Package Insert: Information for the Patient

Cardyl Plus10 mg/20 mg Film-Coated Tablets

Cardyl Plus 10 mg/40 mg Film-Coated Tablets

Cardyl Plus 10 mg/80 mg Film-Coated Tablets

Ezetimibe/Atorvastatin

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See Section 4.

1. What is Cardyl Plus and how is it used

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

3. How to take Cardyl Plus

4. Possible adverse effects

5. Storage of Cardyl Plus

6. Contents of the package and additional information

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

Ezetimibe/atorvastatin is used in adults to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and certain types of fat called triglycerides that circulate in the blood. Additionally, Cardyl Plus increases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin acts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract, as well as the cholesterol that your body produces on its own.

Cholesterol is one of the fatty substances found in the circulatory system. Your total cholesterol is composed mainly of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can trigger a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat present in your blood that can increase the risk of heart disease.

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

Ezetimibe/atorvastatin is used, along with a cholesterol-reducing diet, if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated levels of fatty substances (mixed hyperlipidemia):
• • that are not well controlled with a single statin
  • for which a statin and ezetimibe have been used in separate tablets

• a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood.You may also receive other treatments.

• cardiovascular disease, Cardyl Plus reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Cardyl Plus does not help you lose weight.

Do not take Cardyl Plus

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take ezetimibe/atorvastatin

• 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 "statins" or "fibrates"),
• If you regularly consume 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 medication,
• If you are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Cardyl Plus may cause severe muscle problems (rhabdomyolysis),
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking Cardyl Plus.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. Further tests and additional medications may be needed to diagnose and treat this problem.

Consult your doctor or pharmacist before starting to take Cardyl Plus:

- If you have severe respiratory failure.

If you are in any of the above circumstances (or are unsure), consult your doctor before starting to take ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, and possibly during it, to predict the risk of experiencing adverse muscle effects. It is known that the risk of experiencing adverse muscle effects, e.g., rhabdomyolysis, increases when certain medications are taken simultaneously (see section 2 “Other medications and Cardyl Plus”).

While you are taking this medication, your doctor will monitor if you have diabetes or a 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 of all your medical problems, including allergies.

Combining Cardyl Plus with fibrates (certain medications to lower cholesterol) should be avoided, as the combined use of Cardyl Plus and fibrates has not been studied.

Children

Ezetimibe/atorvastatin is not recommended for children and adolescents.

Other medications and Cardyl Plus

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

There are some medications that may modify the effect of Cardyl Plus or whose effects may be affected by Cardyl Plus (see section 3). 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 adverse effects, including a serious condition in which muscle is destroyed, known as “rhabdomyolysis”, which is described in section 4:

• Ciclosporin (a medication often used in transplant patients),
• Erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medications used to treat bacterial infections),
• Ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medications used to treat fungal infections),
• Gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol, cholestyramine (medications used to regulate lipid levels),
• Some calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
• Digoxin, verapamil, amiodarone (medications that regulate heart rhythm),
• Medications used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS), some medications used to treat hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir
• Letermovir, a medication that helps prevent cytomegalovirus disease
• Daptomycin (a medication used to treat complicated skin and soft tissue infections and bacteremia).

** If you need to take fusidic acid orally to treat a bacterial infection, temporarily, you will need to stop taking this medication. Your doctor will tell you when you can restart the treatment with Cardyl Plus. The use of Cardyl Plus with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis).For more information on rhabdomyolysis, see section 4.

• Other medications that are known to interact with ezetimibe/atorvastatin
• • Oral contraceptives (medications that prevent pregnancy),
  • Stiripentol (an anticonvulsant medication used to treat epilepsy),
  • Cimetidine (a medication used for stomach acid and ulcers),
  • Fenazone (an analgesic),
  • Antacids (products used to treat indigestion containing aluminum or magnesium),
  • Warfarin, phenprocoumon, acenocoumarol, or fluindione (medications that prevent blood clotting),
  • Colchicine (used to treat gout),
  • St. John's Wort (a medication used to treat depression).

