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 You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 used to lower increased levels of cholesterol. Atozet contains ezetimibe and atorvastatin.
Atozet is used in adults to lower total cholesterol, “bad” cholesterol (LDL), and fats called triglycerides in the blood.
Atozet also raises the level of “good” cholesterol (HDL).
Atozet works by reducing the absorption of cholesterol in the gut and 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 narrowing of the arteries, which can reduce or block blood flow to important organs such as 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 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. You should keep to a cholesterol-lowering diet while taking Atozet.

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial or non-familial]) or high levels of fats in the blood (mixed hyperlipidaemia)
• when the levels of cholesterol have not been adequately lowered by statins alone;
• when statins and ezetimibe have been taken separately.
• 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 attack, stroke, the need for heart surgery, or hospitalization due to chest pain in patients who have already had a heart attack or have heart disease.

Atozet does not help you lose weight.

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 blood tests for liver function;
• if you are a woman able to have children and are not using reliable contraception;
• if you are pregnant or breast-feeding;
• 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 blood vessels in the brain as a result of previous strokes;
• you have kidney problems;
• you have hypothyroidism (an underactive thyroid gland);
• you have had muscle problems or have a family history of muscle problems;
• you have previously had muscle problems while taking other cholesterol-lowering medicines;
• you regularly drink large amounts of alcohol;
• you have had liver disease;
• you are over 70 years old;
• you have ever had an intolerance to certain sugars, you should contact your doctor before taking this medicine;
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) by mouth or by injection. The combination of fusidic acid and Atozet can cause serious muscle problems (rhabdomyolysis),

or if you have a history of muscle disease or have had muscle problems with other medicines used to lower cholesterol.

• if you have or have had muscle weakness that is persistent and progresses, double vision, drooping eyelids, or difficulty swallowing or breathing, as these can be signs of a muscular disorder;

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

or weakness while taking Atozet.As with other statins, muscle damage (rhabdomyolysis) can occur rarely, which can lead to kidney damage.
Atorvastatin can cause muscle damage. Muscle damage has also been reported with ezetimibe.
Your doctor or pharmacist will also need to be informed if muscle weakness persists. Additional tests and additional medications may be needed to diagnose and treat this condition.
Before taking Atozet, tell your doctor or pharmacist if:

• you have severe respiratory problems.

If any of the above apply to you, your doctor will need to carry out a blood test before and possibly during treatment with Atozet to predict the risk of muscle-related side effects.
It is known that certain medicines can increase the risk of muscle-related side effects when taken with Atozet (see section 2 “Atozet with other medicines”).
During treatment with this medicine, your doctor will monitor you for signs of diabetes or increased risk of developing diabetes, particularly if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure. You are at a higher risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure.
Tell your doctor about any medical conditions you have, including allergies.
Avoid taking Atozet with fibrates (medicines used to lower cholesterol), as this combination has not been extensively studied.

Children

Atozet should not be used in children and adolescents.

Atozet with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription, and those you plan to take.
There are some medicines that may affect how Atozet works or that may be affected by Atozet. This type of interaction may make one or both medicines less effective or increase the risk of side effects, including a serious condition called rhabdomyolysis (see section 4), or worsen its course:

• cyclosporin (a medicine often given to patients who have had organ transplants);
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (antibiotics used to treat bacterial infections);
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungal medicines);
• gemfibrozil, other fibrates, nicotinic acid, or derivatives, colestyramine, colestipol (medicines used to lower cholesterol);
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem;
• digoxin, verapamil, amiodarone (medicines used to treat irregular heartbeat);
• HIV protease inhibitors such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc. (used to treat AIDS);
• certain hepatitis C virus protease inhibitors 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 must temporarily stop taking Atozet.
Your doctor will tell you when you can safely take Atozet again.
Taking Atozet with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
More information about rhabdomyolysis is provided in section 4.

• Other medicines that may 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);
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines used to prevent blood clots);
• colchicine (used to treat gout);
• St. John's Wort (a herbal remedy used to treat depression).

Atozet with food and drink

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

Grapefruit juice
Do not drink more than 1 liter of grapefruit juice per day, as large quantities may affect how Atozet works.

Alcohol
Avoid excessive alcohol consumption while taking Atozet. More information can be found in section 2 “Warnings and precautions”.

Pregnancy and breast-feeding

Women who are pregnant, trying to become pregnant, or suspect they are pregnant should not take Atozet. You should 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 it immediately and contact your doctor.
Do not take Atozet if you are breast-feeding.
The safety of Atozet in pregnancy and breast-feeding has not been established.
Before taking Atozet, consult your doctor or pharmacist.

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 told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Atozet contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially sodium-free.

3. How to take Atozet

Always take this medicine exactly as your doctor has told you. Your doctor will prescribe the dose that is right for you based on your current treatment and risk factors. If you are not sure, ask your doctor or pharmacist.

• Before starting Atozet, you should be on a cholesterol-lowering diet.
• You should continue with 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 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 immediately or go to the nearest hospital emergency department.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may make breathing difficult;
• severe skin disease with blistering and peeling of the skin, with or without fever;
• muscle weakness, tenderness, or pain, or dark urine, especially if you also feel unwell or have a fever, as these can be signs of a serious muscle condition that can lead to kidney damage;
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

If you experience unexpected 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 disorders;
• dizziness, headache, tingling sensation;
• slow heartbeat;
• 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, muscle weakness, pain in the arms and legs;
• unusual tiredness, feeling weak or unwell, swelling, especially swelling of the ankles;
• increased results of some liver or muscle blood tests;
• weight gain.

The following side effects have been reported with a frequency that cannot be estimated from the available data:

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

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

Additional 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 may cause difficulty in breathing or swallowing (requiring immediate treatment);
• raised, red skin rash;
• 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 may cause abdominal pain, nausea, vomiting);
• pancreatitis, often with severe abdominal pain;
• reduced number of certain blood cells, which may 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 closely);
• nightmares;
• numbness or tingling in the fingers and toes;
• reduced sensation or sensitivity to 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).

Side effects that have been reported with some statins:

• sexual problems;
• depression;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• muscle pain, tenderness, or weakness, that is persistent and progresses, especially if you also feel unwell or have a fever, which may not resolve after stopping treatment with Atozet (frequency not known).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system listed in the contact details below.
You can also report side effects directly via the national reporting system:
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.

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 atorvastatin calcium trihydrate).
• The other ingredients are calcium carbonate, silicon dioxide, croscarmellose sodium, 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: 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: 10, 30, 90, and 100 film-coated tablets in nitrogen-filled, aluminum/aluminum blisters (oPA-Al-PVC with Al closure).
Pack sizes of 30 x 1 and 45 x 1 film-coated tablets in nitrogen-filled, aluminum/aluminum blisters (oPA-Al-PVC with Al closure).
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
[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