CARDYL PLUS 10 mg/40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cardyl Plus10 mg/20 mg film-coated tablets EFG

Cardyl Plus 10 mg/40 mg film-coated tablets EFG

Cardyl Plus 10 mg/80 mg film-coated tablets EFG

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 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

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

1. What is Cardyl Plus and what is it used for

Ezetimibe/Atorvastatin is a medicine that lowers high cholesterol levels. Cardyl Plus contains ezetimibe and atorvastatin.

Ezetimibe/Atorvastatin is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fats (triglycerides) that are found in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/Atorvastatin works by reducing cholesterol in two ways. It reduces the amount of cholesterol absorbed in the gut and also reduces the amount of cholesterol produced by the body.

Cholesterol is one of the fats found in the bloodstream. Your total cholesterol is made up 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can lead to 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 found in the blood that can increase the risk of heart disease.

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

Ezetimibe/Atorvastatin is used, along with a low-cholesterol diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidaemia):
• • that are not well controlled with a statin alone
  • for which you have taken a statin and ezetimibe in separate tablets

• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia), which can lead to high levels of cholesterol in the blood. You may also receive other treatments.

• heart disease, Cardyl Plus reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart or hospitalization for chest pain.

Cardyl Plus does not help you lose weight.

2. What you need to know before you take Cardyl Plus

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• 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 any unexplained abnormal blood test results indicating liver problems,
• if you are a woman who can become pregnant and are not using reliable contraception,
• if you are pregnant, trying to become pregnant or are breast-feeding,
• if you are taking the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.

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Consult your doctor or pharmacist before taking ezetimibe/atorvastatin

• if you have had a stroke with bleeding in the brain, or have small amounts of fluid in the brain caused by previous strokes,
• if you have kidney problems,
• if your thyroid gland does not produce enough thyroid hormone (hypothyroidism),
• if you have had muscle pain or weakness or have a history of muscle problems,
• if you have had muscle problems while taking other medicines to lower cholesterol (e.g. other medicines containing "statins" or "fibrates"),
• if you regularly drink 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 some sugars, contact them before taking this medicine,
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Cardyl Plus can cause serious muscle problems (rhabdomyolysis),
• if you have or have had myasthenia (a disease that causes muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic syndrome (a disease that causes muscle weakness of the eye muscles), as statins can sometimes worsen the condition or trigger myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness or weakness while taking Cardyl Plus.This is because, in rare cases, muscle problems can be serious, including muscle breakdown resulting in kidney damage. Atorvastatin can cause muscle problems and muscle problems have also been reported with ezetimibe.

Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

Consult your doctor or pharmacist before taking Cardyl Plus:

• if you have severe respiratory problems.

If you are in any of the above situations (or are unsure), consult your doctor before taking ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, and possibly during treatment, to predict the risk of muscle side effects. The risk of muscle side effects, e.g. rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 "Other medicines and Cardyl Plus").

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 sugar and fat in the blood, are overweight and have high blood pressure.

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

The combined use of Cardyl Plus and fibrates (certain cholesterol-lowering medicines) should be avoided, as the combined use of Cardyl Plus and fibrates has not been studied.

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Ezetimibe/Atorvastatin is not recommended for children and adolescents.

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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

There are some medicines that can affect the way Cardyl Plus 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 disorder in which muscle tissue is destroyed, known as "rhabdomyolysis", which is described in section 4:

• cyclosporin (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, colestyramine (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
• letermovir, a medicine that helps prevent cytomegalovirus disease
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

** S. s. eFor more information on rhabdomyolysis, see section 4.

• Other medicines that are known to interact with ezetimibe/atorvastatin
• • oral contraceptives (medicines that prevent pregnancy),
  • stiripentol (an anticonvulsant medicine used to treat epilepsy),
  • cimetidine (a medicine used for stomach acidity and peptic ulcers),
  • phenazone (a pain reliever),
  • antacids (indigestion treatments that contain aluminium or magnesium),
  • warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
  • colchicine (used to treat gout),
  • St. John's Wort (a medicine used to treat depression).

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See section 3 for instructions on how to take Cardyl Plus. 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 Cardyl Plus works.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more information, see section 2 "Warnings and precautions".

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Do not take Cardyl Plus if you are pregnant, trying to become pregnant or think you may be pregnant. Do not take ezetimibe/atorvastatin if you can become pregnant, unless you use reliable contraception. If you become pregnant while taking Cardyl Plus, stop taking it immediately and inform your doctor.

Do not take Cardyl Plus if you are breast-feeding.

The safety of ezetimibe/atorvastatin during pregnancy and breast-feeding has not yet been established. Consult your doctor or pharmacist before taking this medicine.

