Atozet

Package Leaflet: Information for the Patient

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

Read all of this leaflet carefully before 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 Atozet is and what it is used for
• 2. What you need to know before you take 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 to lower high cholesterol levels. 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 by lowering the absorption of cholesterol in the small intestine and by reducing the production of cholesterol in the body.
Cholesterol is one of several fats found in the blood. 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 the arteries and form plaques. Over time, this can lead to a 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, strokes, and other cardiovascular diseases.
HDL cholesterol is often called “good” cholesterol because it helps prevent the buildup of LDL cholesterol in the walls of the arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood, which 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 also follow a cholesterol-lowering diet.

• 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 in monotherapy;
• when statins and ezetimibe were previously taken as separate tablets.
• a rare inherited cholesterol condition (homozygous familial hypercholesterolaemia) that causes very high cholesterol levels in the blood. Other treatments may also be used.
• to reduce the risk of heart attacks, strokes, operations to improve blood flow to the heart, or hospitalizations due to chest pain.

Atozet does not affect weight loss.

2. What you need to know before you take Atozet

Do not 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 liver function tests;
• if you are a woman of childbearing age and are not using a reliable method of contraception;
• if you are pregnant, trying to become pregnant, or are breastfeeding;
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before taking Atozet, tell your doctor or pharmacist:

• if you have had a hemorrhagic 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 family history of muscle problems;
• if you have had muscle problems while taking other cholesterol-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 be life-threatening.

• if you have or have had myasthenia gravis (a disease characterized by muscle weakness, including muscles used for breathing) or myasthenic syndrome (a condition that causes muscle weakness, especially 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 problems can be serious, including muscle breakdown, which can cause kidney damage.
It is known that atorvastatin can cause muscle problems. Muscle problems 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 muscle-related side effects.
It is known that certain medications taken at the same time can increase the risk of muscle-related side effects, such as rhabdomyolysis (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 fats in your blood, are overweight, and have high blood pressure.
Inform your doctor about all your medical conditions, including allergies.
Avoid taking Atozet and fibrates (cholesterol-lowering medicines) at the same time, as this combination has not been tested.

Children

Atozet is not recommended for use in children and adolescents.

Atozet and other medicines

Tell your doctor or pharmacist about all 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);
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections);
• 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 used to regulate heart rhythm);
• HIV protease inhibitors such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc. (used to treat AIDS);
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination of elbasvir and grazoprevir;
• daptomycin (a medicine 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 must temporarily stop taking Atozet. Your doctor will tell you when you can safely resume taking Atozet. Taking Atozet and fusidic acid at the same time can rarely 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 ulcers);
• phenazone (a pain reliever);
• antacids (medicines used to treat heartburn, containing aluminum 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 can be found in section 3. Pay attention to the following:

Grapefruit juice
Do not drink more than 1-2 small glasses of grapefruit juice per day, as larger amounts 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

Women who are pregnant, trying to become pregnant, or think they may be pregnant should not take Atozet. Do not take Atozet if you are pregnant or think you may be pregnant, and are not using a reliable method of contraception. If you become pregnant while taking Atozet, stop taking the medicine immediately and inform 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, some people may experience dizziness while 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 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 factors. If you are unsure, 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 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 product, 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 room 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; skin rash with reddish-purple spots, especially on the hands and feet, which can lead to blistering;
• muscle weakness, tenderness, or pain, or dark-colored 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;
• lupus-like syndrome (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 damage.
The following common side effects (may affect up to 1 in 10 people) have been reported:

• diarrhea;
• 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, tingling sensation;
• slow heart rate;
• hot flushes;
• shortness of breath;
• abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort;
• acne, hives;
• joint pain, back pain, muscle cramps, fatigue, muscle spasms or weakness;
• unusual weakness, feeling tired or unwell, swelling, especially swelling of the ankles;
• increased levels of certain liver or muscle enzymes in the blood;
• 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 muscle weakness, including muscles used for breathing),
• myasthenic syndrome (a condition that causes muscle weakness, especially 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, which can cause difficulty breathing or swallowing (requiring immediate treatment);
• 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 gallbladder inflammation (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);
• nasal inflammation, nosebleeds;
• neck pain, pain, chest pain, throat pain;
• increased or decreased blood sugar levels (in diabetic patients, continue to monitor blood sugar levels carefully);
• nightmares;
• numbness or tingling in the fingers and toes;
• reduced sensation of pain or touch;
• altered 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 with some statins:

• sexual problems;
• depression;
• breathing difficulties, including persistent coughing and/or shortness of breath or fever;
• diabetes; its occurrence is more likely in patients with high levels of sugar and fats in the blood, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine;
• muscle pain, tenderness, or weakness, especially if you also feel unwell or have a fever, which may not resolve after stopping Atozet (frequency unknown).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 which is 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. These measures 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, colloidal anhydrous silica, sodium croscarmellose, 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.
Pack sizes:
Packs of 10, 30, 90, and 100 film-coated tablets in nitrogen-filled aluminum/aluminum (oPA-Al-PVC with Al closure) blisters.
Packs of 30 x 1 and 45 x 1 film-coated tablets in single-dose, nitrogen-filled aluminum/aluminum (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.
Marszałkowska Street 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