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.

• 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. Do not pass it on to others 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. See section 4.

Table of Contents

1. What is Ezetimiba/Simvastatina Normon and what it is used for
2. What you need to know before you start taking Ezetimiba/Simvastatina Normon
3. How to take Ezetimiba/Simvastatina Normon
4. Possible side effects
5. Storage of Ezetimiba/Simvastatina Normon
6. Contents of the pack and additional information

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:

• elevated blood levels of cholesterol (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated blood levels of fatty substances (mixed hyperlipidemia):
• that are not well controlled with a single statin
• for whom a statin and ezetimiba have been used in separate tablets

• a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.

• cardiovascular disease,ezetimiba/simvastatina reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

This medicationdoes not help you lose weight.

Do not take Ezetimiba/Simvastatina Normon if:

• You are allergic to ezetimiba, simvastatina or any of the other ingredients of this medicine (listed in section 6, Contents of the pack and additional information)
• You have liver problems
• You are pregnant or breastfeeding
• You are taking medicines with one or more of the following active ingredients:

• Itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)
• Erythromycin, clarithromycin or telithromycin (used to treat infections)
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (protease inhibitors for HIV are used to treat HIV infections)
• Boceprevir or telaprevir (used to treat hepatitis C infection)
• Nefazodone (used to treat depression)
• Cobicistat
• Gemfibrozil (used to reduce cholesterol)
• Ciclosporin (used in patients who have undergone organ transplantation)
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)

• If you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Ezetimiba/Simvastatina may cause severe muscle problems (rhabdomyolysis).

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:

• About all your medical problems, including allergies.
• If you consume large amounts of alcohol or have ever had liver disease. Ezetimiba/Simvastatina may not be suitable for you.
• If you are due to have an operation. You may need to stop taking the ezetimiba/simvastatina tablets for a short time.
• If you are of Asian origin, as you may need a different dose.

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:

• If you have kidney problems
• If you have thyroid problems
• If you are over 65 years old
• If you are a woman
• If you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” (such as simvastatina, atorvastatina and rosuvastatina) or fibrates (such as gemfibrozilo or bezafibrato).
• If you or close relatives have a hereditary muscle disorder
• If you have or have had myasthenia (a condition that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a condition that causes eye muscle weakness), as statins can sometimes worsen the condition or cause it to develop (see section 4).

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

• Ezetimiba/simvastatina is not recommended for children under 10 years old.

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”).

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking Ezetimiba/Simvastatina Normon. Your doctor will tell you when you can start taking Ezetimiba/Simvastatina Normon again. The use of Ezetimiba/Simvastatina Normon with fusidic acid rarely causes muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see Section 4.

• Ciclosporin (often used in patients who have undergone organ transplantation)
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)
• Medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
• Fibrates with an active ingredient such as gemfibrozil and bezafibrato (used to reduce cholesterol)
• Erythromycin, clarithromycin, telithromycin (used to treat bacterial infections).
• Protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV infections)
• Antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C infection)
• Nefazodone (used to treat depression)
• Medicines with an active ingredient called cobicistat
• Amiodarone (used to treat irregular heart rhythm)
• Verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart diseases)
• Lomitapida (used to treat rare and severe genetic cholesterol disorders)
• Large doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol)
• Colchicine (used to treat gout).

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:

• Medicines with an active ingredient to prevent blood clotting, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants)
• Colestiramine (also used to reduce cholesterol), as it affects how ezetimiba/simvastatina works
• Fenofibrate (also used to reduce cholesterol)
• Rifampicin (used to treat tuberculosis).

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.

• Before starting to take ezetimiba/simvastatina, you must be following a diet to reduce cholesterol.
• You will need to continue this cholesterol-reducing diet while taking ezetimiba/simvastatina.

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

• In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forgot to take Ezetimiba/Simvastatina Normon

• Do not take a double dose to make up for the missed doses, take your usual amount of Ezetimiba/Simvastatina Normon at the usual time.

If you interrupt treatment with Ezetimiba/Simvastatina Normon

• Talk to your doctor or pharmacist because your cholesterol may increase again.

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:

• Muscle pain
• Laboratory blood test elevations in liver function (transaminases) and/or muscle (CK)

The following infrequent side effects (can affect up to 1 in 100 people) have been reported:

• Liver function elevation in blood tests; elevated uric acid in the blood; prolonged blood clotting time; protein in urine; weight loss
• Dizziness; headache; tingling sensation
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn
• Rash; itching; urticaria
• Joint pain; muscle pain, hypersensitivity, weakness, or spasms; neck pain; arm and leg pain; back pain
• Unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• Sleep disorder; difficulty sleeping

In addition, the following side effects have been reported in people taking ezetimiba/simvastatina or medications containing the active ingredients ezetimiba or simvastatina:

• Low red blood cell count (anemia), reduced blood cell count, which can cause hematoma/hemorrhage (thrombocytopenia)
• Numbness or weakness of the arms and legs; poor memory, memory loss, confusion
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Constipation
• Pancreatitis, often with intense abdominal pain
• Hepatitis with the following symptoms: yellowing of the skin and eyes, itching, dark urine, pale stools, feeling tired or weak, loss of appetite; liver insufficiency; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• Hair loss; red, swollen, and sometimes blistered rash, sometimes with target lesions (erythema multiforme)
• Blurred vision and vision deterioration (can affect up to 1 in 1,000 people)
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (can affect up to 1 in 10,000 people)
• Hypersensitivity reaction that can include the following: hypersensitivity (allergic reactions including facial swelling, lip, tongue, and/or throat swelling, which can cause difficulty breathing or swallowing and requires immediate treatment, joint pain or inflammation, blood vessel inflammation, atypical hematomas, skin rash, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, lupus-like syndrome (including skin rash, joint disorders, and effects on white blood cells))
• Muscle pain, sensitivity to pressure, weakness, or muscle cramps; muscle failure; muscle rupture (can affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• Gynecomastia (breast enlargement in men) (can affect up to 1 in 10,000 people)
• Loss of appetite
• Hot flashes; high blood pressure
• Pain
• Erectile dysfunction
• Depression
• Alterations in some liver function blood tests

With some statins, the following additional adverse events have been reported:

• Sleep disorders, including nightmares
• Sexual dysfunction
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping ezetimiba/simvastatina treatment (unknown frequency)

Adverse reactions of unknown frequency:

• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

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

• The active principles are ezetimiba and simvastatina.Each tablet contains 10 mg of ezetimiba and 40 mg of simvastatina.
• The other components are:Lactose monohydrate, maize pregelatinized starch (1500), crospovidone type B,hypromellose 3 CPS, sodium lauryl sulfate, microcrystalline cellulose (E460i),butylated hydroxyanisole, citric acid, ascorbic acid, lactose, sodium croscarmellose,sodium stearate fumarate, and magnesium stearate (E470b).

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/