Azibe 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Azibe 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, 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 may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Azibe is and what it is used for
- What you need to know before taking Azibe
- How to take Azibe
- Possible adverse effects
- How to store Azibe
- Contents of the pack and other information
1. What Azibe is and what it is used for
Azibe is a medication used to lower elevated cholesterol levels.
Azibe reduces the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Azibe increases the levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Azibe, works by reducing the cholesterol absorbed in the digestive tract.
Ezetimibe 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 lead to 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 cause 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.
Azibe 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
- a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may also be given other treatments.
If you have heart disease, Azibe 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.
Azibe does not help you lose weight.
2. What you need to know before taking Azibe
If you are taking Azibe together with a statin, please read the leaflet of that medicine.
Do not take Azibe
- If you are allergic to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
Do not take Azibe together with a statin
- If you currently have liver problems.
- If you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Azibe.
- Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking Azibe with a statin. This is to check that your liver is functioning properly.
- Your doctor may also want to carry out further blood tests to monitor your liver function after you start taking Azibe with a statin.
Azibe is not recommended if you have moderate or severe liver problems.
The safety and efficacy of combining Azibe 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.
Other medicines and Azibe
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 active substances used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
- colestyramine (also used to lower cholesterol), as it affects how Azibe 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 Azibe with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Azibe with a statin, stop taking both medicines immediately and inform your doctor.
There is no experience with the use of ezetimibe with a statin during pregnancy. Consult your doctor before using Azibe if you are pregnant.
Do not take Azibe 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 Azibe, even without taking a statin. Consult your doctor.
Talk to your doctor or pharmacist before using any medicine.
Driving and using machines
Azibe 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 ezetimibe.
Azibe contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Azibe
Follow exactly the instructions for administration 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 Azibe, you must already be on a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking Azibe.
The recommended dose is one 10 mg ezetimibe tablet once daily, taken orally.
Take this medicine at any time of day. It may be taken with or without food.
If your doctor has prescribed Azibe 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 Azibe together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Azibe at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Azibe 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 package leaflet to the healthcare professional.
If you forget to take Azibe
Do not take a double dose to make up for the missed dose; simply take your usual dose the next day.
If you stop taking Azibe
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 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 severe 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; and 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; 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; urticaria; 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 urticaria; raised and 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 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 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 Azibe
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Azibe
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (Type A) (from potato), povidone, sodium lauryl sulfate, and magnesium stearate.
Appearance of the product and contents of the pack
White or almost white, round, biconvex tablets, smooth on both sides.
Pack sizes:
PVC/PCTFE (polychlorotrifluoroethylene)-aluminum blisters in packs of 28 tablets.
Marketing Authorization Holder
Laboratorios Alter, S.A.
C/ Mateo Inurria, 30
28036 Madrid
Spain
Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria, 30
28036 Madrid
Spain
or
Laboratorios Alter, S.A.
C/ Zeus, 6
Polígono Industrial R2
28880 Meco (Madrid)
Spain
Date of the most recent review of this leaflet:
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/.