Package Leaflet: Information for the User

Ezetimiba ratiopharm 10 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 package leaflet. See section 4.

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

2. What you need to know before taking Ezetimiba ratiopharm

3. How to take Ezetimiba ratiopharm

4. Possible side effects

5. Storage of Ezetimiba ratiopharm

6. Contents of the pack and additional information

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

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

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

Ezetimiba ratiopharm 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 that are found in the bloodstream. Its total cholesterol is composed mainly 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 to 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.

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.

Ezetimiba ratiopharmis 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])

• 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 heart disease, Ezetimiba ratiopharm combined with medications to lower cholesterol called statins, reduce the risk of heart attack, stroke, heart surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimiba ratiopharm does not help you lose weight.

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

DO NOT takeEzetimiba ratiopharm:

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

DO NOT takeEzetimiba ratiopharmtogether 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 ratiopharm.

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

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

The safety and efficacy of the combined use of Ezetimiba ratiopharm and certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years old) unless prescribed by a specialist, as the safety and efficacy data are limited. Do not administer this medicine to children under 6 years old, as there is no information available for this age group.

TakingEzetimiba ratiopharmwith 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 patients who have undergone organ transplantation)
• medicines with an active ingredient to prevent the formation of blood clots, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how Ezetimiba ratiopharm works
• fibrates (also used to lower cholesterol)

Ezetimiba ratiopharm with food

Ezetimiba ratiopharm can be taken with or without food.

Pregnancy and breastfeeding

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

The safety and efficacy of Ezetimiba ratiopharm with a statin during pregnancy have not been studied. Consult your doctor before using Ezetimiba ratiopharm if you are pregnant.

Do not take Ezetimiba ratiopharm with a statin if you are breastfeeding, as it is unknown whether the medicine passes into breast milk.

If you are breastfeeding, do not take Ezetimiba ratiopharm, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Ezetimiba ratiopharmcontains lactose

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

Ezetimiba ratiopharm 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 medications to lower cholesterol unless your doctor tells you to stop..In case of doubt, consult your doctor or pharmacist again.

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

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

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

If your doctor has prescribed Ezetimiba ratiopharm along with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions in the medication package insert.

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

If you take moreEzetimiba ratiopharmthan you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

If you forgot to takeEzetimiba ratiopharm

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

If you interrupt treatment withEzetimiba ratiopharm

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)

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.

Contact your doctor immediately if you experienceallergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing. These reactions have been reported during general use.

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

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

Uncommon: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.

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

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

Uncommon:tingling sensation; dry mouth; stomach inflammation; 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 side effect has been reported:common:abdominal pain.

In addition, during 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 lesions in the form of a target (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 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 the 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, blister pack, or bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition ofEzetimiba ratiopharm

• The active ingredient is ezetimiba.
• Each tablet contains 10 mg of ezetimiba.
• The other components are: lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, stearic acid, and poloxamer 407.

Appearance of the product and content of the container

Ezetimiba ratiopharm tablets are white, biconvex, capsule-shaped tablets marked with “10” on one side.

Formats

Ezetimiba ratiopharm is packaged in PVC/ACLAR/PVC-Al or PVC/AquaBA SW/PVC-Al blisters of 14, 28, 28x1, 30, 30x1, 50, 60, 90, 90x1, 98, 98x1, 100, 105, and 120 tablets or HDPE bottles with a PP child-resistant closure and an inner seal to induce sealing with a silica gel desiccant container containing 100 and 105 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1ª planta

Alcobendas 28108 (Madrid)

Spain

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren

89143 Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000 Croatia

Last review date of this leaflet:February 2022

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