Introduction

Package Leaflet: Information for the User

Ezetimibe Kern Pharma 10 mg Tablets EFG

Ezetimibe

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 pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Ezetimibe Kern Pharma and what it is 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. Contents of the pack and additional information

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

Ezetimibe is a medication to reduce elevated levels of cholesterol.

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

Ezetimibe, the active ingredient of Ezetimibe Kern Pharma, acts by reducing the cholesterol absorbed in the digestive tract. Ezetimibe is added to the effect of lowering 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.

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 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 myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and protects against cardiovascular diseases.

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

Ezetimibe 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.

If you have cardiovascular disease, ezetimibe combined with medications to lower cholesterol, called statins, reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimibe does not help reduce weight.

2. What you need to know before starting to take Ezetimiba Kern Pharma

If you are taking Ezetimiba Kern Pharma with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba Kern Pharma if:

You are allergic to ezetimiba or to any of the other ingredients of this medicine (listed in section 6).

Do not take Ezetimiba 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 Ezetimiba Kern Pharma.

Inform your doctor of all your medical conditions, including allergies.
Your doctor will do a blood test before you start taking Ezetimiba Kern Pharma with a statin to check if your liver is working properly.
Your doctor may also want to do blood tests to check if your liver is working properly after you start taking Ezetimiba Kern Pharma with a statin.

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

The safety and efficacy of the combined use of Ezetimiba Kern Pharma and certain cholesterol-lowering medications, fibrates, have not been studied.

Children and adolescents

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

Taking Ezetimiba Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

Ciclosporin (often used in organ transplant patients)
Medicines with an active ingredient to prevent blood clots, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants)
Colestiramine (also used to lower cholesterol), as it affects how Ezetimiba Kern Pharma works
Fibrates (also used to lower 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 medicines 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 medicines 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 medicine.

Driving and operating machinery

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

Ezetimiba Kern Pharma contains lactose

The Ezetimiba Kern Pharma tablets contain a sugar called lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

3. How to Take Ezetimiba Kern Pharma

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 10 mg ezetimiba 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 cholestyramine 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 Kern Pharma than you should

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

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

If you forgot to take Ezetimiba Kern Pharma

Do not take a double dose, simply take your usual amount of ezetimiba at the usual dose the next day.

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

4. Possible Adverse Effects

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, including isolated cases)

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:increased 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, warmth; high blood pressure.

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

Common: increased results of 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; arm and leg pain; 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 skin, 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 severe abdominal pain; constipation; reduced 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 of 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.

5. Conservation of Ezetimiba Kern Pharma

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

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

Store in the original packaging to protect the product from moisture. Do not remove the tablet from the blister pack until it is to be taken.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Ezetimiba Kern Pharma

- The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.

- The other components are: lactose monohydrate, croscarmellose sodium (E468), povidone K30 (E1201), sodium lauryl sulfate (E487), magnesium stearate (E572).

Appearance of the product and contents of the packaging

Ezetimiba Kern Pharma tablets are capsule-shaped, white or off-white in color, engraved with “E 10” on one face and nothing on the other face. The dimensions of the tablets are 8.1 x 4.1 mm.

Packaging sizes:

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible manufacturer:

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 Palau-Solità i Plegamans

(Barcelona) – Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands: Ezetimibe Noucor 10 mg tabletten

Bulgaria: Ezetimibe Noucor 10 mg tablets

Greece: DELIPID 10 mg δισκ?α

Romania: Ezetimib Noucor 10 mg comprimate

Spain: Ezetimiba Kern Pharma 10 comprimidos

Last review date of this leaflet: January 2018.

More detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es