Prospect: information for the patient

Ezetimiba STADA 10 mg tablets EFG

Read this entire prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Ezetimiba Stada

3.How to take Ezetimiba Stada

4.Possible adverse effects

5.Storage of Ezetimiba Stada

6.Contents of the package and additional information

Ezetimibe is a medication to reduce elevated levels of cholesterol.

Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly composed 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 slow or stop blood flow to vital organs such as the heart and brain. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating 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 concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and other fatty substances called triglycerides that circulate in the blood. Additionally, ezetimibe elevates levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in Ezetimibe Stada, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimibe adds to the effect of lowering cholesterol of statins, a group of medications that reduce cholesterol produced by the body itself.

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.

Ezetimibe is 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])

• along with a statin, when your cholesterol level is not well controlled with a statin alone
• alone, when statin treatment is inappropriate or not tolerated

• a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.
• a genetic disorder (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.

If you have heart disease, ezetimibe combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Ezetimibe does not help you lose weight.

If you take ezetimiba with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba Stada:

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

Do not take Ezetimiba Stada 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 Stada.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will make a blood test before you start taking ezetimiba 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 with a statin.

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

The safety and efficacy of using ezetimiba with certain cholesterol-lowering medicines, such as 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.

Other medicines and Ezetimiba Stada

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 transplant patients)
• blood-thinning medicines, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how ezetimiba works
• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take ezetimiba with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant.

If you become pregnant while taking ezetimiba with a statin, stop taking both medicines immediately and inform your doctor.

There is no experience of using ezetimiba with a statin during pregnancy.

Consult your doctor before using ezetimiba if you are pregnant.

Breastfeeding

Do not take ezetimiba with a statin if you are breastfeeding, as it is unknown whether the medicines pass into breast milk.

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

Driving and operating machinery

Ezetimiba is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking ezetimiba; if you feel affected in this way, do not drive or operate machinery until you feel better.

Ezetimiba Stada contains lactose and sodium

Ezetimiba Stada tablets contain a sugar called lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) 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. If in doubt, consult your doctor or pharmacist again.

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

Dosage

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

Administration Form

This medication is for oral use.

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

If your doctor has prescribed ezetimiba together 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 together with another cholesterol-lowering medication that contains the active ingredient cholestyramine or any other medication that contains a bile acid sequestrant, you should take ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Stada than you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication package insert to the healthcare professional.

If you forget to take Ezetimiba Stada Stada

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

If you interrupt treatment with Ezetimiba Stada Stada

Continue taking your cholesterol-lowering medications unless your doctor tells you otherwise. 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 can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience pain, pressure sensitivity, 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.

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

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

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

•abdominal pain

•diarrhea

•gas

•fatigue

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

•elevation of results from 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

•flushing

•high blood pressure

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

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

•elevation of results from some liver function tests (transaminases)

•headache

•muscle pain

•sensitivity or weakness

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

•tingling sensation

•dry mouth

•itching

•eruption

•hives

•back pain

•muscle weakness

•pain in arms and legs

•unusual fatigue or weakness

•swelling, especially in hands and feet

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

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

•abdominal pain

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

•dizziness

•muscle pain

•liver problems

•allergic reactions including skin rash and hives

•bulging and inflamed eruptions, sometimes with lesions in the form of a target (erythema multiforme)

•pain, sensitivity, or weakness

•muscle degradation

•gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)

•pancreatitis, often with severe abdominal pain

•constipation

•reduction in blood cell count, which may cause bruising or bleeding (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 Vigilance 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 after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Ezetimibe Stada Composition

-The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.

-The other components 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 contents of the package

The tablets are white to off-white, oval, capsule-shaped, approximately 8 mm in length and 4 mm in width.

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

The medication is available in package sizes of 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 156, or 168 tablets packaged in single-dose blisters with a PVC/PCTFE-PVC or PVC/PE/PVdC (colorless, transparent) // Aluminum laminate.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible 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-E4814 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

Last review date of this leaflet:October 2019

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/