Ezetimibe/atorvastatin Krka 10 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ezetimibe/Atorvastatin Krka 10mg/10mg film-coated tablets EFG

Ezetimibe/Atorvastatin Krka 10mg/20mg film-coated tablets EFG

Ezetimibe/Atorvastatin Krka 10mg/40mg film-coated tablets EFG

Ezetimibe/Atorvastatin Krka 10mg/80mg film-coated tablets EFG

Read the entire 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 must not be given to other people, 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ezetimiba/Atorvastatina Krka is and what it is used for

Ezetimiba/Atorvastatina Krka is a medicine that lowers high cholesterol levels. This medicine contains ezetimibe and atorvastatin.

Ezetimiba/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and blood fat substances called triglycerides. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba/atorvastatin works by reducing cholesterol in two ways: by decreasing the cholesterol absorbed in the gastrointestinal tract and by reducing the cholesterol produced by your body.

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. This 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 in your blood that may increase the risk of heart disease.

Ezetimiba/atorvastatin 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.

Ezetimiba/atorvastatin is used, together with a cholesterol-lowering diet, in patients who have:

• high blood cholesterol levels (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 a statin and ezetimibe have previously been used as separate tablets.

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

• heart disease; in these patients, ezetimiba/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba/Atorvastatina Krka does not help you lose weight.

2. What you need to know before taking Ezetimiba/Atorvastatina Krka

Do not take Ezetimiba/Atorvastatina Krka

• 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 a liver disease,
• if you have previously had unexplained abnormal blood test results for 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

Talk to your doctor or pharmacist before starting ezetimiba/atorvastatina

• if you have previously had a stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain due to prior strokes,
• if you have kidney problems,
• if you have low thyroid activity (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or have 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 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 certain sugars, consult with your doctor before taking this medicine,
• if 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 ezetimiba/atorvastatina may cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease characterized by 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking Ezetimiba/Atorvastatina Krka. 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 experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Talk to your doctor or pharmacist before starting Ezetimiba/Atorvastatina Krka

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before starting ezetimiba/atorvastatina, as your doctor may need to perform a blood test before starting and possibly during treatment with ezetimiba/atorvastatina to assess your risk of developing muscle-related side effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Taking Ezetimiba/Atorvastatina Krka with other medicines”).

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.

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

The combined use of ezetimiba/atorvastatina and fibrates (certain medicines to lower cholesterol) should be avoided, as the combination of ezetimiba/atorvastatina and fibrates has not been studied.

Children and adolescents

Ezetimiba/atorvastatina is not recommended for use in children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Krka

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

Some medicines may alter the effect of ezetimiba/atorvastatina, or their effects may be altered by ezetimiba/atorvastatina (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis,” 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, 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,
• 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 need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with ezetimiba/atorvastatina. Using ezetimiba/atorvastatina with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines known to interact with ezetimiba/atorvastatina

• 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 (an analgesic),

• antacids (products for treating indigestion containing aluminum or magnesium),

• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots),

• colchicine (used to treat gout),

• St. John’s wort (a herbal medicine used to treat depression).

Taking Ezetimiba/Atorvastatina Krka with food and alcohol

See section 3 for instructions on how to take ezetimiba/atorvastatina. 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 may alter the effects of ezetimiba/atorvastatina.

Alcohol

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

Pregnancy and breastfeeding

Do not take ezetimiba/atorvastatina if you are pregnant, trying to become pregnant, or think you might be pregnant. Do not take ezetimiba/atorvastatina if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking ezetimiba/atorvastatina, stop taking it immediately and inform your doctor.

Do not take ezetimiba/atorvastatina if you are 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 using machines

Ezetimiba/Atorvastatina is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking ezetimiba/atorvastatina.

Ezetimiba/Atorvastatina Krka contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.

3. How to take Ezetimiba/Atorvastatina Krka

Follow exactly the instructions for using this medicine as given by your doctor. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk situation.

