PAZOPANIB STADA 400 mg FILM-COATED TABLETS

Introduction

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Pazopanib Stada 200 mg film-coated tablets EFG

Pazopanib Stada 400 mg film-coated tablets EFG

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• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What is Pazopanib Stada and what is it used for

Pazopanib is a type of medicine called a protein kinase inhibitor. It works by preventing the activity of proteins involved in the growth and spread of cancer cells.

Pazopanib is used in adults to treat:

• advanced or metastatic renal cell cancer.
• certain types of soft tissue sarcoma, which is a type of cancer that affects the connective tissue of the body. It can occur in muscles, blood vessels, fat tissue, or other tissues that connect, surround, and support the organs.

2. What you need to know before taking Pazopanib Stada

Do not take Pazopanib Stada

• if you are allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6).

Consult your doctorif you think this may apply to you.

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Consult your doctor before starting treatment with Pazopanib Stada:

• if you have heart disease.
• ifyou have liver disease.
• if you have had heart failure or a heart attack.
• if you have had a pulmonary embolism.
• if you have had bleeding, blood clotting, or artery narrowing problems.
• if you have had stomach or intestinal problemssuch as perforation(hole) or fistula(abnormal passages that form between some parts of the intestine).
• if you have thyroid problems.
• if you have kidney problems.
• if you have or have had an aneurysm(enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Consult your doctorif you think you may have any of these problems. Your doctor will decide if pazopanib is suitable for you. You may need additional teststo check that your kidneys, heart, and liver are working properly.

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Pazopanib may increase your blood pressure. Your doctor will check your blood pressure before taking pazopanib and while you are taking it. If you have high blood pressure, you will receive treatment with medicines that help reduce it.

• Tell your doctorif you have high blood pressure.

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Your doctor will tell you to stop taking pazopanib at least 7 days before your operation, as this may affect wound healing. Your treatment will be resumed when the wounds have healed properly.

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Pazopanib Stada may worsen other conditions or cause serious side effects. You should be aware of certain symptoms while taking pazopanib to reduce the risk of any problems. See section 4.

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Pazopanib is not recommended for people under 18 years of age. It is not yet known how it works in this age group. Additionally, it should not be used in children under 2 years of age due to safety concerns.

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Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription.

Some medicines may affect how pazopanib works or increase the chance of you experiencing side effects. Pazopanib may also affect how other medicines work. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections).
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV).
• nefazodone (used to treat depression).
• simvastatin and possibly other statins (used for high cholesterol treatment).
• medicines that reduce stomach acidity. The type of medicine you are taking to reduce stomach acidity (e.g., a proton pump inhibitor, H2 receptor antagonists, or antacids) may affect how you take pazopanib. Consult your doctor or nurse for more information.

Tell your doctoror pharmacist if you are taking any of these medicines.

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Do not take pazopanib with food, as this affects the absorption of the medicine. Take it at least 2 hours after a meal or 1 hour before a meal (see section 3).

Do not drink grapefruit juicewhile being treated with pazopanib, as this may increase the chance of side effects.

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Pazopanib is not recommended if you are pregnant.The effect of pazopanib during pregnancy is not known.

• Tell your doctor if you are pregnantor planning to become pregnant.
• Use a reliable contraceptive methodwhile taking pazopanib and for at least 2 weeks after, to prevent pregnancy.
• If you become pregnant during treatmentwith pazopanib, tell your doctor.

Do not breastfeed while taking pazopanib. It is not known if pazopanib passes into breast milk. Inform your doctor of this.

Male patients(including those who have undergone vasectomy) who have partners who are pregnant or may become pregnant (including those using other contraceptive methods) must use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose.

Fertility may be affectedby treatment with pazopanib. Consult your doctor about this.

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Pazopanib may cause side effects that can affect your ability to drive or use machines.

• Avoid driving or using machines if you feel dizzy, tired, or weak, or if you are low on energy.

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This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Pazopanib Stada

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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Pazopanib Stada 200 mg film-coated tablets EFG

The normal doseis four 200 mg pazopanib tablets (800 mg of pazopanib) taken once a day. This is the maximum dose per day. Your doctor may need to reduce your dose if you experience side effects.

Pazopanib Stada 400 mg film-coated tablets EFG

The normal doseis two 400 mg pazopanib tablets (800 mg of pazopanib) taken once a day. This is the maximum dose per day. Your doctor may need to reduce your dose if you experience side effects.

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Do not take pazopanib with food.Take it at least 2 hours after a meal or 1 hour before a meal.

