EZETIMIBE/ATORVASTATIN KRKA 10 mg/10 mg FILM-COATED TABLETS

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

1. What is Ezetimibe/Atorvastatin Krka and what is it used for

Ezetimibe/Atorvastatin Krka is a medicine that lowers high levels of cholesterol. This medicine contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing the cholesterol absorbed in the gut and the cholesterol produced by the body.

Cholesterol is one of the fatty substances that can be found in the blood. 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. This narrowing can reduce or completely block the blood flow to important organs such as the heart and brain. This blockage is the cause of most heart attacks and strokes.

HDL cholesterol is often called "good" cholesterol because it helps prevent the "bad" cholesterol from building up in the arteries and protects against heart disease.

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

Ezetimibe/atorvastatin 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 triglycerides 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 hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You may also receive other treatments.
• heart disease, ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart or hospitalisation due to chest pain.

Ezetimibe/Atorvastatin Krka does not help you lose weight.

2. What you need to know before you take Ezetimibe/Atorvastatin Krka

Do not take Ezetimibe/Atorvastatin 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 had any unexplained abnormal blood test results showing 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 for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before you start taking ezetimibe/atorvastatin

• if you have had a stroke with bleeding in the brain, or have small pockets 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 lipid-lowering medicines (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 your doctor before taking this medicine,
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/atorvastatin can cause muscle problems (rhabdomyolysis).
• if you have or have had muscle weakness (myasthenia gravis) or muscle weakness in the eye (ocular myasthenia), as statins can sometimes worsen these conditions or trigger the onset of myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness or weakness while taking Ezetimibe/Atorvastatin Krka.This is because, on rare occasions, 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, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.

Consult your doctor or pharmacist before you start taking Ezetimibe/Atorvastatin 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 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 you have of experiencing 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 "Taking Ezetimibe/Atorvastatin Krkawith other medicines").

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

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

The combined use of ezetimibe/atorvastatinand fibrates (certain medicines used to lower cholesterol) should be avoided, as the combined use of ezetimibe/atorvastatinand fibrates has not been studied.

Children and adolescents

Ezetimibe/atorvastatinis not recommended for children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Krka

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 may affect the way ezetimibe/atorvastatinworks or that ezetimibe/atorvastatinmay affect. 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 broken down (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 to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir,
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria in the blood).

** If you have to take fusidic acid by mouth to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when you can restart the treatment with ezetimibe/atorvastatin. The use of ezetimibe/atorvastatin with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For 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 to treat stomach acidity and peptic ulcers),
• phenazone (a pain reliever),
• antacids (products used to treat indigestion 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).

Taking Ezetimibe/Atorvastatin Krka with food and drink

See section 3 for instructions on how to take ezetimibe/atorvastatin. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can affect the action of ezetimibe/atorvastatin.

Alcohol

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

Pregnancy and breast-feeding

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

Do not take ezetimibe/atorvastatinif you are breast-feeding.

The safety of ezetimibe/atorvastatinduring pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ezetimibe/atorvastatinis not expected to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin Krka contains lactose and sodium

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

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

3. How to take Ezetimibe/Atorvastatin Krka

Follow the instructions for administration of this medicine exactly as told by your doctor. Your doctor will determine the appropriate dose of the tablet for you, depending on your current treatment and your personal risk situation.

In case of doubt, consult your doctor or pharmacist again.

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

Since the tablet is not scored, it should be swallowed whole and not divided.

How much to take

The recommended dose is one ezetimibe/atorvastatin tablet per day, orally.

Method of administration

Take ezetimibe/atorvastatin at any time of the 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), you should take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Atorvastatin Krka than you should

Consult your doctor or pharmacist.

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

If you forget to take Ezetimibe/Atorvastatin Krka

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 inform your doctor immediately, 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 soles of the feet, which can lead to blisters

• weakness, sensitivity, rupture, or muscle pain, 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, which can be potentially fatal and lead to kidney problems

• lupus-like disease syndrome (which includes skin 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 be indicative of 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 heartbeat,
• 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 weakness; pain in the arms and legs,
• unusual weakness; feeling of tiredness or discomfort; swelling, especially in the ankles (edema),
• increase or decrease in some liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

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

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

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 difficulty breathing.

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

• allergic reactions, including inflammation of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing (requiring immediate medical treatment),
• red skin rash, and sometimes in a target shape,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions, including the appearance of skin rash and hives,
• tendon injury,
• 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; nosebleeds,
• neck pain; 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 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).

Adverse 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 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, especially if it occurs at the same time as a feeling of discomfort or high temperature, which may not disappear after stopping treatment with ezetimibe/atorvastatin (unknown frequency).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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 Ezetimibe/Atorvastatin Krka

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

Do not use this medicine after the expiration date that appears on the box and blister pack, after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatin Krka

• The active ingredients 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 ingredients are calcium carbonate, hydroxypropylcellulose, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate, povidone, mannitol, sodium 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 "Ezetimibe/Atorvastatin Krka contains lactose and sodium".

Appearance of the Product and Package Contents

Ezetimibe/Atorvastatin 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.

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

Ezetimibe/Atorvastatin 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.

Ezetimibe/Atorvastatin 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.

Ezetimibe/Atorvastatin Krka is available in blister packs containing 10, 20, 30, 60, 90, or 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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

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

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

Date of the Last Revision of this Leaflet:October 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/).