Prospect: information for the patient

Ezetimiba/Simvastatina Alter 10 mg/10 mg tablets EFG

Ezetimiba/Simvastatina Alter 10 mg/20 mg tablets EFG

Ezetimiba/Simvastatina Alter 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 to you, and you should 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 are not listed in this prospect.See section 4.

Content of theprospect

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

Content of the package 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 raises the levels 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/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 in separate tablets have been used

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

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

This medicationdoes not help you lose weight.

Do not takeEzetimiba/Simvastatina Alter

• if you are allergic to ezetimiba, simvastatina or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you are pregnant or breastfeeding
• if 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 had an organ transplant)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

• if you are taking or have taken in the last 7 days a medicine that contains 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 mg/40 mg of ezetimiba/simvastatina if you are taking lomitapida (used to treat rare and severe cholesterol disorders)

Consult your doctor if you are not sure if your medicine is mentioned above.

Warnings and precautions

Consult your doctor before starting to take Ezetimiba/Simvastatina Alter. 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 fat in your blood, are overweight and have high blood pressure.

Talk to your doctor if you have a serious 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 kidney damage; and very rarely, deaths have occurred.

The risk of muscle damage is higher with high doses of ezetimiba/simvastatina, especially the 10 mg/80 mg dose. The risk of muscle damage 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

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

Other medicines and Ezetimiba/Simvastatina Alter

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 Alter”).

• if you have to take fusidic acid orally to treat a bacterial infection, you will temporarily have to stop taking this medicine. Your doctor will tell you when you can start taking ezetimiba/simvastatina again. Taking ezetimiba/simvastatina with fusidic acid rarely may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• ciclosporin (often used in transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the 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 the active ingredient 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 cholesterol disorders)
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). Muscle problems may be more severe when this medicine is taken during treatment with simvastatina (for example ezetimiba/simvastatina). Your doctor may decide that you should 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 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)
• cholestyramine (also used to reduce cholesterol), as it affects how ezetimiba/simvastatina works
• fenofibrate (also used to reduce cholesterol)
• rifampicin (used to treat tuberculosis)
• ticagrelor (antiplatelet agent).

You should also inform any doctor who prescribes a new medicine that you are taking ezetimiba/simvastatina.

Taking Ezetimiba/Simvastatina Alter 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

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Do not take ezetimiba/simvastatina if you are pregnant, if you are trying to become pregnant or if you 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.

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 Alter contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Your doctor will determine the appropriate dose for you, based on your current treatment and personal risk factors.

The tablets do not have a score line 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-lowering 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 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 Alter 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 Alter

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

If you interrupt treatment with Ezetimiba/Simvastatina Alter

• 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 Alter).Que you need to know before starting to take this medicine.Ezetimiba/Simvastatina Alter.

The following side effects were reported frequently (may affect up to 1 in 10 people):

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

The following side effects were reported infrequently (may affect up to 1 in 100 people):

• Liver function elevations in blood tests; uric acid elevations in the blood; blood clotting time elevations; proteinuria; weight loss
• Dizziness; headache; tingling sensation
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; stomach burning
• 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.

Additionally, the following side effects were 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 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 may cause abdominal pain, nausea, vomiting)
• Hair loss; red, swollen, and sometimes blistering 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 (lichenoid drug eruptions (may affect up to 1 in 10,000 people)
• Hypersensitivity reactions that may include the following: allergic reactions, including facial swelling, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing and require immediate treatment (angioedema), joint pain or inflammation, blood vessel inflammation, atypical hematomas, skin eruptions, and swelling, 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). A severe allergic reaction may occur very rarely (may affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• 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
• 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, being overweight, and high blood pressure. Your doctor will monitor you while taking this medicine
• Constant muscle pain, sensitivity, or weakness, which may not disappear after stopping ezetimiba/simvastatina treatment (unknown frequency).
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) (unknown frequency)
• Myasthenia ocular (a disease that causes weakness of the eye muscles) (unknown frequency).
• Consult your doctor if you experience weakness in the 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 causes 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 leaflet. 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 medicine.

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

Do not store above 25°C.

Do not use this medication after the expiration date that appears on the label, box, or blister after CAD. The expiration date is the last day of the month indicated.

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 collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Ezetimibe/Simvastatin Alter Composition

• The active principles are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg or 40 mg of simvastatin.
• The other components are:Tablet core: lactose monohydrate, hypromellose, croscarmellose sodium, microcrystalline cellulose, ascorbic acid, anhydrous citric acid, butylated hydroxyanisole (E320), propyl gallate and magnesium stearate. Colorant mixture: lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the package

Ezetimibe/Simvastatin Alter 10 mg/10 mg: brownish-colored tablets, speckled, round, biconvex, 6 mm in diameter, with a smooth face and the other marked with “511”.

Ezetimibe/Simvastatin Alter 10 mg/20 mg: brownish-colored tablets, speckled, round, biconvex, 8 mm in diameter, with a smooth face and the other marked with “512”.

Ezetimibe/Simvastatin Alter 10 mg/40 mg: brownish-colored tablets, speckled, round, biconvex, 10 mm in diameter, with a smooth face and the other marked with “513”.

OPA/Aluminum/PVC-aluminum foil blister and HDPE bottles with desiccant.

Package sizes:

10 mg/10 mg: 28 and 30 tablets.

10 mg/20 mg: 28, 30 and 90 tablets.

10 mg/40 mg: 28, 30 and 90 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Balkanpharma - Dupnitsa AD

3 Samokovko Shosse Str.

Dupnitsa 2600

Bulgaria

or

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainEzetimibe/Simvastatin Alter tablets EFG

FranceEZETIMIBE/SIMVASTATIN ALTER, tablet

ItalyEzetimibe and Simvastatin Alter tablets

Last review date of this leaflet:April 2023

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