Patient Information Leaflet: Information for the Patient

Ezetimiba Almus 10 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine, as 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, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Ezetimiba Almus

3. How to take Ezetimiba Almus

4. Possible side effects

5. Storage of Ezetimiba Almus

6. Contents of the pack and additional informationadditional information

Ezetimiba Almus is a medication to reduce elevated levels of cholesterol.

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

Ezetimiba, the active ingredient of Ezetimiba Almus, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimiba 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 heart disease.

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

Ezetimiba Almus 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.

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

• elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial])
• • along 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 genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may receive other treatments.
• a genetic disorder (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.

If you have heart disease, Ezetimiba Almus combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, coronary artery bypass surgery, and hospitalization for chest pain.

Ezetimiba Almus does not help you lose weight.

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

Do not take Ezetimiba Almus:

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

Do not take Ezetimiba Almus together with a statin:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba Almus.

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

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

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

Children and adolescents

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

Do not administer this medicine to children under 6 years as there is no information in this age group.

Taking Ezetimiba Almus with other medicines

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may have 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 transplant patients)
• medicines with an active ingredient to prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how Ezetimiba Almus works
• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

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

The use of Ezetimiba Almus with a statin during pregnancy has not been established. Consult your doctor before using Ezetimiba Almus if you are pregnant.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Ezetimiba Almus is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking Ezetimiba Almus.

Ezetimiba Almus containslactose

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

Ezetimiba Almus contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this 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 Ezetimiba Almus, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking Ezetimiba Almus.

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

You can take Ezetimiba Almus at any time of the day. You can take it with or without food.

If your doctor has prescribed Ezetimiba Almus 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 Almus 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 Almus at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Ezetimiba Almus

Do not take a double dose to make up for the missed dose. Simply take your usual amount of Ezetimiba Almus, at the usual dose, the next day.

If you interrupt treatment with Ezetimiba Almus

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

The following terms are used to describe how often side effects have been reported:

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

Immediately contact your doctor if you experience pain, sensitivity to pressure, or unexplained muscle weakness. This is because, in rare cases, muscle problems, including muscle degeneration 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 (which requires immediate treatment).

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

Common:abdominal pain; diarrhea; gas and feeling of fatigue.

Uncommon:elevation of liver function test results (transaminases) or muscle function test results (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:

Common:elevation of liver function test results (transaminases); headache; muscle pain; sensitivity to pressure or weakness.

Uncommon: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 common side effect has been reported: abdominal pain.

Additionally, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; swollen and inflamed skin, sometimes with target lesions (erythema multiforme); muscle pain, sensitivity to pressure, or muscle weakness; muscle degeneration; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with intense abdominal pain; constipation; reduced blood cell count, which may cause hematoma/hemorrhage (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting of 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: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.

Do not store at a temperature above 25°C. Store the medication in its 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ezetimiba Almus

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components arelactose monohydrate, crospovidone (type B), copovidone K28, sodium lauryl sulfate, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the packaging

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

Package size

Ezetimiba Almus is presented in transparent Triplex blisters (PVC-PE-PVDC)/Aluminum with 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100, or 300 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible 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) with the following names:

FI: Ezetimib Liconsa 10 mg tabletti

FR: Ezetimibe Almus 10 mg, comprimé

DE: Ezetimib AXiromed 10 mg tabletten

UK (NI): Ezetimibe 10 mg, tablets

IE: Ezetimibe Rowa 10 mg Tablets

ES: Ezetimiba Almus 10 mg comprimidos EFG

PL: Ezetimibe Genoptim

Last review date of this leaflet:February 2021

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