Ezetimibe Sandoz 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ezetimibe Sandoz 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 may 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 Ezetimibe Sandoz is and what it is used for
- What you need to know before taking Ezetimibe Sandoz
- How to take Ezetimibe Sandoz
- Possible side effects
- How to store Ezetimibe Sandoz
- Contents of the pack and other information
1. What Ezetimiba Sandoz is and what it is used for
Ezetimiba Sandoz is a medicine used to lower elevated cholesterol levels.
Ezetimibe is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, this medicine increases concentrations of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimiba Sandoz, works by reducing the cholesterol absorbed in the digestive tract.
Ezetimiba Sandoz adds to the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate 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 interruption in blood flow may 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 them from 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 Sandoz 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.
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alone, when treatment with a statin is inappropriate or not tolerated.
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a hereditary condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin, and possibly other treatments as well.
If you have heart disease, ezetimibe 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.
Ezetimibe does not help you lose weight.
2. What you need to know before taking Ezetimiba Sandoz
If you are taking Ezetimiba Sandoz together with a statin, please read the package leaflet of that medicine.
Do not take Ezetimiba Sandoz
- if you are allergic to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
DO NOT take Ezetimiba Sandoz 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 Sandoz.
- Inform your doctor about all your medical conditions, including allergies.
- Your doctor will perform a blood test before you start taking this medicine with a statin. This is to check how your liver is functioning.
- Your doctor may also want to perform blood tests to monitor liver function after you start taking this medicine with a statin.
Ezetimiba Sandoz is not recommended if you have moderate or severe liver problems.
The combined use of ezetimibe and fibrates (medicines used to lower cholesterol) is not recommended, as safety and efficacy have not been studied.
Contact your doctor immediately if you experience:
- unexplained muscle pain, tenderness, or weakness.
This is because, although rarely, muscle problems—including muscle breakdown leading to kidney damage—can be serious and potentially life-threatening.
The risk of muscle breakdown is higher in some patients taking ezetimibe with cholesterol-lowering medicines such as statins.
Children and adolescents
Do not give this medicine to children and adolescents (aged 6 to 17 years) 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 Sandoz 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 any of the following:
- cyclosporine (a medicine often used in organ transplant patients),
- medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
- colestyramine (a medicine used to lower cholesterol), as it affects how ezetimibe works,
- fibrates (medicines used to lower cholesterol) (see also section 2: Warnings and precautions).
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 ezetimibe with a statin if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking ezetimibe with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of ezetimibe without a statin during pregnancy.
Breastfeeding
Do not take ezetimibe 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 ezetimibe, even without a statin. Consult your doctor.
Driving and using machines
Ezetimibe is not expected to affect your ability to drive or use machines. However, some people may experience dizziness after taking ezetimibe. If this happens to you, do not drive or operate machinery until you feel better.
Ezetimiba Sandoz contains sodium and lactose
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.
If your doctor has advised you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Ezetimiba Sandoz
Follow exactly the instructions for administration of this medicine given to you 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 ezetimiba, you should be on a cholesterol-lowering diet.
- You must continue this cholesterol-lowering diet while taking this medicine.
The dose is one tablet once daily, taken orally.
Take ezetimiba at any time of day. You may take it 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, read the instructions on how to take the medicine in the package leaflet of that particular medicine.
If your doctor has prescribed ezetimiba together with colestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), you must take ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba Sandoz than you should
If you have taken more Ezetimiba Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount taken.
If you forget to take Ezetimiba Sandoz
Do not take a double dose to make up for forgotten doses. Simply take your usual dose of Ezetimiba Sandoz the next day.
If you stop taking Ezetimiba Sandoz
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.
Contact your doctor immediately if you experience:
- muscle pain or weakness,
- unexplained muscle pain.
This is because, very rarely, muscle problems—including muscle breakdown—can occur, which may lead to kidney damage and can be serious, potentially life-threatening.
Allergic reactions, including:
- swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing,
- dizziness or fainting and unusually fast or irregular heartbeat,
which require immediate treatment.
Other adverse effects reported in clinical trials
When used alone, the following adverse effects have been reported:
Common adverse effects (may affect up to 1 in 10 people):
- abdominal pain,
- diarrhoea,
- flatulence (gas),
- feeling of tiredness.
