Package Insert:Information for the Patient

Atorduo 10 mg/10 mg Hard Capsules

Atorduo 20 mg/10 mg Hard Capsules

Atorduo 40 mg/10 mg Hard Capsules

atorvastatina/ezetimiba

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this package insert. See section 4.

1.What is Atorduo and how is it used

2.What you need to knowbeforestarting totake Atorduo

3.How to take Atorduo

4.Possible adverse effects

5Storage of Atorduo

6.Contents of the package and additional information

Atorduo contains two different active principles in one capsule. One of the active principles is atorvastatina, which belongs to the group of statins, the other active principle is ezetimiba.

Atorduo is a medication used in adults that reduces total cholesterol levels, “bad” cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, it increases the concentrations of “good” cholesterol (HDL cholesterol).

This medication acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract, as well as the cholesterol that the body produces on its own.

For most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. Nevertheless, if left untreated, fatty deposits can accumulate 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 would cause a heart attack or stroke. By reducing cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

This medication is used in patients who cannot control their cholesterol levels solely with a diet. While taking this medication, you should follow a cholesterol-reducing diet.

Your doctor may prescribe Atorduo if you are already taking both medications, atorvastatina and ezetimiba, at the same dosage level.

This medication does not help with weight loss.

Do not take Atorduo

• if you are allergic to atorvastatin, ezetimibe, or any of the other ingredients of this medication (listed in section 6),
• if you have or have had any liver disease,
• if you have had any unexplained abnormal results in blood tests to check liver function,
• if you are a woman who may become pregnant and is not using reliable contraceptive methods,
• if you are pregnant or trying to become pregnant,
• if you are breastfeeding,
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorduo:

• if you have severe respiratory failure,
• if you are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic) orally or injectable. The combination of fusidic acid and this medication may cause severe muscle problems (rhabdomyolysis). (See section “Other medications and Atorduo”),
• if you have had a previous stroke with intracranial hemorrhage, or have small fluid accumulations in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland has low activity (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort or a personal or family history of muscle problems,
• if you have had muscle problems during previous treatment with other lipid-lowering medications (e.g., other medications containing "statins" or "fibrates"),
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4),
• if you regularly consume large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years old.

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking Atorduo.This is because, in rare cases, muscle problems can be severe, including muscle rupture causing kidney damage. It is known that atorvastatin causes 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 medications may be necessary to diagnose and treat this problem.

While you are taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, obesity, and high blood pressure.

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

The combined use of Atorduo and fibrates (certain medications for lowering cholesterol) should be avoided, as the combined use of this medication and fibrates has not been studied.

Children and adolescents

Atorduo is not recommended for children and adolescents under 18 years of age.

Other medications and Atorduo

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

There are some medications that may modify the effect of Atorduo or whose effects may be affected by Atorduo. This type of interaction could reduce the effectiveness of one or both medications. On the other hand, it could also increase the risk or severity of side effects, including a serious condition in which muscle is destroyed, known as “rhabdomyolysis”, which is described in section 4:

• Medications used to alter the way the immune system works, e.g. ciclosporin
• Certain antibiotics, e.g. erythromycin, clarithromycin, telithromycin, rifampicin (antibacterial medications)
• Certain antifungals, e.g. ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole
• Other medications for regulating lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid and derivatives, cholestyramine, colestipol
• Some calcium channel blockers used for the treatment of angina or high blood pressure, e.g., amlodipine, diltiazem

• Medications for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone

• Letermovir, a medication that helps you avoid getting citomegalovirus
• Medications used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir,efavirenz, fosamprenavir, delavirdina,the combination of tipranavir/ritonavir, etc.
• Some medications used in the treatment of hepatitis C (liver inflammation), e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir,ledipasvir/sofosbuvir
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will tell you when it is safe to restart the treatment with Atorduo. Taking this medication with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections and bacteremia).
• Other medications that are known to interact with this medication:
• • warfarin, phenprocoumon, acenocoumarol, or fluindione (medications that prevent blood clotting)
  • oral contraceptives (medications to prevent pregnancy)
  • estiripentol (an anticonvulsant medication used to treat epilepsy)
  • cimetidine (a medication used for stomach acid and peptic ulcers)
  • phenazone (an analgesic)
  • colchicine (used to treat gout)
  • antacids (products for the treatment of indigestion containing aluminum or magnesium)
  • St. John's Wort (a medication for treating depression).

Taking Atorduo with food and alcohol

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

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of this medication.

Alcohol

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

Pregnancy and breastfeeding

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

Do not take Atorduo if you are breastfeeding.

The safety of this medication during pregnancy and breastfeeding has not been proven.

If you are pregnant or breastfeeding, trying to become pregnant, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Atorduo is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking this medication. If you feel dizzy, consult your doctor before driving or operating machinery.

This medication contains saccharose and sodium

Atorduo contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You must continue with a cholesterol-reducing diet while taking this medication.

The recommended daily dose for adults is one capsule of the appropriate concentration.

Take Atorduo once a day.

You can take the capsules at any time of the day, with or without food. However, try to take the capsule at the same time every day.

Swallow each capsule whole with water.

This medication is not suitable for starting treatment. The initiation of treatment or dose adjustments, if necessary, should only be made by taking the active ingredients separately, and once the appropriate doses have been adjusted, it is possible to switch to Atorduo at the corresponding dose.

If your doctor has prescribed Atorduo along with another cholesterol-lowering medication containing the active ingredient cholestyramine or any other bile acid sequestrant, you should take this medication at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Atorduo than you should

If you accidentally take too many capsules (more than your recommended daily dose), contact your doctor or the nearest hospital for medical assistance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorduo

If you forget to take a dose, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Atorduo

Consult your doctor if you want to stop taking Atorduo. Your cholesterol levels may increase again if you stop taking this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects or symptoms, stop taking this medicine and immediately inform your doctor, or visit the nearest hospital emergency department.

