Ezetimibe/simvastatin Sun 10 mg/20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe/Simvastatin SUN 10 mg/20 mg tablets EFG

Ezetimibe/Simvastatin SUN 10 mg/40 mg tablets EFG

Ezetimibe and simvastatin

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ezetimibe/Simvastatin SUN is and what it is used for

2. What you need to know before taking Ezetimibe/Simvastatin SUN

3. How to take Ezetimibe/Simvastatin SUN

4. Possible adverse effects

5. How to store Ezetimibe/Simvastatin SUN

6. Contents of the pack and other information

1. What Ezetimibe/Simvastatin SUN is and what it is used for

Ezetimibe/Simvastatin SUN contains the active substances ezetimibe and simvastatin. Ezetimibe/Simvastatin is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, Ezetimibe/Simvastatin increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/Simvastatin works to reduce cholesterol in two ways. The active substance ezetimibe reduces the cholesterol absorbed through the digestive tract. The active substance simvastatin, which belongs to the group of "statins," inhibits the body's own production of cholesterol.

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

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage can lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and protects against heart disease.

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

Ezetimibe/Simvastatin is used in patients who cannot control their cholesterol levels through diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Ezetimibe/Simvastatin is used, together with a cholesterol-lowering diet, if you have:

• elevated blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated blood levels of fatty substances (mixed hyperlipidemia):

• that are not well controlled with a statin alone

• for whom a statin and ezetimibe have previously been used as separate tablets

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease; Ezetimibe/Simvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/Simvastatin does not help you lose weight.

2. What you need to know before starting to take Ezetimibe/Simvastatin SUN

Do not take Ezetimibe/Simvastatin SUN if

• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6. Contents of the container and additional information)

• you currently have liver problems

• you are pregnant or breastfeeding

• you are taking medications containing one or more of the following active substances:

• Ribociclib (used to treat breast cancer)

• Palbociclib (used to treat breast cancer)

• Itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)

• Erythromycin, clarithromycin, or telithromycin (used to treat infections)

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections)

• Boceprevir or telaprevir (used to treat hepatitis C virus infection)

• Nefazodone (used to treat depression)

• Cobicistat

• Gemfibrozil (used to lower cholesterol)

• Cyclosporine (used in organ transplant patients)

• 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 an oral or injectable medication called fusidic acid (a medication for bacterial infections). The combination of fusidic acid and Ezetimibe/Simvastatin may cause serious muscle problems (rhabdomyolysis).

Do not take more than 10/40 mg of Ezetimibe/Simvastatin if you are taking lomitapide (used to treat rare, severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medication is listed above.

Warnings and precautions

Inform your doctor:

• about all your medical conditions, including allergies.
• if you consume large amounts of alcohol or have ever had liver disease. Ezetimibe/Simvastatin may not be suitable for you.
• if you are scheduled for surgery. You may need to temporarily stop taking Ezetimibe/Simvastatin tablets.
• if you are of Asian descent, as you may require a different dose.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking Ezetimibe/Simvastatin and may also do so if you develop symptoms of liver problems while taking Ezetimibe/Simvastatin. This is to monitor your liver function.

Your doctor may also want to perform blood tests to monitor your liver function after you start treatment with Ezetimibe/Simvastatin.

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

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

The combined use of Ezetimibe/Simvastatin and fibrates (certain cholesterol-lowering medications) should be avoided, as the combination has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, pressure, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of Ezetimibe/Simvastatin, especially the 10/80 mg dose. The risk of muscle breakdown 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 while being treated with cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate)
• if you or your close relatives have an inherited muscle disorder

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

Ezetimibe/Simvastatin is not recommended for children under 10 years of age.

Taking Ezetimibe/Simvastatin SUN with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines containing any of the following active substances. Taking Ezetimibe/Simvastatin tablets with any of the following medicines may increase the risk of muscle problems (some of which are already listed in the section above “Do not take Ezetimibe/Simvastatin SUN if”).

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Ezetimibe/Simvastatin treatment. Taking Ezetimibe/Simvastatin with fusidic acid may very rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

• Ribociclib (used to treat breast cancer)

• Palbociclib (used to treat breast cancer)

• Cyclosporine (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)

• Medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)

• Fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol)

• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)

• Hepatitis C antivirals such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)

• Nefazodone (used to treat depression)

• Medicines containing the active substance 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 conditions)

• Lomitapide (used to treat rare, severe genetic cholesterol disorders)

• Daptomycin (a medicine used to treat complicated skin infections, structural skin infections, and bacteremia). Adverse reactions affecting the muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., Ezetimibe/Simvastatin tablets). Your doctor may decide that you should temporarily stop taking Ezetimibe/Simvastatin tablets

• High doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol)

• Colchicine (used to treat gout)

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

• Medicines containing active substances used to prevent blood clotting, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants)
• Colestipol or colestyramine (also used to lower cholesterol), as they affect how Ezetimibe/Simvastatin works
• Fenofibrate (also used to lower cholesterol)
• Rifampicin (used to treat tuberculosis)
• Ticagrelor (an antiplatelet medicine)

You should also inform any doctor who prescribes you a new medicine that you are taking Ezetimibe/Simvastatin.

