Package Leaflet: Information for the User

Ezetimiba/Simvastatina Viso Pharmaceutical 10 mg/10 mg Tablets EFG

Ezetimiba/Simvastatina Viso Pharmaceutical 10 mg/20 mg Tablets EFG

Ezetimiba/Simvastatina Viso Pharmaceutical 10 mg/40 mg Tablets EFG

Ezetimiba/Simvastatina Viso Pharmaceutical 10 mg/80 mg Tablets EFG

Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Contents of thePackage Leaflet

1. What isEzetimiba/SimvastatinaViso Pharmaceuticaland what it is used for
2. What you need to know before you start takingEzetimiba/SimvastatinaViso Pharmaceutical
3. How to takeEzetimiba/SimvastatinaViso Pharmaceutical
4. Possible side effects
5. Storage ofEzetimiba/SimvastatinaViso Pharmaceutical

6. Contents of the package and additional information

This medicationcontains the active ingredients ezetimibe and simvastatin.It is used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain types of fat called triglycerides that circulate in the blood. Additionally, it increases the levels of "good" cholesterol (high-density lipoprotein, HDL).

Ezetimibe/simvastatinacts by reducing cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in the digestive tract. The active ingredient simvastatin, 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 composed mainly of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. 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 your blood that can increase the risk of heart disease.

Ezetimibe/simvastatinis used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-lowering diet.

Ezetimibe/simvastatinis used, along with a cholesterol-lowering diet,if you have:

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

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

• heart disease,ezetimibe/simvastatinreduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

This medicationdoes not help you lose weight.

Do not take Ezetimiba/Simvastatina Viso Farmacéutica if:

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

• 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)

• You are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) 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 have a scheduled operation. You may need to stop taking ezetimiba/simvastatina for a short period of time.
• If you are Asian, 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, overweight, and high blood pressure.

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

Avoid the combined use of ezetimiba/simvastatina and fibrates (certain medications to reduce cholesterol), as the combined use of ezetimiba/simvastatina and fibrates 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, which can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of ezetimiba/simvastatina, especially the dose of 10/80 mg. 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 a woman
• If you have ever had muscle problems during treatment with medications that reduce cholesterol 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.

Other medications and Ezetimiba/Simvastatina Viso Farmacéutica

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

• If you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medication. Your doctor will indicate when you can restart the treatment with ezetimiba/simvastatina. The use of ezetimiba/simvastatina with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see 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 principle such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Fibrates with an active principle 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 principle 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 skin and skin structure infections with complications and bacteremia). It is possible that the muscle-related side effects may be greater when this medication is taken during treatment with simvastatina (such as Ezetimiba/Simvastatina Viso Farmacéutica). Your doctor may decide that you 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 mentioned 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 principle 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 Viso Farmacéutica 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 this medication 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 machines

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

Ezetimiba/Simvastatina Viso Farmacéutica contains lactose

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

Ezetimiba/Simvastatina Viso Farmacéutica contains sodium

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

Your doctor will determine the appropriate dose for you, depending on your current treatment and your personal risk situation.

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. In case of 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 old): the dose is1 tabletof ezetimiba/simvastatina once a day by mouth (do not exceed a maximum dose of 10mg/40mg once a day).

The ezetimiba/simvastatina 10mg/80mg dose 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 colestiramine 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 Viso Farmaceuticathan 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 Viso Farmaceutica

• Do not take a double dose to compensate for the missed doses, take your usual amount of Ezetimiba/Simvastatina Viso Farmaceutica at the usual time.

If you interrupt the treatment with Ezetimiba/Simvastatina Viso Farmaceutica

• 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 Viso Farmaceutica).