Uncommon adverse effects (may affect up to 1 in 100 people):
- increased results in certain liver function tests (transaminases) or muscle function tests (CK),
- cough,
- indigestion,
- heartburn,
- nausea,
- joint pain,
- muscle cramp,
- neck pain,
- decreased appetite,
- pain,
- chest pain,
- hot flushes,
- high blood pressure.
Additionally, when taken together with a statin, the following adverse effects have been reported:
Common adverse effects (may affect up to 1 in 10 people):
- increased results in certain liver function tests (transaminases),
- headache,
- muscle pain or weakness.
Uncommon adverse effects (may affect up to 1 in 100 people):
- tingling sensation (pins and needles),
- dry mouth,
- inflammation of the stomach lining,
- 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 together with fenofibrate (a medicine for high cholesterol), the following adverse effect has been reported:
Common adverse effects (may affect up to 1 in 10 people):
- abdominal pain.
Additionally, the following adverse effects have been reported during general use (after the medicine has been marketed):
Adverse effects of unknown frequency (cannot be estimated from available data):
- dizziness,
- liver problems,
- allergic reactions such as skin rash, hives, swelling of the face, tongue or throat, and fainting,
- red rash, sometimes with ring-shaped red lesions surrounding a pale center,
- muscle pain/soreness,
- muscle weakness: cramps, stiffness or spasms,
- severe muscle pain or weakness and brownish-red urine due to 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,
- reduced 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, 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 Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, container, or bottle after EXP. The expiry date refers to the last day of the month indicated.
Blister packs: Store in the original packaging to protect from moisture.
Bottles: Keep the container tightly closed to protect from moisture. Shelf life after first opening: 9 months. Store below 25°C.
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 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 Sandoz
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are lactose monohydrate (for further information see the end of section 2), hypromellose, sodium croscarmellose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.
Appearance of the product and contents of the pack
Ezetimiba Sandoz 10 mg tablets are white or off-white, oval-shaped tablets (7.4 mm x 4.0 mm), with the imprint “10” on one side and “EZT” on the other.
Alu/Alu blisters: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets.
HDPE bottles with polypropylene child-resistant closure: 100 and 250 tablets (hospital pack).
White to off-white HDPE bottles with polypropylene closure, induction-sealed with a foil liner, and containing a separately added silica gel desiccant: 250 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana,
Slovenia
or
LEK, S.A.
u.l. Domaniewska 50 C
02-672 Warszawa
Poland
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
or
S.C. Sandoz, S.R.L.
Str. Livezeni nr. 7A,
RO-540472 Targu-Mures,
Romania
or
Lek Pharmaceuticals d.d.
Trimlini 2D, 9220
Lendava
Slovenia
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Ezetimib – 1 A Pharma 10 mg Tabletten
Austria: Ezetimib Sandoz 10 mg - Tabletten S
Belgium: Ezetimibe Sandoz 10 mg tabletten
Cyprus: Ezetimibe Sandoz 10 mg
Croatia: Elanix 10 mg tablete
Slovenia: Elanix 10 mg tablete
Denmark: Ezetimib Sandoz
Estonia: Kolxip
Finland: Ezetimib Sandoz 10 mg tabletti
France: EZETIMIBE SANDOZ 10 mg, comprimé
Greece: Ezetimibe/Sandoz
Hungary: Ezetimibe Sandoz 10 mg tabletta
Italy: EZETIMIBE SANDOZ
Luxembourg: Ezetimib Sandoz 10 mg comprimés
Malta: Ezetimibe 10mg Tablets
Norway: Ezetimib Sandoz 10 mg tabletter
Netherlands: Ezetimibe Sandoz 10 mg, tabletten
Portugal: Ezetimiba Sandoz
United Kingdom: Ezetimibe 10mg Tablets
Czech Republic: Tezzimi 10mg
Slovak Republic: Ezetimibe Sandoz 10 mg
Romania: EZETIMIB SANDOZ 10 mg comprimate
Sweden: Ezetimib Sandoz, 10 mg tablett
Date of the most recent review of this summary: June 2020
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/