Ezetimibe Viso Farmaceutica 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ezetimiba Viso Farmacéutica 10 mg tablets EFG

Read the entire 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 other people, 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 these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ezetimiba Viso Farmacéutica is a medicine used to reduce elevated cholesterol levels.

Ezetimiba Viso Farmacéutica reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat substances called triglycerides circulating in the blood. In addition, Ezetimiba Viso Farmacéutica increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba Viso Farmacéutica tablets, works by reducing the cholesterol absorbed through the digestive tract.

Ezetimiba Viso Farmacéutica complements the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.

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 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. This interruption in blood flow may 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.

Ezetimiba Viso Farmacéutica is used in patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Ezetimiba Viso Farmacéutica is used together with a cholesterol-lowering diet if you have:

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]):

  • in combination with a statin, when your cholesterol level is not well controlled by a statin alone
  • as monotherapy, when treatment with a statin is inappropriate or not tolerated

• a hereditary disease (known as homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may also be prescribed other treatments.

• a hereditary disease (known as homozygous sitosterolemia or phytosterolemia) that increases levels of plant sterols in the blood. If you have heart disease, Ezetimiba Viso Farmacéutica in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba Viso Farmacéutica does not help you lose weight.

2. What you need to know before you start taking Ezetimiba Viso Farmacéutica

If you are taking Ezetimiba Viso Farmacéutica together with a statin, please read the leaflet of that medicine.

Do not take Ezetimiba Viso Farmacéutica if:

• you are allergic (hypersensitive) to ezetimiba or to any of the other ingredients of this medicine (see section 6: Package contents and other information).

Do not take Ezetimiba Viso Farmacéutica together with a statin if:

• you currently have liver problems.
• you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ezetimiba Viso Farmacéutica.

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

• Your doctor will perform a blood test before you start taking Ezetimiba Viso Farmacéutica with a statin. This is to check that your liver is functioning properly.

• Your doctor may also want to carry out blood tests to monitor your liver function after you start taking Ezetimiba Viso Farmacéutica with a statin.

Ezetimiba Viso Farmacéutica is not recommended if you have moderate or severe liver problems.

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

Children and adolescents

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

Taking Ezetimiba Viso Farmacéutica with other medicines

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• ciclosporine (often used in organ transplant patients)

• medicines containing an active substance to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)

• cholestyramine (also used to lower cholesterol), as these affect how ezetimiba works.

• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

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

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

Do not take Ezetimiba Viso Farmacéutica with a statin if you are breastfeeding, as it is unknown whether the medicines pass into breast milk.

If you are breastfeeding, you should not take Ezetimiba Viso Farmacéutica, even without taking a statin. Consult your doctor.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimiba is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking ezetimiba.

Ezetimiba Viso Farmacéutica contains lactose

Ezetimiba Viso Farmacéutica tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Ezetimiba Viso Farmacéutica contains sodium

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

3. How to take Ezetimiba Viso Farmacéutica

Follow exactly the instructions for use of this medicine as given by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba Viso Farmacéutica, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking Ezetimiba Viso Farmacéutica.

The recommended dose is one 10 mg Ezetimiba Viso Farmacéutica tablet once daily by oral administration.

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

If your doctor has prescribed Ezetimiba Viso Farmacéutica together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions in the leaflet of the statin medicine.

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

If you take more Ezetimiba Viso Farmacéutica than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Ezetimiba Viso Farmacéutica

Do not take a double dose to make up for missed doses. Simply take your usual dose of Ezetimiba Viso Farmacéutica at the regular time the next day.

If you stop taking Ezetimiba Viso Farmacéutica

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems—including muscle breakdown leading to kidney damage—can be serious and potentially life-threatening.

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

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

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

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

Additionally, when used in combination with a statin, the following adverse effects have been reported:

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

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

When used in combination with fenofibrate, the following adverse reaction has been reported

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

• abdominal pain.

Additionally, the following adverse reactions have been reported during general use: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised and red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness to pressure or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often with severe abdominal pain; constipation; reduction in blood cell counts, which may lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of adverse reactions: If you experience any adverse reaction, talk to your doctor or pharmacist, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba Viso Farmacéutica

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

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

This medicine does not require any special storage conditions.

For bottles only: use within 200 days after first opening the container.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba Viso Farmacéutica

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

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible:

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer Responsible:

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

Further information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states 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 the most recent review of this leaflet: January 2024

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