If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimiba/atorvastatina, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba/atorvastatina.

Since the tablet has no score line, it must be swallowed whole and must not be divided.

What dose should be taken

The recommended dose is one ezetimiba/atorvastatina tablet once daily by oral administration.

Method of administration

Take ezetimiba/atorvastatina at any time of day. It may be taken with or without food.

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

If you take more Ezetimiba/Atorvastatina Krka than you should

Consult your doctor or pharmacist.

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 Ezetimiba/Atorvastatina Krka

Do not take a double dose; the following day, take your usual dose of ezetimiba/atorvastatina at the regular 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 experiences them.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor 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, 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, tenderness, breakage, or pain, change in urine color to red-brown, and especially if occurring together with feeling unwell or high temperature, which may be due to abnormal muscle breakdown that could be potentially fatal and lead to kidney problems

• lupus-like syndrome (including skin 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 patients):

• diarrhea,
• muscle pain.

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

• flu,
• depression; sleep problems; sleep disorder,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flushes,
• choking,
• abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; gastric distress,
• acne; hives,
• joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema),
• increased levels in certain liver function or muscle (CK) tests in laboratory blood analyses,
• weight gain.

The following adverse effects have been reported with unknown frequency (cannot be estimated from available data):

• myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing),
• ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you develop arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported in patients taking ezetimibe/atorvastatin, 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),
• red skin rash, sometimes target-shaped,
• liver problems,
• cough,
• acid reflux,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including skin rash and hives,
• traumatic 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 count, which may lead to bruising/bleeding (thrombocytopenia),
• nasal inflammation; nosebleeds,
• neck pain; pain, chest pain; sore throat,
• increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in fingers or toes,
• reduced sensitivity to pain or touch,
• altered 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 (enlargement of the breast in men).

Possible adverse effects reported with some statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or choking or fever,
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness, or weakness, especially if occurring together with feeling unwell or high temperature, which may not resolve after stopping ezetimibe/atorvastatin treatment (frequency unknown).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe/Atorvastatin Krka

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

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

No special storage temperature requirements apply to this medicine.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Atorvastatina Krka

• The active substances are ezetimibe and atorvastatin.

10 mg/10 mg: Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/20 mg: Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/40 mg: Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/80 mg: Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components are calcium carbonate, hydroxypropylcellulose, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate, povidone, mannitol, sodium stearyl fumarate, and yellow iron oxide (E172) in the tablet core; and hypromellose, macrogol (E1521), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) (only for 10 mg/10 mg, 10 mg/20 mg), red iron oxide (E172) (only for 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg), and black iron oxide (E172) (only for 10 mg/80 mg) in the film coating. See section 2 “Ezetimiba/Atorvastatina Krka contains lactose and sodium”.

Nature of the product and pack size

Ezetimiba/Atorvastatina Krka 10 mg/10 mg film-coated tablets: light yellow, oval, biconvex, film-coated tablets marked with A1 on one side. Tablet dimensions: approximately 13 mm x 6 mm.

Ezetimiba/Atorvastatina Krka 10 mg/20 mg film-coated tablets: light orange, capsule-shaped, biconvex, film-coated tablets marked with A2 on one side. Tablet dimensions: approximately 14 mm x 6 mm.

Ezetimiba/Atorvastatina Krka 10 mg/40 mg film-coated tablets: light pink, oval, biconvex, film-coated tablets marked with A4 on one side. Tablet dimensions: approximately 17 mm x 8 mm.

Ezetimiba/Atorvastatina Krka 10 mg/80 mg film-coated tablets: light purple, oval, biconvex, film-coated tablets marked with A8 on one side. Tablet dimensions: approximately 19 mm x 9 mm.

Ezetimiba/Atorvastatina Krka is available in blisters containing 10, 20, 30, 60, 90 or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Date of the most recent review of this leaflet: October 2024

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