EZETIMIBE TEVA-RATIOPHARM 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

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

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

Ezetimibe, the active ingredient in Ezetimibe Teva-ratiopharm, works by reducing the amount of cholesterol absorbed in the gut.

Ezetimibe Teva-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. This narrowing can reduce or completely block the blood flow 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 the 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 Teva-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 Teva-ratiopharm is used along 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 statin treatment is not suitable or not tolerated
• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia), which can increase the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments
• a rare inherited disorder (sitosterolaemia, also known as phytosterolaemia), which can increase the levels of plant sterols in the blood

If you have heart disease, Ezetimibe Teva-ratiopharm, in combination with statin medicines, reduces the risk of heart attack, stroke, the need for heart surgery, or hospitalisation due to chest pain.

Ezetimibe Teva-ratiopharm does not help you lose weight.

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

If you take Ezetimibe Teva-ratiopharm with a statin, please read the package leaflet of that medicine.

Do not take Ezetimibe Teva-ratiopharm:

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

Do not take Ezetimibe Teva-ratiopharm with 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 Teva-ratiopharm.

• Tell your doctor about all your medical conditions, including allergies
• Your doctor will do a blood test before you start taking Ezetimibe Teva-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 how well your liver is working after you start taking Ezetimibe Teva-ratiopharm with a statin

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

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

Children and adolescents

Do not give this medicine to children and adolescents (6 to 17 years of age) unless it has been prescribed by a specialist. This is because there is limited information on the safety and efficacy of Ezetimibe Teva-ratiopharm in this age group. Do not give this medicine to children under 6 years of age because there is no information on its use in this age group.

Taking Ezetimibe Teva-ratiopharm 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 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), because it affects how Ezetimibe Teva-ratiopharm works
• fibrates (also used to lower cholesterol)

Ezetimibe Teva-ratiopharm with food

Ezetimibe Teva-ratiopharm can be taken with or without food.

Pregnancy and breast-feeding

Do not take Ezetimibe Teva-ratiopharm 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 Teva-ratiopharm with a statin, stop taking both medicines immediatelyand tell your doctor.

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

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

If you are breast-feeding, do not take Ezetimibe Teva-ratiopharm, even if you are not taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe Teva-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 Teva-ratiopharm.

Ezetimibe Teva-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 Teva-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 Teva-ratiopharm

Follow the instructions for administration of this medicine exactly as told by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop.

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

The recommended dose is one 10 mg Ezetimibe Teva-ratiopharm tablet per day by mouth.

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

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

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

If you take more Ezetimibe Teva-ratiopharm than you should

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

If you forget to take Ezetimibe Teva-ratiopharm

Do not take a double dose to make up for a forgotten dose. Simply take your normal dose of Ezetimibe Teva-ratiopharm at the usual time the next day.

If you stop taking Ezetimibe Teva-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 product, 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 unexplained muscle pain, tenderness, or weakness. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown, which can cause kidney damage, and can be 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 in breathing or swallowing. These reactions have been reported during general use.

The following side effects have been reported when Ezetimibe Teva-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.

Additionally, when taken with a statin, the following side effects have been reported:

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 the arms and legs; unusual tiredness or weakness; swelling, especially in the hands and feet.

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

Additionally, during general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering and peeling of the skin, some of which may be severe, including Stevens-Johnson syndrome; muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which may cause bruising or 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 Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe Teva-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 shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Teva-ratiopharm

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

Appearance and packaging

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

Pack sizes

Ezetimibe Teva-ratiopharm is packaged in PVC/ACLAR/PVC-Al or PVC/AquaBA SW/PVC-Al blisters of 14, 28, 28x1, 30, 30x1, 50, 90, 90x1, 98, 98x1, 100, 105, and 120 tablets, or HDPE bottles with a child-resistant PP cap and an inner seal to induce 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

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: Ezetimib AbZ 10 mg Tabletten

Austria: Ezetimib ratiopharm 10 mg Tabletten

Belgium: Ezetimibe Teva 10 mg Tabletten

Croatia: Ezact 10 mg tablets

Czech Republic: Ezetimib Teva

Finland: Ezetimibe ratiopharm 10 mg tablets

France: Ezetimibe Teva 10 mg comprimé

Ireland: Ezetimibe Teva 10 mg Tablets

Italy: Ezetimibe Teva 10 mg compresse

Netherlands: Ezetimibe Teva 10 mg, tablets

Portugal: Ezetimiba Teva 10 mg, Comprimido

Slovakia: Ezetimib Teva 10 mg

Spain: Ezetimiba Teva-ratiopharm 10 mg comprimidos EFG

United Kingdom (Northern Ireland): Ezetimibe 10 mg Tablets

Date of last revision of this leaflet:May 2020

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/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82226/P_82226.html