Ezetimibe Ratiopharm 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe ratiopharm 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Ezetimiba ratiopharm lowers blood concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. In addition, Ezetimiba ratiopharm increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba ratiopharm, works by reducing the amount of cholesterol absorbed in the digestive tract.

Ezetimiba ratiopharm adds to the cholesterol-lowering effect 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. Your total cholesterol is mainly composed 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 plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow 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 your blood that may increase the risk of heart disease.

It is used in patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

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

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial 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 inappropriate or not tolerated

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may be prescribed other treatments as well

• a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.

If you have heart disease, Ezetimiba ratiopharm, when combined with cholesterol-lowering medications called statins, reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba ratiopharm does not help you lose weight.

2. What you need to know before taking Ezetimiba ratiopharm

If you are taking Ezetimiba ratiopharm together with a statin, please read the package leaflet of that medicine.

DO NOT take Ezetimiba ratiopharm:

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

DO NOT take Ezetimiba ratiopharm together with a statin if:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ezetimiba ratiopharm.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimiba ratiopharm with a statin. This is to check that your liver is functioning properly.
• Your doctor may also want to perform further blood tests to monitor your liver function after you start taking Ezetimiba ratiopharm with a statin.

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

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

Taking Ezetimiba ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (often used in organ transplant patients)
• medicines containing an active substance to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (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 medicines immediately and inform your doctor.

There is no experience with the use of Ezetimiba ratiopharm with a statin during pregnancy. 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, you should not take Ezetimiba ratiopharm, even without a statin. Consult your doctor.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimiba ratiopharm is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Ezetimiba ratiopharm.

Ezetimiba ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him 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”.

3. How to take Ezetimiba ratiopharm

Follow exactly the instructions given by your doctor for taking this medicine. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba ratiopharm, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking Ezetimiba ratiopharm.

The recommended dose is one 10 mg ezetimibe tablet once daily, taken orally.

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

If your doctor has prescribed Ezetimiba ratiopharm together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions provided in the package leaflet of the statin medicine.

If your doctor has prescribed Ezetimiba ratiopharm together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing 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 more Ezetimiba ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, stating the medicine and the amount taken.

If you forget to take Ezetimiba ratiopharm

Do not take a double dose to make up for forgotten doses. Simply take your usual dose of Ezetimiba ratiopharm at the next scheduled time.

If you stop taking Ezetimiba ratiopharm

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following terms are used to describe how often the adverse effects have been 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 unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be serious and become a potentially life-threatening condition.

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.

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

Common: abdominal pain; diarrhoea; flatulence and feeling of tiredness.

Uncommon: increased results of certain liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasm; neck pain; decreased appetite; pain; chest pain, hot flushes; high blood pressure.

Additionally, when used together with a statin, the following adverse effects have been reported:

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

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

When used together with fenofibrate, the following common adverse effect has been reported: abdominal pain.

Additionally, during general use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised and red rashes, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often with severe abdominal pain; constipation; reduction in blood cell count, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba ratiopharm

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

Do not use this medicine after the expiry date stated on the carton, blister, or bottle following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba ratiopharm

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

Appearance of the product and contents of the pack

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

Pack sizes

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

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 the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/