Package Leaflet: Information for the User

Ezetimiba/Atorvastatina cinfa 10 mg/10 mg Film-Coated TabletsEFG

Ezetimiba/Atorvastatina cinfa 10 mg/20 mg Film-Coated TabletsEFG

Ezetimiba/Atorvastatina cinfa 10 mg/40 mg Film-Coated TabletsEFG

Ezetimiba/Atorvastatina cinfa 10 mg/80 mg Film-Coated TabletsEFG

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 their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Ezetimibe/atorvastatin is a medication that lowers high levels of cholesterol. Ezetimibe/atorvastatin contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain types of fat called triglycerides that circulate in the blood. Additionally, ezetimibe/atorvastatin raises the concentrations of "good" cholesterol (high-density lipoprotein, HDL).

Ezetimibe/atorvastatin acts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract, as well as the cholesterol that your body produces on its own.

Cholesterol is one of the fatty substances found in the circulatory system. Your total cholesterol is composed mainly of LDL and HDL.

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 trigger 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 present in your blood that can increase the risk of heart disease.

Ezetimibe/atorvastatin is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you should follow a cholesterol-lowering diet.

Ezetimibe/atorvastatin is used, along with a cholesterol-lowering 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 statin alone
• 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/atorvastatin reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

Do not take Ezetimiba/Atorvastatina cinfa

• if you are allergic to ezetimiba, atorvastatina or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had any liver disease,
• if you have had any unexplained abnormal results in liver function blood tests,
• if you are a woman who may become pregnant and is not using reliable contraceptive methods,
• if you are pregnant, trying to become pregnant or breastfeeding,
• if you are taking the combination of glecaprevir / pibrentasvir in the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ezetimiba/atorvastatina

• if you have had a previous stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain resulting from previous strokes
• if you have kidney problems,
• if your thyroid gland has low activity (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort or a personal or family history of muscle problems,
• if you have experienced muscle problems during previous treatment with other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• if you regularly consume large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years old,
• if your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine,
• if you have or have had myasthenia (a disease that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4),
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and ezetimiba/atorvastatina may cause severe muscle problems (rhabdomyolysis).

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking ezetimiba/atorvastatina.This is because, in rare cases, muscle problems can be severe, including muscle rupture causing kidney damage. It is known that atorvastatina causes muscle problems and muscle problems have also been reported with ezetimiba.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.

Consult your doctor or pharmacist before starting to take ezetimiba/atorvastatina

-if you have severe respiratory failure.

If you are in any of the above circumstances (or are unsure), consult your doctor before starting to take ezetimiba/atorvastatina, as your doctor will need to take a blood test before starting your treatment with ezetimiba/atorvastatina and possibly during it, to predict the risk you have of experiencing muscle adverse effects. It is known that the risk of experiencing muscle adverse effects, e.g. rhabdomyolysis, increases when certain medicines are taken simultaneously (see section 2 “Taking Ezetimiba/Atorvastatina cinfa with other medicines”).

While you are taking this medicine, your doctor will monitor whether 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, being overweight and high blood pressure.

Inform your doctor of all your medical problems, including allergies.

You should avoid the combined use of ezetimiba/atorvastatina and fibrates (certain medicines for lowering cholesterol), as the combined use of ezetimiba/atorvastatina and fibrates has not been studied.

Children

Ezetimiba/atorvastatina is not recommended for children and adolescents.

Other medicines and Ezetimiba/Atorvastatina cinfa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including over-the-counter medicines.

There are some medicines that may modify the effect of ezetimiba/atorvastatina whose effects may be affected by ezetimiba/atorvastatina (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of adverse effects, including a serious condition in which muscle is destroyed, known as “rhabdomyolysis”, which is described in section 4:

• ciclosporin (a medicine used in patients who have undergone transplantation),
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),
• gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels),
• some calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• some medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir / grazoprevir,
• daptomycin (a medicine used to treat complicated skin and structure infections and bacteremia).

