EZETIMIBE ALMUS 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ezetimibe Almus 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 Package Leaflet

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

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

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

Ezetimibe Almus reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol).

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

Ezetimibe 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 in the blood. 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 can lead to a narrowing of the arteries. This narrowing can reduce or completely block the flow of blood to vital organs such as the heart and brain. This blockage can cause 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 Almus is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

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

• high levels of cholesterol in the blood (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 hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You will also be prescribed a statin and may receive other treatments.
• a hereditary disease (familial sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Almus, combined with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, and hospitalization due to chest pain.

Ezetimibe Almus does not help you lose weight.

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

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

Do not take Ezetimibe Almus:

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

Do not take Ezetimibe Almus with a statin:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Almus.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe Almus with a statin. This is to check if your liver is in good condition.
• Your doctor may also want to do blood tests to check your liver again after you start taking Ezetimibe Almus with a statin.

If you have moderate or severe liver problems, Ezetimibe Almus is not recommended.

The safety and efficacy of the combined use of Ezetimibe Almus and certain cholesterol-lowering medicines, fibrates, have not been established.

Children and adolescents

Do not give this medicine to children and adolescents (between 6 and 17 years) unless it has been prescribed by a specialist, as the 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 Almus 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:

• cyclosporine (often used in patients with organ transplants)
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it affects how Ezetimibe Almus works
• fibrates (also used to lower cholesterol)

Pregnancy and breast-feeding

Do not take Ezetimibe Almus 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 Almus with a statin, stop taking both medicines immediately and tell your doctor.

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

Do not take Ezetimibe Almus 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 Almus, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe Almus 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 Almus.

Ezetimibe Almus containslactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ezetimibe Almuscontains sodium

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

3. How to take Ezetimibe Almus

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

• Before starting to take Ezetimibe Almus, you should be following a low-cholesterol diet.
• You should continue with this low-cholesterol diet while taking Ezetimibe Almus.

The recommended dose is one Ezetimibe Almus 10 mg tablet once a day by mouth.

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

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

If your doctor has prescribed Ezetimibe Almus with another cholesterol-lowering medicine containing the active ingredient cholestyramine or any other medicine containing a bile acid sequestrant, you should take Ezetimibe Almus at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and package leaflet of the medicine to the healthcare professional.

If you forget to take Ezetimibe Almus

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

If you stop taking Ezetimibe Almus

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.

The following terms are used to describe how often side effects may occur:

• 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)

Immediately contact your doctor if you experience pain, tenderness, or weakness of the muscles that cannot be explained. This is because, in rare cases, muscle problems, including muscle breakdown that causes kidney damage, can be serious and potentially life-threatening.

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

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

Common: abdominal pain; diarrhea; gas and feeling tired.

Uncommon: 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: elevated results of some 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 with fenofibrate, the following common side effect has been reported: abdominal pain.

In addition, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering and reddened skin, sometimes with target-like lesions (erythema multiforme); 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; reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe Almus

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 packaging after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Store the medicine in its original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Almus

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are lactose monohydrate, crospovidone (type B), copovidone K28, laurilsulfate sodium, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and packaging

Ezetimibe Almus are white to off-white, round, convex tablets, approximately 6 mm in diameter.

Pack size

Ezetimibe Almus are available in Triplex transparent (PVC-PE-PVDC)/Aluminum blister packs of 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100, or 300 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7, Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara) Spain

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

FI: Ezetimib Liconsa 10 mg tablets

FR: Ezetimibe Almus 10 mg, tablet

DE: Ezetimib AXiromed 10 mg tablets

UK (NI): Ezetimibe 10 mg, tablets

IE: Ezetimibe Rowa 10 mg Tablets

ES: Ezetimiba Almus 10 mg tablets EFG

PL: Ezetimibe Genoptim

Date of last revision of this leaflet:February 2021

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