Label: information for the user

Ezetimiba/Simvastatina SUN 10mg/20mg tablets EFG

Ezetimiba/Simvastatina SUN 10mg/40mg tablets EFG

Ezetimiba and simvastatina

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

Table of contents

1. What is Ezetimiba/Simvastatina SUN and what it is used for
2. What you need to know before starting to take Ezetimiba/Simvastatina SUN
3. How to take Ezetimiba/Simvastatina SUN
4. Possible adverse effects
5. Storage of Ezetimiba/Simvastatina SUN

6. Contents of the package and additional information

Ezetimiba/Simvastatina SUNcontains the active principles ezetimiba and simvastatina.Ezetimiba/Simvastatinais a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally,Ezetimiba/Simvastatinaincreases the concentrations of "good" cholesterol (HDL cholesterol).

Ezetimiba/Simvastatinaacts by reducing cholesterol in two ways. The active principle ezetimiba reduces the cholesterol absorbed in the digestive tract. The active principle simvastatina, which belongs to the group of "statins", inhibits the production of cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of its arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in the blood that can increase the risk of heart disease.

Ezetimiba/Simvastatina is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet.

Ezetimiba/Simvastatina is used, along with a cholesterol-reducing diet,if you have:

• elevated blood levels of cholesterol (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated blood levels of fatty substances (mixed hyperlipidemia):
• that are not well controlled with a single statin
• for whom a statin and ezetimiba have been used in separate tablets

• a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.

• cardiovascular disease,Ezetimiba/Simvastatina reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimiba/Simvastatinadoes not help you lose weight.

Do not take Ezetimiba/Simvastatina SUN if

• You are allergic (hypersensitive) to ezetimiba, simvastatina, or any of the other components of this medication (listed in section 6. Contents of the pack and additional information)
• You have liver problems
• You are pregnant or breastfeeding
• You are taking medications with one or more of the following active ingredients:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Erythromycin, clarithromycin, or telithromycin (used to treat infections)
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections)
• Boceprevir or telaprevir (used to treat hepatitis C infection)
• Nefazodone (used to treat depression)
• Cobicistat
• Gemfibrozil (used to reduce cholesterol)
• Ciclosporin (used in patients with organ transplants)
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)

• If you are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic) by mouth or injection. The combination of fusidic acid and Ezetimiba/Simvastatina may cause severe muscle problems (rhabdomyolysis).

Do not take more than 10/40 mg of Ezetimiba/Simvastatina if you are taking lomitapida (used to treat rare and severe cholesterol disorders).

Consult your doctor if you are unsure if your medication is mentioned above.

Warnings and precautions

Inform your doctor:

• About all your medical problems, including allergies.
• If you consume large amounts of alcohol or have ever had liver disease. Ezetimiba/Simvastatina may not be suitable for you.
• If you are scheduled for surgery. You may need to stop taking Ezetimiba/Simvastatina for a short period.
• If you are of Asian descent, as you may need a different dose.
• If you have or have had myasthenia (a condition characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenic eye (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor will perform a blood test before you start taking Ezetimiba/Simvastatina and also if you have any symptoms of liver problems while taking Ezetimiba/Simvastatina. This is to check how well your liver is working.

Your doctor may also want to perform blood tests to check how well your liver is working after you start taking Ezetimiba/Simvastatina.

While you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in your blood, obesity, and high blood pressure.

Talk to your doctor if you have a severe lung disease.

Avoid taking Ezetimiba/Simvastatina with fibrates (certain medications to reduce cholesterol), as the combination has not been studied.

Consult your doctor immediately if you experience pain, sensitivity to pressure, or unexplained muscle weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of Ezetimiba/Simvastatina, especially the 10/80 mg dose. The risk of muscle failure is also higher in certain patients. Inform your doctor in the following situations:

• If you have kidney problems
• If you have thyroid problems
• If you are over 65 years old
• If you are female
• If you have ever had muscle problems during treatment with cholesterol-lowering medications called "statins" (such as simvastatina, atorvastatina, and rosuvastatina) or fibrates (such as gemfibrozilo or bezafibrato).
• If you or your close relatives have a hereditary muscle disorder

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this condition.

