Package Leaflet: Information for the Patient

Ezetimiba Krka 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 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. See section 4.

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

2.What you need to know before you start taking Ezetimiba Krka

3.How to take Ezetimiba Krka

4.Possible side effects

5.Storage of Ezetimiba Krka

6.Contents of the pack and additional information

Ezetimibe Krka is a medication to reduce elevated levels of cholesterol.

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

Ezetimibe, the active ingredient of Ezetimibe Krka, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimibe Krka adds to the effect of lowering cholesterol of 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 mainly composed 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 accumulation of plaque can cause a 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 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 them from cardiovascular diseases.

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 solely with a cholesterol-lowering diet. While taking this medication, you must follow a cholesterol-lowering diet.

Ezetimibe Krka is used in combination with a cholesterol-lowering 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, Ezetimibe Krka combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Ezetimibe Krka does not help you lose weight.

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

Do not take Ezetimiba Krka

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

Do not take Ezetimiba Krka 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 Krka.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimiba Krka 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 Krka with a statin.
• If you have moderate or severe liver problems, Ezetimiba is not recommended.
• The combined use of Ezetimiba Krka and fibrates (medicines to reduce cholesterol) is not recommended, as their safety and efficacy have not been studied.

Children and adolescents

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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. 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, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
• colestiramine (also used to reduce cholesterol), because it affects how ezetimiba works,
• fibrates (also used to reduce cholesterol).

Taking Ezetimiba Krka with food and drinks

You can 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 may 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 of using 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 if you are breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, do not take Ezetimiba Krka, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Ezetimiba Krka is not expected to interfere with your ability to drive or operate machines. However, 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; it is essentially "sodium-free".

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

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

The recommended dose is one Ezetimiba Krka 10 mg tablet once a day taken orally.

You can 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 Krka 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 leaflet to the healthcare professional.

If you forgot to take Ezetimiba Krka

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 Krka

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 can cause side effects, although not everyone will experience them.

Contact your doctor immediately 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:

Frequent (may affect up to 1 in 10 patients):abdominal pain; diarrhea; gas and feeling of fatigue.

Rare (may affect up to 1 in 100 patients):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:

Frequent (may affect up to 1 in 10 patients):elevation of results from some liver function tests (transaminases); headache; muscle pain; sensitivity or weakness.

Rare (may affect up to 1 in 100 patients):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 frequent side effect has been reported: abdominal pain.

Additionally, in general use, the following side effects have been reported (frequency unknown): dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised, red, and sometimes blistered 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 bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting 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.

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.

Store in the original packaging to protect it from moisture.

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

Composition ofEzetimiba Krka

• The active ingredient 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 stearate fumarate. See section 2 “Ezetimiba Krka contains sodium”.

Appearance of the product and contents of the pack

Description of the product: White or off-white capsule-shaped tablets with beveled 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 perforated unit dose 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

You can obtain more information about this medicinal product by contacting 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:

Last review date of this leaflet:November 2023

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