Label: information for the user

Ezetimibe/Simvastatin Cinfamed 10 mg/40 mg tablets EFG

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

• Keep this label, 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 should not give it to others 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 label.See section 4.

Contents of thelabel

1. What isEzetimibe/Simvastatin Cinfamedand for what it is used
2. What you need to know before starting to takeEzetimibe/Simvastatin Cinfamed
3. How to takeEzetimibe/Simvastatin Cinfamed
4. Possible adverse effects
5. Storage ofEzetimibe/Simvastatin Cinfamed
6. Contents of the package and additional information

This medicationcontains the active principles ezetimibe and simvastatin.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).

Ezetimibe/simvastatinacts by reducing cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in the digestive tract. The active ingredient simvastatin, 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.

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

Ezetimibe/simvastatinis 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 ezetimibe 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,ezetimibe/simvastatin 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 cinfamed

• If you are allergic to ezetimiba, simvastatina or any of the other ingredients of this medicine (listed in section 6).
• If you currently 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 (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 have taken within 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 10/40 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

Consult your doctor or pharmacist before starting to take ezetimiba/simvastatina cinfamed.

Inform your doctor:

• of 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 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 make 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 severe lung disease.

You should avoid taking ezetimiba/simvastatina and fibrates (certain cholesterol-lowering medicines) together, as they have not been studied together.

Consult your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because muscle problems can be severe, including kidney failure; 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 female,
• 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.

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 cinfamed

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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 cinfamed").

• If you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medicine. Your doctor will tell you when you can restart the treatment with ezetimiba/simvastatina. The use of 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 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 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). It is possible that muscle-related side effects may be greater when this medicine is taken during treatment with simvastatina (such as 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 well as with the medicines mentioned above, especially inform your doctor if you are taking any of the following:

• medicines with an active ingredient to prevent blood clot formation, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants),
• colestiramine (also used to reduce cholesterol), because it affects how ezetimiba/simvastatina works,
• fenofibrate (also used to reduce cholesterol),
• rifampicin (used to treat tuberculosis),
• ticagrelor (antiplatelet medicine).

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

Taking ezetimiba/simvastatina cinfamed with food and drinks

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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 unknown 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 operate machines. However, some people may experience dizziness after taking ezetimiba/simvastatina.

Ezetimiba/simvastatina cinfamed contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Ezetimiba/simvastatina cinfamed contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and your personal risk situation.

The tablets do not have a groove and should not be divided.

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

Adults: the dose is 1 tablet of ezetimiba/simvastatina once a day orally.

Use in adolescents (10 to 17 years old): the dose is 1 tablet of ezetimiba/simvastatina once a day orally (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 this medication 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 cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take ezetimiba/simvastatina cinfamed

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

If you interrupt the treatment with ezetimiba/simvastatina cinfamed

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them..

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

• Liver function elevation in blood tests; blood uric acid elevation; blood clotting time elevation; 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 muscle 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.

The following side effects of unknown frequency (cannot be estimated from available data) have been reported:

• Myasthenia gravis (a disease that causes generalized muscle weakness that, 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 muscle weakness in your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

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

• 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 severe abdominal pain,
• Hepatitis with the following symptoms: yellowing of the skin and eyes, itching, dark urine, or 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 (erythema multiforme),
• Blurred vision and vision deterioration (may affect up to 1 in 1,000 people)
• Rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid 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 can 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, which can cause difficulty breathing or dizziness and requires immediate treatment (anaphylaxis), may occur in rare cases (may affect up to 1 in 10,000 people),
• 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,

The following additional adverse events have been reported with some statins:

• 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 ezetimibe/simvastatin treatment (unknown frequency: cannot be estimated from available data).

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 or pharmacist, 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 Medicinal Products 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 that appears on the packagingor on the blisterafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Ezetimibe/Simvastatina Cinfamed Composition

The active principles are ezetimibe and simvastatina. Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatina.

The other components are: lactose monohydrate, hypromellose, croscarmellose sodium, microcrystalline cellulose, ascorbic acid, citric acid, butylhydroxyanisole, propyl gallate and magnesium stearate.Mixture of the pigment: lactose monohydrate, yellow iron oxide (E-172), red iron oxide (E-172) and black iron oxide (E-172).

Product Appearance and Packaging Content

Round, biconvex tablets, white to bone-colored, speckled, 10 mm in diameter, and engraved with “513” on one face.

OPA/Aluminum/PVC blisters attached to an aluminum foil.

Packaging sizes:

10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible Manufacturer

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Street,

Dupnitsa, 2600,

Bulgaria

or

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

Actavis Ltd.

BLB015-016,

Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last Review Date of this Leaflet:May 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/82800/P_82800.html

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