EZETIMIBE MABO 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

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

Ezetimibe Mabo reduces the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides that circulate in the blood. In addition, Ezetimibe Mabo increases the concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in Ezetimibe Mabo, works by reducing the cholesterol absorbed in the digestive tract.

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

Cholesterol is one of the fatty substances found in the bloodstream. Your 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 buildup of plaque can cause the arteries to narrow. This narrowing can slow down or block the flow of blood 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 called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects them from heart disease.

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 with diet alone. While taking this medicine, you should follow a cholesterol-reducing diet.

Ezetimibe Mabo is used in combination with a cholesterol-reducing diet if you have:

• High blood levels of cholesterol (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 statin treatment is not appropriate or not tolerated

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

If you have heart disease, Ezetimibe Mabo in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe Mabo does not help you lose weight.

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

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

Do not take Ezetimibe Mabo if:

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

Do not take Ezetimibe Mabo with a statin if:

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

Warnings and precautions

• Tell your doctor or pharmacist before you start taking Ezetimibe Mabo. Inform your doctor of all your medical problems, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe Mabo with a statin. This is to check that your liver is in good condition.
• Your doctor may also want to do blood tests to check your liver condition again after you start taking Ezetimibe Mabo with a statin.

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

The combined use of Ezetimibe Mabo and fibrates (cholesterol-reducing medicines) is not recommended, as the safety and efficacy of the combined use of Ezetimibe Mabo and fibrates have not been studied.

Children and adolescents

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

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

Taking Ezetimibe Mabo 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 substances:

• Cyclosporine (often used in patients with organ transplants).
• Medicines with an active substance to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• Colestyramine (also used to reduce cholesterol), as it affects how ezetimibe works.
• Fibrates (also used to reduce cholesterol).

Pregnancy and breastfeeding

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

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

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

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

If you are breastfeeding, do not take Ezetimibe Mabo, with or without a statin. Ask your doctor.

Driving and using machines

Ezetimibe Mabo 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 Mabo.

Ezetimibe Mabo contains lactose

Ezetimibe Mabo tablets 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.

Ezetimibe Mabo 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 Mabo

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 unsure, ask your doctor or pharmacist again.

• Before you start taking this medicine, you should be following a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing diet while taking this medicine.

The recommended dose is one Ezetimibe Mabo 10 mg tablet once a day by mouth.

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

If your doctor has prescribed Ezetimibe Mabo with a statin, both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of the medicine.

If your doctor has prescribed Ezetimibe Mabo with another cholesterol-reducing medicine that contains the active substance colestyramine or any other medicine that contains a bile acid sequestrant, you should take Ezetimibe Mabo at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Mabo than you should

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

It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Ezetimibe Mabo

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

If you stop taking Ezetimibe Mabo

Talk to your doctor or pharmacist, as 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 experienced:

• 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 pain, tenderness, or unexplained muscle weakness. This is because, in rare cases, muscle problems, including muscle breakdown that causes kidney damage, can be serious and potentially life-threatening.

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

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

Common:

• Abdominal pain;
• Diarrhea;
• Gas;
• 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;
• Loss of appetite;
• Pain;
• Chest pain;
• Flushing;
• High blood pressure.

In addition, when used in combination 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:

• Feeling of tingling;
• Dry mouth; itching; rash; hives;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Unusual tiredness or weakness;
• Swelling, especially in hands and feet.

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

In addition, the following side effects have been reported in general use: dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering and reddened skin eruptions, some of which may have target-like lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia); feeling of tingling; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products 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 Mabo

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 that month.

Store in the original package to protect from moisture. Do not remove the tablet from the blister pack until you are ready to take it.

Medicines should not be disposed of via wastewater or household waste. Return the package and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Mabo

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate (see section 2: 'Ezetimibe Mabo contains lactose'), croscarmellose sodium (E-468) (see section 2: 'Ezetimibe Mabo contains sodium'), povidone K30 (E-1201), lauryl sulfate sodium (E-487), and magnesium stearate (E-572).

Appearance of the product and pack size

Ezetimibe Mabo tablets are capsule-shaped, white or almost white, engraved with "E 10" on one side and nothing on the other. The tablet dimensions are 8.1 x 4.1 mm.

Pack size: Ezetimibe Mabo is provided in packs of 28 tablets in blisters.

Marketing authorization holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

NOUCOR HEALTH, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Date of last revision of this leaflet:July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/