Package Insert: Information for the User

Ezetimiba/Atorvastatina Olpha 10 mg/10 mg Film-Coated Tablets

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

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

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

Read this package insert carefully before starting to take this medicine, as 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 Olpha is a medication that decreases high levels of cholesterol. Ezetimibe/Atorvastatin Olpha contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to decrease total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, ezetimibe/atorvastatin increases 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 that are 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 the blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can trigger a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps to prevent the accumulation of bad cholesterol 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 cardiovascular 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-reducing diet.

Ezetimibe/atorvastatin 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 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 myocardial infarction, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

• If you are allergic to ezetimibe, atorvastatin, or any of the other components of this medication (listed in section 6),
• If you have or have had a liver disease that affects the liver,
• 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 for hepatitis C treatment.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take ezetimibe/atorvastatin.

• 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 recurring or unexplained muscle pain or discomfort, or have a personal or family history of muscle problems,
• If you have had muscle problems during previous treatment with other lipid-lowering medications (e.g., other "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 them before taking this medication,
• If you are taking or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and ezetimibe/atorvastatin can 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 can 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 ezetimibe/atorvastatin.This is because, in rare cases, muscle problems can be severe, including muscle rupture causing kidney damage. It is known that atorvastatin causes muscle problems, and muscle problems have also been reported with ezetimibe.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Consult your doctor or pharmacist before starting to take ezetimibe/atorvastatin:

• 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 ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, 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 medications are taken simultaneously (see section 2 “Other Medications and Ezetimibe/Atorvastatin Olpha”).

While you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, obesity, and high blood pressure.

Inform your doctor about all your medical conditions, including allergies.

You should avoid using ezetimibe/atorvastatin and fibrates (certain medications to lower cholesterol) together, as the combined use of ezetimibe/atorvastatin and fibrates has not been studied.

Children

Ezetimibe/atorvastatin is not recommended for children and adolescents.

Other Medications and Ezetimibe/Atorvastatin Olpha

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

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

• Ciclosporin (a medication often used in transplant patients),
• Erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medications used to treat bacterial infections),
• Ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medications used to treat fungal infections),
• Gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol, cholestyramine (medications used to regulate lipid levels),
• Some calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
• Digoxin, verapamil, amiodarone (medications that regulate heart rhythm),
• Medications used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),

some medications used to treat hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir,

• Letermovir, a medication that helps you avoid getting sick from cytomegalovirus

• Daptomycin (a medication used to treat complicated skin and structure infections and bacteremia).

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

• Other medications that are known to interact with ezetimibe/atorvastatin
• • Oral contraceptives (medications that prevent pregnancy),
  • Stiripentol (an anticonvulsant medication used to treat epilepsy),
  • Cimetidine (a medication used to treat stomach acid and ulcers),
  • Fenazone (a pain reliever),
  • Antacids (products used to treat indigestion that contain aluminum or magnesium),
  • Warfarin, phenprocoumon, acenocoumarol, or fluindione (medications that prevent blood clotting),
  • Colchicine (used to treat gout),
  • St. John's Wort (a medication used to treat depression).

Taking Ezetimibe/Atorvastatin Olpha with Food and Alcohol

See section 3 for instructions on how to take ezetimibe/atorvastatin. 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 can alter the effects of ezetimibe/atorvastatin.

Alcohol

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take ezetimibe/atorvastatin if you may become pregnant, unless you use reliable contraceptive methods. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and inform your doctor.

Do not takeezetimibe/atorvastatinif you are breastfeeding.

The safety of ezetimibe/atorvastatin during pregnancy and breastfeeding has not been proven.

Consult your doctor or pharmacist before taking this medication.

Driving and Using Machines

Ezetimibe/atorvastatin is not expected to interfere with your ability to drive or use machines. However, some people may experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin Olpha contains lactose

The tablets of Ezetimibe/Atorvastatin contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking this medication.

Ezetimibe/Atorvastatin Olpha contains sodium

This medication contains less than 1 mmol of sodium (23 mg) 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.

What quantity to take

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

Administration form

Take Ezetimiba/Atorvastatina Olpha 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 Olpha than you should

Consult with your doctor or pharmacist.

If you forgot to take Ezetimiba/Atorvastatina Olpha

Do not take a double dose to compensate for the missed doses. The next day, take your usual amount 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 go to the nearest hospital emergency department.

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause severe difficulty breathing
• Severe disease with symptoms of intense peeling and skin inflammation, blistering 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 accompanied by a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction, which can be potentially fatal and lead to 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 be indicative of liver disease.

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

• Diarrhea,
• Muscle pain.

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

• Flu,
• Depression; insomnia; 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 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.

In addition, the following side effects have been reported in people taking ezetimibe/atorvastatin, 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, sometimes target-like, skin rash,
• Liver problems,
• Cough,
• Heartburn,
• Loss of appetite; lack of appetite,
• High blood pressure,
• Itchy skin rash and allergic reactions that include 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; 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).
• 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 your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

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,
• Constant muscle pain, sensitivity, or weakness, especially if accompanied by a feeling of discomfort or high temperature that may not subside after discontinuing ezetimibe/atorvastatin treatment (unknown frequency).

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 not listed 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 that appears on the packaging or on the container after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

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

Composition of Ezetimiba/Atorvastatina Olpha

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 are: calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hydroxypropylcellulose; lactose monohydrate; povidone, magnesium stearate; microcrystalline cellulose; polisorbate 80; sodium laurylsulfate (E487).

The coating of the tablet contains: hypromelose, lactose monohydrate, titanium dioxide (E171), macrogol, talc.

Appearance of the product and content of the package

Film-coated, biconvex, capsule-shaped tablets, white to off-white in color.

Ezetimiba/Atorvastatina Olpha 10 mg/10 mg tablets EFG: with “1T” engraved on one face.

Ezetimiba/Atorvastatina Olpha 10 mg/20 mg tablets EFG: with “2T” engraved on one face.

Ezetimiba/Atorvastatina Olpha 10 mg/40 mg tablets EFG: with “4T” engraved on one face.

Ezetimiba/Atorvastatina Olpha 10 mg/80 mg tablets EFG: with “8T” engraved on one face.

Pack sizes:

Pack sizes of 10, 30, 90 and 100 film-coated tablets in aluminium/aluminium blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Responsible for manufacturing

Delorbis Pharmaceuticals LTD,

17 Athinon street,

Ergates Industrial Area,

2643Ergates Lefkosia,

Cyprus

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: November 2024

Detailed and updated information on this medicinal product is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es