EZETIMIBE STADA 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

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

Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly made up 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 narrowing of the arteries, which can reduce or completely block the flow of blood 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 “bad” cholesterol from building up in the arteries and protects against heart disease.

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

Ezetimibe reduces the levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and triglycerides in the blood, and also increases the levels of “good” cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in Ezetimibe Stada, works by reducing the absorption of cholesterol in the gut.

Ezetimibe adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by the body.

It 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 is 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 statin treatment is not appropriate or not tolerated

• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia), which can lead to high levels 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 lead to high levels of plant sterols in the blood.

If you have heart disease, ezetimibe in combination with statin medicines reduces the risk of heart attack, stroke, the need for heart surgery, or hospitalization for chest pain.

Ezetimibe does not help you lose weight.

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

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

Do not take Ezetimibe Stada:

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

Do not take Ezetimibe Stada 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 Stada.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking ezetimibe with a statin to make sure your liver is working normally.
• Your doctor may also want to do blood tests to check how well your liver is working after you start taking ezetimibe with a statin.

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

The safety and effectiveness of using ezetimibe with certain cholesterol-lowering medicines, such as 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.

Other medicines and Ezetimibe Stada

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 works
• fibrates (also used to lower cholesterol)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take ezetimibe 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 with a statin, stop taking both medicines immediately and tell your doctor.

There is no experience of the use of ezetimibe with a statin during pregnancy.

Ask your doctor for advice before taking ezetimibe if you are pregnant.

Breast-feeding

Do not take ezetimibe with a statin if you are breast-feeding, as it is not known if the medicines pass into breast milk.

If you are breast-feeding, do not take ezetimibe, even without taking a statin. Ask your doctor.

Driving and using machines

Ezetimibe is unlikely 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; if you feel affected, do not drive or use machinery until you feel better.

Ezetimibe Stada contains lactose and sodium

The tablets of Ezetimibe Stada contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, ask your doctor before taking this medicine.

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

3. How to take Ezetimibe Stada

Always take this medicine exactly as your doctor has told you. 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, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking ezetimibe.

Dose

The recommended dose is one 10 mg ezetimibe tablet once a day.

Method of administration

This medicine is for oral use.

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

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

If you take more Ezetimibe Stada than you should

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Ezetimibe Stada

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

If you stop taking Ezetimibe Stada

Continue taking your cholesterol-lowering medicines unless your doctor tells you to stop. 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.

Contact your doctor immediately if you experience pain, tenderness, or weakness of the muscles that you cannot explain. This is because muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening.

In general use, allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing (requiring immediate treatment), have been reported.

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

Common (may affect up to 1 in 10 people):

• abdominal pain
• diarrhea
• gas
• feeling tired

Uncommon (may affect up to 1 in 100 people):

• increased results of some liver function tests (transaminases) or muscle function tests (CK)
• cough
• indigestion
• heartburn
• nausea
• joint pain
• muscle spasms
• neck pain
• loss of appetite
• pain
• chest pain
• hot flushes
• high blood pressure

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

Common (may affect up to 1 in 10 people):

• increased results of some liver function tests (transaminases)
• headache
• muscle pain
• tenderness or weakness

Uncommon (may affect up to 1 in 100 people):

• tingling sensation
• dry mouth
• itching
• rash
• hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual tiredness or weakness
• swelling, especially in the hands and feet

When used with fenofibrate, the following side effect has been reported:

Common (may affect up to 1 in 10 people):

• abdominal pain

In addition, the following side effects have been reported in general use:

• dizziness
• muscle pain
• liver problems
• allergic reactions, including skin rash and hives
• blisters and redness, sometimes with target-shaped lesions (erythema multiforme)
• muscle pain, tenderness, or weakness
• muscle breakdown
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas, often with severe abdominal pain
• constipation
• reduced 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 to the Spanish Medicines Agency's Pharmacovigilance 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 Stada

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 after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Stada

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), povidone (E 1201), sodium croscarmellose (E 468), sodium lauryl sulfate, and magnesium stearate (E 470b).

Appearance of the product and pack size

The tablets are white to off-white, oval, capsule-shaped, approximately 8 mm long and 4 mm wide.

The medicine is available in pack sizes of 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 156, or 168 tablets in blisters with a PVC/PCTFE/PVC or PVC/PE/PVdC (colorless, transparent) // aluminum foil.

The medicine is available in pack sizes of 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 156, or 168 tablets in unit-dose blisters with a PVC/PCTFE-PVC or PVC/PE/PVdC (colorless, transparent) // aluminum foil.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E 4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of last revision of this leaflet:October 2019

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.gob.es/