Patient Information Leaflet

ABSORCOL 10 mg Tablets

ezetimiba

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

-If you have any questions, ask your doctor or pharmacist.

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

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

Table of Contents

1.What ABSORCOL is and what it is used for

2.What you need to know before you start taking ABSORCOL

3.How to take ABSORCOL

4.Possible side effects

5.Storage of ABSORCOL

6.Contents of the pack and additional information

ABSORCOL is a medication to reduce elevated levels of cholesterol.

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

Ezetimiba, the active ingredient in ABSORCOL, acts by reducing the cholesterol absorbed in the digestive tract.

ABSORCOL adds to the effect of lowering cholesterol from 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 composed 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 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 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 solely with a cholesterol-lowering diet. While taking this medication, you must follow a cholesterol-lowering diet.

ABSORCOL is used with a cholesterol-lowering diet if you have:

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

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

ABSORCOL does not help you lose weight.

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

Do not take ABSORCOL if:

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

• Inform your doctor of all your medical conditions, including allergies.

• Your doctor will make a blood test before you start takingABSORCOL 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 takingABSORCOL with a statin.

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

The safety and efficacy of the combined use ofABSORCOLand certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years of age) unless prescribed by a specialist, as the safety and efficacy data are limited.

Do not administer this medicine to children under 6 years of age, as there is no information available for this age group.

Taking ABSORCOL with other medicines

Inform your doctor or pharmacist if you aretaking, have recently taken 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)

• medicines with an active ingredient toprevent the formation of blood clots, such as warfarin, fenprocomon, acenocoumarol or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how ABSORCOL works

• fibrates (also used to lower 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 medicines immediately and inform your doctor. There is no experience of 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 medicines 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 using any medicine.

Driving and operating machines

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

ABSORCOL contains lactose

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

ABSORCOL contains sodium

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

Follow the medication administration instructions exactly as indicated by your doctor. Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. In case of doubt, consult your doctor or pharmacist again.

• Before starting ABSORCOL, you must be following a diet to reduce cholesterol.
• You will need to continue this cholesterol-reducing diet while taking ABSORCOL.

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

You can take ABSORCOL at any time of the 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. Please read the dosage instructions on the medication packaging.

If your doctor has prescribed ABSORCOL with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you must 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 Toxicological Information Service at 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take ABSORCOL

Do not take a double dose to make up for the missed dose. Simply take your usual amount of ABSORCOL at the usual time the next day.

If you interrupt treatment with ABSORCOL

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)

Immediately contact your doctor 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.

Generally, 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:abdominal pain; diarrhea; gas and feeling of fatigue.

Uncommon:elevation of results from 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, warmth; high blood pressure.

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

Common:elevation of results from some liver function tests (transaminases); headache; muscle pain; sensitivity to pressure 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.

Additionally, 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 lesions in the form of a target (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 intense abdominal pain; constipation; reduction in blood cell count, which may cause hematoma/hemorrhage (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 prospectus. You can also report them directly through the Spanish System for 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 medicationafter the expiration date that appears on the packaging or on the container after CAD. 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 packaging. Bottles: Keep the bottles perfectly closed. These measures will protect the product from moisture.

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

Composition ofABSORCOL

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

Appearance of the product and contents of the packaging

ABSORCOL tablets are capsule-shaped, white or off-white in color, and have “414” engraved on one side.

Packaging sizes:

7, 10, 14, 20, 28, 30, 50, 98, 100, or 300tablets in push-through blisters or single-dose blisters;

84 or 90 tablets in push-through blisters;

50, 100, or 300 tablets in single-dose push-through blisters;

100 tablets in a bottle.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

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

Last review date of this leaflet:08/2020.

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.es/