremities
• Abnormally decreased / increased sensitivity , particularly to touch .
• High levels of uric acid in the blood.
• Hot flashes .
• Difficulty falling asleep.
• Unusually colored urine .
• Change in color of your nails .

Uncommon side effects (likely to affect 1 to 10 of 1000 users)
• Stroke.
• Changes in the electrical activity of the heart or irregular heartbeat .
• Fluid around the heart ( pericardial effusion) .
• Liver failure .
• An abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis ) .
• Pain in the abdomen (stomach ) caused by inflammation of the pancreas .
• tumor lysis syndrome (CTP ) - CTP comprises a group of metabolic complications that can appear during the treatment of cancer . These complications are caused by breakdown products of dying cancer cells and may include the following : nausea , shortness of breath , irregular heartbeat , muscle spasms , seizures, clouding of urine and fatigue associated with abnormalities in laboratory test results (high levels of potassium, uric acid and phosphorus and low levels of calcium in the blood) , which may result in changes in renal function , acute renal failure .
• The breakdown of the tumor, leading to a breakthrough bowel ( perforation ) .
• Inflammation of the liver (hepatitis) .
• inflammation ( redness and swelling ) of the bladder , with or without associated gallstones .
• Unusual changes in the brain that can cause a variety of symptoms , including headache , confusion and loss of vision ( syndrome of reversible posterior leukoencephalopathy ) .
• Pain in the mouth, teeth and / or jaw , swelling or sores in the mouth , numbness or a feeling of heaviness in the jaw or loosening of a tooth . These may be symptoms of bone damage in the jaw ( osteonecrosis ) . Tell your doctor or dentist if you have any of them.
• Abnormal duct connecting a body cavity or other skin .
• Blood clots in the blood vessels.
• overproduction of thyroid hormones , which increases the amount of energy that the body uses at rest . Inflammation of the thyroid gland .
• Problem wound healing after surgery .
• Abnormal blood test results , including the pancreas and liver enzymes.
• loss of protein in the urine , sometimes leading to swelling .
• Unusual and very severe reaction to an allergen.
Rare side effects (likely to affect 1 to 10 of 10 000 users)
• Life-threatening infection of the soft tissue , including the anogenital area . Contact your doctor immediately if you develop signs of infection around a skin injury, including fever , pain, redness, swelling or discharge or blood.
• Painful ulceration of the skin ( pyoderma gangrenosum ) .
• Severe skin reaction and / or mucous membranes (Stevens -Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
If you get any side effects , tell your doctor. This includes all listed in this leaflet ..

5 . How to store Sutent?
- Keep out of reach of children.
- Do not use this medicine after the expiry date stated on the carton and label after " EXP" . 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 packaging is damaged or shows signs of tampering .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
What does Sutent?
Sutent 12,5 mg hard capsules
The active substance is sunitinib . Each capsule contains sunitinib malate, equivalent to 12,5 mg sunitinib . Other ingredients are:
- Capsule mannitol (E421), croscarmellose sodium, povidone (K- 25) and magnesium stearate.
- Capsule shell: gelatin, red iron oxide (E172) and titanium dioxide (E171).
- 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.
Other ingredients are:
- Capsule : mannitol , croscarmellose sodium, povidone (K- 25) and magnesium stearate.
- Capsule shell: gelatin , titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), black iron oxide (E172).
- 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.
Other ingredients are:
- Capsule : mannitol , croscarmellose sodium, povidone (K- 25) and magnesium stearate.
- Capsule shell: gelatin , titanium dioxide (E171), yellow iron oxide (E172).
- Ink : shellac, propylene glycol , sodium hydroxide, black iron oxide (E172).
Sutent 50 mg hard capsules
The active substance is sunitinib . Each capsule contains sunitinib malate equivalent to 50 mg.
Other ingredients are:
- Capsule : mannitol , croscarmellose sodium, povidone (K- 25) and magnesium stearate.

 

 

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SUTENT. 12.5 mg. 30 capsules

SUTENT. 12.5 mg. 30 capsules

Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is used for treating cancer by preventing activation of a specific group of proteins known to be involved in the growth and spread of cancer cells

Write your review