EZETIMIBA KRKA 10 mg TABLETS

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Ezetimibe Krka is a medicine to lower high levels of cholesterol.

Ezetimibe Krka lowers the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in Ezetimibe Krka, works by reducing the amount of cholesterol absorbed from the gut.

Ezetimibe Krka adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by the body.

Cholesterol is one of the fatty substances that can be found in the blood. Your total cholesterol level 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to important organs such as the heart and brain. This blocking of 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 the blood that can increase the risk of heart disease.

Ezetimibe Krka is used in patients who cannot control their cholesterol levels by diet alone. While you are taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe Krka is used, together with a low-cholesterol diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolaemia [heterozygous familial and non-familial]):
• • together with a statin, when your cholesterol level is not well controlled with a statin alone;
  • alone, when statin treatment is not suitable or not tolerated.
• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia), which can cause very high levels of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.
• a rare inherited disorder (sitosterolaemia, also known as phytosterolaemia), which can cause very high levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Krka, combined with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, the need for heart surgery, or hospitalisation for chest pain.

Ezetimibe Krka does not help you lose weight.

2. What you need to know before you take Ezetimibe Krka

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

Do not take Ezetimibe Krka

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

Do not take Ezetimibe Krka with a statin if:

• you currently have liver problems,
• you are pregnant or breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Krka.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe Krka with a statin to make sure that your liver is working normally.
• Your doctor may also want to do blood tests to check how well your liver is working after you start taking Ezetimibe Krka with a statin.
• If you have moderate or severe liver problems, Ezetimibe Krka is not recommended.
• The combined use of Ezetimibe Krka and fibrates (medicines for lowering cholesterol), as the safety and efficacy has not been studied.

Children and adolescents

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

Taking Ezetimibe Krka with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking medicines with any of the following active ingredients:

• ciclosporin (often used in patients with transplanted organs),
• medicines with an active ingredient to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol or fluindione (anticoagulants),
• cholestyramine (also used to lower cholesterol), as it affects how ezetimibe works,
• fibrates (also used to lower cholesterol).

Taking Ezetimibe Krka with food and drink

You can take Ezetimibe Krka with or without food.

Pregnancy and breast-feeding

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

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

Do not take Ezetimibe Krka with a statin if you are breast-feeding, as it is not known if the medicines pass into breast milk. If you are breast-feeding, do not take Ezetimibe Krka, even if you are not taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe Krka is not expected to affect your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking Ezetimibe Krka.

Ezetimibe Krka contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Ezetimibe Krka

Always take this medicine exactly as your doctor has told you. Continue to take your other cholesterol-lowering medicines unless your doctor tells you to stop. If you are in doubt, consult your doctor or pharmacist.

• Before you start taking this medicine, you should be on a low-cholesterol diet.
• You should continue with this low-cholesterol diet while you are taking this medicine.

The recommended dose is one Ezetimibe Krka 10 mg tablet a day, taken by mouth.

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

If your doctor has prescribed ezetimibe with a statin, you can take both medicines at the same time. In this case, please read the dosing instructions in the package leaflet of the statin.

If your doctor has prescribed ezetimibe with another cholesterol-lowering medicine that contains the active ingredient cholestyramine or any other medicine that contains 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 Ezetimibe Krka than you should

Consult your doctor, pharmacist or call the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

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

If you forget to take Ezetimibe Krka

Do not take a double dose to make up for a forgotten dose, simply take your normal dose of ezetimibe at the next scheduled time.

If you stop taking Ezetimibe Krka

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience muscle pain, tenderness or weakness. This is because muscle problems, including muscle breakdown, which can cause kidney damage, can be serious and potentially life-threatening.

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

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

Common (may affect up to 1 in 10 people):abdominal pain; diarrhoea; gas and feeling tired.

Uncommon (may affect up to 1 in 100 people):elevated 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, flushing; high blood pressure.

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

Common (may affect up to 1 in 10 people):elevated results of some liver function tests (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon (may affect up to 1 in 100 people):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 (frequency not known): dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering rash, sometimes with mouth sores, and/or eye inflammation; muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; low blood cell count, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe Krka

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ezetimibe Krka contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: sodium lauryl sulfate, povidone K30, mannitol (E421), sodium croscarmellose (E468), microcrystalline cellulose (E460), sodium stearyl fumarate. See section 2 "Ezetimibe Krka contains sodium".

Appearance and packaging

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

Ezetimibe 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 unit-dose blisters (OPA/Al/PVC//Al).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 ask for more information about this medicine from the representative of the marketing authorisation holder:

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

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

Date of last revision of this leaflet:November 2023

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