Ezetimibe Mabo 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ezetimiba Mabo 10 mg tablets EFG
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 other people, 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 Mabo is and what it is used for
- What you need to know before taking Ezetimiba Mabo
- How to take Ezetimiba Mabo
- Possible side effects
- How to store Ezetimiba Mabo
- Contents of the pack and other information
1. What Ezetimiba Mabo is and what it is used for
Ezetimiba Mabo is a medication used to reduce elevated cholesterol levels.
Ezetimiba Mabo reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Ezetimiba Mabo increases levels of "good" cholesterol (HDL cholesterol).
Ezetimiba, the active substance in Ezetimiba Mabo, works by reducing the amount of cholesterol absorbed in the digestive tract.
Ezetimiba Mabo adds to the cholesterol-lowering effect of statins, a group of medications that reduce cholesterol produced by the body itself.
Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly 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. Such disruption 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.
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 MABO is used together with a cholesterol-lowering diet if you have:
-
Elevated 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
-
A hereditary condition (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.
If you have heart disease, Ezetimiba Mabo, when combined 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.
Ezetimiba Mabo does not help you lose weight.
2. What you need to know before taking Ezetimiba Mabo
If you are taking Ezetimiba Mabo together with a statin, please read the package leaflet of that medicine.
Do not take Ezetimiba Mabo 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 Ezetimiba Mabo together 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 Ezetimiba Mabo. Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking Ezetimiba Mabo with a statin. This is to check that your liver is healthy.
- Your doctor may also want to perform further blood tests to monitor your liver function after you start taking Ezetimiba Mabo with a statin.
Ezetimiba Mabo is not recommended if you have moderate or severe liver problems.
The combined use of Ezetimiba Mabo and fibrates (medicines used to lower cholesterol) is not recommended, as the safety and efficacy of combining Ezetimiba Mabo with fibrates have not been studied.
Children and adolescents
Do not give this medicine to children and adolescents between 6 and 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 available information in this age group.
Taking Ezetimiba Mabo 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:
- Cyclosporine (often used in organ transplant patients).
- Medicines containing an active substance used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
- Colestiramine (also used to lower cholesterol), as it affects how ezetimibe 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.
Do not take Ezetimiba Mabo with a statin if you are pregnant, trying to become pregnant, or think you could be pregnant. If you become pregnant while taking Ezetimiba Mabo with a statin, stop taking both medicines immediately and inform your doctor.
There is no experience with the use of Ezetimiba Mabo with a statin during pregnancy.
Do not take Ezetimiba Mabo 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 Ezetimiba Mabo, with or without a statin. Consult your doctor.
Driving and using machines
Ezetimiba Mabo is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Ezetimiba Mabo.
Ezetimiba Mabo contains lactose
Ezetimiba Mabo tablets contain a sugar called lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Ezetimiba Mabo contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Ezetimiba Mabo
Follow exactly the instructions for use of 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 this medicine, you should already be following a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking this medicine.
The recommended dose is one Ezetimiba Mabo 10 mg tablet once daily, taken orally.
Take Ezetimiba Mabo at any time of day. You may take it with or without food.
If your doctor has prescribed Ezetimiba Mabo 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 Mabo together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Ezetimiba Mabo at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba Mabo than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20, stating the medicine and the amount taken.
It is recommended to bring the medicine’s packaging and package leaflet to the healthcare professional.
If you forget to take Ezetimiba Mabo
Do not take a double dose to make up for the missed doses. Simply take your normal dose of Ezetimiba Mabo at the usual time the next day.
If you stop taking Ezetimiba Mabo
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 experiences 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, on rare occasions, 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;
- diarrhea;
- gas;
- feeling tired.
Uncommon:
- 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 together with a statin, the following adverse effects have been reported:
Common:
- increased results in certain liver function tests (transaminases);
- headache;
- muscle pain;
- sensitivity 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 together 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Mabo
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.
Store in the original container to protect it from moisture. Do not remove the tablet from the blister pack until ready to take it.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ezetimiba Mabo
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are: monohydrate lactose (see section 2: 'Ezetimiba Mabo contains lactose'), sodium croscarmellose (E-468) (see section 2: 'Ezetimiba Mabo contains sodium'), povidone K30 (E-1201), sodium lauryl sulfate (E-487), and magnesium stearate (E-572).
Appearance of the product and contents of the pack
Ezetimiba Mabo tablets are capsule-shaped, white or almost white, engraved with "E 10" on one side and blank on the other. The tablet dimensions are 8.1 x 4.1 mm.
Pack size: Ezetimiba Mabo is supplied in packs of 28 tablets in blister packs.
Marketing Authorization Holder
MABO-FARMA, S.A.
Calle Vía de los Poblados, 3, Edificio 6
28033 Madrid,
Spain
Manufacturer
NOUCOR HEALTH, S.A.
Avda. Camí Reial, 51-57
08184 Palau-solità i Plegamans
Barcelona, Spain
Date of the most recent revision of this leaflet: July 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/