Ezetimiba normon 10 mg comprimidos efg

Package Leaflet: Information for the User

Ezetimiba Normon 10 mg Tablets EFG

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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Ezetimiba Normon

3. How to take Ezetimiba Normon

4. Possible side effects

5. Storage of Ezetimiba Normon

6. Contents of the pack and additional information

Ezetimibe Normon is a medication to reduce elevated levels of cholesterol.

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 heart disease.

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

Ezetimibe Normon reduces the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and triglycerides circulating in the blood. Additionally, Ezetimibe Normon raises levels of "good" cholesterol (HDL cholesterol).

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

Ezetimibe Normon 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 Normon 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]):
• • 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.
• A hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

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

Ezetimibe Normon does not help you lose weight.

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

Do not takeEzetimiba Normon:

Do not take Ezetimiba Normon with a statin if:

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba Normon.

If you have moderate or severe liver problems, it is not recommended to take Ezetimiba Normon.

The safety and efficacy of the combined use of ezetimiba and 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.

Taking Ezetimiba Normon with other medicines

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:

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 Normon with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant.

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

There is no experience of using ezetimiba without a statin during pregnancy. Consult your doctor before using Ezetimiba Normon if you are pregnant.

Breastfeeding

Do not take Ezetimiba Normon 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 Normon, even without taking a statin. Consult your doctor.

Driving and operating machinery

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

Ezetimiba Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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.

Dosage

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

Administration Form

This medication is for oral use.

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

If your doctor has prescribed Ezetimiba Normon along 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 Normon along 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 Normon at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Normon than you should

If you have taken more ezetimiba than you should, consult your doctor, pharmacist, 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 package insert to the healthcare professional.

If you forget to take Ezetimiba Normon

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

If you interrupt treatment with Ezetimiba Normon

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.

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 (may affect up to 1 in 10 people):

• Abdominal pain
• Diarrhea
• Gas
• Feeling of fatigue

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

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

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

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

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

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

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

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.

Store below 30°C. Store in the original packaging to protect it from moisture.

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.

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

Composition ofEzetimiba Normon

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

-The other components are: lactose monohydrate, microcrystalline cellulose, copovidone, crospovidone, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and content of the container

The Ezetimiba Normon tablets are round, white or off-white in color, marked with “E” on one face.

It is presented in a blister pack with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet: April 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.gob.es/