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 that you can read it again if you need to.
• If you have any further questions, you should 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 those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Atozet and what is it 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 packaging and other information

1. What is Atozet and what is it used for

Atozet is a medicine that lowers high cholesterol. Atozet contains ezetimibe and atorvastatin.
Atozet is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL) and a type of fat in the blood called triglycerides.
Atozet also raises the levels of "good" cholesterol (HDL).
Atozet works in two ways: it reduces the absorption of cholesterol from the gut and also reduces 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, brain, and other vital organs. Blocking blood flow can lead to heart attacks or strokes.
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 found 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. While taking this medicine, you should follow a cholesterol-lowering diet.
Atozet is used as an addition to a cholesterol-lowering diet in the following cases:

• high levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial or non-familial]) or high levels of fats in the blood (mixed hyperlipidemia)
• inadequate control with statin monotherapy;
• when statins and ezetimibe were previously taken as separate tablets.
• a hereditary disease (homozygous familial hypercholesterolemia) that causes high levels of cholesterol in the blood. Other treatments may also be used.
• heart disease. Atozet reduces the risk of heart attacks, strokes, operations to improve 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 unexplained, abnormal liver function tests;
• if you are a woman of childbearing age and are not using effective contraception;
• if you are pregnant, trying to become pregnant, or breastfeeding;
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting to take Atozet, you should discuss this with your doctor or pharmacist:

• if you have had a hemorrhagic stroke or have small cavities in the brain as a result of previous strokes;
• if you have kidney problems;
• if you have hypothyroidism;
• if you have had muscle pain, tenderness, or weakness, or have had muscle problems in the past or in your family;
• if you have had muscle problems while taking other lipid-lowering medicines (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 consult 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),

which can lead to kidney damage.
While taking this medicine, your doctor will 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 fats in your blood, are overweight, and have high blood pressure.
You should tell your doctor about all your illnesses, including allergies.
You should avoid taking Atozet and fibrates (cholesterol-lowering medicines) at the same time, as this combination has not been tested.

Children

Atozet should not be used in children and adolescents.

Atozet and other medicines

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

• cyclosporine (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, or derivatives, cholestyramine (medicines used to lower lipid levels);
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem;
• digoxin, verapamil, amiodarone (medicines used to 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 virus infection, such as telaprevir, boceprevir, and a combination of elbasvir and grazoprevir;
• daptomycin (an antibiotic used to treat complicated skin and soft tissue infections and bacteremia).

**If you need to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking Atozet. Taking Atozet with fusidic acid 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);
• styrene (an antiepileptic medicine used to treat epilepsy);
• cimetidine (a medicine used to treat heartburn and stomach ulcers);
• phenazone (a pain reliever);
• antacids (medicines used to treat indigestion that contain aluminum or magnesium);
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines used to prevent blood clots);
• colchicine (used to treat gout);
• St. John's Wort (a medicine used to treat depression).

Atozet with food and drink

Instructions for taking Atozet can be found in section 3. You should be aware of the following:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the action of Atozet.
Alcohol
You should avoid excessive alcohol consumption while taking this medicine. More information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Women who are pregnant, trying to become pregnant, or think they may be pregnant should not take Atozet. You should not take Atozet if you are able to become pregnant and are not using effective contraception. If you become pregnant while taking Atozet, you should stop taking it and tell your doctor.
You should not take Atozet while breastfeeding.
The safety of Atozet in pregnancy and breastfeeding has not been established.
You should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Atozet is not expected to affect your ability to drive or use machines. However, you should 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 consult your doctor before taking this medicine.

Atozet contains sodium

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

3. How to take Atozet

You should always take this medicine exactly as your doctor has told you. Your doctor will prescribe the appropriate dose of Atozet based on your current treatment and risk factors. If you are unsure, you should ask your doctor or pharmacist.

• Before starting to take Atozet, you should follow a cholesterol-lowering diet.
• You should continue to follow this 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 cholestyramine or another bile acid sequestrant (used to lower cholesterol), you should take Atozet at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Atozet than you should

You should consult your doctor or pharmacist.

If you forget to take Atozet

You should not take an extra dose. You should take your normal dose of Atozet at the usual time the next day.
If you have any further questions about taking this medicine, you should 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, you should stop taking Atozet and contact your doctor or go to the nearest emergency room immediately.

• severe allergic reactions that cause swelling of the face, tongue, and throat, which can make breathing difficult;
• severe skin disease with severe peeling and swelling of the skin, with blistering of the skin, mouth, eyes, and genitals, and fever; skin rash with reddish-purple spots, especially on the hands and soles of the feet, which can lead to blistering;
• muscle weakness, tenderness, or pain, or muscle rupture, especially if you also have a high temperature or feel generally unwell, which can be caused by abnormal muscle breakdown, which can lead to kidney damage;
• lupus-like syndrome (including rash, joint pain, and effects on blood cells).

If you experience unexpected or unusual bleeding or bruising, you should contact your doctor as soon as possible, as this may be a sign of liver damage.
The following side effects have been reported (may affect up to 1 in 10 people):

• diarrhea;
• muscle pain.

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

• 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, discomfort in the stomach, stomach problems;
• acne, hives;
• joint pain, back pain, muscle cramps, fatigue, muscle spasms or weakness, pain in the arms and legs;
• unusual weakness, feeling tired or unwell, swelling, especially swelling of the ankles;
• increased values of certain blood tests of liver or muscle function (CK);
• weight gain.

The following side effects have been reported (frequency not known):

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

You should 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, which can cause difficulty breathing or swallowing (requiring immediate treatment);
• raised, red rash, sometimes with target-like lesions;
• liver problems;
• cough;
• heartburn;
• loss of appetite, decreased appetite;
• high blood pressure;
• skin rash and itching, allergic reactions including rash and hives;
• tendon damage;
• gallstones or inflammation of the gallbladder (which can cause stomach pain, nausea, vomiting);
• pancreatitis, often with severe stomach pain;
• decreased numbers 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 (in diabetes, you should continue to monitor your blood sugar levels carefully);
• nightmares;
• numbness or tingling in the fingers and toes;
• loss of 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;
• gynecomastia (breast enlargement in men).

The following side effects have been reported in 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 fats in their blood, are overweight, and have high blood pressure. Your doctor will monitor you for signs of diabetes while you are taking this medicine;
• muscle pain, tenderness, or weakness, especially if you also have a high temperature or feel generally unwell, which may not go away after stopping Atozet (frequency not known).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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

• You should 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atozet contains

• The active substances of Atozet 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, colloidal anhydrous silica, sodium croscarmellose, hydroxypropyl cellulose, 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: with "257" engraved on one side.
Atozet 10 mg + 20 mg tablets: with "333" engraved on one side.
Atozet 10 mg + 40 mg tablets: with "337" engraved on one side.
Atozet 10 mg + 80 mg tablets: with "357" engraved on one side.
Pack sizes:
Packs of 10, 30, 90, and 100 film-coated tablets in nitrogen-filled aluminum/aluminum (Alu/Alu) blisters.
Packs of 30 x 1 and 45 x 1 film-coated tablets in single-dose packs, in nitrogen-filled aluminum/aluminum (Alu/Alu) blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
organonpolska@organon.com

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