Package Leaflet: Information for the User
Ezetimiba/Simvastatina Normon 10 mg /40 mg Tablets EFG
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Table of Contents
This medicationcontains the active principles ezetimiba and simvastatina.It is used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, it increases the concentrations of "good" cholesterol (HDL cholesterol).
Ezetimiba/simvastatinaacts by reducing cholesterol in two ways. The active principle ezetimiba reduces the cholesterol absorbed in the digestive tract. The active principle simvastatina, which belongs to the group of "statins", inhibits the production of cholesterol produced by the body itself.
Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of its arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.
Triglycerides are another type of fat in your blood that can increase the risk of heart disease.
Ezetimiba/simvastatinais used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet.
Ezetimiba/simvastatinais used, along with a cholesterol-reducing diet,if you have:
This medicationdoes not help you lose weight.
Do not take Ezetimiba/Simvastatina Normon if:
Do not take more than 10/40 mg of ezetimiba/simvastatina if you are taking lomitapida (used to treat rare and severe genetic cholesterol disorders).
Consult your doctor if you are unsure if your medicine is mentioned above.
Warnings and precautions
Inform your doctor:
Your doctor will do a blood test before you start taking ezetimiba/simvastatina and also if you have any symptoms of liver problems while taking ezetimiba/simvastatina. This is to check how well your liver is working.
Your doctor may also want to do blood tests to check how well your liver is working after you start taking ezetimiba/simvastatina.
While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure.
Talk to your doctor if you have a severe lung disease.
You should avoid taking ezetimiba/simvastatina and fibrates (certain medicines to reduce cholesterol) together, as they have not been studied together.
Consult your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure which can cause kidney damage; and very rarely, deaths have occurred.
The risk of muscle failure is higher with high doses of ezetimiba/simvastatina, especially the 10/80 mg dose. The risk of muscle failure is also higher in certain patients. Inform your doctor in the following situations:
Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.
Children and adolescents
Other medicines and Ezetimiba/Simvastatina Normon
Inform your doctor if you are taking, have taken recently or may need to take any other medicine with any of the following active ingredients. Taking ezetimiba/simvastatina with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above “Do not take Ezetimiba/Simvastatina Normon if”).
As well as with the medicines mentioned above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those bought without a prescription. In particular, inform your doctor if you are taking any of the following:
You should also inform any doctor who prescribes a new medicine that you are taking ezetimiba/simvastatina.
Taking Ezetimiba/Simvastatina Normon with food and drink
Orange juice contains one or more components that alter the metabolism of some medicines, including ezetimiba/simvastatina. You should avoid consuming orange juice, as it may increase the risk of muscle problems.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while taking ezetimiba/simvastatina, stop taking it immediately and inform your doctor. Do not take ezetimiba/simvastatina if you are breastfeeding, as it is not known whether this medicine passes into breast milk.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Ezetimiba/simvastatina is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness after taking ezetimiba/simvastatina.
Ezetimiba/Simvastatina Normon contains lactose and sodium
This medicine contains lactose. If your doctor has told you that you have a problem with certain sugars, consult with them before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.
Your doctor will determine the appropriate dose for you, based on your current treatment and personal risk situation.
The tablets are not scored and should not be divided.
Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Adults: the dose is 1 tablet of ezetimiba/simvastatina once a day by mouth.
Use in adolescents (10 to 17 years old): the dose is 1 tablet of ezetimiba/simvastatina once a day by mouth (do not exceed a maximum dose of 10 mg/40 mg once a day).
The dose of ezetimiba/simvastatina 10 mg/80 mg is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease problems who have not achieved treatment goals with lower doses.
Take ezetimiba/simvastatina at night. You can take it with or without food.
If your doctor has prescribed ezetimiba/simvastatina along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other bile acid sequestrant, you should take ezetimiba/simvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimiba/Simvastatina Normon than you should
If you forgot to take Ezetimiba/Simvastatina Normon
If you interrupt treatment with Ezetimiba/Simvastatina Normon
If you have any other questions about the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them (see section 2. What you need to know before starting to take Ezetimiba/Simvastatina Normon).
The following frequent side effects (can affect up to 1 in 10 people) have been reported:
The following infrequent side effects (can affect up to 1 in 100 people) have been reported:
In addition, the following side effects have been reported in people taking ezetimiba/simvastatina or medications containing the active ingredients ezetimiba or simvastatina:
With some statins, the following additional adverse events have been reported:
Adverse reactions of unknown frequency:
Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.
Consult your doctor immediately if you experience unexplained muscle pain, sensitivity to pressure, or weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.
Reporting of adverse reactions:
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:
https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date that appears on the packaging or on the container after CAD.
This medicine does not require special conditions for conservation.
Do not dispose of medicines through the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.
Composition ofEzetimiba/Simvastatina Normon
Appearance of the product and contents of the packaging
White to off-white colored tablets, in capsule form, with the imprint “14” on one face and smooth on the other.
Ezetimiba/Simvastatina Normon10 mg/40 mg is presented in blisters available in packs of 28 tablets.
Holder of the marketing authorization and responsible manufacturer
Normon Laboratories, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Date of the last review of this leaflet: April 2023
The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.