EZETIMIBE KERN PHARMA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ezetimibe Kern Pharma 10 mg EFG Tablets

Ezetimibe

Read the entire 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 is Ezetimibe Kern Pharma and what is it used for
2. What you need to know before taking Ezetimibe Kern Pharma
3. How to take Ezetimibe Kern Pharma
4. Possible side effects
5. Storage of Ezetimibe Kern Pharma
6. Package Contents and Additional Information

1. What is Ezetimibe Kern Pharma and what is it used for

Ezetimibe is a medication to reduce high cholesterol levels.

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

Ezetimibe, the active ingredient in Ezetimibe Kern Pharma, works by reducing the absorption of cholesterol in the digestive tract. Ezetimibe 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 plaque buildup 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 against 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.

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

• high blood cholesterol levels (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 inappropriate 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.

If you have heart disease, ezetimibe 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.

Ezetimibe does not help you lose weight.

2. What you need to know before taking Ezetimibe Kern Pharma

If you are taking Ezetimibe Kern Pharma with a statin, please read the package leaflet of that medication.

Do not take Ezetimibe Kern Pharma if:

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

Do not take Ezetimibe Kern Pharma 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 Ezetimibe Kern Pharma.

• Tell your doctor about all your medical problems, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimibe Kern Pharma with a statin. This is to check if your liver is working properly.
• Your doctor may also want to perform blood tests to check if your liver is working properly after you start taking Ezetimibe Kern Pharma with a statin.

If you have moderate or severe liver problems, Ezetimibe Kern Pharma is not recommended.

The safety and efficacy of the combined use of Ezetimibe Kern Pharma 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 safety and efficacy data are limited. Do not give this medication to children under 6 years old, as there is no information in this age group.

Taking Ezetimiba Kern Pharma with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription. In particular, inform 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 fluindione (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it affects how Ezetimiba Kern Pharma works
• fibrates (also used to reduce cholesterol)

Pregnancy and Breastfeeding

Do not take Ezetimiba Kern Pharma with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimiba Kern Pharma with a statin, stop taking both medications immediately and inform your doctor. There is no experience with the use of Ezetimiba Kern Pharma without a statin during pregnancy. Consult your doctor before using Ezetimiba Kern Pharma if you are pregnant.

Do not take Ezetimiba Kern Pharma 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 Kern Pharma, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

Ezetimiba Kern Pharma 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 Kern Pharma.

Ezetimiba Kern Pharma contains lactose

The tablets of Ezetimiba Kern Pharma 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.

3. How to take Ezetimiba Kern Pharma

Follow the administration instructions of this medication exactly as indicated by your doctor. Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is one 10 mg ezetimibe tablet once a day, orally.

Take ezetimibe at any time of day. You can take it with or without food.

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

If you take more Ezetimiba Kern Pharma than you should

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

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

If you forget to take Ezetimiba Kern Pharma

Do not take a double dose, simply take your normal dose of ezetimibe at the usual time the next day.

If you have any other questions about the use of this product, 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, including isolated cases)

Contact your doctor immediately if you experience pain, tenderness, or unexplained muscle weakness. This is because 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: elevation of some liver function test results (transaminases) or muscle function (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain, flushing; high blood pressure.

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

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

Uncommon: tingling sensation; dry mouth; itching; rash; hives; 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 hives; bulging and reddened rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; gallstones or gallbladder inflammation (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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ezetimiba Kern Pharma

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

Do not use this medication after the expiration date shown on the carton or packaging after EXP. The expiration date is the last day of the month indicated.

Store in the original package to protect the product from moisture. Do not remove the tablet from the blister pack until you are ready to take it.

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

6. Package Contents and Additional Information

Composition of Ezetimiba Kern Pharma

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, sodium croscarmellose (E468), povidone K30 (E1201), sodium lauryl sulfate (E487), magnesium stearate (E572).

Appearance of the Product and Package Contents

The tablets of Ezetimiba Kern Pharma are capsule-shaped, white or almost white, engraved with "E 10" on one side and nothing on the other side. The dimensions of the tablets are 8.1 x 4.1 mm.

Package sizes:

Ezetimiba Kern Pharma 10 mg is available in 14, 28, 30, 56, 98, or 100 tablets in blister packs.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 Palau-Solità i Plegamans

(Barcelona) – Spain

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

Netherlands: Ezetimibe Noucor 10 mg tablets

Bulgaria: Ezetimibe Noucor 10 mg tablets

Greece: DELIPID 10 mg tablets

Romania: Ezetimib Noucor 10 mg tablets

Spain: Ezetimiba Kern Pharma 10 tablets

Date of the last revision of this package leaflet: January 2018.

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