Taking Ezetimibe/Simvastatin SUN with food and drinks

Grapefruit juice contains one or more components that alter the metabolism of certain medicines, including Ezetimibe/Simvastatin. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimibe/Simvastatin is not expected to interfere with your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Ezetimibe/Simvastatin.

Ezetimibe/Simvastatin SUN contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Ezetimibe/Simvastatin SUN contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per tablet; therefore, it is essentially “sodium-free.”

3. How to take Ezetimiba/Simvastatina SUN

Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your individual risk situation.

The tablets do not have a score line and must not be divided.

Always follow exactly the instructions for use given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba/Simvastatina, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking Ezetimiba/Simvastatina.

Adults: the dose is 1 tablet of Ezetimiba/Simvastatina tablets once daily by oral administration.

Use in adolescents (10 to 17 years of age): the dose is 1 tablet of Ezetimiba/Simvastatina tablets once daily by oral administration (a maximum dose of 10 mg/40 mg once daily must not be exceeded).

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

Take Ezetimiba/Simvastatina in the evening. It may be taken with or without food.

If your doctor has prescribed Ezetimiba/Simvastatina together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must take Ezetimiba/Simvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Simvastatina SUN than you should

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

If you forget to take Ezetimiba/Simvastatina SUN

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

If you stop taking Ezetimiba/Simvastatina SUN

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

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

4. Possible adverse effects

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

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

• muscle pain
• increases in blood laboratory tests of liver function (transaminases) and/or muscle function (CK)

The following uncommon adverse effects have been reported (may affect up to 1 in 100 people):

• increased liver function in blood tests; elevated blood uric acid levels; prolonged blood clotting time; protein in urine; weight loss
• dizziness; headache; tingling sensation
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhoea; dry mouth; heartburn
• rash; itching; urticaria
• joint pain, muscle pain, tenderness, weakness or muscle spasms; neck pain; pain in arms and legs; back pain
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• sleep disorders; difficulty sleeping

Adverse reactions with unknown frequency:

• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, may affect the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).
• Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported in patients taking Ezetimiba/Simvastatina or medicines containing the active substances ezetimibe or simvastatin:

• low red blood cell count (anaemia), reduced blood cell count which may cause bruising/bleeding (thrombocytopenia)
• numbness or weakness in arms and legs; memory impairment, memory loss, confusion
• respiratory problems including persistent cough and/or difficulty breathing or fever
• constipation
• inflammation of the pancreas, often with severe abdominal pain
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale stools, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• hair loss; red, raised rash, sometimes with target-like skin lesions (erythema multiforme)
• blurred vision and deterioration of vision (may affect up to 1 in 1,000 people)
• skin rash or mouth ulcers (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people)
• hypersensitivity reactions which may include: allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing and require immediate treatment (angioedema); joint pain or swelling; inflammation of blood vessels; atypical bruising; skin rashes and swelling; urticaria; skin sensitivity to sunlight; fever; hot flushes; breathing difficulties; general malaise; pseudolupus syndrome (including skin rash, joint disorders and effects on white blood cells). A very rare allergic reaction (may affect up to 1 in 10,000 people) causing difficulty breathing or dizziness and requiring immediate treatment (anaphylaxis) may occur.
• muscle pain, tenderness, weakness or cramps; muscle breakdown; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• gynaecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people)
• decreased appetite
• hot flushes; high blood pressure
• pain
• erectile dysfunction
• depression
• changes in certain blood tests of liver function

The following additional adverse events have been reported with some statins:

• sleep disorders, including nightmares
• sexual dysfunction
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• persistent muscle pain, tenderness or weakness, which may not resolve after stopping treatment with Ezetimiba/Simvastatina (frequency not known).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness, as muscle problems, although rarely, can be serious and may include muscle breakdown leading to kidney failure; and very rarely, deaths have been reported.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor, pharmacist or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe/Simvastatin SUN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or blister after [EXP].
• Do not store Ezetimibe/Simvastatin tablets above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Simvastatina SUN

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

The other components are: butyl 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 contents of the pack

Ezetimiba / Simvastatina SUN 10 mg/20 mg tablets are uncoated tablets, white to off-white, capsule-shaped, 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.

Ezetimiba / Simvastatina SUN 10 mg/40 mg tablets are uncoated tablets, white to off-white, capsule-shaped, 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.

Ezetimiba / Simvastatina is available in unit dose blisters (OPA/Al/PVC/Al). Pack sizes: 14, 21, 28, 30, 50, 56, 84, 90, 98, 100 or 112 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

Manufacturer

Alkaloida Chemical Company Zrt

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

Hungary

Or

Terapia SA

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

Romania

Or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH, Hoofddorp,

The Netherlands

Or

FACTORY BENNETT PHARMACEUTICALS S.A.

Aigaiou 26, Thesi Karela,

Koropi Attiki, 19441,

Greece

Date of the most recent revision of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es