** If you have to take fusidic acid orally to treat a bacterial infection, you will have to temporarily stop taking this medicine. Your doctor will tell you when you can restart your treatment with ezetimiba/atorvastatina. The use of this medicine with fusidic acid rarely may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4

• Other medicines that are known to interact with ezetimiba/atorvastatina
• oral contraceptives (medicines that prevent pregnancy),
• estiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used to treat stomach acid and ulcers),
• phenazone (an analgesic),
• antacids (medicines used to treat indigestion that contain aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
• colchicine (used to treat gout),
• St. John's Wort (a medicine used to treat depression).

Taking Ezetimiba/Atorvastatina cinfa with food and alcohol

See section 3 for instructions on how to take ezetimiba/atorvastatina. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of ezetimiba/atorvastatina.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 “Warnings and precautions”.

Pregnancy and lactation

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

Do not take ezetimiba/atorvastatina if you may become pregnant, unless you are using reliable contraceptive methods. If you become pregnant while taking ezetimiba/atorvastatina, stop taking it immediately and inform your doctor.

Do not take ezetimiba/atorvastatina if you are breastfeeding.

The safety of ezetimiba/atorvastatina during pregnancy and lactation has not been proven. Consult your doctor or pharmacist before taking this medicine.

Driving and operating machines

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

Ezetimiba/Atorvastatina cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Ezetimiba/Atorvastatina cinfa 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg contain lactose

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

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

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

?Before starting to take ezetimiba/atorvastatina, you must be following a diet to reduce cholesterol.

?You will need to continue with this cholesterol-reducing diet while taking ezetimiba/atorvastatina.

How much to take

The recommended dose is one tablet of ezetimiba/atorvastatina once a day taken orally.

Form of administration

Take ezetimiba/atorvastatina at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimiba/atorvastatina along with cholestyramine or any other bile acid sequestrant (medications that reduce cholesterol levels), you must take ezetimiba/atorvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Atorvastatina cinfa 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/Atorvastatina cinfa

Do not take a double dose to make up for the missed dose; the next day, take your usual dose of ezetimiba/atorvastatina at the usual time.

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.

If you experience any of the following serious side effects or symptoms of the same, stop taking your tablets and immediately inform your doctor, or go to the nearest hospital emergency service.

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause severe difficulty breathing

• Severe disease whose symptoms are intense peeling and skin inflammation, blister formation on the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which may lead to blistering

• Weakness, sensitivity, pain, or muscle rupture or change in urine color to brown-red and especially, if it occurs at the same time, feeling unwell or high temperature that may be caused by abnormal muscle destruction that may be potentially fatal and trigger kidney problems

• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience problems associated with the unexpected or unusual appearance of bleeding or bruising, as this may be indicative of liver disease.

The following frequent side effects (may affect up to 1 in 10 patients) were observed:

• Diarrhea,
• Muscle pain.

The following infrequent side effects (may affect up to 1 in 100 patients) were observed:

• Flu,
• Depression; sleep problems; sleep disorder,
• Dizziness; headache; tingling sensation,
• Slow heart rate,
• Angina,
• Shortness of breath,
• Abdominal pain; abdominal swelling; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach upset,
• Acne; hives,
• Joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; arm and leg pain,
• Unusual weakness; feeling tired or unwell; inflammation, especially in the ankles (edema),
• Increased levels of some liver or muscle function tests (CK) in laboratory blood tests,
• Weight gain.

The following side effects with unknown frequency (frequency cannot be estimated from available data) were reported:

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.

