ABSORCOL 10 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

ABSORCOL 10 mg Tablets

ezetimibe

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

• Keep this summary, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this summary. See section 4.

Contents of thesummary

1. What ABSORCOL is and what it is used for
2. What you need to know before taking ABSORCOL
3. How to take ABSORCOL
4. Possible side effects
5. Storage of ABSORCOL
6. Package contents and additional information

1. What ABSORCOL is and what it is used for

ABSORCOL is a medication used to reduce high cholesterol levels.

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

Ezetimibe, the active ingredient in ABSORCOL, works by reducing the amount of cholesterol absorbed in the digestive tract.

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

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or interrupt 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 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 medication, you should follow a cholesterol-reducing diet.

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

• high blood cholesterol levels (primary hypercholesterolemia [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 hereditary disease (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You will also be prescribed a statin and may be prescribed other treatments.
• a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

If you have heart disease, ABSORCOL combined with cholesterol-lowering medications called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

ABSORCOL does not help you lose weight.

2. What you need to know before taking ABSORCOL

If you are taking ABSORCOL with a statin, please read the summary of the statin medication.

Do not take ABSORCOL if:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medication (see section 6: Package contents and additional information).

Do not take ABSORCOL 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 ABSORCOL.

• Tell your doctor about all your medical problems, including allergies.

• Your doctor will perform a blood test before you start taking ABSORCOL with a statin. This is to check that your liver is in good condition.

• Your doctor may also want to perform blood tests to check your liver condition again after you start taking ABSORCOL with a statin.

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

The safety and efficacy of combining ABSORCOL with certain cholesterol-reducing medications, fibrates, have not been studied.

Children and adolescents

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

Do not give this medication to children under 6 years old, as there is no information available for this age group.

Taking ABSORCOL with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, inform your doctor if you are taking medications with any of the following active ingredients:

• cyclosporine (often used in patients with organ transplants)

• medications with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it affects how ABSORCOL works

• fibrates (also used to reduce cholesterol)

Pregnancy and breastfeeding

Do not take ABSORCOL with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ABSORCOL with a statin, stop taking both medications immediately and inform your doctor. There is no experience with the use of ABSORCOL with a statin during pregnancy. Consult your doctor before using ABSORCOL if you are pregnant.

Do not take ABSORCOL with a statin if you are breastfeeding, as it is unknown whether the medications pass into breast milk. If you are breastfeeding, do not take ABSORCOL, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

ABSORCOL is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking ABSORCOL.

ABSORCOL contains lactose

ABSORCOL tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

ABSORCOL contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take ABSORCOL

Follow your doctor's instructions for taking this medication exactly. Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ABSORCOL, you should be following a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing diet while taking ABSORCOL.

The recommended dose is one ABSORCOL 10 mg tablet once a day, taken orally.

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

If your doctor has prescribed ABSORCOL with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions in the statin medication summary.

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

If you take more ABSORCOL than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to take the package and the medication summary to the healthcare professional.

If you forget to take ABSORCOL

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

If you stop taking ABSORCOL

Talk to your doctor or pharmacist, as your cholesterol levels may increase again.

If you have any other questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, ABSORCOL can cause side effects, although not everyone gets 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, tenderness, or unexplained muscle weakness. This is because, in rare cases, muscle problems, including muscle breakdown that causes kidney damage, can be severe 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 and feeling tired.

Uncommon: elevated 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.

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

Common: elevated results of some liver function tests (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; 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 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 urticaria; blistering and reddening of the skin, sometimes with target-shaped 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); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting side effects:If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of ABSORCOL

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date shown on the carton or packaging after EXP. The expiration date is the last day of the month indicated.
• Do not store ABSORCOL at a temperature above 30°C.

Blister packs: Store in the original package. Bottles: Keep the bottles tightly closed. These measures will protect the product from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofABSORCOL

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and package contents

ABSORCOL tablets are capsule-shaped, white or almost white, and engraved with "414" on one side.

Package sizes:

7, 10, 14, 20, 28, 30, 50, 98, 100, or 300 tablets in blister packs or unit-dose blister packs;

84 or 90 tablets in blister packs;

50, 100, or 300 tablets in unit-dose blister packs;

100 tablets in a bottle.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medication is authorized with the name Ezetimibe Organon 10 mg Tabletten in Germany.

Date of the last revision of this summary:08/2020.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/