Taking Cardyl Plus with food and alcohol

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

Alcohol

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

Pregnancy and breastfeeding

Do not take Cardyl Plus if you are pregnant, trying to become pregnant, or breastfeeding.

Do not take ezetimibe/atorvastatin if you may become pregnant, unless you are using reliable contraceptive methods. If you become pregnant while taking Cardyl Plus, stop taking it immediately and inform your doctor.

Do not take Cardyl Plus if you are breastfeeding.

The safety of ezetimibe/atorvastatin during pregnancy and breastfeeding has not been proven. Consult your doctor or pharmacist before taking this medication.

Driving and operating machines

Cardyl Plus is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking Cardyl Plus.

Cardyl Plus contains lactose

Cardyl Plus tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Cardyl Plus contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation. In case of doubt, consult your doctor or pharmacist again.

What quantity to take

The recommended dose is one tablet of ezetimiba/atorvastatina once a day by mouth.

Form of administration

Take ezetimiba/atorvastatina at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimiba/atorvastatina along with colestiramina or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take Cardyl Plus at least 2 hours before or 4 hours after taking the bile acid sequestrant.

T aking more Cardyl Plus than you should

Consult your doctor or pharmacist.

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

T aking less Cardyl Plus than you should

Do not take an extra dose; the next day, take your usual amount of ezetimiba/atorvastatina at the usual time. If you have any other doubts 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 your tablets and immediately inform your doctor, or visit the nearest hospital emergency service

• severe allergic reactions that cause swelling of the face, tongue, and throat and may cause severe difficulty breathing.
• serious disease whose symptoms are 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 or change in urine color to brown-red and especially, if it occurs at the same time, feeling unwell or high temperature that may be caused by abnormal muscle destruction that may 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 may be indicative of liver disease.

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

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

In addition, the following side effects have been reported in people taking Cardyl Plus tablets, ezetimiba, or atorvastatina:

• allergic reactions that include inflammation of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• red skin rash and, in some cases, in the shape of a target,
• liver problems,
• cough,
• heartburn,

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

• nightmares,
• numbness or tingling in the fingers of the hands and feet,
• 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,
• eructation,
• hair loss,
• high temperature,
• presence of white blood cells in urine tests,
• blurred vision; visual disturbances,
• gynecomastia (breast enlargement in men),
• myasthenia gravis (disease that causes general muscle weakness, including in some cases the muscles used for breathing),
• ocular myasthenia (disease that causes eye muscle weakness).

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

Possible side effects reported 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 blood sugar and fat levels, obesity, and high blood pressure.Your doctor will closely monitor you while taking this medication,
• muscle pain, sensitivity, or weakness that is constant and especially, if it occurs at the same time, feeling unwell or high temperature that may not disappear after stopping ezetimiba/atorvastatina treatment (frequency unknown).

Side effect reporting

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

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

Do not use this medication 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 medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cardyl Plus

The active ingredients are ezetimiba and atorvastatina. Each film-coated tablet contains

10 mg of ezetimiba and 20 mg, 40 mg or 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components are: calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hydroxypropylcellulose; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose; polisorbate 80; sodium lauryl sulfate.

The film coating of the tablet 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 contents of the pack

Film-coated, biconvex, capsule-shaped tablets of white to off-white color.

Cardyl Plus 10 mg/20 mg tablets are engraved with “2T” on one face.

Cardyl Plus 10 mg/40 mg tablets are engraved with “4T” on one face.

Cardyl Plus 10 mg/80 mg tablets are engraved with “8T” on one face.

Pack sizes:

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

Only some pack 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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Belgium:Myatorlip 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg filmomhulde tabletten

CroatiaSortis Plus 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg filmon obložene tablete

Spain:Cardyl Plus 10mg/20mg; 10mg/40mg; 10mg/80mg comprimidos recubiertos con película

EFG

Luxembourg:Myatorlip 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg filmomhulde tabletten

Netherlands:Ezetimibe/Atorvastatine Mylan 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg

Filmomhulde tabletten

Portugal:Atorvastatina + Ezetimiba Mylan

Romania:Sortis® Plus 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg comprimate

Last revision date of this leaflet:07/2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es