EZETIMIBE VISO FARMACEUTICA 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ezetimibe Viso Farmacéutica 10 mg Tablets EFG

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

• Keep this leaflet, 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is Ezetimibe Viso Farmacéutica and what is it used for
2. What you need to know before you take Ezetimibe Viso Farmacéutica
3. How to take Ezetimibe Viso Farmacéutica
4. Possible side effects
5. Storage of Ezetimibe Viso Farmacéutica
6. Contents of the pack and further information

1. What is Ezetimibe Viso Farmacéutica and what is it used for

Ezetimibe Viso Farmacéutica is a medicine used to lower high levels of cholesterol.

Ezetimibe Viso Farmacéutica reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and substances called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in Ezetimibe Viso Farmacéutica, works by reducing the amount of cholesterol absorbed in the gut.

Ezetimibe Viso Farmacéutica adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol produced by the body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This reduction or blockage of blood flow 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 the blood that can increase the risk of heart disease.

Ezetimibe Viso Farmacéutica is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe Viso Farmacéutica is used in combination with a low-cholesterol diet if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous and non-familial]):
• • in combination with a statin, when your cholesterol level is not well controlled with a statin alone
  • alone, when statin treatment is not suitable or not tolerated
• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia), which can lead to high levels of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

• a rare inherited disorder (homozygous sitosterolaemia or phytosterolaemia) that leads to high levels of plant sterols in the blood. If you have heart disease, Ezetimibe Viso Farmacéutica in combination with statins, reduces the risk of heart attack, stroke, the need for heart surgery, or hospitalization for chest pain.

Ezetimibe Viso Farmacéutica does not help you lose weight.

2. What you need to know before you take Ezetimibe Viso Farmacéutica

If you are taking Ezetimibe Viso Farmacéutica with a statin, please read the package leaflet that comes with that medicine.

Do not take Ezetimibe Viso Farmacéutica if:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (see section 6: Contents of the pack and further information).

Do not take Ezetimibe Viso Farmacéutica with a statin if:

• you currently have liver problems.
• you are pregnant or breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Viso Farmacéutica.

• Tell your doctor about all your medical conditions, including allergies.

• Your doctor will do a blood testbefore you start taking Ezetimibe Viso Farmacéutica with a statin. This is to check that your liver is working well.

• Your doctor may also want to do blood teststo check your liver again after you start taking Ezetimibe Viso Farmacéutica with a statin.

If you have moderate or severe liver problems, Ezetimibe Viso Farmacéutica is not recommended.

The safety and efficacy of the combined use of ezetimibe and certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist, as the safety and efficacy in this age group are limited. Do not give this medicine to children under 6 years of age, as there is no information in this age group.

Taking Ezetimibe Viso Farmacéutica with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking medicines with any of the following active ingredients:

• cyclosporine(often used in patients with transplanted organs)

• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine(also used to lower cholesterol), as it affects how ezetimibe works.

• fibrates(also used to lower cholesterol)

Pregnancy and breast-feeding

Do not take Ezetimibe Viso Farmacéutica with a statinif you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. If you become pregnant while taking Ezetimibe Viso Farmacéutica with a statin, stop taking both medicines immediately and tell your doctor.

There is no experience of the use of Ezetimibe Viso Farmacéutica with a statin during pregnancy. Consult your doctor before using Ezetimibe Viso Farmacéutica if you are pregnant.

Do not takeEzetimibe Viso Farmacéutica with a statin if you are breast-feeding, as it is not known whether the medicines pass into breast milk.

If you are breast-feeding, do not take Ezetimibe Viso Farmacéutica, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe is not expected to interfere with your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking ezetimibe.

Ezetimibe Viso Farmacéutica contains lactose

Ezetimibe Viso Farmacéutica tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Ezetimibe Viso Farmacéutica contains sodium

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

3. How to take Ezetimibe Viso Farmacéutica

Follow the instructions for administration of this medicine exactly as told by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If you are in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimibe Viso Farmacéutica, you should be following a low-cholesterol diet.
• You should continue with this low-cholesterol diet while taking Ezetimibe Viso Farmacéutica.

The recommended dose is one Ezetimibe Viso Farmacéutica 10 mg tablet once a day by mouth.

Take Ezetimibe Viso Farmacéutica at any time of day. You can take it with or without food.

If your doctor has prescribed Ezetimibe Viso Farmacéutica with a statin, you can take both medicines at the same time. In this case, please read the dosage instructions in the package leaflet of the other medicine.

If your doctor has prescribed Ezetimibe Viso Farmacéutica with another cholesterol-lowering medicine containing the active ingredient cholestyramine or any other medicine containing a bile acid sequestrant, you should take Ezetimibe Viso Farmacéutica at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Viso Farmacéutica than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

If you forget to take Ezetimibe Viso Farmacéutica

Do not take a double dose to make up for forgotten doses, simply take your normal dose of Ezetimibe Viso Farmacéutica at the usual time the next day.

If you stop taking Ezetimibe Viso Farmacéutica

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

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

4. Possible side effects

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

Immediately contact your doctor if you experience pain, tenderness, or weakness of the muscles that you cannot explain.This is because, in rare cases, muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening.

With general use, allergic reactions, including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (requiring immediate treatment), have been reported.

When used alone, the following side effects have been reported:

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

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

In addition, when used with a statin, the following side effects have been reported:

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

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

When used with fenofibrate, the following side effect has been reported:

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

• abdominal pain

In addition, the following side effects have been reported in general use:

dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering and peeling of the skin, sometimes with mouth sores (Stevens-Johnson syndrome); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; low blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe Viso Farmacéutica

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Only for bottles: use within 200 days after first opening of the container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofEzetimibe Viso Farmacéutica

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, sodium lauryl sulfate, sodium croscarmellose, povidone K-30, and magnesium stearate.

Appearance and packaging of the product

Ezetimibe Viso Farmacéutica tablets are white to almost white, capsule-shaped, approximately 8.0 x 4.0 x 2.6 mm in size, flat, uncoated, with beveled edges, marked with a "G" on one face and "44" on the other.

Ezetimibe 10 mg tablets are available in PVC/Aclar-Aluminum blisters containing 14, 28, 30, 50, 90, 98, and 100 tablets, and HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoke Myto

Czech Republic

Pharmadox Healthcare Ltd.

KW20 A Kordin Industrial Park

Paola PLA3000

Malta

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

You can obtain further information on this medicine from the representative of the marketing authorization holder in your country:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Germany:Ezetimibe Glenmark 10 mg Tabletten

Netherlands:Ezetimibe Glenmark 10 mg Tabletten

Czech Republic:Ezetimibe Glenmark 10 mg tablety

Slovakia:Ezetimibe Glenmark 10 mg Tablety

Austria:Ezetimib Glenmark 10 mg Tabletten

Spain:Ezetimiba Viso Farmacéutica 10 mg comprimidos EFG

Finland:Ezetimibe Orion 10 mg tabletti

Date of last revision of this leaflet:January 2024

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