Package Insert: Information for the Patient

Ezetimiba Mabo 10 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

Ezetimiba Mabo is a medication to reduce elevated levels of cholesterol.

Ezetimiba Mabo reduces total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba Mabo increases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient of Ezetimiba Mabo, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimiba Mabo adds to the effect of lowering cholesterol 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. Its 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 make blood flow to vital organs such as the heart and brain slower or interrupted. 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 them from cardiovascular diseases.

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

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.

Ezetimiba MABO is used along 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 hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

If you have cardiovascular disease, Ezetimiba Mabo combined with medications to lower cholesterol called statins, reduce the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimiba Mabo does not help you lose weight.

If you take Ezetimiba Mabo together with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba Mabo if:

• You are allergic (hypersensitive) to ezetimiba or to any of the other ingredients in this medicine (see section 6: Contents of the pack and additional information).

Do not take Ezetimiba Mabo together 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 Mabo. Inform your doctor of all your medical conditions, including allergies.
• Your doctor will make a blood test before you start taking Ezetimiba Mabo 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 Mabo with a statin.

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

The combined use of Ezetimiba Mabo and fibrates (medicines to reduce cholesterol), as the safety and efficacy of the combined use of Ezetimiba Mabo and fibrates have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents between 6 and 17 years old unless it has been prescribed by a specialist, as the data on safety and efficacy are limited.

Do not administer this medicine to children under 6 years old as there is no information in this age group.

Taking Ezetimiba Mabo with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have 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 patients with organ transplants).
• Medicines with an active ingredient to prevent the formation of blood clots, such as warfarin, fenprocomon, acenocoumarol or fluindione (anticoagulants).
• Colestiramine (also used to reduce cholesterol), as it affects the way ezetimiba works.
• Fibrates (also used to reduce 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.

Do not take Ezetimiba Mabo with a statin if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while taking Ezetimiba Mabo with a statin, stop taking both medicines immediately and inform your doctor.

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

Do not take Ezetimiba Mabo 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 Mabo, with or without taking a statin. Consult your doctor.

Driving and operating machines

Ezetimiba Mabo is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking Ezetimiba Mabo.

Ezetimiba Mabo contains lactose

Ezetimiba Mabo tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Ezetimiba Mabo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) 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 this medication, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking this medication.

The recommended dose is one Ezetimiba Mabo 10 mg tablet once a day taken orally.

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

If your doctor has prescribed Ezetimiba Mabo along with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions on the medication packaging.

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

If you take more Ezetimiba Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call 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 packaging to the healthcare professional.

If you forget to take Ezetimiba Mabo

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

If you interrupt treatment with Ezetimiba Mabo

Speak with your doctor or pharmacist as your 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 may cause side effects, although not everyone will experience them.

The following terms are used to describe how often side effects have been reported:

• Very common (may affect more than 1 in 10 patients).
• Common (may affect up to 1 in 10 patients).
• Uncommon (may affect up to 1 in 100 patients).
• Rare (may affect up to 1 in 1,000 patients).
• Very rare (may affect up to 1 in 10,000 patients, including isolated cases).

Contact your doctor immediately if you experience pain, sensitivity to pressure, 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:

Common:

Uncommon:

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

Common:

Uncommon:

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

In addition, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; swollen and inflamed skin, sometimes with target lesions (erythema multiforme); muscle pain, sensitivity to pressure, or muscle 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/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 Pharmacovigilance 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. Do not remove the tablet from the blister pack until you are going to take it.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofEzetimiba Mabo

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are: lactose monohydrate (see section 2: ‘Ezetimiba Mabo contains lactose’), sodium croscarmellose (E-468) (see section 2: ‘Ezetimiba Mabo contains sodium’), povidone K30 (E-1201), sodium lauryl sulfate (E-487), and magnesium stearate (E-572).

Appearance of the product and contents of the packaging

Ezetimiba Mabo tablets are capsule-shaped, white or off-white in color, engraved with ”E 10” on one face and nothing on the other. The dimensions of the tablet are 8.1 x 4.1 mm.

Packaging size: Ezetimiba Mabo is provided in packs of 28 tablets in blister packaging.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Avda.Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Last review date of this leaflet:July 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/