Ezetimibe Kern Pharma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ezetimibe Kern Pharma 10 mg tablets EFG

Ezetimibe

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ezetimibe Kern Pharma is 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 adverse effects
5. How to store Ezetimibe Kern Pharma
6. Contents of the pack and other information

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

Ezetimibe is a medicine used to reduce elevated cholesterol levels.

Ezetimibe lowers the blood concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. In addition, ezetimibe increases the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in Ezetimiba Kern Pharma, works by reducing the amount of cholesterol absorbed from the digestive tract. Ezetimibe complements the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage may result in a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and protects against heart disease.

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

This medicine is used in patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Ezetimibe is used together with a cholesterol-lowering diet if you have:

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])

  • in combination with a statin, when your cholesterol level is not well controlled with a statin alone
  • alone, when treatment with a statin is inappropriate or not tolerated

• a hereditary condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You will also be prescribed a statin, and possibly other treatments as well.

If you have heart disease, ezetimibe in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe does not help you lose weight.

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

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

Do not take Ezetimiba Kern Pharma if:

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

Do not take Ezetimiba Kern Pharma together with a statin if:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ezetimiba Kern Pharma.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimiba Kern Pharma with a statin. This is to check whether your liver is functioning properly.
• Your doctor may also want to carry out blood tests to monitor your liver function after you start taking Ezetimiba Kern Pharma with a statin.

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

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

Children and adolescents

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

Taking Ezetimiba Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (often used in organ transplant patients)
• medicines containing an active ingredient used to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestyramine (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, you should not take Ezetimiba Kern Pharma, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimiba Kern Pharma is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Ezetimiba Kern Pharma.

Ezetimiba Kern Pharma contains lactose

Ezetimiba Kern Pharma tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ezetimiba Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimiba, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba.

The recommended dose is one 10 mg ezetimiba tablet once daily, taken by mouth.

Take ezetimiba at any time of day. It can be taken with or without food.

If your doctor has prescribed ezetimiba together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions in the leaflet of the statin medicine.

If your doctor has prescribed ezetimiba together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing 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

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone 91.562.04.20, indicating the medicine and the amount taken.

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

If you forget to take Ezetimiba Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following terms are used to describe how frequently adverse effects have been reported:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people, including isolated cases)

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

In general use, allergic reactions have been reported, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment).

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

Common: abdominal pain; diarrhoea; gas; feeling tired.

Uncommon: increased results in certain liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasm; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure.

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

Common: increased results in certain liver function tests (transaminases);
headache; muscle pain; tenderness or 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 together with fenofibrate, the following common adverse effect has been reported: abdominal pain.

Additionally, in general use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised and red rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba Kern Pharma

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

Do not use this medicine after the expiry date stated on the carton or container after EXP. The expiry 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 just before taking it.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba Kern Pharma

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

Appearance of the product and contents of the pack

Ezetimiba Kern Pharma tablets are capsule-shaped, white or almost white, engraved with "E 10" on one side and blank on the other side. The dimensions of the tablets are 8.1 x 4.1 mm.

Pack sizes:

Ezetimiba Kern Pharma 10 mg is supplied in blisters containing 14, 28, 30, 56, 98 or 100 tablets.

Only some pack 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 medicinal product is authorized in the Member States of the European Economic Area under 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

Date of the most recent revision of this leaflet: January 2018.

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