Ezetrol 10 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
EZETROL 10 mg Tablets
ezetimibe
Read the entire 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What EZETROL is and what it is used for
- What you need to know before taking EZETROL
- How to take EZETROL
- Possible side effects
- How to store EZETROL
- Contents of the pack and other information
1. What EZETROL is and what it is used for
EZETROL is a medication used to reduce elevated cholesterol levels.
EZETROL lowers blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. In addition, EZETROL increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in EZETROL, works by reducing the amount of cholesterol absorbed in the digestive tract.
EZETROL 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 is mainly composed of LDL cholesterol 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in 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 may increase the risk of heart disease.
It is used in patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medication, you must continue to follow a cholesterol-lowering diet.
EZETROL is used together with a cholesterol-lowering diet if you have:
- high blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
- in combination with a statin, when your cholesterol level is not well controlled with a statin alone
- as monotherapy, when treatment with a statin is inappropriate or not tolerated
- a hereditary condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You will also be prescribed a statin, and you may also be given other treatments.
- a hereditary condition (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.
If you have heart disease, EZETROL in combination with cholesterol-lowering medications called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
EZETROL does not help you lose weight.
2. What you need to know before starting to take EZETROL
If you are taking EZETROL together with a statin, please read the leaflet of that medicine.
Do not take EZETROL if:
- you are allergic (hypersensitive) to ezetimibe or to any of the other ingredients of this medicine (see section 6: Contents of the pack and further information).
Do not take EZETROL together with a statin if:
- you currently have liver problems.
- you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take EZETROL.
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Inform your doctor about all your medical conditions, including allergies.
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Your doctor will perform a blood test before you start taking EZETROL with a statin. This is to check that your liver is functioning properly.
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Your doctor may also want to perform further blood tests to monitor your liver function after you start taking EZETROL with a statin.
EZETROL is not recommended if you have moderate or severe liver problems.
The safety and efficacy of combining EZETROL with certain cholesterol-lowering medicines, fibrates, have not been studied.
Children and adolescents
Do not give this medicine to children and adolescents (6 to 17 years of age) unless prescribed by a specialist, as data on safety and efficacy are limited.
Do not give this medicine to children under 6 years of age, as there is no information available for this age group.
Taking EZETROL with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking medicines containing any of the following active substances:
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cyclosporine (often used in organ transplant patients)
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medicines containing active substances used to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
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colestyramine (also used to lower cholesterol), as it affects how EZETROL works
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fibrates (also used to lower cholesterol)
Pregnancy and breastfeeding
Do not take EZETROL with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking EZETROL with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of EZETROL with a statin during pregnancy. Consult your doctor before using EZETROL if you are pregnant.
Do not take EZETROL with a statin if you are breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, you should not take EZETROL, even without taking a statin. Consult your doctor.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
EZETROL is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking EZETROL.
EZETROL contains lactose
EZETROL tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
EZETROL contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take EZETROL
Follow exactly the instructions for administering this medicine as given by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.
- Before starting to take EZETROL, you should already be following a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking EZETROL.
The recommended dose is one 10 mg EZETROL tablet once daily by oral route.
Take EZETROL at any time of day. You may take it with or without food.
If your doctor has prescribed EZETROL together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions in the leaflet of the statin medicine.
If your doctor has prescribed EZETROL together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take EZETROL at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more EZETROL than you should
Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medicine and the amount taken.
It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take EZETROL
Do not take a double dose to make up for missed doses. Simply take your normal dose of EZETROL at the usual time on the following day.
If you stop taking EZETROL
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following terms are used to describe how often the reported adverse effects 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)
Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems—including muscle breakdown leading to kidney damage—can be serious and potentially life-threatening.
In general use, allergic reactions have been reported, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment).
When used alone, the following adverse effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of tiredness.
Uncommon: increased results in certain liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain, hot flushes; high blood pressure.
Additionally, when used together with a statin, the following adverse effects have been reported:
Common: increased results in certain liver function tests (transaminases); headache; muscle pain; tenderness or weakness.
Uncommon: tingling sensation; 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 adverse effect has been reported: abdominal pain.
Additionally, in general use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised and red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.
Reporting of adverse effects: If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of EZETROL
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton or container following EXP. The expiry date refers to the last day of the month indicated.
- Do not store EZETROL above 30°C.
Blister packs: Store in the original packaging. Bottles: Keep bottles tightly closed. These measures will protect the product from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of EZETROL
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate and magnesium stearate.
Appearance of the product and contents of the pack
EZETROL tablets are capsule-shaped, white or off-white, engraved with "414" on one side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in press-through blisters or single-dose folding blisters;
84 or 90 tablets in press-through blisters;
50, 100 or 300 tablets in single-dose press-through blisters;
100 tablets in a bottle.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized under the name EZETROL in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Date of the most recent revision of this leaflet: 08/2020.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.es/