EZETIMIBE RATIOPHARM 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

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

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

Ezetimibe, the active ingredient in Ezetimibe ratiopharm, works by reducing the amount of cholesterol absorbed by the body.

Ezetimibe ratiopharm 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, which can reduce or block blood flow to vital 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 the buildup of LDL cholesterol 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 ratiopharm 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 ratiopharmis used in combination with a low-cholesterol diet if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous and non-familial])

• in combination with a statin, when your cholesterol level is not well controlled with a statin alone
• alone, when treatment with a statin 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 be prescribed 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 ratiopharm, in combination with statins, reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe ratiopharm does not help you lose weight.

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

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

Do not takeEzetimibe ratiopharmif:

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

Do not takeEzetimibe ratiopharmwith 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 ratiopharm.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe ratiopharm with a statin. This is to check that your liver is working properly.
• Your doctor may also want to do blood tests to check your liver after you start taking Ezetimibe ratiopharm with a statin.

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

The safety and efficacy of using Ezetimibe ratiopharm in combination with certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 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 of age as there is no information in this age group.

TakingEzetimibe ratiopharmwith 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 ratiopharm works
• fibrates (also used to lower cholesterol)

Ezetimibe ratiopharm with food

Ezetimibe ratiopharm can be taken with or without food.

Pregnancy and breast-feeding

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

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

Do not take Ezetimibe ratiopharm with a statin if you are breast-feeding as it is not known whether the medicine passes into breast milk.

If you are breast-feeding, do not take Ezetimibe ratiopharm, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe ratiopharm 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 ratiopharm.

Ezetimibe ratiopharm contains lactose

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

Ezetimibe ratiopharm contains sodium

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

3. How to take Ezetimibe ratiopharm

Follow exactly the instructions of your doctor for taking this medicine. 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 ratiopharm, you should be following a low-cholesterol diet.
• You should continue with this low-cholesterol diet while taking Ezetimibe ratiopharm.

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

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

If your doctor has prescribed Ezetimibe ratiopharm 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 statin.

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

If you take moreEzetimibe ratiopharmthan you should

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

If you forget to takeEzetimibe ratiopharm

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

If you stop takingEzetimibe ratiopharm

Talk to your doctor or pharmacist because 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 are reported:

• 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)

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

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

The following side effects have been reported when Ezetimibe ratiopharm is taken alone:

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

Uncommon:increased 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.

In addition, the following side effects have been reported when Ezetimibe ratiopharm is taken with a statin:

Common:increased results of some liver function tests (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon:tingling sensation; dry mouth; stomach inflammation; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially in hands and feet.

When taken with fenofibrate, the following commonside effect has been reported: abdominal pain.

In addition, the following side effects have been reported during general use: dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering and peeling of the skin, sometimes with mouth sores (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduction in 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe ratiopharm

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, blister, or bottle after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition ofEzetimibe ratiopharm

• The active substance is ezetimibe.
• Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, stearic acid, poloxamer 407.

Appearance and packaging

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

Pack sizes

Ezetimibe 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 child-resistant PP closure and inner seal for induction sealing with a silica gel desiccant container containing 100 and 105 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Teva Pharma, S.L.U.

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

Alcobendas 28108 (Madrid)

Spain

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

Date of last revision of this leaflet:February 2022

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