Atorduo 40 mg/10 mg hard capsules

Package leaflet: Information for the user

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 the entire 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 others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Atorduo is and what it is used for

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

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

This medicine works by reducing cholesterol in two ways: it reduces cholesterol absorbed in the digestive tract, as well as cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they cause no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels may become blocked, cutting off blood supply to the heart or brain, which could result in a heart attack or stroke. By lowering cholesterol levels, your risk of having a heart attack, stroke, or other related health problems may 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 Atorduo to you if you are already taking both atorvastatin and ezetimibe at the same dose levels.

This medicine does not help you to lose weight.

2. What you need to know before taking 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 liver disease,
• if you have had unexplained abnormal results in blood tests checking liver function,
• if you are a woman who could become pregnant and are 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

Talk to 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 an oral or injectable medicine called fusidic acid (an antibacterial medicine). The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis). (See section “Other medicines and Atorduo”),
• if you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland is underactive (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or personal or family history of muscle disorders,
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• if you have or have had myasthenia (a disease causing 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),
• 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, tenderness, or muscle weakness while taking Atorduo. 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 have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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

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

The combined use of Atorduo and fibrates (certain medicines to lower cholesterol) should be avoided, as the combination of this medicine with 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 need to take any other medicines.

Some medicines may alter the effect of Atorduo or their effects may be affected by Atorduo. 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:

• Medicines used to alter the way the immune system works, e.g., cyclosporine
• Certain antibiotics, e.g., erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
• Certain antifungals, e.g., ketoconazole, itraconazol, voriconazole, fluconazole, posaconazole
• Other medicines to regulate lipid levels, e.g., gemfibrozil, other fibrates, nicotinic acid and derivatives, colestipol, cholestyramine
• Some 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 cytomegalovirus infection
• Medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, the combination of tipranavir/ritonavir, etc.
• Some medicines 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 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 restart treatment with Atorduo. Taking this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteria in the blood)
• Other medicines 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 (an analgesic)
  • colchicine (used to treat gout)
  • antacids (products for treating indigestion containing aluminium or magnesium)
  • St. John’s wort (a medicine used to treat depression)

Taking Atorduo with food and alcohol

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 quantities of grapefruit juice may alter the effects of this medicine.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further 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 medicine if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor.

Do not take Atorduo if you are breastfeeding.

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

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

Driving and using machines

Atorduo is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking this medicine. If you feel dizzy, consult your doctor before driving or operating machinery.

This medicine contains sucrose and sodium

Atorduo contains sucrose. If your doctor has informed you that you have an intolerance to certain 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

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

You must continue a cholesterol-lowering diet while taking this medicine.

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

Take Atorduo once daily.

You may 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 performed by taking the active substances separately. Once the appropriate doses have been established, switching to the corresponding dose of Atorduo is possible.

If your doctor has prescribed Atorduo together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Atorduo

Consult your doctor if you wish to stop treatment with Atorduo. 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.

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

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

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• A serious illness characterized by extensive skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with pink or red spots, particularly on the palms of the hands or soles of the feet, which may progress to blistering.
• Muscle weakness, sensitivity, pain or tearing, or brownish-red discoloration of urine, especially if accompanied by a general feeling of being unwell or high temperature, which may be due to abnormal muscle breakdown (rhabdomyolysis). This abnormal muscle breakdown does not always resolve even after stopping this medicine and may 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 unexpected or unusual bleeding or bruising, as this may indicate liver disease, consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects

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

• Common cold (nasopharyngitis)
• Allergic reactions
• Increased blood sugar levels
• Headache
• Sore throat
• Nosebleeds
• Constipation
• Flatulence (excess gas in the gastrointestinal tract)
• Dyspepsia
• Dizziness (nausea)
• Diarrhea
• Abdominal pain
• Muscle pain
• Joint pain
• Pain in arms and legs
• Muscle spasms
• Joint inflammation
• Back pain
• Feeling tired (fatigue)
• Elevations in certain blood tests of muscle function (CK)
• Abnormal liver function test results, elevations in certain blood tests of liver function (transaminases)

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

• Low blood sugar levels
• Weight gain
• Decreased or loss of appetite
• Nightmares
• Sleep problems
• Dizziness
• Numbness or tingling in fingers and toes
• Reduced sensation to pain or touch
• Disturbance in taste sensation
• Memory loss
• Blurred vision
• Ringing or buzzing in the ears
• Hot flushes
• High blood pressure
• Cough
• Vomiting
• Belching
• Pancreatitis, causing severe stomach pain that may spread to the back
• Acid indigestion
• Dry mouth
• Stomach inflammation (gastritis)
• Liver inflammation (hepatitis)
• Hives
• Itching
• Skin rash
• Hair loss
• Neck pain
• Muscle weakness
• Malaise (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 level of liver enzyme in your blood

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

• Reduced levels of blood platelets, increasing the risk of bruising/bleeding (thrombocytopenia)
• Nerve damage in arms and legs (such as numbness)
• Visual disturbances
• Cholestasis (yellowing of the skin and whites of the eyes)
• Raised, red skin rashes, sometimes with target-like lesions (erythema multiforme)
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)
• Muscle disease with muscle weakness (myopathy)
• Muscle inflammation
• Tendon injury

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

• Hearing loss
• Liver failure
• Breast enlargement in men (gynaecomastia)

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

• Depression
• Shortness of breath
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• Persistent muscle weakness (immune-mediated necrotizing myopathy)
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

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

Possible adverse effects reported with some statins:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide 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 from moisture.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Atorduo

• The active substances 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: calcium carbonate, hydroxypropylcellulose, polysorbate 80, sodium croscarmellose (SD711), sugar spheres (containing sucrose and corn starch), talc, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose (L-HPC B1), povidone K25, sodium lauryl sulfate, 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 strengths: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Appearance of Atorduo and contents of the pack

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

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

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

Capsule contents:

Atorvastatin IR pellets: round-shaped pellets.

Ezetimibe 10 mg tablet: a round, smooth tablet with bevelled edges, with a stylized E engraved on one side and 612 engraved on the other side.

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

Only certain pack 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

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Laboratorios Servier S.L.
Avenida de los Madroños 33
28043 Madrid
Spain

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

Date of the most recent review of this leaflet: 09/2024

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