ATORDUO 20 mg/10 mg HARD CAPSULES

Introduction

Package Leaflet: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

atorvastatin/ezetimibe

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 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 is Atorduo and what is it used for
2. What you need to know before you take Atorduo
3. How to take Atorduo
4. Possible side effects

5 Storage of Atorduo

1. Contents of the pack and further information

1. What is Atorduo and what is it used for

Atorduo contains two different active substances in one capsule. One of the active substances is atorvastatin, which belongs to a group of medicines called statins, the other active substance is ezetimibe.

Atorduo is a medicine used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways: it reduces the amount of cholesterol absorbed in the gut and the amount of cholesterol produced by the body.

For most people, high cholesterol does not affect how they feel. However, if left untreated, fatty deposits can build up in the walls of the blood vessels and narrow them.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or other health problems can be reduced.

This medicine is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

Your doctor may prescribe Atorduo if you are already taking both medicines, atorvastatin and ezetimibe, at the same dose level.

This medicine will not help you lose weight.

2. What you need to know before you take Atorduo

Do not take Atorduo

• if you are allergic to atorvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6),
• if you have or have ever had a disease that affects the liver,
• if you have had any unexplained abnormal blood test results for liver function,
• if you are a woman who can become pregnant and are not using reliable contraceptive methods,
• if you are pregnant or are trying to become pregnant,
• if you are breast-feeding,
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Atorduo:

• if you have severe respiratory failure,
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) by mouth or by injection. The combination of fusidic acid and this medicine can cause serious muscle problems (rhabdomyolysis). (See section “Other medicines and Atorduo”),
• if you have had a previous stroke with bleeding in the brain, or have small amounts of fluid in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland does not produce enough hormones (hypothyroidism),
• if you have had repeated or unexplained muscle pains or weaknesses or a personal or family history of muscle problems,
• if you have had muscle problems while taking other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• if you have or have had myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or trigger myasthenia (see section 4),
• if you regularly drink 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, tenderness, or muscle weakness while taking Atorduo.This is because muscle problems can be serious, including muscle breakdown causing kidney damage. Atorvastatin is known to cause muscle problems and muscle problems have also been reported with ezetimibe.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. You may need tests and additional medicines to diagnose and treat this problem.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. The risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Tell your doctor about all your medical problems, including allergies.

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

Children and adolescents

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

Other medicines and Atorduo

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

There are some medicines that can affect the way Atorduo works or that can increase the risk of side effects. This type of interaction could reduce the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of side effects, including a serious condition in which muscle tissue is broken down, known as "rhabdomyolysis", which is described in section 4:

• Medicines used to alter the way the immune system works, e.g. ciclosporin
• Certain antibiotics, e.g. erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
• Certain antifungals, e.g. ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole
• Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid and derivatives, colestipol, colestyramine
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem

• Medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone

• Letermovir, a medicine that helps prevent you from getting ill with cytomegalovirus
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, the combination of tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C (inflammation of the liver), e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Fusidic acid. If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart the treatment with Atorduo. Taking this medicine with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).
• Other medicines that are known to interact with this medicine:
• • warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clots)
  • oral contraceptives (medicines to prevent pregnancy)
  • stiripentol (an anticonvulsant medicine used to treat epilepsy)
  • cimetidine (a medicine used for stomach acidity and peptic ulcers)
  • phenazone (a pain reliever)
  • colchicine (used to treat gout)
  • antacids (products for the treatment of indigestion that contain aluminium or magnesium)
  • St. John's Wort (a medicine used to treat depression).

Taking Atorduo with food and drink

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

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can affect the way this medicine works.

Alcohol

Avoid drinking excessive amounts of alcohol while taking this medicine. For more details, see section 2 “Warnings and precautions”.

Pregnancy and breast-feeding

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

Do not take Atorduo if you are breast-feeding.

The safety of this medicine during pregnancy and breast-feeding has not yet been proven.

If you are pregnant or breast-feeding, if you are trying to become pregnant or if you think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Atorduo is unlikely to affect your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking this medicine. If you feel dizzy, consult your doctor before driving or using machines.

This medicine contains sugar and sodium

Atorduo contains sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Atorduo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You should continue with a low-cholesterol diet while taking this medicine.

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

Take Atorduo once a day.

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

Swallow each capsule whole with water.

