Package Leaflet: Information for the Patient

Ezetimibe Cinfa 10 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.

Ezetimiba Cinfa is a medication to reduce elevated levels of cholesterol.

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

Ezetimiba acts by reducing the cholesterol absorbed in the digestive tract. Ezetimiba combines with the effect to lower cholesterol from 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 its arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make the blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps to prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

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

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

Ezetimiba is used in combination with a cholesterol-reducing 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 hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may also 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 cardiovascular disease, ezetimiba combined with medications to lower cholesterol called statins, reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimiba Cinfa does not help to reduce weight.

If you take ezetimiba with a statin, please read the leaflet for that medicine.

Do not take ezetimiba cinfa.

• If you are allergic to ezetimiba or any of the other ingredients in this medicine (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.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will do 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 do blood tests to check your liver again after you start taking ezetimiba with a statin.

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

The safety and efficacy of using ezetimiba with certain cholesterol-lowering medicines, such as fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years old) unless prescribed by a specialist, as the safety and efficacy data are limited.

Do not administer this medicine to children under 6 years old, as there is no information available for this age group.

Other medicines and ezetimiba cinfa

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

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

• ciclosporin (often used in organ transplant patients)
• blood-thinning medicines, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how ezetimiba works
• fibrates (also used to lower 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 medicines immediately and inform 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 medicines 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 using any medicine.

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 cinfa contains lactose.

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Ezetimiba cinfa contains sodium.

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

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

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

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

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

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

If your doctor has prescribed ezetimiba along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you must 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take ezetimiba cinfa

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

If you interrupt treatment with ezetimiba cinfa

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.

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).

Immediately contact your doctor 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 severe and potentially life-threatening.

In general use, allergic reactions have been reported, 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:

Common:Abdominal pain; diarrhea; gas and feeling of fatigue.

Uncommon:Elevation of results from 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, warmth; high blood pressure.

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

Common:Elevation of results from some liver function tests (transaminases); headache; muscle pain; sensitivity to pressure or weakness.

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

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

Additionally, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; swollen and inflamed patches, sometimes with target lesions (erythema multiforme); muscle pain, sensitivity to pressure, or muscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with intense abdominal pain; constipation; reduction in blood cell count, which may cause hematoma/hemorrhage (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 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.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of ezetimiba cinfa

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

Appearance of the product and contents of the packaging

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

Presented in aluminum/aluminum blisters. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

or

Cinfa Laboratories, S.A.

Roncesvalles Avenue, s/n

31699 Olloki (Navarra), Spain

Last review date of this leaflet:November 2021

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/.

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the leaflet and packaging. 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