Ateroger 10 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ateroger 10mg/10mg film-coated tablets

Ateroger 20mg/10mg film-coated tablets

rosuvastatin and ezetimibe

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Ateroger is and what it is used for

Ateroger contains two different active substances in a film-coated tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Ateroger is a medicine used in adult patients to reduce elevated levels of cholesterol, specifically "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the digestive tract as well as the cholesterol produced by the body itself.

For most people, elevated cholesterol levels do not affect how they feel, as they do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels and narrow them. Sometimes, these narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which could lead to a heart attack or stroke. By lowering cholesterol levels, your risk of having a heart attack, stroke, or other related health problems can be reduced.

This medicine 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. Your doctor may prescribe Ateroger if you are already taking rosuvastatin and ezetimibe at the same dose levels.

This medicine is used in patients with heart disease. Ateroger reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you lose weight.

2. What you need to know before starting to take Ateroger

Do not take Ateroger if:

• you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated or unexplained muscle pain or cramps (myopathy),
• you are taking a medicine called cyclosporine (used, for example, after an organ transplant),
• you are pregnant or breastfeeding. If you become pregnant while taking Ateroger, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medicine by using an appropriate contraceptive method,
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking Ateroger or other related medicines.

If you are in any of the above situations (or are unsure), consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ateroger if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also feel generally unwell or have a fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate dose for you,
• you are taking medicines to treat infections, including HIV (human immunodeficiency virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See “Other medicines and Ateroger”,
• you have severe respiratory insufficiency,
• you are taking other cholesterol-lowering medicines called fibrates; see “Taking Ateroger with other medicines”,
• you regularly consume large amounts of alcohol,
• your thyroid gland is not functioning properly (hypothyroidism),
• you are over 70 years old (as your doctor must choose the appropriate dose of rosuvastatin/ezetimibe for you),
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Ateroger may cause serious muscle problems (rhabdomyolysis),
• severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Ateroger treatment. Stop taking Ateroger and seek immediate medical attention if you notice any of the symptoms described in section 4,
• you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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).

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before starting to take this medicine.

In a small number of people, statins may affect the liver. This is detected by a simple blood test that shows increased levels of liver enzymes. For this reason, your doctor will usually perform blood tests (liver function tests) during your treatment with this medicine. It is important that you attend your scheduled appointments for these tests.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age.

Other medicines and Ateroger

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

Inform your doctor if you are taking any of the following medicines:

• Cyclosporine (used, for example, after an organ transplant to prevent organ rejection). The effect of rosuvastatin increases when taken together with cyclosporine. Do not take Ateroger if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or phenindione (their anticoagulant effects and risk of bleeding may increase when taken with this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases when gemfibrozil is taken with this medicine.
• Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Treatments for indigestion containing aluminium and magnesium (used to neutralize stomach acid, as they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken together.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to resume Ateroger. Taking this medicine together with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• An oral contraceptive (the pill). Levels of absorbed sex hormones may be increased.
• Hormone replacement therapy (increased hormone levels in the blood).
• Regorafenib (used to treat cancer).

If you go to a hospital or are receiving treatment for another illness, tell the medical staff that you are taking Ateroger.

Pregnancy and breastfeeding

Do not take Ateroger if you are pregnant, think you might be pregnant, or plan to become pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medicine.

Do not take Ateroger if you are breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and use of machines

This medicine is not expected to affect your ability to drive or operate machinery. However, some people may experience dizziness after taking this medicine. If you feel dizzy, do not drive or operate machinery.

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

3. How to take Ateroger

Follow exactly the instructions for the use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be performed by taking the active substances separately; once the appropriate doses have been established, it is then possible to switch to the appropriate dose of rosuvastatin/ezetimibe.

You must follow a low-cholesterol diet and exercise while taking rosuvastatin/ezetimibe.

The recommended daily dose for adults is one film-coated tablet.

Take Ateroger once a day.

You may take it at any time of day, regardless of meals. Take the medicine at the same time every day. Swallow the film-coated tablets whole with a glass of water.