This medicine is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be done by taking the active substances separately, and once the appropriate doses have been adjusted, it is possible to switch to Atorduo of the corresponding dose.

If your doctor has prescribed Atorduo with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you should take this medicine 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 Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

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 make up for forgotten doses.

If you stop taking Atorduo

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

If you have any further questions on 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 all people suffer from them.

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

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

• Severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty breathing.
• Severe disease whose symptoms are intense exfoliation 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 can lead to blisters.
• Weakness, sensitivity, pain, or muscle rupture, or brownish-red urine color, and especially if it occurs at the same time, a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction (rhabdomyolysis). This abnormal muscle destruction does not always disappear, even after stopping this medicine, and can be potentially fatal and lead to 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 fact may be indicative of a liver disease, consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).

Other Possible Adverse 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 nauseous (nausea)
• Diarrhea
• Abdominal pain
• Muscle pain
• Joint pain
• Pain in arms and legs
• Muscle spasms
• Joint inflammation
• Back pain
• Feeling tired (fatigue)
• Increased levels in some blood tests of muscle function (CK)
• Abnormal liver function test results, increased levels in some blood tests of liver function (transaminases)

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

• Low blood sugar levels
• Weight gain
• Decreased or lost appetite
• Nightmares
• Sleeping problems
• Dizziness
• Numbness or tingling in the fingers of hands and feet
• Decreased sensation of pain or touch
• Altered sense of taste
• Memory loss
• Blurred vision
• Ringing/buzzing in the ears
• Hot flashes
• High blood pressure
• Cough
• Vomiting
• Belching
• Pancreatitis, which causes intense stomach pain that can extend to the back
• Stomach acidity
• Dry mouth
• Stomach inflammation (gastritis)
• Liver inflammation (hepatitis)
• Hives
• Itching
• Skin rash
• Hair loss
• Neck pain
• Muscle weakness
• Discomfort (feeling of general 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 level of liver enzyme in the blood

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

• Reduction of blood platelet levels, which increases the risk of bruising/bleeding (thrombocytopenia)
• Nerve damage in the legs and arms (such as numbness)
• Visual disturbance
• Cholestasis (yellowish skin and eye discoloration)
• Bumpy and reddened rashes, sometimes with target-like lesions (erythema multiforme)
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-colored skin lesions (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):

• Hearing loss
• Liver failure
• Male breast enlargement (gynecomastia)

Frequency Not Known (cannot be estimated from available data):

• Depression
• Shortness of breath
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting)
• Constant muscle weakness (immunomediated necrotizing myopathy)
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (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, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible Adverse Effects Notified with Some Statins:

• Sexual dysfunction
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Diabetes. It is more likely if you have high sugar and fat levels in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting Adverse Effects

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

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

5. Storage of Atorduo

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Atorduo

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

Core:

Carbonate calcium, hydroxypropylcellulose, polysorbate 80, sodium croscarmellose (SD711), sugar spheres (containing sucrose and cornstarch), talc, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose (L-HPC B1), povidone K25, sodium lauryl sulfate, magnesium stearate.

Capsule shell:

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.

Body of the capsule for all doses: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Appearance of Atorduo and Package Contents

Atorduo 10 mg/10 mg hard capsules: Hard gelatin capsule with no markings, size 0, with caramel-colored cap and yellow body, filled with pellets and a tablet.

Atorduo 20 mg/10 mg hard capsules: Hard gelatin capsule with no markings, size 0, with reddish-brown cap and yellow body, filled with pellets and a tablet.

Atorduo 40 mg/10 mg hard capsules: Hard gelatin capsule with no markings, size 0, with dark brown cap and yellow body, filled with pellets and a tablet.

Capsule filling:

IR atorvastatin pellets: Round pellets.

Ezetimibe 10 mg tablet: A round, smooth, and beveled-edge tablet with a stylized E engraved on one face of the tablet and 612 engraved on the other face.

Blister packs (OPA/Al/PVC//Al) of 30, 60, 70, 80, 90, 100, or 120 hard capsules in a cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38.

Hungary

Manufacturer

Egis Pharmaceuticals PLC

9900 Körmend, Mátyás király utca 65

Hungary

Egis Pharmaceuticals PLC, Site 2.

1165 Budapest, Bökényföldi út 118-120.

Hungary

You can request more information about this medicine by contacting 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 under the following names:

Date of the last revision of this leaflet: 09/2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)