Atozet

Leaflet accompanying the packaging: patient information

Atozet, 10 mg + 10 mg, film-coated tablets

Atozet, 10 mg + 20 mg, film-coated tablets

Atozet, 10 mg + 40 mg, film-coated tablets

Atozet, 10 mg + 80 mg, film-coated tablets

Ezetimibe + atorvastatin

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

• 1. What Atozet is and what it is used for
• 2. Important information before taking Atozet
• 3. How to take Atozet
• 4. Possible side effects
• 5. How to store Atozet
• 6. Contents of the pack and other information

1. What Atozet is and what it is used for

Atozet is a medicine used to lower high cholesterol. Atozet contains ezetimibe and atorvastatin.
Atozet is used in adults to lower total cholesterol, "bad" cholesterol (LDL) and a type of fat in the blood called triglycerides.
Atozet also raises the level of "good" cholesterol (HDL).
Atozet works in two ways: by reducing the absorption of cholesterol in the gut and by reducing the production of cholesterol in the body.
Cholesterol is one of several fats found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries and form plaques. Over time, this can lead to narrowing of the arteries, which can reduce or block blood flow to the heart and brain. Blocking blood flow can lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the walls of the arteries and reduces the risk of heart disease.
Triglycerides are other fats in the blood that can increase the risk of heart disease.
Atozet is used in patients who cannot control their cholesterol levels by diet alone. You should keep to a cholesterol-lowering diet while taking this medicine.

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial or non-familial]) or high levels of fats in the blood (mixed hyperlipidaemia)
• inadequate control with statins as monotherapy;
• when statins and ezetimibe were previously taken as separate tablets.
• a hereditary disease (homozygous familial hypercholesterolaemia) that causes high levels of cholesterol in the blood. Other treatments may also be used.
• heart disease. Atozet reduces the risk of heart attack, stroke, the need for a procedure to increase blood flow to the heart, or hospitalization due to chest pain.

Atozet does not affect weight loss.

2. Important information before taking Atozet

When not to take Atozet

• 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 liver disease;
• if you have had unexplained, abnormal blood test results indicating liver problems;
• if you are a woman of childbearing age and are not using reliable contraception;
• if you are pregnant, trying to become pregnant or are breastfeeding;
• if you are taking glecaprevir with pibrentasvir to treat hepatitis C virus infection.

Warnings and precautions

Before taking Atozet, tell your doctor or pharmacist:

• if you have had a bleeding stroke or have small aneurysms in the brain as a result of previous strokes;
• if you have kidney problems;
• if you have hypothyroidism;
• if you have had muscle problems or have a history of muscle problems in yourself or your family;
• if you have had side effects with other medicines used to lower cholesterol (e.g. other "statins" or "fibrates");
• if you regularly drink large amounts of alcohol;
• if you have had liver disease in the past;
• if you are over 70 years old;
• if you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine;
• if you are currently taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Atozet can cause serious muscle problems (rhabdomyolysis),

including:

• if you have or have had myasthenia gravis (a disease characterized by general muscle weakness, including in some cases muscles used for breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes worsen the condition or trigger myasthenia (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness

or weakness while taking Atozet.Because in rare cases, muscle disorders can be severe, including muscle breakdown, which can lead to kidney damage.
It is known that atorvastatin can cause muscle disorders. Cases of muscle disorders have also been reported with ezetimibe.
Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
Before taking Atozet, consult your doctor or pharmacist:

• if you have severe respiratory failure.

In case of any of the above situations, consult your doctor or pharmacist, as your doctor will need to perform a blood test before starting treatment with Atozet and, if possible, during treatment to determine the risk of side effects related to the muscles.
It is known that the risk of muscle-related side effects, such as rhabdomyolysis (muscle damage), is increased by certain medicines taken at the same time (see section 2 "Atozet and other medicines").
During treatment with this medicine, your doctor will carefully monitor you for signs of diabetes or an increased risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
Tell your doctor about all your illnesses, including allergies.
Avoid taking Atozet and fibrates (cholesterol-lowering medicines) at the same time, as this treatment has not been studied.

Children

Atozet should not be used in children and adolescents.

Atozet and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• cyclosporin (a medicine often used in patients who have had organ transplants);
• erythromycin, clarithromycin, telithromycin, fusidic acid **, rifampicin (antibiotics);
• ketokonazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungal medicines);
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestyramine, colestipol (medicines used to regulate lipid levels);
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem;
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm);
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc. (medicines used in AIDS);
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir;
• daptomycin (an antibiotic used to treat complicated skin and soft tissue infections and bacteraemia).

**If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop taking this medicine. Your doctor will tell you when you can safely restart taking Atozet. Taking Atozet and fusidic acid at the same time can, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

• Other medicines that have been reported to interact with Atozet:
• oral contraceptives (used to prevent pregnancy);
• stiripentol (an antiepileptic medicine used to treat epilepsy);
• cimetidine (a medicine used to treat heartburn and peptic ulcers);
• phenazone (a pain reliever);
• antacids (medicines used to treat indigestion that contain aluminium or magnesium);
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines used to prevent blood clots);
• colchicine (used to treat gout);
• St. John's Wort (a herbal medicine used to treat depression).

Atozet with food and drink

Instructions for taking Atozet are provided in section 3. Pay attention to the following:

Grapefruit juice

Do not drink more than 1 or 2 small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can affect the action of Atozet.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. More information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Pregnant women, women trying to become pregnant, and women who think they may be pregnant should not take Atozet. Do not take Atozet if you are able to become pregnant and are not using reliable contraception. If you become pregnant while taking Atozet, stop taking the medicine immediately and tell your doctor.

Do not take Atozet while breastfeeding.

