Ezetimiba viso farmaceutica 10 mg comprimidos efg

Prospect: information for the patient

Ezetimiba Viso Pharmaceutical 10 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people 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 prospect. See section 4.

Content of theprospect

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

2.What you need to know before starting totake Ezetimiba Viso Pharmaceutical

3.How to take Ezetimiba Viso Pharmaceutical

4.Possible adverse effects

5.Storage of Ezetimiba Viso Pharmaceutical

6.Contents of the package and additional information

Ezetimiba Viso Farmacéutica is a medication to reduce elevated levels of cholesterol.

Ezetimiba Viso Farmacéutica reduces total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba Viso Farmacéutica increases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active ingredient of Ezetimiba Viso Farmacéutica tablets, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimiba Viso Farmacéutica adds to the effect of lowering cholesterol of statins, a group of medications that reduce 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 cholesterol.

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 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 heart disease.

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

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

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

• elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]):
• • with a statin, when your cholesterol level is not well controlled with a statin alone
  • alone, when statin treatment is inappropriate or not tolerated
• a genetic disorder (known as familial homozygous hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

• a genetic disorder (known as homozygous sitosterolemia or phytosterolemia) that increases levels of plant sterols in the blood. If you have heart disease, Ezetimiba Viso Farmacéutica combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimiba Viso Farmacéutica does not help you lose weight.

If you take Ezetimiba Viso Farmacéutica with a statin, please read the prospectus of that medication.

Do not take Ezetimiba Viso Farmacéutica if:

• You are allergic (hypersensitive) to ezetimiba or to any of the other components of this medication (see section 6: Contents of the package and additional information).

Do not take Ezetimiba Viso Farmacéutica with a statin if:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba Viso Farmacéutica.

• Inform your doctor of all your medical problems, including allergies.

• Your doctor will make ablood testbefore you start takingEzetimiba Viso Farmacéutica with a statin. This is to check that your liver is in good condition.

• Your doctor may also want to make ablood testto check your liver again after you start takingEzetimiba Viso Farmacéutica with a statin.

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

The safety and efficacy of the combined use of ezetimiba and certain medications to reduce cholesterol, fibrates, have not been studied.

Children and adolescents

Do not administer this medication to children and adolescents (6 to 17 years old) unless a specialist has prescribed it, as the safety and efficacy information in this age group is limited. Do not administer this medication to children under 6 years old, as there is no information in this age group.

Taking Ezetimiba Viso Farmacéutica with other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecently or may have to take any other medication.

Especially, inform your doctor if you are taking medications with any of the following active ingredients:

• ciclosporina(often used in patients with organ transplants)

• Medications with an active ingredient toprevent blood clots, such as warfarin, fenprocomon, acenocoumarol or fluindione (anticoagulants)
• colestiramine,(alsousedto reduce cholesterol), because they affect how ezetimiba works.

• fibrates(alsousedto reduce cholesterol)

Pregnancy and breastfeeding

Do not take Ezetimiba 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 Ezetimiba Viso Farmacéutica with a statin, stop taking both medications immediately and inform your doctor.

The use of Ezetimiba Viso Farmacéutica with a statin during pregnancy has not been studied. Consult your doctor before using Ezetimiba Viso Farmacéutica if you are pregnant.

Do not takeEzetimiba Viso Farmacéutica with a statin if you are breastfeeding, as it is unknown if the medications pass into breast milk.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Ezetimiba Viso Farmacéutica contains lactose

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

Ezetimiba Viso Farmacéutica contains sodium

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

Follow exactly the administration instructionsof this medicationindicated by your doctor.Continue taking your other medications to lower cholesterol unless your doctor tells you to stop. In case of doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba Viso Farmacéutica, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing dietwhile taking Ezetimiba Viso Farmacéutica.

The recommended dose is one Ezetimiba Viso Farmacéutica 10 mg tablet once a day taken orally.

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

If your doctor has prescribed Ezetimiba Viso Farmacéutica along with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions in the medication package insert.

If your doctor has prescribed Ezetimiba Viso Farmacéutica along withanother cholesterol-lowering medication that contains the active ingredientcolestiramine or any other medication that contains 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

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Ezetimiba Viso Farmacéutica

Do not take a double dose to make up for the missed dose, simply take your usual amount of Ezetimiba Viso Farmacéutica at the usual time the next day.

If you interrupt treatment with Ezetimiba Viso Viso Farmacéutica

Speak with your doctor or pharmacist as your cholesterol levels may increase again.

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

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

Contact your doctor immediately if you experience pain, sensitivity to pressure, or unexplained muscle weakness.This is because, in rare cases, muscle problems, including muscle degradation that causes kidney damage, can be serious andpotentially life-threatening.

General use has reported allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate treatment).

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

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

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

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

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

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

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

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

• abdominal pain.

In addition, in general use, the following side effects have been reported::dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; swollen and inflamed skin lesions, sometimes with target-shaped lesions (erythema multiforme); muscle pain, sensitivity to pressure, ormuscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduction in blood cell count, which may cause bruising or bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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 medicine.

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

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofEzetimiba Viso Pharmaceutical

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

Appearance of the product and contents of the package

Ezetimiba Viso Pharmaceutical tablets are white to almost white, in capsule form, approximately 8.0 x 4.0 x 2.6 mm in size, flat, non-coated with beveled edges marked with a “G” on one face 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 HDPE bottles of 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing:

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

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with 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 last review of this prospectus:January 2024

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/)