Children and adolescents

Ezetimiba/Simvastatina is not recommended for children under 10 years old.

Taking Ezetimiba/Simvastatina SUN with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication with any of the following active ingredients. Taking Ezetimiba/Simvastatina with any of the following medications may increase the risk of muscle problems (some of which are already listed in the section above "Do not take Ezetimiba/Simvastatina SUN if").

• If you need to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking Ezetimiba/Simvastatina. Your doctor will tell you when it is safe to restart the treatment with Ezetimiba/Simvastatina. Taking Ezetimiba/Simvastatina with fusidic acid may cause very rarely muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4,

• Ciclosporin (often used in transplant patients),
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus),
• Medications with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• Fibrates with an active ingredient such as gemfibrozil and bezafibrato (used to reduce cholesterol),
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)
• Protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections),
• Antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection),
• Nefazodone (used to treat depression),
• Medications with the active ingredient cobicistat ,
• Amiodarone (used to treat irregular heart rhythm),
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases),
• Lomitapida (used to treat rare and severe cholesterol disorders),
• Daptomycin (a medication used to treat complicated skin infections and structural skin infections and bacteremia). It is possible that muscle-related adverse reactions may be increased when this medication is taken while on simvastatina (e.g., Ezetimiba/Simvastatina tablets). Your doctor may decide to stop taking Ezetimiba/Simvastatina for a time,
• Large doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol),
• Colchicine (used to treat gout).

As with the medications listed above, inform your doctor or pharmacist if you are taking or have taken recently other medications, even those purchased without a prescription. In particular, inform your doctor if you are taking any of the following:

• Medications with an active ingredient to prevent blood clot formation, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants)
• Colestiramine (also used to reduce cholesterol), as it affects how Ezetimiba/Simvastatina works
• Fenofibrate (also used to reduce cholesterol)
• Rifampicin (used to treat tuberculosis)
• Ticagrelor (antiplatelet medication).

You should also inform any doctor who prescribes a new medication that you are taking Ezetimiba/Simvastatina.

Taking Ezetimiba/Simvastatina SUN with food and drinks

Orange juice contains one or more components that alter the metabolism of some medications, including Ezetimiba/Simvastatina. You should avoid consuming orange juice, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take Ezetimiba/Simvastatina if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimiba/Simvastatina, stop taking it immediately and inform your doctor. Do not take Ezetimiba/Simvastatina if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Ezetimiba/Simvastatina is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking Ezetimiba/Simvastatina.

Ezetimiba/Simvastatina SUN contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Ezetimiba/Simvastatina SUN contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per tablet; that is, it is essentially "sodium-free".

Your doctor will determine the appropriate dose for you, based on your current treatment and your individual risk factors.

The tablets do not have a notch and should not be divided.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba/Simvastatina, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-lowering diet while taking Ezetimiba/Simvastatina.

Adults:The dose is1 tabletof Ezetimiba/Simvastatina once a day by mouth.

Use in adolescents(10 to 17 years of age): The dose is1 tabletof Ezetimiba/Simvastatina once a day by mouth (do not exceed a maximum dose of 10mg/40mg once a day).

The dose ofEzetimiba/Simvastatina tablets of 10mg/80mg is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease problems who have not achieved treatment goals with lower doses.

Take Ezetimiba/Simvastatina at night. You can take it with or without food.

If your doctor has prescribed Ezetimiba/Simvastatina along with another cholesterol-lowering medication that contains the active ingredient cholestyramine or any other bile acid sequestrant, you should take Ezetimiba/Simvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Simvastatina SUNthan you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forgot to take Ezetimiba/Simvastatina SUN

Do not take a double dose to make up for the missed dose, take your usual amount of Ezetimiba/Simvastatina at the usual time.

If you interrupt treatment with Ezetimiba/Simvastatina SUN

Talk to your doctor or pharmacist because your cholesterol may increase again.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them (see section 2. What you need to know before starting to take Ezetimiba/Simvastatina SUN).

