Ezetimibe Normon 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ezetimiba Normon 10 mg tablets EFG
Ezetimibe
Read the entire 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, 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 adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Ezetimiba Normon is and what it is used for
- What you need to know before taking Ezetimiba Normon
- How to take Ezetimiba Normon
- Possible side effects
- How to store Ezetimiba Normon
- Contents of the pack and other information
1. What Ezetimiba Normon is and what it is used for
Ezetimiba Normon is a medicine used to reduce elevated cholesterol levels.
Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly composed of LDL 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 may 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.
Ezetimiba Normon reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and triglycerides circulating in the blood. In addition, Ezetimiba Normon increases levels of "good" cholesterol (HDL cholesterol).
Ezetimiba, the active substance in Ezetimiba Normon, works by reducing the cholesterol absorbed from the digestive tract.
Ezetimiba Normon adds to the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.
It is used in patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
Ezetimiba Normon 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,
- alone, when treatment with a statin is inappropriate or not tolerated.
- An inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may additionally be prescribed other treatments.
- An inherited disease (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.
If you have heart disease, Ezetimiba Normon combined with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
Ezetimiba Normon does not help you lose weight.
2. What you need to know before taking Ezetimiba Normon
If you are using Ezetimiba Normon together with a statin, please read the package leaflet of that medicine.
Do not take Ezetimiba Normon:
- if you are allergic (hypersensitive) to ezetimiba or to any of the other ingredients of this medicine (listed in section 6).
Do not take Ezetimiba Normon 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 Ezetimiba Normon.
- Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking Ezetimiba Normon with a statin. This is to check that your liver is functioning properly.
- Your doctor may also want to perform further blood tests to monitor your liver function after you start taking Ezetimiba Normon with a statin.
If you have moderate or severe liver problems, taking Ezetimiba Normon is not recommended.
The safety and efficacy of combining ezetimiba with 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 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 Ezetimiba Normon 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:
- ciclosporin (often used in organ transplant patients),
- medicines containing active substances used to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants),
- colestyramine (also used to lower cholesterol), as it affects how Ezetimiba Normon works,
- fibrates (also used to lower cholesterol).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become 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 might 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 with the use of Ezetimiba alone (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 these medicines pass into breast milk.
If you are breastfeeding, you should not take Ezetimiba Normon, even without taking a statin. Consult your doctor.
Driving and using machines
Ezetimiba Normon 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 Ezetimiba Normon; if you are 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Ezetimiba Normon
Follow exactly the instructions for administration of this medicine given by your doctor.
Continue taking your other cholesterol-lowering medicines unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist again.
- Before starting to take Ezetimiba Normon, you should already be following a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking Ezetimiba Normon.
Dosage
The recommended dose is one 10 mg Ezetimiba Normon tablet once daily.
Method of administration
This medicine is for oral use.
Take Ezetimiba Normon at any time of day. It may be taken with or without food.
If your doctor has prescribed Ezetimiba Normon together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions in the package leaflet of the statin medicine.
If your doctor has prescribed Ezetimiba Normon together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must 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 ezetimibe than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 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 Ezetimiba Normon
Do not take a double dose to make up for missed doses. Simply take your usual dose of Ezetimiba Normon at the next scheduled time.
If you stop taking Ezetimiba Normon
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 adverse effects have been reported:
- 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 (may affect up to 1 in 10 people):
- abdominal pain
- diarrhea
- gas
- feeling of tiredness
Uncommon (may affect up to 1 in 100 people):
- increased results in certain liver function tests (transaminases) or muscle function tests (CK)
- cough
- indigestion
- heartburn
- nausea
- joint pain
- muscle spasm
- 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 in certain liver function tests (transaminases)
- headache
- muscle pain
- sensitivity 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 adverse effects have been reported in general use:
- dizziness
- muscle pain
- liver problems
- allergic reactions including rash and hives
- raised, red skin rashes, sometimes with target-like lesions (erythema multiforme)
- muscle pain, tenderness, or 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 count, 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, talk to 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 Ezetimiba Normon
Store below 30°C. Keep in the original packaging to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.
6. Contents of the pack and other information
Composition of Ezetimiba Normon
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are: monohydrate lactose, microcrystalline cellulose, copovidone, crospovidone, sodium lauryl sulfate, and magnesium stearate.
Appearance of the product and contents of the pack
Ezetimiba Normon tablets are round, white or almost white, marked with "E" on one side.
It is presented in a blister pack containing 28 tablets.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
C/ Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain
Date of the most recent review of this leaflet: April 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/