Cardyl Plus 10 mg/20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cardyl Plus 10 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, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See Section 4.

Leaflet contents

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

1. What Cardyl Plus is and what it is 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 reduce total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Cardyl Plus increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works to reduce cholesterol in two ways: by decreasing cholesterol absorbed from the gastrointestinal tract and by reducing cholesterol produced by the body itself.

Cholesterol is one of the fatty substances 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such interruption in blood flow may trigger 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 present in your blood that may increase the risk of heart disease.

Cardyl Plus 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.

Ezetimibe/atorvastatin is used, together with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):

  • that are not well controlled by a statin alone
  • for whom treatment with a statin and ezetimibe in separate tablets has been used

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

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

Cardyl Plus does not help you lose weight.

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

Do not take Cardyl Plus

• if you are allergic to ezetimibe, atorvastatin, or any of the other components of this medicine (listed in section 6),
• if you have or have ever had liver disease,
• if you have ever had unexplained abnormal results in blood tests of liver function,
• if you are a woman who could become pregnant and are 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 the treatment of hepatitis C.

Warnings and precautions

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

• you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• you have kidney problems,
• your thyroid gland is underactive (hypothyroidism),
• you have experienced recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders,
• you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• you regularly consume large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years of age,
• your doctor has informed you that you have an intolerance to certain sugars; contact your doctor before taking this medicine,
• you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Cardyl Plus may cause serious muscle problems (rhabdomyolysis),
• you have or have had myasthenia (a disease causing generalized muscle weakness that, 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking Cardyl Plus. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. Muscle problems are known to occur with atorvastatin, and have also been reported with ezetimibe.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be required to diagnose and manage this condition.

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 situations (or are unsure), consult your doctor before starting ezetimibe/atorvastatin, as your doctor may need to perform a blood test before starting and possibly during treatment with ezetimibe/atorvastatin to assess your risk of developing muscle-related adverse effects. The risk of muscle-related adverse effects, e.g., rhabdomyolysis, is known to increase when certain medicines are taken concomitantly (see section 2 “Other medicines and Cardyl Plus”).

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

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

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

Children

Ezetimibe/atorvastatin is not recommended for use in children and adolescents.

Other medicines and Cardyl Plus

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

There are some medicines that may alter the effect of Cardyl Plus or whose effects may be altered by Cardyl Plus (see section 3). 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 adverse effects, including a serious condition involving destruction of muscle tissue known as “rhabdomyolysis,” which is described in section 4:

• cyclosporine (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 and its derivatives, colestipol, cholestyramine (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, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS), some medicines used in the treatment of hepatitis C, for example, 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).

** If you need to take oral fusidic acid to treat a bacterial infection, you will temporarily have to stop using this medicine. Your doctor will advise you when you can restart treatment with Cardyl Plus. Using Cardyl Plus together with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For further information about rhabdomyolysis, see section 4.

• Other medicines 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 acid and peptic ulcers),
  • phenazone (a painkiller),
  • antacids (products for treating indigestion containing aluminium or magnesium),
  • warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clots),
  • colchicine (used to treat gout),
  • St. John's wort (a herbal remedy 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:

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 Cardyl Plus.

Alcohol

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

Pregnancy and breastfeeding

Do not take Cardyl Plus if you are pregnant, trying to become pregnant, or think you might be pregnant. Do not take ezetimiba/atorvastatina if there is any possibility of becoming 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 while breastfeeding.

The safety of ezetimiba/atorvastatina during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery

Cardyl Plus is not expected to impair your ability to drive or operate machinery. However, it should be noted that 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 informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Cardyl plus contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Cardyl Plus

Follow exactly the instructions for use of this medicine provided by your doctor. Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your individual risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting ezetimibe/atorvastatin, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

What dose to take

The recommended dose is one tablet of ezetimibe/atorvastatin taken once daily by mouth.

Method of administration

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

If your doctor has prescribed ezetimibe/atorvastatin together with colestyramine 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.

If you take 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Cardyl Plus

Do not take a double dose; the next day, take your regular dose of ezetimiba/atorvastatin at the usual time. 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 your tablets immediately and contact your doctor right away or go to the nearest hospital emergency department

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing.

• A serious illness characterized by severe skin peeling and inflammation, blistering of the skin, mouth, eyes, and genitals, and fever; skin rash with red or pink spots, particularly on the palms of the hands or soles of the feet, which may progress to blistering.

• Muscle weakness, tenderness, pain, or rupture; change in urine color to red-brown; and particularly, if occurring together with a feeling of malaise or high temperature—this may be due to abnormal muscle breakdown, which can be potentially life-threatening and lead to kidney problems.

• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this may indicate liver disease.

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

• Diarrhea,
• Muscle pain.

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

• Influenza-like illness,
• Depression; sleep disturbances; sleep disorders,
• Dizziness; headache; tingling sensation,
• Slow heart rate,
• Hot flushes,
• Choking sensations,
• Abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; gastrointestinal discomfort,
• Acne; urticaria,
• Joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• Unusual weakness; feeling of tiredness or malaise; swelling, especially in the ankles (edema),
• Increased liver function tests or muscle enzyme levels (CK) in blood laboratory tests,
• Weight gain.

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

• Allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment),

• Reddish skin rash, sometimes target-shaped,

• Liver problems,

• Cough,

• Heartburn,

• Decreased appetite; loss of appetite,

• High blood pressure,

• Skin rash and itching; allergic reactions including skin rash and hives,

• Tendon injury,

• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),

• Inflammation of the pancreas, often accompanied by severe abdominal pain,

• Decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia),

• Nasal inflammation; nosebleeds,

• Neck pain; chest pain; sore throat,

• Increase or decrease in blood sugar levels (if you have diabetes, your blood glucose levels should be closely monitored),

• Nightmares,

• Numbness or tingling in fingers and toes,

• Reduced sensitivity to pain or touch,

• Taste disturbances; 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 causing generalized muscle weakness, including in some cases the muscles used for breathing),

• Ocular myasthenia (a disease causing eye muscle weakness).

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

Possible adverse effects reported with some statins

• Sexual dysfunction,
• Depression,
• Respiratory problems, including persistent cough and/or choking sensations or fever,
• Diabetes. This is more likely if you have high levels of sugar 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, tenderness, or weakness that is persistent and particularly, if occurring together with a feeling of malaise or high temperature, which may not resolve after stopping treatment with ezetimibe/atorvastatin (frequency not known).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the carton or container following “EXP” or “CAD”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Cardyl Plus

The active substances 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 components 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 contents of the pack

Film-coated tablets, biconvex, capsule-shaped, white to off-white in colour.

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

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

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

Pack sizes:

Blister packs containing 10, 30, 90 and 100 film-coated tablets.

Only certain 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:

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola, PLA 3000,
Malta

or

Delorbis Pharmaceutical Ltd
17 Athinon Street,
Ergates Industrial Area,
2643 Ergates Lefkosia,
Cyprus

For more information about this medicine, contact 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 European Economic Area member states under the following names:

Belgium: Myatorlip 10mg/10mg; 10mg/20mg; 10mg/40mg; 10mg/80mg filmomhulde tablletten
Croatia: Sortis 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

Date of the most recent review of this summary: 07/2024.

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