Regular cholesterol level checks

It is important that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and remain at appropriate levels.

If you take more Ateroger than you should

Contact your doctor or the nearest hospital emergency department, as you may require medical assistance.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Ateroger

Do not worry. Skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Ateroger

Consult your doctor if you wish to discontinue treatment with this medicine. Your cholesterol levels may rise again if you stop taking this medicine.

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.

It is important that you are aware of what these adverse effects may be.

Stop taking Aterogery and seek immediate medical attention if you experience any of the following adverse effects:

Rare adverse effects (may affect up to 1 in 1,000 people):

Allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and swallowing; drug-induced lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells); and muscle rupture.

Unexplained muscle pain and cramps lasting longer than expected. In rare cases, this may progress to potentially life-threatening muscle damage known as rhabdomyolysis, leading to general malaise, fever, and kidney failure.

Frequency not known (cannot be estimated from available data):

Flat, reddish, non-elevated spots on the trunk, often target-shaped or circular, sometimes with central blisters; skin peeling; mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other adverse effects

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache;
• Constipation;
• General malaise;
• Muscle pain;
• Weakness;
• Dizziness;
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the gastrointestinal tract);
• Feeling tired;
• Elevated levels in certain blood tests of liver function (transaminases).

Uncommon adverse effects (may affect up to 1 in 100 people)

• Skin rash, itching, hives;
• Elevated levels in certain blood tests of muscle function (Creatine Kinase test);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Swelling, especially of the hands and feet.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Inflammation of the pancreas, causing severe stomach pain that may spread to the back;
• Reduced levels of blood platelets.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes);
• Inflammation of the liver (hepatitis);
• Traces of blood in the urine;
• Nerve damage in arms and legs (such as numbness);
• Memory loss;
• Enlargement of the breasts in men (gynecomastia).

Frequency not known (cannot be estimated from available data)

• Difficulty breathing;
• Edema (swelling);
• Sleep disturbances, including insomnia and nightmares;
• Sexual dysfunction;
• Depression;
• Respiratory problems including persistent cough and/or difficulty breathing or fever;
• Tendon injuries;
• Persistent muscle weakness;
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);
• 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 weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may 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 Ateroger

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 "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

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 dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ateroger

• The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

• Each film-coated tablet contains rosuvastatin calcium equivalent to 10 mg or 20 mg of rosuvastatin and 10 mg of ezetimibe.

• Other components are:

Rosuvastatin - Core

Pregelatinized starch (corn); Microcrystalline cellulose (E460); Meglumine; Calcium hydrogen phosphate dihydrate (E-341); Crospovidone (E-1202); Colloidal anhydrous silica (E-551); Sodium stearyl fumarate.

Ezetimibe - Core

Mannitol (E-421); Butylhydroxyanisole (E-320); Sodium lauryl sulfate (E-487); Sodium croscarmellose (E-468); Povidone (K-30) (E-1201); Red iron oxide (E-172); Magnesium stearate (E470 b); Sodium stearyl fumarate.

Coating

Hypromellose (E-464); Titanium dioxide (E-171); Macrogol 4000; Red iron oxide (E-172).

Nature and contents of the container

Ateroger 10 mg/10 mg are pink, round, film-coated tablets with a diameter of 10.1 mm, marked with "AL" on one side.

Ateroger 20 mg/10 mg are pink, round, film-coated tablets with a diameter of 10.7 mm, smooth on both sides.

Ateroger is available in OPA/Al/PVC-Al blister packs containing 10, 30, 60, or 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer responsible for manufacturing

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000
Malta

or

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

or

McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

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

ROSUVASTATINE/EZETIMIBE MYLAN HEALTHCARE – Netherlands
ROSUVASTATINE/EZETIMIBE MYLAN – Italy, France
Rosuvastatina + Ezetimiba BGP – Portugal
Ateroger – Spain
Rozor – Austria

Date of the most recent revision of this leaflet: May 2025

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