The safety of Atozet in pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Atozet is unlikely to affect your ability to drive or use machines. However, be aware that some people may experience dizziness after taking Atozet.

Atozet contains lactose

Atozet tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Atozet contains sodium

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

3. How to take Atozet

Always take this medicine exactly as your doctor has told you. Your doctor will prescribe the appropriate strength of tablets based on your current treatment and risk status. If you are unsure, ask your doctor or pharmacist.

• Before starting to take Atozet, you should be on a cholesterol-lowering diet.
• You should continue with a cholesterol-lowering diet while taking Atozet.

Recommended dose

The recommended dose is one Atozet tablet per day, taken orally.

When to take Atozet

Atozet can be taken at any time of day, with or without food.

If your doctor has prescribed Atozet with colestyramine or another bile acid sequestrant (to lower cholesterol), take Atozet at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Atozet than you should

Ask your doctor or pharmacist for advice.

If you forget to take Atozet

Do not take an extra dose. Take your normal dose of Atozet 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 side effects

Like all medicines, Atozet can cause side effects, although not everybody gets them.

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

• severe allergic reactions causing swelling of the face, tongue, and throat, which can make breathing difficult;
• severe skin disease with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, and genitals, and fever; a skin rash with red, flat, lumps, especially on the hands and feet, which can lead to blistering;
• muscle weakness, tenderness, or pain, or dark urine, especially if you also feel unwell or have a fever, which can be caused by abnormal muscle breakdown, which can lead to kidney damage;
• systemic lupus erythematosus (including rash, joint pain, and effects on blood cells).

If you experience unexpected or unusual bleeding or bruising, contact your doctor as soon as possible, as this may be a sign of liver problems.

The following common side effects (may affect up to 1 in 10 people) have been reported:

• diarrhoea;
• muscle pain.

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

• flu;
• depression, difficulty sleeping, sleep disturbances;
• dizziness, headache, feeling of tingling;
• slow heart rate;
• hot flushes;
• shortness of breath;
• abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, stomach upset;
• acne, hives;
• joint pain, back pain, muscle cramps, fatigue, muscle spasms or weakness, pain in the hands and feet;
• unusual weakness, feeling tired or unwell, swelling, especially swelling of the ankles;
• increased values of some blood tests of liver function or muscle (CK);
• weight gain.

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

• myasthenia gravis (a disease characterized by general muscle weakness, including in some cases muscles used for breathing),
• myasthenic syndrome (a disease that causes muscle weakness in the eyes).

Contact your doctor if you experience muscle weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Additionally, the following side effects have been reported in patients taking Atozet or ezetimibe or atorvastatin tablets:

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, causing difficulty breathing or swallowing (requiring immediate treatment);
• a raised, red rash, sometimes with target-shaped lesions;
• liver problems;
• cough;
• heartburn;
• loss of appetite;
• high blood pressure;
• skin rash and itching, allergic reactions including rash and hives;
• tendon injury;
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting);
• pancreatitis, often with severe abdominal pain;
• reduced number of certain blood cells, which can increase the risk of bruising/bleeding (thrombocytopenia);
• inflammation of the nasal passages, nosebleeds;
• neck pain, pain, chest pain, throat pain;
• increased or decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully);
• nightmares;
• numbness or tingling in the fingers and toes;
• reduced sensation of pain or touch;
• change in taste, dry mouth;
• memory loss;
• ringing in the ears and/or head, hearing loss;
• vomiting;
• belching;
• hair loss;
• fever;
• positive urine test for white blood cells;
• blurred vision; vision disturbances;
• gynaecomastia (breast enlargement in men).

Other possible side effects of some statins:

• sexual problems;
• depression;
• breathing difficulties, including persistent coughing and/or shortness of breath or fever;
• diabetes; it is more likely to occur in patients who have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• muscle pain, tenderness, or weakness, especially if you also feel unwell or have a fever, which may not go away after stopping Atozet (frequency not known).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309,

Website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atozet

• Keep this medicine out of the sight and reach of children.
• Do not use Atozet after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
• Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atozet contains

• The active substances 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 calcium trihydrate).
• The other ingredients are calcium carbonate, silica colloidal anhydrous, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, sodium lauryl sulfate.

The tablet coating contains hypromellose, macrogol 8000, titanium dioxide (E 171), talc.

What Atozet looks like and contents of the pack

White or almost white, biconvex, film-coated tablets.

Atozet 10 mg + 10 mg tablets: engraved with "257" on one side.

Atozet 10 mg + 20 mg tablets: engraved with "333" on one side.

Atozet 10 mg + 40 mg tablets: engraved with "337" on one side.

Atozet 10 mg + 80 mg tablets: engraved with "357" on one side.

Package sizes:

Pack sizes of 10, 30, 90, and 100 film-coated tablets in nitrogen-filled aluminium/aluminium (oPA-Al-PVC with Al closure) blisters.

Pack sizes of 30 x 1 and 45 x 1 film-coated tablets in nitrogen-filled aluminium/aluminium (oPA-Al-PVC with Al closure) blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.

ul. Marszałkowska 126/134

00-008 Warsaw

Tel.: +48 22 105 50 01

[email protected]

Manufacturer

Merck Sharp & Dohme B.V.,

Waarderweg 39,

2031 BN Haarlem,

Netherlands

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Organon N.V.

Kloosterstraat 6, 5349 AB,

Oss, Netherlands

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

DE/H/3895/001-004/DC

ATOZET: Austria, Belgium, Bulgaria, Croatia, Denmark, Germany, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

LIPTRUZET: Cyprus, France, Greece, Hungary

ZOLETORV: Czech Republic

Date of last revision of the leaflet: 07/2023