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Cardyl Plus is unlikely to affect your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking Cardyl Plus.

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The tablets of Cardyl Plus contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Cardyl Plus

Take this medicine exactly as your doctor has told you. Your doctor will determine the appropriate dose of Cardyl Plus for you, depending on your current treatment and your personal risk situation. If you are unsure, consult your doctor or pharmacist again.

• Before starting to take ezetimibe/atorvastatin, you should be following a low-cholesterol diet.
• You should continue with this low-cholesterol diet while taking ezetimibe/atorvastatin.

How much to take

The recommended dose is one tablet of ezetimibe/atorvastatin once a day by mouth.

Method of administration

Take ezetimibe/atorvastatin at any time of day. You can take it with or without food.

If your doctor has prescribed ezetimibe/atorvastatin with colestyramine or any other bile acid sequestrant (medicines that lower cholesterol levels), you should take Cardyl Plus at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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Do not take an extra dose; the next day, take your normal dose of ezetimibe/atorvastatin at the usual time. 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 your tablets and immediately inform your doctor, or go to the emergency department of the nearest hospital

• 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 the soles of the feet, which can lead to blisters.

• weakness, sensitivity, pain, or muscle rupture or change in urine color to reddish-brown and especially, if it occurs at the same time, a feeling of discomfort or high temperature that can be caused by abnormal muscle destruction that can be potentially fatal and trigger 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 the unexpected or unusual appearance of bleeding or bruising, as this fact may indicate a liver disease.

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

• diarrhea,
• muscle pain.

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

• flu,
• depression; sleep problems; sleep disorder,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flashes,
• shortness of breath,
• abdominal pain; abdominal swelling; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach upset,
• acne; hives,
• joint pain; back pain; muscle cramps in the legs; muscle fatigue, spasms, or muscle weakness; pain in the arms and legs,
• unusual weakness; feeling of tiredness or discomfort; inflammation, especially in the ankles (edema),
• increase in some liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

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

• allergic reactions that include inflammation of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (which require immediate medical treatment),
• red rash, and occasionally, target-shaped rash,
• liver problems,
• cough,
• heartburn,

• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions that include the appearance of skin rash and hives,
• tendon trauma,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, or vomiting),
• pancreatitis, often accompanied by severe abdominal pain,
• decrease in blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nasal bleeding,
• neck pain; chest pain; throat pain,
• increase or decrease in blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels)

• nightmares,
• numbness or tingling in the fingers and toes,
• decreased sensitivity to pain or touch,
• alteration of the 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 (breast enlargement in men),
• myasthenia gravis (a disease that causes general muscle weakness, including, in some cases, the muscles used for breathing),
• ocular myasthenia (a disease that causes eye muscle weakness).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Possible Adverse Effects Noted with Some Statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or shortness of breath or fever,
• diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• muscle pain, sensitivity, or weakness that is constant and especially, if it occurs at the same time, a feeling of discomfort or high temperature that may not disappear after stopping treatment with ezetimibe/atorvastatin (frequency not known).

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

5. Storage of Cardyl Plus

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

Do not use this medicine after the expiration date that appears on the packaging or on the container after "CAD" or "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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 your 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 Cardyl Plus

The active ingredients 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 ingredients are: calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hydroxypropylcellulose; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose; polysorbate 80; sodium lauryl sulfate.

The tablet coating contains: hypromellose, lactose monohydrate, titanium dioxide (171), macrogol, and talc.

See also section 2 "Cardyl plus contains lactose" and "Cardyl plus contains sodium".

Appearance of the Product and Package Contents

White to off-white, biconvex, capsule-shaped film-coated tablets.

Cardyl Plus 10 mg/20 mg tablets are engraved with "2T" on one side.

Cardyl Plus 10 mg/40 mg tablets are engraved with "4T" on one side.

Cardyl Plus 10 mg/80 mg tablets are engraved with "8T" on one side.

Package sizes:

Packaging of 10, 30, 90, and 100 film-coated tablets in blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Delorbis Pharmaceutical Ltd

17 Athinon Street,

Ergates Industrial Area,

2643 Ergates Lefkosia,

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Belgium: Myatorlip 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg film-coated tablets

Croatia: Sortis Plus 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg film-coated tablets

Spain: Cardyl Plus 10mg/20mg; 10mg/40mg; 10mg/80mg film-coated tablets

EFG

Luxembourg: Myatorlip 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg film-coated tablets

Netherlands: Ezetimibe/Atorvastatine Mylan 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg film-coated tablets

Portugal: Atorvastatina + Ezetimiba Mylan

Romania: Sortis Plus 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg tablets

Date of the Last Revision of this Prospectus:07/2024

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