Prospect: information for the user

Ezetimiba/Simvastatina Stada 10 mg/20 mg tablets EFG

Ezetimiba/Simvastatina Stada 10 mg/40 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.See section 4.

Content of theprospect

1. What isEzetimiba/SimvastatinaStadaand for what it is used
2. What you need to know before starting to takeEzetimiba/SimvastatinaStada
3. How to takeEzetimiba/SimvastatinaStada
4. Possible adverse effects
5. Storage ofEzetimiba/SimvastatinaStada

6. Contents of the package and additional information

This medication contains 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 your 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 heart disease.

Triglycerides are another type of fat in your blood that can increase the risk of heart disease.

Ezetimiba/simvastatina is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet.

Ezetimiba/simvastatina is 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 in separate tablets have been used
• a hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
• heart 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 Stada if:

• You are allergic to ezetimiba, simvastatina or any of the other ingredients of this medicine (listed in section 6)
• 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 (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 have taken, within the last 7 days, a medicine called fusidic acid (used to treat bacterial infections), by mouth or injection. The combination of fusidic acid with ezetimiba/simvastatina may lead to 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 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 had any liver disease. Ezetimiba/simvastatina may not be suitable for you
• If you are scheduled for surgery. You may need to stop taking ezetimiba/simvastatina for a short period of time
• If you are of Asian origin, as you may need a different dose
• If you have or have had myasthenia (a condition that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia (see section 4)

Your doctor will do a blood test before you start 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 fat 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 their combined use has not been studied.

Consult your doctor immediately if you experience:

Pain, sensitivity to pressure or unexplained muscle weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.

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.

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 your close relatives have a hereditary muscle disorder

Children and adolescents

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

Other medicines and Ezetimiba/Simvastatina Stada

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 Stada if").

• If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking ezetimiba/simvastatina temporarily. Your doctor will tell you when it is safe to restart ezetimiba/simvastatina. The combination of ezetimiba/simvastatina with fusidic acid may cause, in rare cases, muscle weakness, sensitivity or pain (rhabdomyolysis).See more information about rhabdomyolysis in section 4.
• Ciclosporin (often used in transplant patients)
• 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 or 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 conditions)
• Lomitapida (used to treat rare and severe cholesterol disorders)
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). The muscle problems caused by this medicine may be more severe when taken during simvastatina treatment (e.g. ezetimiba/simvastatina). Your doctor may decide to stop taking ezetimiba/simvastatina for a time
• Large doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol)
• Colchicine (used to treat gout)

As with the medicines mentioned above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those purchased 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 Stada with food and drinks

The juice of the grapefruit contains one or more components that alter the metabolism of some medicines, including ezetimiba/simvastatina. You should avoid consuming grapefruit 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 operating machines

Ezetimiba/simvastatina is not expected to interfere with your ability to drive or use machines. However, some people may experience dizziness after taking ezetimiba/simvastatina.

This medicine contains lactose and sodium

If your doctor has told you that you have an intolerance to 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 do not have a notch 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 levels.
• You will need to continue this cholesterol-reducing diet while taking ezetimiba/simvastatina.

Adults: the dose is1 tabletof ezetimiba/simvastatina once a day by mouth.

Use in adolescents(10 to 17 years old): the dose is1 tabletof ezetimiba/simvastatina once a day by mouth (do not exceed a maximum dose of 10mg/40mg once a day).

The dose of ezetimiba/simvastatina 10mg/80mg 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.

If the optimal dosage cannot be achieved using ezetimiba/simvastatina 10 mg/20 mg, your doctor may prescribe other tablets containing ezetimiba/simvastatina.

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 Stadathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, Tfno. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Ezetimiba/Simvastatina Stada

Do not take a double dose to compensate for the missed doses, take your usual amount of ezetimiba/simvastatina at the usual time the next day.

If you interrupt the treatment with Ezetimiba/Simvastatina Stada

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them (see section 2).

The following frequent side effects (may affect up to 1 in 10 people) have been reported:

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

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

• Liver function abnormalities 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 disturbances; 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 may 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 severe 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 failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• Hair loss; red, swollen, and sometimes blistered rash, sometimes with target lesions (erythema multiforme)
• Blurred vision and vision deterioration (may affect up to 1 in 1,000 people)
• Rash that may occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions) (may affect up to 1 in 10,000 people)
• A hypersensitivity reaction that may include the following: hypersensitivity (allergic reactions including facial swelling, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing and requires immediate treatment (angioedema), a severe allergic reaction very rarely causing difficulty breathing or dizziness (anaphylaxis), joint pain, inflammation of blood vessels, atypical hematomas, skin eruptions, and swelling, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, pseudolupus-like syndrome (including skin rash, joint disorders, and effects on white blood cells))
• Muscle pain, pressure sensitivity, weakness, or muscle cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• Gynecomastia (breast enlargement in men) (may affect up to 1 in 10,000 people)
• Loss of appetite
• Hot flashes; high blood pressure
• Pain
• Erectile dysfunction
• Depression
• Abnormalities in some liver function blood tests
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) (unknown frequency: cannot be estimated from available data)*
• Myasthenia ocular (a disease that causes weakness of the eye muscles) (unknown frequency: cannot be estimated from available data)*

* Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

In addition to the side effects listed above, the following additional adverse events have been reported with some statins:

• Sleep disturbances, 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)

Consult your doctor immediately if you experience unexplained muscle pain, pressure sensitivity, 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 side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect 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 side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25?°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Ezetimiba/Simvastatina Stada Composition

The active ingredients are ezetimiba and simvastatina.

10 mg/20 mg:Each tablet contains 10 mg of ezetimiba and 20 mg of simvastatina.

10 mg/40 mg:Each tablet contains 10 mg of ezetimiba and 40 mg of simvastatina.

The other components are:Tablet core: lactose monohydrate, hypromellose, croscarmellose sodium, microcrystalline cellulose, ascorbic acid, citric acid, hydroxyanisole butylated, propyl gallate, magnesium stearate.Pigment mixture: lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Product appearance and packaging contents

10 mg/20 mg:Ezetimiba/Simvastatina Stada 10 mg/20 mg tablets are light brown, speckled, round, 8 mm in diameter, biconvex, and marked with “512” on one side.

10 mg/40 mg:Ezetimiba/Simvastatina Stada 10 mg/40 mg tablets are light brown, speckled, round, 10 mm in diameter, biconvex, and marked with “513” on one side.

Packaging sizes:

Blister: 28, 30, 50, 90, 98, and 100 tablets.

HDPE bottle: 90 and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitza 2600

Bulgaria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de?Reijtstraat?31-E?

4814 NE Breda?

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co.Tipperary

Ireland

or

Sanico N.V.

Veedijk 59

2300 Turnhout

Belgium

or

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last review date of this leaflet:May 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/