EZETIMIBE CINFA 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

ezetimiba cinfa 10 mg tablets EFG

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What ezetimiba cinfa is and what it is used for

ezetimiba cinfa is a medication to reduce high levels of cholesterol.

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

Ezetimiba works by reducing the amount of cholesterol absorbed in the digestive tract. Ezetimiba adds to the cholesterol-lowering effect of statins, a group of medications that reduce cholesterol produced by the body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists 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 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 heart disease.

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

It is used in patients who cannot control their cholesterol levels with diet alone. While taking this medication, you should follow a cholesterol-reducing diet.

Ezetimiba is used in combination with a cholesterol-reducing diet if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [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 appropriate or not tolerated
• a hereditary disease (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You will also be prescribed a statin and may be prescribed other treatments.
• a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

If you have heart disease, ezetimiba combined with cholesterol-lowering medications called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

ezetimiba cinfa does not help you lose weight.

2. What you need to know before taking ezetimiba cinfa

If you take ezetimiba with a statin, please read the package leaflet of that medication.

Do not take ezetimiba cinfa

• If you are allergic to ezetimiba or any of the other ingredients of this medication (listed in section 6).

Do not take ezetimiba cinfa with a statin

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take ezetimiba cinfa.

• Tell your doctor about all your medical problems, including allergies.
• Your doctor will perform a blood test before you start taking ezetimiba with a statin. This is to check that your liver is in good condition.
• Your doctor may also want to perform blood tests to check your liver condition again after you start taking ezetimiba with a statin.

If you have moderate or severe liver problems, ezetimiba is not recommended.

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

Children and adolescents

Do not give this medication to children and adolescents (6 to 17 years old) unless it has been prescribed by a specialist, as the data on safety and efficacy are limited.

Do not give this medication to children under 6 years old, as there is no information in this age group.

Other medications and ezetimiba cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• cyclosporine (often used in patients with organ transplants)
• medications with an active ingredient to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or flindione (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it affects how ezetimiba works
• fibrates (also used to reduce cholesterol).

Pregnancy and breastfeeding

Do not take ezetimiba with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ezetimiba with a statin, stop taking both medications immediately and consult your doctor. There is no experience with the use of ezetimiba with a statin during pregnancy. Consult your doctor before using ezetimiba if you are pregnant.

Do not take ezetimiba with a statin if you are breastfeeding, as it is unknown whether the medications pass into breast milk. If you are breastfeeding, do not take ezetimiba, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

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

ezetimiba cinfa 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 cinfa contains sodium.

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

3. How to take ezetimiba cinfa

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist.

Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimiba, you should be following a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing diet while taking ezetimiba.

The recommended dose is one ezetimiba cinfa 10 mg tablet once a day by mouth. Take ezetimiba at any time of day. You can take it with or without food.

If your doctor has prescribed ezetimiba with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of the medication.

If your doctor has prescribed ezetimiba with another cholesterol-reducing medication that contains the active ingredient cholestyramine or any other medication that contains a bile acid sequestrant, you should take ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more ezetimiba cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the package and package leaflet of the medication to the healthcare professional.

If you forget to take ezetimiba cinfa

Do not take a double dose to make up for forgotten doses; simply take your normal dose of ezetimiba at the usual time the next day.

If you stop taking ezetimiba cinfa

Talk to 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following terms are used to describe how often side effects have been reported:

• Very common (may affect more than 1 in 10 patients).
• Common (may affect up to 1 in 10 patients).
• Uncommon (may affect up to 1 in 100 patients).
• Rare (may affect up to 1 in 1,000 patients).
• Very rare (may affect up to 1 in 10,000 patients).

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

In 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: Abdominal pain; diarrhea; gas and feeling of tiredness.

Uncommon: Elevated results of some liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; flushing.

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

Common: Elevated results of some liver function tests (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon: Tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially in hands and feet.

When used with fenofibrate, the following common side effect has been reported: abdominal pain.

In addition, the following side effects have been reported in general use: dizziness; muscle pain; liver problems; allergic reactions, including rash and urticaria; blistering and reddening of the skin, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of ezetimiba cinfa

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Dispose of the package and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Contents of the pack and further information composition of ezetimiba cinfa.

Composition of ezetimiba cinfa

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium croscarmellose, and sodium stearyl fumarate.

Appearance of the product and contents of the pack

White, flat, beveled, oblong tablets marked with the code "EZ1" and dimensions of 8.2 x 4.1 +/- 0.5 mm.

They are presented in aluminum/aluminum blisters. Each package contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Laboratorios Cinfa, S.A.

Avda. de Roncesvalles, s/n

31699 Olloki (Navarra), Spain

Date of the last revision of this package leaflet:November 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80305/P_80305.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80305/P_80305.html