Atozet 10 mg/80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ATOZET 10mg/20mg film-coated tablets

ATOZET 10mg/40mg film-coated tablets

ATOZET 10mg/80mg film-coated tablets

ezetimiba/atorvastatina

(ezetimibe/atorvastatin)

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See Section 4.

Contents of the package leaflet

1. What ATOZET is and what it is used for
2. What you need to know 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 that lowers high cholesterol levels. ATOZET contains ezetimibe and atorvastatin.

ATOZET is used in adults to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, ATOZET increases levels of "good" cholesterol (HDL cholesterol).

ATOZET works by reducing cholesterol in two ways: it reduces cholesterol absorbed in the digestive tract and also reduces cholesterol produced by your body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists 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 plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such disruption in blood flow may trigger 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 present in your blood that may increase the risk of heart disease.

ATOZET is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

ATOZET is used, together with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):

• that are not well controlled with a statin alone

• for whom a statin and ezetimibe have previously been used as separate tablets

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease; ATOZET reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

ATOZET does not help you lose weight.

2. What you need to know before taking 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 ever had liver disease,

• if you have had unexplained abnormal results in blood tests assessing liver function,

• if you are a woman who could become pregnant and are not using reliable contraceptive methods,

• if you are pregnant, trying to become pregnant, or breastfeeding,

• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take ATOZET

• if you have previously had a stroke involving intracranial bleeding, or have small accumulations of fluid in the brain due to previous strokes,

• if you have kidney problems,

• if you have low thyroid activity (hypothyroidism),

• if you have experienced recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders,

• if you previously had muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),

• if you regularly consume large amounts of alcohol,

• if you have a history of liver disease,

• if you are over 70 years old,

• if your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine,

• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and ATOZET may cause serious muscle problems (rhabdomyolysis),

• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking ATOZET. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and muscle problems have also been reported with ezetimibe.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Talk to your doctor or pharmacist before starting to take ATOZET:

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before starting ATOZET, as your doctor will need to perform a blood test before starting and possibly during treatment with ATOZET to assess your risk of developing muscle-related side effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Taking ATOZET with other medicines”).

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

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

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

Children

ATOZET is not recommended in children and adolescents.

Taking ATOZET with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Some medicines may alter the effect of ATOZET or their effects may be altered by ATOZET (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. It could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis,” described in section 4:

• cyclosporine (a medicine often used in transplant patients),
• 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, cholestyramine (medicines used to regulate lipid levels),
• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• some medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir,
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

** If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with ATOZET. The use of ATOZET with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4

• Other medicines known to interact with ATOZET

• oral contraceptives (medicines that prevent pregnancy),

• stiripentol (an anticonvulsant medicine used to treat epilepsy),

• cimetidine (a medicine used for stomach acid and peptic ulcers),

• phenazone (an analgesic),

• antacids (products for treating indigestion containing aluminium or magnesium),

• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots),

• colchicine (used to treat gout),

• St. John’s wort (a herbal medicine used to treat depression).

Taking ATOZET with food and alcohol

See section 3 for instructions on how to take ATOZET. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of ATOZET.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take ATOZET if you are pregnant, trying to become pregnant, or think you might be pregnant. Do not take ATOZET if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking ATOZET, stop taking it immediately and inform your doctor.

Do not take ATOZET if you are breastfeeding.

The safety of ATOZET during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

ATOZET is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking ATOZET.

ATOZET contains lactose

ATOZET tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

ATOZET contains sodium

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

3. How to take ATOZET

Follow exactly the instructions for use of this medicine provided by your doctor. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ATOZET, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ATOZET.

What dose to take

The recommended dose is one ATOZET tablet once daily by oral administration.

Method of administration

Take ATOZET at any time of day. You may take it with or without food.

If your doctor has prescribed ATOZET together with colestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take ATOZET at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more ATOZET than you should

Consult your doctor or pharmacist.

If you forget to take ATOZET

Do not take a double dose; the following day, take your usual amount of ATOZET at the regular time.

If you have any further questions about 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 everyone will experience them.

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

• severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing

• a serious illness characterized by severe skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which may progress to blisters

• muscle weakness, tenderness, pain or rupture, or change in urine color to red-brown, particularly if accompanied by a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown that could be potentially life-threatening and lead to 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 unexpected or unusual bleeding or bruising, as this may indicate liver disease.

The following frequent adverse effects have been reported (may affect up to 1 in 10 patients):

• diarrhea,
• muscle pain.

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

• influenza-like illness,
• depression; sleep problems; sleep disorders,
• 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; gastrointestinal discomfort,
• acne; hives,
• joint pain; back pain; leg cramps; muscle fatigue; muscle spasms or muscle weakness; pain in arms and legs,
• unusual weakness; feeling of tiredness or malaise; swelling, especially in the ankles (edema),
• increased levels in certain liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

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

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

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

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

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• red skin rash, sometimes target-shaped,
• liver problems,
• cough,
• acid reflux,
• decreased appetite; 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, or vomiting),
• inflammation of the pancreas, often accompanied by severe abdominal pain,
• decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia),
• nasal inflammation; nosebleeds,
• neck pain; chest pain; sore throat,
• increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in fingers and toes,
• reduced 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 (enlargement of breast tissue in men).

Possible adverse effects reported with some statins:

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or shortness of breath or fever,
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or high temperature that does not resolve after stopping ATOZET (frequency not known).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ATOZET

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or container following “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.
• Store in the original packaging to protect from oxygen.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of ATOZET

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

The other components are: calcium carbonate; anhydrous colloidal 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) and talc.

Appearance of the product and contents of the pack

Film-coated tablets, capsule-shaped, biconvex, white to off-white in colour.

ATOZET 10 mg/20 mg tablets: with the code “333” on one side

ATOZET 10 mg/40 mg tablets: with the code “337” on one side

ATOZET 10 mg/80 mg tablets: with the code “357” on one side

Pack sizes:

Blister packs of 10, 30, 90 and 100 film-coated tablets in aluminium/aluminium blisters (oriented polyamide-aluminium-PVC well with aluminium lidding foil).

Blister packs of 30 x 1 and 45 x 1 film-coated tablets in unit dose packs, in aluminium/aluminium blisters (oriented polyamide-aluminium-PVC well with aluminium lidding foil).

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Organon N.V.

Kloosterstraat 6, 5349 AB,

Oss, The Netherlands.

This medicinal product is authorised in the European Economic Area member states under the following names:

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

LIPTRUZET: Cyprus, France, Greece and Hungary

ZOLETORV: Czech Republic

Date of the most recent revision of this leaflet: 07/2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es