For example, you can take it 2 hours after breakfast or 1 hour before lunch. Take pazopanib at the same time every day.

Swallow the tablets whole with water, one after the other. Do not break or crush the tablets, as this affects how the medicine is absorbed and may increase the chance of side effects.

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If you take more tablets than you should, ask your doctor or pharmacist for advice.If possible, show them the pack or this leaflet.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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Do not take a double dose to make up for forgotten doses. Only take your next dose at the usual time.

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Take pazopanib for the time your doctor has recommended. Do not stop treatment unless your doctor advises you to.

4. Possible side effects

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

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Brain inflammation(posterior reversible leukoencephalopathy syndrome).

Rarely, pazopanib can cause brain inflammation, which can be life-threatening. Symptoms include:

• loss of speech
• changes in vision
• seizures (epileptic fits)
• confusion
• high blood pressure

Stop taking pazopanib and seek medical attention immediatelyif you experience any of these symptoms or if you have a headache accompanied by any of these symptoms.

Hypertensive crises(sudden and severe increase in blood pressure)

Pazopanib can cause a sudden and severe increase in blood pressure in some cases. This is known as a hypertensive crisis. Your doctor will check your blood pressure while you are taking pazopanib. Signs and symptoms of a hypertensive crisis can include:

• severe chest pain
• severe headache
• blurred vision
• confusion
• nausea
• vomiting
• severe anxiety
• difficulty breathing
• seizures
• fainting

Stop taking pazopanib and seek medical attention immediatelyif you experience a hypertensive crisis.

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The risk of these problems may be greater in people with heart problems or those taking other medicines. While taking pazopanib, you will be checked for any heart problems.

Cardiac disorder/heart failure, cardiac arrest

Pazopanib may affect the heart's pumping ability or increase the risk of cardiac arrest.

Symptoms include:

• irregular or rapid heartbeat
• rapid heart palpitations
• fainting
• pain or pressure in the chest
• pain in the arms, back, neck, or jaw
• difficulty breathing
• swelling in the legs

Seek medical attention immediatelyif you experience any of these symptoms.

Changes in heart rhythm (QT interval prolongation)

Pazopanib may affect the heart rhythm, which in some people can trigger a potentially serious heart condition known as torsades de pointes. This can cause a rapid heartbeat that can lead to loss of consciousness.

Tell your doctorif you notice any unusual change in heartbeat, such as beats that are too fast or too slow.

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Pazopanib may increase the risk of stroke. Symptoms of stroke can include:

• numbness or weakness on one side of the body
• difficulty speaking
• headache
• dizziness

Seek medical attention immediatelyif you experience any of these symptoms.

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Pazopanib can cause severe bleeding in the digestive tract (in the stomach, esophagus, rectum, or intestine), or in the lungs, kidneys, mouth, vagina, and brain, although this is rare. Symptoms can include:

• blood in the stool or black stool
• blood in the urine
• stomach pain
• coughing or vomiting blood

Seek medical attention immediatelyif you experience any of these symptoms.

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Pazopanib can cause a hole in the stomach or intestine wall or the formation of an abnormal connection between two parts of the digestive tract (a fistula). Symptoms can include:

• severe stomach pain
• nausea and/or vomiting
• fever
• development of a hole in the stomach or intestine from which bloody, foul-smelling pus is released

Seek medical attention immediatelyif you experience any of these symptoms.

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Pazopanib can cause liver problems that can become serious diseases such as liver failure, which can be fatal. Your doctor will check your liver enzymes while you are taking pazopanib. Signs that your liver may not be working properly can include:

• yellowing of the skin or the white part of the eyes (jaundice)
• dark-colored urine
• fatigue
• nausea
• vomiting
• loss of appetite
• pain in the right side of the stomach area (abdomen)
• easy bruising

Seek medical attention immediatelyif you experience any of these symptoms.

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Deep vein thrombosis (DVT) and pulmonary embolism

Pazopanib can cause blood clots in the veins, especially in the legs (deep vein thrombosis or DVT), which can move to the lungs (pulmonary embolism). Symptoms can include:

• severe chest pain
• difficulty breathing
• rapid breathing
• leg pain
• swelling of the arms and hands or legs and feet

Thrombotic microangiopathy (TMA)

Pazopanib can cause blood clots in the small blood vessels of the kidneys and brain, accompanied by a reduction in red blood cells and cells involved in blood clotting (thrombotic microangiopathy, TMA). Symptoms can include:

• easy bruising
• high blood pressure
• fever
• confusion
• drowsiness
• seizures
• decreased urine output

Seek medical attention immediatelyif you experience any of these symptoms.

