EZETIMIBE NORMON 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ezetimibe Normon 10 mg Tablets EFG

Ezetimibe

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 Package Leaflet

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

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

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

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can lead to 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 against heart disease.

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

Ezetimibe Normon reduces the levels of total cholesterol, "bad" cholesterol (LDL), and triglycerides in your blood. It also increases the levels of "good" cholesterol (HDL).

Ezetimibe, the active ingredient in Ezetimibe Normon, works by reducing the amount of cholesterol absorbed in the gut.

Ezetimibe Normon adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by your own body.

It is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe Normon is used in combination with a low-cholesterol diet if you have:

• High levels of cholesterol in your blood (primary hypercholesterolaemia [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 hypercholesterolaemia) that increases the level of cholesterol in your blood. You will also be prescribed a statin and may be prescribed other treatments.
• A hereditary disease (sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in your blood.

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

Ezetimibe Normon does not help you lose weight.

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

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

Do not takeEzetimibe Normonif:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (listed in section 6).

Do not take Ezetimibe Normon with a statin if:

• you currently have liver problems,
• you are pregnant or breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Normon.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe Normon with a statin. This is to check that your liver is working well.
• Your doctor may also want to do a blood test to check your liver again after you start taking Ezetimibe Normon with a statin.

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

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

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist, as the safety and efficacy are limited in this population.

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

Taking Ezetimibe Normon 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 ingredients:

• cyclosporin (often used in patients with transplanted organs),
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
• cholestyramine (also used to lower cholesterol), as it affects how Ezetimibe Normon works,
• fibrates (also used to lower cholesterol).

Pregnancy and breast-feeding

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

Pregnancy

Do not take Ezetimibe Normon with a statin if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant.

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

There is no experience of the use of Ezetimibe without a statin during pregnancy. Ask your doctor for advice before taking Ezetimibe Normon if you are pregnant.

Breast-feeding

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

If you are breast-feeding, do not take Ezetimibe Normon, even without a statin. Ask your doctor for advice.

Driving and using machines

Ezetimibe Normon is unlikely 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 Normon; if you feel affected in this way, do not drive or use machinery until you feel better.

Ezetimibe Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

3. How to take Ezetimibe Normon

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 in doubt, consult your doctor or pharmacist again.

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

Dose

The recommended dose is one 10 mg Ezetimibe Normon tablet per day.

Method of administration

This medicine is for oral use.

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

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

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

If you take more Ezetimibe Normon than you should

If you have taken more ezetimibe than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, stating 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 Normon

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

If you stop taking Ezetimibe Normon

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

If you have any further questions on the use of this medicine, 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 may occur:

• 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)

Immediately contact your doctor if you experience muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening.

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

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

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

• abdominal pain
• diarrhea
• gas
• feeling tired

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

• increased 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
• high blood pressure

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

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

• increased results of some liver function tests (transaminases)
• headache
• muscle pain
• tenderness or weakness

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

• tingling sensation
• dry mouth
• itching
• rash
• hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual tiredness or weakness
• swelling, especially in the hands and feet

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

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

• abdominal pain

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

• dizziness
• muscle pain
• liver problems
• allergic reactions, including rash and hives
• bulging and red rashes, sometimes with target-like lesions (erythema multiforme)
• muscle pain, tenderness, or weakness
• muscle breakdown
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas, often with severe abdominal pain
• constipation
• reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia)
• tingling sensation
• depression
• unusual tiredness or weakness
• shortness of breath

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring 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 Normon

Store below 30°C. Keep in the original package to protect from moisture.

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 the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofEzetimibe Normon

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

Appearance of the product and contents of the pack

The tablets of Ezetimibe Normon are round, white or almost white, marked with "E" on one side.

They are available in blister packs of 28 tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of last revision of this leaflet: April 2022

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