Ezetimibe STADA 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Ezetimiba STADA 10 mg tablets EFG
Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
Leaflet contents
- What Ezetimiba STADA is and what it is used for
- What you need to know before taking Ezetimiba STADA
- How to take Ezetimiba STADA
- Possible side effects
- How to store Ezetimiba STADA
- Contents of the pack and other information
1. What Ezetimiba Stada is and what it is used for
Ezetimibe is a medication used to reduce elevated cholesterol levels.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often referred to as “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 may 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.
Ezetimibe reduces blood concentrations of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, ezetimibe increases levels of “good” cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimiba Stada, works by reducing the amount of 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.
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.
Ezetimibe 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
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as monotherapy, when treatment with a statin is inappropriate or not tolerated
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a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may be prescribed additional treatments.
-
a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.
If you have heart disease, ezetimibe 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.
Ezetimibe does not help you lose weight.
2. What you need to know before taking Ezetimiba Stada
If you are taking ezetimiba together with a statin, please read the package leaflet of that medicine.
Do not take Ezetimiba Stada:
- if you are allergic to ezetimiba or to any of the other ingredients of this medicine (listed in section 6).
DO NOT take Ezetimiba Stada 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 Stada.
- Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking ezetimiba 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 with a statin.
Ezetimiba is not recommended if you have moderate or severe liver problems.
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 (6 to 17 years of age) unless specifically 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 Stada
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, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
- colestyramine (also used to lower cholesterol), as it affects how ezetimiba 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 with a statin if you are pregnant, trying to become pregnant, or think you might be pregnant.
If you become pregnant while taking ezetimiba with a statin, stop taking both medicines immediately and inform your doctor.
There is no experience with the use of ezetimiba with a statin during pregnancy.
Consult your doctor before using ezetimiba if you are pregnant.
Breastfeeding
Do not take ezetimiba 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, even without taking a statin. Consult your doctor.
Driving and using machines
Ezetimiba 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; if you are affected in this way, do not drive or operate machinery until you feel better.
Ezetimiba Stada contains lactose and sodium
Ezetimiba Stada tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Ezetimiba Stada
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 ezetimiba, you should already be following a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking ezetimiba.
Dosage
The recommended dose is one 10 mg ezetimiba tablet once daily.
Method of administration
This medicine is for oral use.
Take ezetimiba at any time of day. It may be taken with or without food.
If your doctor has prescribed ezetimiba 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 respective medicine.
If your doctor has prescribed ezetimiba together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba Stada than you should
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Ezetimiba Stada
Do not take a double dose to make up for missed doses. Simply take your normal dose of ezetimiba at the usual time the next day.
If you stop taking Ezetimiba Stada
Continue taking your cholesterol-lowering medicines unless your doctor tells you otherwise. 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.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems—including muscle breakdown that may lead 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:
Frequent (may affect up to 1 in 10 people):
- abdominal pain
- diarrhea
- gas
- feeling of tiredness
Uncommon (may affect up to 1 in 100 people):
- elevated 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
In addition, when used in combination with a statin, the following side effects have been reported:
Frequent (may affect up to 1 in 10 people):
- elevated results in certain liver function tests (transaminases)
- headache
- muscle pain
- tenderness 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 in combination with fenofibrate, the following side effect has been reported:
Frequent (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 skin 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 counts, which may lead to bruising/bleeding (thrombocytopenia)
- tingling sensation
- depression
- unusual tiredness or weakness
- shortness of breath
Reporting of adverse effects:
If you experience any 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 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 Stada
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.
Store in the original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Deposit unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ezetimiba Stada
- The active substance is ezetimiba. Each tablet contains 10 mg of ezetimiba.
- The other components are: monohydrate lactose, microcrystalline cellulose (E460), povidone (E 1201), sodium croscarmellose (E 468), sodium lauryl sulfate and magnesium stearate (E 470b).
Appearance of the product and contents of the pack
The tablets are white to off-white, oval-shaped, capsule-shaped, approximately 8 mm in length and 4 mm in width.
The medicine is available in pack sizes of 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 156 or 168 tablets, packed in blisters with PVC/PCTFE/PVC or PVC/PE/PVdC (colourless, transparent) // Aluminium.
The medicine is also available in pack sizes of 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 156 or 168 tablets, packed in unit-dose blisters with PVC/PCTFE-PVC or PVC/PE/PVdC (colourless, transparent) // Aluminium.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
or
STADA Arzneimittel GmbH
Muthgasse 36
1190 Wien
Austria
or
Centrafarm Services B.V.
Van de Reijtstraat 31-E 4814 NE Breda
The Netherlands
or
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland
or
STADA M&D SRL
Str. Trascaului nr. 10,
Municipiul Turda,
Judet Cluj 401135,
Romania
Date of the most recent revision of this leaflet: October 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/