In addition, the following side effects were reported in people taking ezetimibe/atorvastatin tablets, or ezetimibe or atorvastatin tablets alone:

• Allergic reactions that include facial inflammation, lip, tongue, and/or throat inflammation that may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• Red and, in some cases, target-shaped skin rash,
• Liver problems,
• Cough,
• Heartburn,
• Loss of appetite; lack of appetite,
• High blood pressure,
• Itchy skin rash and hives; allergic reactions that include the appearance of skin rash and hives,
• Tendon injury,
• Bile stones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),
• Pancreatitis, often accompanied by severe abdominal pain,
• Decreased blood cell count, which may cause bruising or bleeding (thrombocytopenia),
• Nasal congestion; nosebleeds,
• Neck pain; chest pain; throat pain,
• Increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• Nightmares,
• Numbness or tingling in the fingers of the hands and feet,
• Decreased sensitivity to pain or touch,
• Altered sense of taste; dry mouth,
• Memory loss,
• Tinnitus and/or headache; hearing loss,
• Vomiting,
• Belching,
• Hair loss,
• High temperature,
• Presence of white blood cells in urine tests,
• Blurred vision; visual disturbances,
• Gynecomastia (breast enlargement in men).

Possible side effects observed with some statins

• Sexual dysfunction,
• Depression,
• Respiratory problems, including persistent cough and/or shortness of breath or fever,
• 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, and especially, if it occurs at the same time, feeling unwell or high temperature that may not disappear after stopping ezetimibe/atorvastatin treatment (unknown frequency).

Reporting 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 use this medication after the expiration date that appears on the packaging and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Ezetimiba/Atorvastatina cinfa

The active principles are ezetimiba and atorvastatina. Each film-coated tablet contains 10 mg of ezetimiba and 10 mg, 20 mg, 40 mg or 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components (excipients) are:

Core of the tablet:

Manitol, croscarmelosa sodium, povidona, laurilsulfato de sodio, estearato de magnesio, celulosa microcristalina, carbonato de calcio, hidroxipropilcelulosa, polisorbato 80 and óxido de hierro amarillo (E-172).

Coating of the tablet:

Ezetimiba/Atorvastatina cinfa 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg

Opadry white (hypromelosa, macrogol, dióxido de titanio (E-171) and lactosa monohidrato)

Ezetimiba/Atorvastatina cinfa 10 mg/80 mg

DrCoat FCU (hypromelosa, dióxido de titanio (E-171), talco, macrogol, óxido de hierro amarillo (E-172))

Appearance of the product and contents of the package

Ezetimiba/Atorvastatina cinfa 10 mg/10 mg: white, round, biconvex, film-coated tablets, with a diameter of approximately 8.1 mm.

Ezetimiba/Atorvastatina cinfa 10 mg/20 mg: white, oval, biconvex, film-coated tablets, with dimensions of approximately 11.6 x 7.1 mm.

Ezetimiba/Atorvastatina cinfa 10 mg/40 mg: white, capsule-shaped, biconvex, film-coated tablets, with dimensions of approximately 16.1 x 6.1 mm.

Ezetimiba/Atorvastatina cinfa 10 mg/80 mg: yellow, oblong, biconvex, film-coated tablets, with dimensions of approximately 19.1 x 7.6 mm.

Package sizes:

Blister packs of OPA/Al/PVC//Al of 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95, Pikermi, Attiki,

190 09, Greece

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea,

190 01, Greece

Last review date of this prospectus: October 2024

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

Ezetimiba/Atorvastatina cinfa 10 mg/10 mg film-coated tablets EFG

You can access detailed and updated information on this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/89581/P_89581.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89581/P_89581.html

Ezetimiba/Atorvastatina cinfa 10 mg/20 mg film-coated tablets EFG

You can access detailed and updated information on this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/89582/P_89582.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89582/P_89582.html

Ezetimiba/Atorvastatina cinfa 10 mg/40 mg film-coated tablets EFG

You can access detailed and updated information on this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/89583/P_89583.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89583/P_89583.html

Ezetimiba/Atorvastatina cinfa 10 mg/80 mg film-coated tablets EFG

You can access detailed and updated information on this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/89584/P_89584.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89584/P_89584.html