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Pazopanib can cause rapid destruction of cancer cells, leading to tumor lysis syndrome, which can be fatal in some people. Symptoms can include irregular heartbeat, seizures, confusion, muscle cramps or spasms, or decreased urine output. Seek medical attention immediatelyif you experience any of these symptoms.

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Infections that occur while taking pazopanib can become serious. Symptoms of infections can include:

• fever
• flu-like symptoms, such as cough, fatigue, and body pain that does not go away
• difficulty breathing and/or wheezing
• pain while urinating
• cuts, scratches, or wounds that are red, hot, swollen, or painful

Seek medical attention immediatelyif you experience any of these symptoms.

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Pazopanib Stada can cause, in rare cases, lung inflammation (interstitial lung disease, pneumonitis), which can be fatal in some people. Symptoms include difficulty breathing or cough that does not go away. You will be checked for any lung problems while taking pazopanib.

Seek medical attention immediatelyif you experience any of these symptoms.

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Pazopanib may decrease the amount of thyroid hormone produced in your body. This can cause weight gain and fatigue. Your thyroid hormone levels will be checked while you are taking pazopanib.

Tell your doctorif you notice significant weight gain or fatigue.

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Pazopanib can cause the separation or tearing of the back of the eye (retinal detachment or tear). This can cause blurred vision or changes in vision.

Tell your doctorif you notice any change in vision.

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Very common side effects(may affect more than 1 in 10people):

• high blood pressure
• diarrhea
• feeling or being sick (nausea or vomiting)
• stomach pain
• loss of appetite
• weight loss
• changes in taste or loss of taste
• mouth irritation
• headache
• tumor pain
• lack of energy, feeling weak or tired
• changes in hair color
• unusual hair loss or fragility
• loss of skin pigmentation
• skin rash, possibly with skin peeling
• redness and swelling on the palms of the hands and soles of the feet.

Tell your doctor or pharmacistif any of these side effects become troublesome.

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• increase in liver enzymes
• decrease in blood albumin
• proteins in the urine
• decrease in platelet count (blood cells involved in blood coagulation)
• decrease in white blood cell count.

Common adverse effects(may affect up to 1 in 10people):

• indigestion, feeling bloated, flatulence
• nosebleed
• dry mouth or mouth ulcers
• infections
• abnormal numbness
• difficulty sleeping
• chest pain, difficulty breathing, leg pain, swelling of the legs/feet. These may be signs of blood clotting in the body (thromboembolism). If the clot breaks loose, it can travel to the lungs and become a health threat or even cause death.
• reduced heart function to pump blood to the rest of the body (heart failure)
• slow heartbeats
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling caused by fluid retention in the face, hands, ankles, feet, or eyelids
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin disorders, redness, itching, dry skin
• nail disorders
• burning, itching, itching, or tingling sensation on the skin
• feeling of coldness, with chills
• excessive sweating
• dehydration
• muscle, joint, tendon pain, or chest pain, muscle spasms
• hoarseness
• difficulty breathing
• cough
• coughing up blood
• hiccups
• collapsed lungs with air trapped in the space between the lungs and chest, often causing difficulty breathing (pneumothorax).

Inform your doctoror pharmacist if any of these adverse effects become problematic.

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• low thyroid gland activity
• altered liver function
• increase in bilirubin (substance produced by the liver)
• increase in lipases (enzyme involved in digestion)
• increase in creatinine (substance produced in the muscles)
• changes in the levels of other blood chemicals/enzymes. Your doctor will inform you of the results of the blood tests.

Uncommon adverse effects(may affect up to 1 in 100people):

• stroke
• temporary decrease in blood supply to the brain (transient ischemic attack)
• interruption of blood supply to a part of the heart or heart attack (myocardial infarction)
• partial interruption of blood supply to a part of the heart (myocardial ischemia)
• blood clots accompanied by a decrease in red blood cells and other cells involved in blood coagulation (thrombotic microangiopathy, TMA). These can cause damage to organs such as the brain and kidneys.
• increase in red blood cell count
• sudden difficulty breathing, especially when accompanied by acute chest pain and/or rapid breathing (pulmonary embolism)
• severe bleeding in the digestive system (in the stomach, esophagus, or intestine), or in the kidneys, vagina, and brain
• alterations in heart rhythm (QT interval prolongation)
• hole (perforation) in the stomach or intestine
• abnormal connections that form between parts of the intestine (fistula)
• heavy or irregular menstrual periods
• sudden increases in blood pressure (hypertensive crisis)
• pancreatitis (inflammation of the pancreas)
• inflamed, poorly functioning, or damaged liver
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• rashes that can itch or become inflamed (flat or raised spots, or blisters)
• frequent bowel movements
• increased sensitivity of the skin to sunlight
• decreased sensitivity, especially in the skin
• skin wound that does not heal (skin ulcer)

