EZETIMIBE/ATORVASTATIN ZENTIVA 10 mg/80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ezetimibe/Atorvastatin Zentiva 10 mg/10 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Zentiva 10 mg/20 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Zentiva 10 mg/40 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Zentiva 10 mg/80 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Ezetimibe/Atorvastatin Zentiva and what is it used for
2. What you need to know before you take Ezetimibe/Atorvastatin Zentiva
3. How to take Ezetimibe/Atorvastatin Zentiva
4. Possible side effects
5. Storage of Ezetimibe/Atorvastatin Zentiva
6. Contents of the pack and other information

1. What is Ezetimibe/Atorvastatin Zentiva and what is it used for

Ezetimibe/Atorvastatin Zentiva is a medicine that lowers high cholesterol levels. This medicine contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fats (triglycerides) in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways. It reduces the amount of cholesterol absorbed in the gut and also the amount of cholesterol made by the body.

Cholesterol is one of the fats (lipids) found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat found in the blood that can increase the risk of heart disease.

Ezetimibe/atorvastatin is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe/atorvastatin is used, along with a low-cholesterol diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidaemia):
• • that are not well controlled with a statin alone;
  • for which a statin and ezetimibe have been taken as separate tablets.
• a hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You may also receive other treatments.
• heart disease, ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart or hospitalisation due to chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

2. What you need to know before you take Ezetimibe/Atorvastatin Zentiva

Do not takeEzetimibe/Atorvastatin Zentiva

• if you are allergic to ezetimibe, atorvastatin 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 unusual liver test results that cannot be explained,
• if you are a woman able to become pregnant and are not using reliable contraception,
• if you are pregnant, trying to become pregnant or are breast-feeding,
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Tell your doctor or pharmacist before you start taking this medicine if:

• you have had a previous stroke with bleeding in the brain, or have small pockets of fluid in the brain from previous strokes,
• you have kidney problems,
• your thyroid gland does not produce enough hormones (hypothyroidism),
• you have had muscle pain or weakness that cannot be explained or a personal or family history of muscle problems,
• you have had muscle problems while taking other cholesterol-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• you regularly drink large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years old,
• your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine,
• you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/atorvastatin can cause muscle problems (rhabdomyolysis),
• you have or have had myasthenia (a disease that causes muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic syndrome (a disease that causes muscle weakness, particularly of the eye muscles), as statins can sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Tell your doctor as soon as possible if you experience unexplained muscle pain, tenderness or weakness while taking ezetimibe/atorvastatin.This is because, on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage. Atorvastatin can cause muscle problems and muscle problems have also been reported with ezetimibe.

Also tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.

Tell your doctor or pharmacist before you start taking this medicine:

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before taking this medicine, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, and possibly during treatment, to predict the risk you have of experiencing muscle side effects. The risk of muscle side effects, e.g. rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 "Other medicines and Ezetimibe/Atorvastatin Zentiva").

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 sugars and fats in the blood, are overweight and have high blood pressure.

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

The combined use of ezetimibe/atorvastatin and fibrates (certain medicines used to lower cholesterol) should be avoided, as the combined use of ezetimibe/atorvastatin and fibrates has not been studied.

Children

Ezetimibe/atorvastatin is not recommended for use in children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are some medicines that may affect the way ezetimibe/atorvastatin works or their effects may be altered by ezetimibe/atorvastatin (see section 3). This type of interaction could reduce the effect of one or both medicines. Alternatively, it could increase the risk or severity of side effects, including the serious muscle damage known as rhabdomyolysis described in section 4:

• cyclosporin (a medicine often used in patients who have had an organ transplant),
• 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, colestyramine (medicines used to regulate lipid levels),
• certain calcium channel blockers used to treat high blood pressure or angina, 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), certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir,
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia).

** If you have to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when you can restart taking ezetimibe/atorvastatin. The use of ezetimibe/atorvastatin with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

• Other medicines that are known to interact with ezetimibe/atorvastatin
• • oral contraceptives (medicines that prevent pregnancy),
  • stiripentol (an anticonvulsant medicine used to treat epilepsy),
  • cimetidine (a medicine used to treat stomach acidity and peptic ulcers),
  • phenazon (a pain reliever),
  • antacids (products 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).

TakingEzetimibe/Atorvastatin Zentivawith food and drink

See section 3 for instructions on how to take Ezetimibe/Atorvastatin Zentiva. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can affect the action of ezetimibe/atorvastatin.

