Ezetimibe Krka 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ezetimibe Krka 10 mg tablets EFG

Read all of this 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 should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ezetimibe Krka is and what it is used for
2. What you need to know before taking Ezetimibe Krka
3. How to take Ezetimibe Krka
4. Possible side effects
5. How to store Ezetimibe Krka
6. Contents of the pack and other information

1. What Ezetimiba Krka is and what it is used for

Ezetimiba Krka is a medicine used to reduce elevated cholesterol levels.

Ezetimiba Krka lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, Ezetimiba Krka increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba Krka, works by reducing the cholesterol absorbed in the gastrointestinal tract.

Ezetimiba Krka adds to 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 cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow can lead to 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.

It 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.

Ezetimiba Krka 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 disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may additionally be prescribed other treatments.
• a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.

If you have heart disease, Ezetimiba Krka, when combined 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.

Ezetimiba Krka does not help you lose weight.

2. What you need to know before starting to take Ezetimiba Krka

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

Do not take Ezetimiba Krka

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

Do not take Ezetimiba Krka 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 you start taking Ezetimiba Krka.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimiba Krka with a statin. This is to check that your liver is functioning properly.
• Your doctor may also want to perform further blood tests to monitor your liver function after you start taking Ezetimiba Krka with a statin.
• Ezetimiba is not recommended if you have moderate or severe liver problems.
• The combined use of Ezetimiba Krka and fibrates (medicines used to lower cholesterol) is not recommended, as the safety and efficacy 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 Krka with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 active substances used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
• colestyramine (also used to lower cholesterol), as it affects how ezetimiba works,
• fibrates (also used to lower cholesterol).

Taking Ezetimiba Krka with food and drink

You may take Ezetimiba Krka with or without food.

Pregnancy and breastfeeding

Do not take Ezetimiba Krka with a statin if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking Ezetimiba Krka with a statin, stop taking both medicines immediately and inform your doctor.

There is no experience with the use of Ezetimiba Krka with a statin during pregnancy. Consult your doctor before using Ezetimiba Krka if you are pregnant.

Do not take Ezetimiba Krka with a statin while breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, you should not take Ezetimiba Krka, even without a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimiba Krka is not expected to affect your ability to drive or use machinery. However, you should be aware that some people may experience dizziness after taking Ezetimiba Krka.

Ezetimiba Krka contains sodium

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

3. How to take Ezetimiba Krka

Follow exactly the instructions for administration of this medicine as given by your doctor. 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 this medicine, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking this medicine.

The recommended dose is one Ezetimiba Krka 10 mg tablet once daily, taken orally.

Take ezetimiba at any time of day. You may take it 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 Krka than you should

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

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

If you forget to take Ezetimiba Krka

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

If you stop taking Ezetimiba Krka

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

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

4. Possible adverse effects

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

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 (may affect up to 1 in 10 patients): abdominal pain; diarrhoea; flatulence; and feeling tired.

Uncommon (may affect up to 1 in 100 patients): 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; flushing.

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

Common (may affect up to 1 in 10 patients): increased results in certain liver function tests (transaminases); headache; muscle pain; sensitivity or weakness.

Uncommon (may affect up to 1 in 100 patients): 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 (frequency not known): dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised, red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness to pressure, 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 lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba Krka

• The active substance is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are: Sodium lauryl sulfate, povidone K30, mannitol (E421), sodium croscarmellose (E468), microcrystalline cellulose (E460), sodium stearyl fumarate. See section 2 “Ezetimiba Krka contains sodium”.

Nature of the product and contents of the container

Product description: white or almost white capsule-shaped tablets with bevelled edges. Tablet dimensions: 8×4 mm.

Ezetimiba Krka is available in packs containing:

• 14, 28, 30, 50, 56, 60, 90, 98 or 100 tablets in blisters (OPA/Al/PVC//Al).
• 14×1, 28×1, 30×1, 50×1, 56×1, 60×1, 90×1, 98×1 or 100×1 tablets in single-dose perforated blisters (OPA/Al/PVC//Al).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last review of this leaflet: November 2023

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