Package Insert: Information for the Patient

Ezetimiba/Atorvastatina Alter 10 mg/20 mg Film-Coated Tablets

Ezetimiba/Atorvastatina Alter 10 mg/40 mg Film-Coated Tablets

Ezetimiba/Atorvastatina Alter 10 mg/80 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Ezetimibe/atorvastatin is used in adults to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, ezetimibe/atorvastatin raises the concentrations of "good" cholesterol (HDL cholesterol).

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 that are found in the circulatory system. Your total cholesterol is composed mainly 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 trigger a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps to 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/atorvastatinis used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you should follow a cholesterol-lowering diet.

Ezetimibe/atorvastatinis used, along with a cholesterol-lowering diet, if you have:

?high levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidemia):

?that are not well controlled with a statin alone

?for which 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 surgery, or hospitalization for chest pain.

Ezetimibe/atorvastatindoes not help you lose weight.

Do not takeEzetimiba/Atorvastatina Alter

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 a liver disease,

if you have had any unexplained abnormal results in liver function blood tests,

if you are a woman of childbearing potential and are not using reliable contraceptive methods,

if you are pregnant, trying to become pregnant or breastfeeding,

if you are taking the combination of glecaprevir/pibrentasvir for 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 fluid accumulations in the brain due to 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 have a personal or family history of muscle problems,

if you have had 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 are taking or have taken in 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),

if you have or have had myasthenia (a disease that causes generalized 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).

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 needed 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 perform a blood test before starting your treatment with ezetimiba/atorvastatina, and possibly during it, to predict the risk of experiencing adverse muscle effects. It is known that the risk of experiencing adverse muscle effects, e.g. rhabdomyolysis, increases when certain medicines are taken simultaneously (see section 2 “Taking Ezetimiba/Atorvastatina Alter with other medicines”).

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

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

Combination use of ezetimiba/atorvastatina and fibrates (certain medicines to reduce cholesterol) should be avoided, as the combination has not been studied.

Children

Ezetimiba/atorvastatina is not recommended for children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Alter

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 or whose effects may be affected by ezetimiba/atorvastatina (see section 3). This type of interaction may reduce the effectiveness of one or both medicines. On the other hand, it may 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:

?ciclosporina (a medicine often used in transplant patients),

?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 ezetimiba/atorvastatina 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 (products used to treat indigestion containing 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 Alterwith 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 this medicine.

Alcohol

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

Pregnancy and lactation

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

Do not take ezetimiba/atorvastatina if you can 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 established.

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 Alter 10 mg/20 mg and 10 mg/40 mg contains lactose

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

Ezetimiba/Atorvastatina Altercontains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation. In case of doubt, consult your doctor or pharmacist again.

?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.

Administration form

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 moreEzetimiba/Atorvastatina Alterthan you should

Consult with your doctor or pharmacist.

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

If you forgot to takeEzetimiba/Atorvastatina Alter

Do not take an extra dose; the next day, take your normal 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, stop taking your tablets and immediately inform your doctor, or visit the nearest hospital emergency department.

Severe allergic reactions that cause swelling of the face, tongue, and throat, and may cause 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 a change in urine color to brown-red, and especially if accompanied by a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction, which can be potentially fatal and trigger kidney problems

Lupus-like syndrome (including 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 indicate liver disease.

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

Diarrea,

Muscle pain.

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

Flu,

Depression; sleep disorders; sleep disturbances,

Dizziness; headache; numbness,

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; muscle cramps in the legs; muscle fatigue, spasms, or weakness; pain in the arms and legs,

Unusual weakness; feeling of fatigue or discomfort; 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 were reported with unknown frequency (frequency cannot be estimated from available data):

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 the 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 patients taking ezetimibe/atorvastatin, ezetimibe, or atorvastatin tablets:

Severe allergic reactions that include inflammation of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate medical treatment),

Red, inflamed skin rash, sometimes in the shape of a target,

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),

Inflammation of the nasal passages; nasal bleeding,

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 reported 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,

Continuous muscle pain, sensitivity, or weakness, and especially if accompanied by a feeling of discomfort or high temperature that may not disappear after stopping ezetimibe/atorvastatin treatment (unknown frequency).

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 leaflet. You can also report them directly through the national notification system: Spanish System for 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ezetimiba/Atorvastatina Alter

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

The other components are: microcrystalline cellulose, mannitol, calcium carbonate, sodium croscarmellose, hydroxypropyl cellulose, polisorbate 80, yellow iron oxide (E-172), magnesium stearate, povidone and sodium lauryl sulfate.

The tablet coating contains: lactose monohydrate (Ezetimiba/Atorvastatina Alter 10 mg/20mg and 10 mg/40 mg), hypromellose (E-464), titanium dioxide (E-171), macrogol; and talc and yellow iron oxide (E-172) (Ezetimiba/Atorvastatina Alter 10 mg/80 mg).

Appearance of the product and content of the container

The tablets of Ezetimiba/Atorvastatina Alter 10 mg/20 mg are film-coated, oval, biconvex and white in color with an approximate size of 11.6 x 7.1 mm.

The tablets of Ezetimiba/Atorvastatina Alter 10 mg/40 mg are film-coated, capsule-shaped, biconvex and white in color with an approximate size of 16.1 x 6.1 mm.

The tablets of Ezetimiba/Atorvastatina Alter 10 mg/80 mg are film-coated, oblong, biconvex and yellow in color with an approximate size of 19.1 x 7.6 mm.

The tablets are available in containers with OPA/Al/PVC//Al blisters in containers of 30 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea, 190 01

Greece

Last review date of this leaflet: January 2024

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