Alcohol

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

Pregnancy and breast-feeding

Do not take ezetimibe/atorvastatin if you are pregnant, think you may be pregnant or are planning to become pregnant. Do not take ezetimibe/atorvastatin if you are able to become pregnant and are not using reliable contraception.

If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and tell your doctor.

Do not take ezetimibe/atorvastatin if you are breast-feeding.

The safety of ezetimibe/atorvastatin during pregnancy and breast-feeding has not yet been established.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ezetimibe/atorvastatin is unlikely to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin Zentivacontains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take Ezetimibe/Atorvastatin Zentiva

Always take this medicine exactly as your doctor has told you. Your doctor will determine the appropriate dose of ezetimibe/atorvastatin for you, depending on your current treatment and your personal risk factors.

If you are unsure, consult your doctor again.

• Before you start taking ezetimibe/atorvastatin, you should be on a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

How much to take

The recommended dose is one ezetimibe/atorvastatin tablet once a day by mouth.

Method of administration

Take ezetimibe/atorvastatin at any time of day. You can take it with or without food.

If your doctor has prescribed ezetimibe/atorvastatin with colestyramine or any other bile acid sequestrant (medicines that lower cholesterol), you should take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take moreEzetimibe/Atorvastatin Zentivathan you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeEzetimibe/Atorvastatin Zentiva

Do not take a double dose to make up for forgotten doses. Simply take your normal dose of this medicine at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty breathing.
• severe disease whose symptoms are intense exfoliation 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 the soles of the feet, which can lead to blisters.
• weakness, sensitivity, pain, or muscle rupture or change in urine color to reddish-brown and especially, if it occurs at the same time, a feeling of discomfort or high temperature that can be caused by abnormal muscle destruction that 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 fact may be indicative of liver disease.

Other Possible Adverse Effects with Ezetimibe/Atorvastatin Zentiva

Frequent: may affect up to 1 in 10 people

• diarrhea,
• muscle pain.

Infrequent: may affect up to 1 in 100 people

• flu,
• depression; sleep disorders; sleep disturbance,
• dizziness; headache; tingling sensation,
• slow heartbeat,
• hot flashes,
• breathing difficulties,
• 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 tiredness or discomfort; swelling, especially in the ankles (edema),
• increase or decrease in some liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

Rare: may affect up to 1 in 1,000 people

• skin rash or mouth ulcers (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)

Frequency not known: the frequency cannot be estimated from the available data

• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Myasthenic ocular (a disease that causes weakness of the eye muscles).

Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin, ezetimibe, or atorvastatin tablets:

• allergic reactions, including facial, lip, tongue, and/or throat inflammation that can cause difficulty breathing or swallowing (which require immediate medical treatment),
• red, sometimes target-shaped, skin rash,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions, including the appearance of skin rash and hives,
• tendon injury,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, or vomiting),
• pancreatitis, often accompanied by severe abdominal pain,
• decrease in blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nosebleeds,
• neck pain; chest pain; throat pain,
• increase or decrease in blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in the fingers and toes, decreased sensitivity to pain or touch,
• altered sense of taste; dry mouth,
• memory loss,
• ringing in the ears and/or head; 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).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or breathing difficulties.

Possible Adverse Effects Reported with Some Statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or difficulty breathing or fever,
• diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• constant muscle pain, sensitivity, or weakness, and especially if it occurs at the same time, a feeling of discomfort or high temperature that may not disappear after stopping treatment with ezetimibe/atorvastatin (frequency not known).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ezetimibe/Atorvastatin Zentiva

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

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in 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. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatin Zentiva

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

The other ingredients are calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hypromellose, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium lauryl sulfate (E487).

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

Appearance of the Product and Package Contents

White to off-white, film-coated, biconvex, capsule-shaped tablets.

Ezetimibe/Atorvastatin Zentiva 10 mg/10 mg film-coated tablets EFG: with "1T" engraved on one side

Ezetimibe/Atorvastatin Zentiva 10 mg/20 mg film-coated tablets EFG: with "2T" engraved on one side

Ezetimibe/Atorvastatin Zentiva 10 mg/40 mg film-coated tablets EFG: with "4T" engraved on one side

Ezetimibe/Atorvastatin Zentiva 10 mg/80 mg film-coated tablets EFG: with "8T" engraved on one side

Package size:

10, 30, 90, and 100 film-coated tablets in aluminum/aluminum blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Delorbis Pharmaceuticals Limited

Industrial Area

Athinon 17

2643 Ergates

Nicosia

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus: February 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/