Ezetimibe Almus 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ezetimibe Almus 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, consult 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, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Ezetimibe Almus is and what it is used for
- What you need to know before taking Ezetimibe Almus
- How to take Ezetimibe Almus
- Possible side effects
- How to store Ezetimibe Almus
- Contents of the pack and other information
1. What Ezetimiba Almus is and what it is used for
Ezetimiba Almus is a medicine used to reduce elevated cholesterol levels.
Ezetimiba Almus reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Ezetimiba Almus increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimiba Almus, works by reducing the cholesterol absorbed from the digestive tract.
Ezetimibe 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 present in the bloodstream. Your total cholesterol consists 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. 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.
Ezetimiba Almus 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.
Ezetimibe is used together with a cholesterol-lowering diet if you have:
- elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
- together 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 receive other treatments as well.
- an inherited disease (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.
If you have heart disease, Ezetimiba Almus in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, and hospitalization due to chest pain.
Ezetimiba Almus does not help you lose weight.
2. What you need to know before taking Ezetimiba Almus
If you are taking Ezetimiba Almus together with a statin, please read the leaflet of that medicine.
Do not take Ezetimiba Almus:
- if you are allergic to ezetimiba or to any of the other ingredients of this medicine (listed in section 6).
Do not take Ezetimiba Almus 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 Almus.
- Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking Ezetimiba Almus with a statin. This is to check whether 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 Almus with a statin.
Ezetimiba Almus is not recommended if you have moderate or severe liver problems.
The safety and efficacy of combining Ezetimiba Almus with certain cholesterol-lowering medicines, fibrates, have not been established.
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 information available for this age group.
Taking Ezetimiba Almus with other medicines
Inform 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 to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
- cholestyramine (also used to lower cholesterol), as it affects how Ezetimiba Almus works
- fibrates (also used to lower cholesterol)
Pregnancy and breastfeeding
Do not take Ezetimiba Almus with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimiba Almus with a statin, stop taking both medicines immediately and inform your doctor.
There is no experience with the use of Ezetimiba Almus with a statin during pregnancy. Consult your doctor before using Ezetimiba Almus if you are pregnant.
Do not take Ezetimiba Almus 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 Almus, even without taking a statin. Consult your doctor.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Ezetimiba Almus 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 Almus.
Ezetimiba Almus 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.
Ezetimiba Almus contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this means it is essentially “sodium-free”.
3. How to take Ezetimiba Almus
Follow exactly the administration instructions for 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 Ezetimiba Almus, you should already be following a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking Ezetimiba Almus.
The recommended dose is one Ezetimiba Almus 10 mg tablet once daily by oral route.
Take Ezetimiba Almus at any time of day. It may be taken with or without food.
If your doctor has prescribed Ezetimiba Almus 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 Ezetimiba Almus together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Ezetimiba Almus at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba Almus than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Ezetimiba Almus
Do not take a double dose to make up for missed doses. Simply take your normal dose of Ezetimiba Almus at the usual time the next day.
If you stop taking Ezetimiba Almus
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further questions about using 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 frequently adverse effects have been reported:
- Very common (may affect more than 1 in 10 patients)
- Common (may affect up to 1 in 10 patients)
- Uncommon (may affect up to 1 in 100 patients)
- Rare (may affect up to 1 in 1,000 patients)
- Very rare (may affect up to 1 in 10,000 patients, 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; and feeling tired.
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 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-shaped 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ezetimiba Almus
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.
Do not store above 25°C. Keep the medicine in its original packaging to protect it from moisture.
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 in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ezetimiba Almus
- The active substance is ezetimiba. Each tablet contains 10 mg of ezetimiba.
- The other components are monohydrate lactose, crospovidone (type B), copovidone K28, sodium lauryl sulfate, microcrystalline cellulose and magnesium stearate.
Appearance of the product and contents of the pack
Ezetimiba Almus are white to off-white, round, convex tablets, approximately 6 mm in diameter.
Pack sizes
Ezetimiba Almus is available in packs with transparent Triplex (PVC-PE-PVDC)/Aluminum blisters containing 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100 or 300 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]
Manufacturer:
Laboratorios Liconsa, S.A.
Avda. Miralcampo, 7, Pol. Ind. Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
FI: Ezetimib Liconsa 10 mg tabletti
FR: Ezetimibe Almus 10 mg, comprimé
DE: Ezetimib AXiromed 10 mg tabletten
UK (NI): Ezetimibe 10 mg, tablets
IE: Ezetimibe Rowa 10 mg Tablets
ES: Ezetimiba Almus 10 mg comprimidos EFG
PL: Ezetimibe Genoptim
Date of the most recent revision of this leaflet: February 2021
Detailed 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/).