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

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause severe difficulty breathing.
• Severe disease with symptoms of intense peeling and skin inflammation, blister formation on 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 lead to blistering.
• Weakness, sensitivity, pain, or muscle rupture orbrownish-red urine color,and especially if it occurs simultaneously, a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction (rhabdomyolysis). This abnormal muscle destruction may not always disappear, even after stoppingthis medicine, and may be potentially fatal and trigger kidney problems.

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

• If you experience problems associated with the unexpected or unusual appearance of bleeding or bruising, as this may be indicative of liver disease, consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).

Other possible side effects

Frequent (may affect up to 1 in 10 people):

• Common cold(nasopharyngitis)
• Allergic reactions
• Increased blood sugar levels
• Headache
• Sore throat
• Nasal bleeding
• Constipation
• Flatulence (excess gas in the intestinal tract)
• Indigestion
• Feeling dizzy (nausea)
• Diarrhea
• Abdominal pain
• Muscle pain
• Joint pain
• Pain in arms and legs
• Muscle spasms
• Joint inflammation
• Back pain
• Feeling tired (fatigue)
• Elevations in some blood tests for muscle function (CK)
• Abnormal results of liver function tests, elevations in some blood tests for liver function (transaminases)

Occasional (may affect up to 1 in 100 people):

• Low blood sugar levels
• Weight gain
• Loss of appetite
• Nightmares
• Difficulty sleeping
• Dizziness
• Numbness or tingling in fingers and toes
• Decreased sensation of pain or touch
• Alteration of taste
• Memory loss
• Blurred vision
• Ringing or buzzing in the ears
• Headaches
• High blood pressure
• Coughing
• Vomiting
• Belching
• Inflammation of the pancreas, causing severe stomach pain that may radiate to the back
• Heartburn
• Dry mouth
• Inflammation of the stomach (gastritis)
• Inflammation of the liver (hepatitis)
• Hives
• Itching
• Skin rash
• Hair loss
• Neck pain
• Muscle weakness
• Discomfort(general feeling of weakness)
• Tiredness(lack of energy and strength)
• Chest pain
• Pain
• Swelling, especially in the hands and feet
• Fever
• Positive urine test for white blood cells
• Increased levels of liver enzyme in your blood

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

• Reduction of platelet levels in the blood, which increases the risk of bleeding or bruising (thrombocytopenia)
• Nerve damage in the legs and arms (such as numbness)
• Visual disturbance
• Jaundice (yellowing of the skin and white of the eyes)
• Swollen and red rashes, sometimes with target-shaped lesions (erythema multiforme)
• Skin eruption or ulcers in the mouth (drug-induced lichenoid reaction)
• Lesions on the skin with a purplish color (signs of inflammation of blood vessels, vasculitis)
• Muscle disease with muscle weakness (myopathy)
• Muscle inflammation
• Tendon damage

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

• Loss of hearing
• Liver failure
• Enlargement of the breast in men (gynecomastia).

Unknown frequency (cannot be estimated from available data):

• Depression
• Shortness of breath
• Calculi in the gallbladder or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• Constant muscle weakness (immunemediated necrotizing myopathy)
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Myasthenia ocular (a disease that causes 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Side effects reported with some statins:

• Sexual dysfunction
• Respiratory problems, including persistent coughing and/ordifficulty breathingor fever.
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Store below 30°C in the original packaging to protect it from moisture.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Atorduo

• The active principles are atorvastatina (as atorvastatina calcium trihydrate) and ezetimiba. Each capsule contains 10 mg, 20 mg, or 40 mg of atorvastatina and 10 mg of ezetimiba.
• The other components are:

Core:calcium carbonate, hydroxypropylcellulose, polisorbate 80, croscarmellose sodium (SD711), sugar spheres (containing saccharose and cornstarch), talc, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose (L-HPC B1), povidone K25, sodium laurylsulfate, magnesium stearate.

Capsule coating:

Atorduo 10 mg/10 mg hard capsules: Capsule cap: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), gelatin.

Atorduo 20 mg/10 mg hard capsules: Capsule cap: titanium dioxide (E171), red iron oxide (E172), gelatin.

Atorduo 40 mg/10 mg hard capsules:Capsule cap: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), gelatin.

Capsule body for all doses: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Appearance of Atorduo and packaging content

Atorduo 10 mg/10 mg hard capsules: Hard gelatin capsule with unmarked automatic closure, size 0, with a caramel-colored cap and a yellow-colored body filled with pellets and a tablet.

Atorduo 20 mg/10 mg hard capsules: Hard gelatin capsule with unmarked automatic closure, size 0, with a reddish-brown cap and a yellow-colored body filled with pellets and a tablet.

Atorduo 40 mg/10 mg hard capsules: Hard gelatin capsule with unmarked automatic closure, size 0, with a dark brown cap and a yellow-colored body filled with pellets and a tablet.

Capsule filling:

Atorvastatina IR pellets: round pellets.

Ezetimiba 10 mg tablet: a round, smooth, and bisected-edged tablet, with an E stylized logo engraved on one face of the tablet and 612 engraved on the other face.

Packaging type blister (OPA/Al/PVC//Al) of30, 60, 70, 80, 90, 100 or 120hard capsules inside a cardboard box.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38.

Hungary

Responsible manufacturer

Egis Pharmaceuticals PLC

9900 Körmend, Mátyás király utca 65

Hungary

Egis Pharmaceuticals PLC, Site 2.

1165 Budapest, Bökényföldi út 118-120.

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last revision date of thisleaflet: 09/2024

For detailed information about this medicine, please visit the website of the {Spanish Agency for Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)