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

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

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

• Liver function elevation in blood tests; uric acid elevation in the blood; blood clotting time elevation; protein in urine; weight loss
• Dizziness; headache; tingling sensation
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; stomach burning
• Rash; itching; urticaria
• Joint pain; muscle pain, hypersensitivity, weakness, or 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 disorder; difficulty sleeping

Additionally, the following side effects were reported in people taking ezetimiba/simvastatina or medications containing the active principles ezetimiba or simvastatina:

• Low red blood cell count (anemia), reduction of blood cell count, which may 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 intense abdominal pain
• Hepatitis inflammation 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 may cause abdominal pain, nausea, vomiting)
• Hair loss; red, swollen, and sometimes blistered rash, sometimes with target lesions (erythema multiforme)
• Blurred vision and loss of vision (can affect up to 1 in 1000 people)
• Rash or ulcers in the mouth (erythema multiforme) (can affect up to 1 in 10,000 people)
• Hypersensitivity reaction, which may include the following: hypersensitivity (allergic reactions including facial swelling, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing and requires immediate treatment (angioedema), joint pain, inflammation of blood vessels, atypical hematomas, skin rash, 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 severe allergic reaction may occur very rarely (can affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• Muscle pain, sensitivity to pressure, weakness, or muscle cramps; muscle failure; muscle rupture (can affect up to 1 in 10,000 people); tendon problems, sometimes complicated with 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 disorders, 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 ezetimiba/simvastatina treatment (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

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 causes kidney damage; 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 box or in the bottle after the CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Blister: store the blister in the outer packaging to protect it from moisture.

Bottles: keep the bottle perfectly closed and store in the outer packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Ezetimiba/Simvastatina Viso Pharmaceutical

The active principles are ezetimiba and simvastatina. Each tablet contains 10 mg of ezetimiba and 10 mg, 20, 40 mg or 80 mg of simvastatina.

The other components are: lactose monohydrate, microcrystalline cellulose (E 460), hypromellose, croscarmellose sodium (E 468), propyl gallate (E 310), butylated hydroxyanisole (E 320), citric acid monohydrate (E 330), sodium lauryl sulfate, magnesium stearate (E 470b).

See also section 2 “What you need to know before taking Ezetimiba/Simvastatina Viso Pharmaceutical”

Appearance of Ezetimiba/Simvastatina Viso Pharmaceutical and contents of the package

10 mg/ 10 mg:

White to off-white, uncoated tablets in capsule shape, with “G” engraved on one face and “321” on the other face, approximately 8.5 mm in length and 4.25 mm in width.

10 mg/ 20 mg:

White to off-white, uncoated tablets in capsule shape, with “G” engraved on one face and “322” on the other face, approximately 10.7 mm in length and 5.3 mm in width.

10 mg/ 40 mg:

White to off-white, uncoated tablets in capsule shape, with “G” engraved on one face and “323” on the other face, approximately 14.0 mm in length and 6.0 mm in width.

10 mg/ 80 mg:

White to off-white, uncoated tablets in capsule shape, with “G” engraved on one face and “324” on the other face, approximately 17.5 mm in length and 7.5 mm in width.

Ezetimiba/Simvastatina Viso Pharmaceutical 10 mg/10 mg, 10 mg/20 mg, 20 mg/40 mg and 10 mg/80 mg are presented in PVC-Aluminio-OPA / Aluminio blisters of 7, 10, 14, 28, 30, 49, 50, 56, 84, 90, 98, multiple pack containing 98 (2 boxes of 49), 100, 196, 300 or 392 tablets and HDPE bottles of 90 tablets (only Ezetimiba/Simvastatina Viso Pharmaceutical 10 mg/40 mg). The tablets packaged in HDPE bottles include a desiccant that protects the tablets from moisture. The desiccant should not be swallowed.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, Vysoké Mýto

566 17

Czech Republic

O

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola PLA3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Netherlands:Ezetimibe/Simvastatine Glenmark 10 mg/10 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/20 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/40 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/80 mg tablets

Germany:Ezetimibe/Simvastatine Glenmark 10 mg/10 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/20 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/40 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/80 mg tablets

Czech Republic:Glezisim

Slovakia:Glezisim 10 mg/10 mg tablets

Glezisim 10 mg/20 mg tablets

Glezisim 10 mg/40 mg tablets

Glezisim 10 mg/80 mg tablets

Norway:Ezetimib/Simvastatin Glenmark 10 mg/20 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/40 mg tablets

Denmark:Ezetimib/Simvastatin Glenmark

Sweden:Ezetimib/Simvastatin Glenmark 10 mg/10 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/20 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/40 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/80 mg tablets

Last review date of this leaflet: June 2023

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/