Ezetimibe Alter 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
Ezetimibe Alter 10 mg Tablets EFG
Read this entire leaflet carefully before you start taking this medicine, as 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 may 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.
Leaflet Contents
- What Ezetimibe Alter is and what it is used for
- What you need to know before taking Ezetimibe Alter
- How to take Ezetimibe Alter
- Possible adverse effects
- How to store Ezetimibe Alter
- Contents of the pack and other information
1. What Ezetimiba Alter is and what it is used for
Ezetimiba Alter is a medicine used to lower elevated cholesterol levels.
Ezetimiba Alter reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat in the blood called triglycerides. In addition, Ezetimiba Alter increases levels of "good" cholesterol (HDL cholesterol).
Ezetimiba, the active substance in Ezetimiba Alter, works by reducing the amount of cholesterol absorbed in the digestive tract.
Ezetimiba adds to the cholesterol-lowering effect of statins, a group of medicines 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. Such disruption in blood flow may result in 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 Alter 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 adequately controlled with a statin alone
- as monotherapy, when treatment with a statin is inappropriate or not tolerated
- a hereditary condition (homozygous familial hypercholesterolemia) that 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 Alter, when 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 Alter does not help you lose weight.
2. What you need to know before starting Ezetimiba Alter
If you are taking Ezetimiba Alter together with a statin, please read the package leaflet of that medicine.
Do not take Ezetimiba Alter
- If you are allergic to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
Do not take Ezetimiba Alter 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 Ezetimiba Alter.
- Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking Ezetimiba Alter 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 Ezetimiba Alter with a statin.
Ezetimiba Alter is not recommended if you have moderate or severe liver problems.
The safety and efficacy of combining Ezetimiba Alter with certain cholesterol-lowering medicines called 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 Ezetimiba Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, tell 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 Ezetimiba Alter 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 Alter with a statin if you are pregnant, trying to become pregnant, or think you could be pregnant. If you become pregnant while taking Ezetimiba Alter with a statin, stop taking both medicines immediately and inform your doctor.
There is no experience with the use of ezetimibe together with a statin during pregnancy. Consult your doctor before using Ezetimiba Alter if you are pregnant.
Do not take Ezetimiba Alter 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 Alter, even without taking a statin. Consult your doctor.
Talk to your doctor or pharmacist before using any medicine.
Driving and using machines
Ezetimiba Alter 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.
Ezetimiba Alter contains lactose
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.
3. How to take Ezetimiba Alter
Follow exactly the instructions given by your doctor for taking this medicine. 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 Alter, you should already be following a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking Ezetimiba Alter.
The recommended dose is one 10 mg ezetimiba 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 Ezetimiba Alter 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 Alter together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Ezetimiba Alter at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba Alter than you should
Contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91.562.04.20 immediately, stating the medicine and amount taken.
It is recommended to bring the medicine’s packaging and package leaflet to the healthcare professional.
If you forget to take Ezetimiba Alter
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 Ezetimiba Alter
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, 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; gas and feeling of tiredness.
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.
In addition, 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 muscle 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 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 type of 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 Ezetimiba Alter
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Ezetimiba Alter
- The active substance is ezetimiba. Each tablet contains 10 mg of ezetimiba.
- 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 containing 28, 30, 50 or 90 tablets.
Only certain pack sizes may be marketed.
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
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy Ezetimibe Alter 10 mg tablets
Spain Ezetimiba Alter 10 mg tablets EFG
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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.