The following frequent side effects (can affect up to 1 in 10 people) have been reported:

• Muscle pain
• Laboratory blood test elevations in liver function (transaminases) and/or muscle (CK)

The following infrequent side effects (can affect up to 1 in 100 people) have been reported:

• Liver function elevations in blood tests; uric acid elevations in the blood; blood clotting time elevations; proteinuria; weight loss
• Dizziness; headache; tingling sensation
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn
• Rash; itching; urticaria
• Joint pain, muscle pain, sensitivity, weakness, or muscle spasms; neck pain; arm and leg pain; back pain
• Unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• Sleep disturbances; difficulty sleeping

Adverse reactions with unknown frequency:

• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

In addition, the following side effects have been reported in people taking Ezetimiba/Simvastatina or medications containing the active ingredients ezetimiba or simvastatina:

• Low red blood cell count (anemia), reduced white blood cell count, which can cause hematoma/hemorrhage (thrombocytopenia)
• Numbness or weakness of the arms and legs; poor memory, memory loss, confusion
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Constipation
• Pancreatitis, often with severe abdominal pain
• Hepatitis with the following symptoms: yellowing of the skin and eyes, itching, dark urine, pale stools, feeling tired or weak, loss of appetite; liver insufficiency; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• Hair loss; red, swollen, and sometimes blistering rash (erythema multiforme)
• Blurred vision and vision deterioration (can affect up to 1 in 1,000 people)
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (can affect up to 1 in 10,000 people).
• Hypersensitivity reactions that may include the following: allergic reactions, including facial swelling, lip, tongue, and/or throat swelling, which can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), joint pain or inflammation, blood vessel inflammation, atypical hematomas, skin eruptions, and swelling, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, lupus-like syndrome (including skin rash, joint disorders, and effects on white blood cells)) A rare allergic reaction (which can affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• Muscle pain, sensitivity, weakness, or muscle cramps; muscle failure; muscle rupture (can affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• Gynecomastia (breast enlargement in men) (can affect up to 1 in 10,000 people)
• Loss of appetite
• Hot flashes; high blood pressure
• Pain
• Erectile dysfunction
• Depression
• Alterations in some liver function blood tests

With some statins, the following additional adverse events have been reported:

• Sleep disturbances, including nightmares
• Sexual dysfunction
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication
• Constant muscle pain, sensitivity, or weakness that may not disappear after discontinuing treatment with Ezetimiba/Simvastatina (unknown frequency).

Consult your doctor immediately if you experience unexplained muscle pain, sensitivity to pressure, or weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure, which can cause kidney failure; and very rarely, deaths have occurred.

Reporting of side effects:

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

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging or in the blister pack after [CAD].
• Do not store Ezetimiba/Simvastatina tablets at a temperature above 25?°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Ezetimibe/Simvastatin SUN Composition

The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 mg or 40 mg of simvastatin.

The other components are: butylated hydroxyanisole (E320), citric acid monohydrate (E330), sodium croscarmellose (E468), hypromellose (E464), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460i), and propyl gallate (E310).

Appearance of the product and packaging contents

Ezetimibe / Simvastatin SUN 10 mg/20 mg tablets are non-coated, white to off-white capsule-shaped tablets, engraved with the code "I" on one side and smooth on the other. Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.
The tablets have a length of approximately 10.70 mm and a width of approximately 5.4 mm.

Ezetimibe / Simvastatin SUN 10 mg/40 mg tablets are non-coated, white to off-white capsule-shaped tablets, engraved with the code "F" on one side and smooth on the other. Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.
The tablets have a length of approximately 13.80 mm and a width of approximately 6.00 mm.

Ezetimibe / Simvastatin is presented in unit dose blisters (OPA/ Al / PVC / Al).

Packaging size: 14, 21, 28, 30, 50, 56, 84, 90, 98, 100 or 112 tablets

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sun Pharmacutical Industries Europe B.V

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

Responsible manufacturer

Alkaloida Chemical Company Zrt

Kabay János u.29, Tiszavasvári, H-4440,

Hungary

O

Terapia SA

Str. Fabricii nr. 124, Cluj-Napoca, 400 632,

Romania

O

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH, Hoofddorp,

Netherlands

O

FACTORY BENNETT PHARMACEUTICALS S.A.

Aigaiou 26, Thesi Karela,

Koropi Attiki, 19441,

Greece

Last review date of this leaflet: September 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es