Rare adverse effects(may affect up to 1 in 1,000people):

• lung inflammation (pneumonitis)
• increase and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)

Frequency not known(cannot be estimated from the available data):

• tumor lysis syndrome, resulting from rapid destruction of cancer cells
• liver failure

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pazopanib Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration datethat appears on the bottle and on the carton after EXP and CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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Pazopanib Stada 200 mg film-coated tablets EFG

• The active ingredient is pazopanib (as hydrochloride). Each tablet contains 200 mg of pazopanib.
• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (from potato), povidone K30 (E1201), magnesium stearate (E470b).

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), red iron oxide (E172), polysorbate 80 (E433).

Pazopanib Stada 400 mg film-coated tablets EFG

• The active ingredient is pazopanib (as hydrochloride). Each tablet contains 400 mg of pazopanib.
• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (from potato), povidone K30 (E1201), magnesium stearate (E470b).

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433).

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Pazopanib Stada 200 mg film-coated tablets

Pazopanib Stada 200 mg are film-coated tablets, capsule-shaped, pink in color, with the inscription "200" on one side and with dimensions of approximately 14.3 mm x 5.7 mm.

They are supplied in white HDPE bottles with child-resistant caps, containing 30, 90, multiple packaging of 90 (3 bottles of 30) tablets.

They are supplied in aluminum-PVC/PE/PVDC clear/transparent blisters of 30, 60, multiple packaging of 60 (2 packages of 30), 90, multiple packaging of 90 (3 packages of 30) tablets.

They are supplied in single-dose perforated aluminum-PVC/PE/PVDC clear/transparent blisters of 30x1, 60x1, multiple packaging of 60x1 (2 packages of 30x1), 90x1, multiple packaging of 90x1 (3 packages of 30x1) tablets.

Pazopanib Stada 400 mg film-coated tablets

Pazopanib Stada 400 mg are film-coated tablets, capsule-shaped, white in color, with the inscription "400" on one side and with dimensions of approximately 18.0 mm x 7.1 mm.

They are supplied in white HDPE bottles with child-resistant caps, containing 30, 60 tablets.

They are supplied in aluminum-PVC/PE/PVDC clear/transparent blisters of 30, 60, multiple packaging of 60 (2 packages of 30), 90, multiple packaging of 90 (3 packages of 30) tablets.

They are supplied in single-dose perforated aluminum-PVC/PE/PVDC clear/transparent blisters of 30x1, 60x1, multiple packaging of 60x1 (2 packages of 30x1), 90x1, multiple packaging of 90x1 (3 packages of 30x1) tablets.

Not all pack sizes may be marketed.

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Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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Remedica Ltd

Aharnon Street, Limassol Industrial Estate,

Limassol 3056,

Cyprus

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PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

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STADA Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel,

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary: Pazopanib Stada 200 mg/400 mg filmtabletta

Belgium: Pazopanib EG 200 mg/400 mg filmomhulde tabletten

Germany: Pazopanib STADA 200 mg/400 mg Filmtabletten

Denmark: Pazopanib STADA

Greece: Pazopanib/Stada 200 mg/400 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Spain: Pazopanib STADA 200 mg/400 mg comprimidos recubiertos con película EFG

Finland: Pazopanib STADA 200 mg/400 mg kalvopäällysteiset tabletit

France: PAZOPANIB STADA 200 mg/400 mg, comprimé pelliculé

Iceland: Pazopanib STADA 200 mg/400 mg filmuhúðaðar töflur

Luxembourg: Pazopanib EG 200 mg/400 mg comprimé pelliculé

Netherlands: Pazopanib CF 200 mg/400 mg, filmomhulde tabletten

Norway: Pazopanib STADA

Poland: Pazopanib STADA

Portugal: Pazopanib STADA

Sweden: Pazopanib STADA 200 mg/400 mg filmdragerade tabletter

Slovakia: Pazopanib STADA 200 mg/400 mg

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Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)