Rosuvastatin/ezetimibe Krka 20 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatin/Ezetimibe Krka 10 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Krka 20 mg/10 mg film-coated tablets

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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.

Leaflet contents

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

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

Rosuvastatin/Ezetimibe Krka contains two different active substances. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Rosuvastatin/ezetimibe is a medicine used in adult patients to reduce elevated levels of cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol). HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from depositing in the arteries and protects against heart attack.

This medicine works by reducing cholesterol in two ways: it reduces cholesterol absorbed from the digestive tract as well as cholesterol produced by the body itself.

This medicine 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.

Your doctor may prescribe this medicine if you are already taking rosuvastatin and ezetimibe at the same dose levels.

If you have heart disease, this medicine reduces the risk of myocardial infarction, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you lose weight.

You should continue taking this medicine even after your cholesterol levels have reached the desired levels, as it prevents cholesterol levels from rising again and from causing fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatin/Ezetimibe Krka

Do not take Rosuvastatin/Ezetimibe Krka

• If you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medicine by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain and cramps.
• If you are taking a combination of medicines such as sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you are in any of the situations mentioned above (or if you are unsure), please consult your doctor again.

Additionally, do not take rosuvastatin/ezetimibe 40 mg/10 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.

If you are in any of the situations mentioned above (or if you are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin/Ezetimibe Krka:

• if you have kidney problems,
• if you have liver problems,
• if you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• if you regularly consume large amounts of alcohol,
• if your thyroid gland is not functioning properly,
• if you are taking other medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have previously taken other cholesterol-lowering medicines,
• if you are taking medicines to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir. Please see “Other medicines and Rosuvastatin/Ezetimibe Krka”,
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) by oral or injectable route. The combination of fusidic acid and rosuvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis),
• if you are over 70 years old (as your doctor must choose the appropriate dose of rosuvastatin/ezetimibe for you),
• if you have severe respiratory failure,
• if you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate dose for you,
• if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking rosuvastatin/ezetimibe or other medicines containing rosuvastatin,
• if you have or have had myasthenia (a disease characterized by 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).

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased liver enzyme levels. For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with this medicine.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin/ezetimibe treatment. Stop using this medicine and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood such as phenprocoumon, acenocoumarol, or fluindione),
• fibrates (such as gemfibrozil, fenofibrate), or medicines used to lower cholesterol (such as ezetimibe),
• indigestion treatments containing aluminium and magnesium (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• an oral contraceptive (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in blood),
• leflunomide (used to treat rheumatoid arthritis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• roxadustat (used to treat anaemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works,
• momelotinib (used to treat myelofibrosis in adults with anaemia),
• fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to resume taking this medicine. Taking this medicine together with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

If you go to hospital or receive treatment for another illness, tell the medical staff that you are taking this medicine.

Taking Rosuvastatin/Ezetimibe Krka with food and drink

You may take this medicine with or without food.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or think you might be pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant by using contraception during treatment with this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, some people may feel dizzy after taking this medicine. If you feel dizzy, do not drive or operate machinery.

Rosuvastatin/Ezetimibe Krka contains lactose and sodium

This medicine contains lactose. 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 tablet; this is essentially "sodium-free".

3. How to take Rosuvastatina/Ezetimiba Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Before starting to take this medicine, you must begin a cholesterol-lowering diet and initiate treatment with rosuvastatin and ezetimiba at the same dose level. This medicine is not suitable for initiating treatment.

• You must continue to follow a low-cholesterol diet while taking this medicine.

The recommended dose for adults is one tablet daily. You may take it at any time of day, with or without food. Swallow each tablet whole with water. Take the tablets every day at the same time.

Use in children and adolescents

This medicine must not be used in children and adolescents.

Regular cholesterol level checks

It is important that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and remain at appropriate levels.

If you take more Rosuvastatina/Ezetimiba Krka than you should

Contact your doctor or the nearest hospital emergency department, as you may require medical assistance.

In case of overdose or accidental ingestion, consult 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 Rosuvastatina/Ezetimiba Krka

Do not worry. Miss the forgotten dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatina/Ezetimiba Krka

Consult your doctor if you wish to stop treatment with this medicine. Your cholesterol levels may rise again if you stop taking this medicine.

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.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Rosuvastatin/Ezetimibe Krka and seek immediate medical attention if:

You experience any of the following adverse effects:

• Difficulty breathing, with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing.
• Severe skin itching (with raised bumps).
• Or if you experience any of the following:
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Red, non-elevated spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin/ezetimibe and consult your doctor immediately if you experience unusual muscle discomfort or pain that lasts longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, and in rare cases these have led to a potentially life-threatening muscle injury known as rhabdomyolysis.

Other adverse effects

Common adverse effects (may affect up to 1 in 10 people)

• Headache
• Stomach pain
• Constipation
• General malaise
• Muscle pain
• Weakness
• Dizziness
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Elevated levels in certain blood tests of liver function (transaminases)
• Muscle sensitivity or weakness
• Diarrhea
• Flatulence
• Feeling tired

Uncommon adverse effects (may affect up to 1 in 100 people)

• Skin rash, itching, or other skin disturbances
• Increased levels of protein in the urine, which usually normalizes without the need to discontinue treatment with rosuvastatin/ezetimibe
• Tingling sensation
• Dry mouth
• Urticaria (hives)
• Back pain
• Muscle weakness, pain in arms and legs
• Swelling, especially of the hands and feet
• Elevated levels in certain blood tests of muscle function (Creatine Kinase test)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle spasms
• Neck pain
• Loss of appetite
• Pain
• Chest pain
• Hot flushes
• High blood pressure

Rare adverse effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction: signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, intense skin itching (with raised bumps). If you think you are experiencing an allergic reaction, stop taking Rosuvastatin/Ezetimibe Krka and seek medical help immediately.
• Muscle damage in adults: as a precaution, stop taking Rosuvastatin/Ezetimibe Krka and consult your doctor immediately if you experience unusual muscle discomfort or pain that lasts longer than expected.
• Severe stomach pain (inflammation of the pancreas)
• Decrease in blood cells, which may cause bruising or bleeding (thrombocytopenia)

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflammation of the liver)
• Blood traces in urine
• Nerve damage in arms and legs (such as numbness)
• Memory loss
• Breast enlargement in men (gynecomastia)

Frequency not known (cannot be estimated from available data)

• Sleep disturbances, including insomnia and nightmares
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Tendon injuries
• Persistent muscle weakness
• Liver disorders
• Urticaria and target-shaped skin lesions (erythema multiforme)
• Muscle sensitivity
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).
• Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rosuvastatin/Ezetimibe Krka Storage Instructions

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

No special storage temperature requirements apply to this medicine.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe Krka

• The active substances are rosuvastatin and ezetimibe.

Rosuvastatin/Ezetimibe Krka 10 mg/10 mg: Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Krka 20 mg/10 mg: Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

• Other components are:

Tablet core: microcrystalline cellulose, lactose, mannitol (E421), crospovidone, sodium croscarmellose, magnesium stearate, povidone, sodium lauryl sulfate, and colloidal anhydrous silica.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172) – only for the 10 mg/10 mg dose, and iron oxide red (E172) – only for the 20 mg/10 mg dose.

See section 2 “Rosuvastatin/Ezetimibe Krka contains lactose and sodium”.

Nature of the product and contents of the pack

Rosuvastatin/Ezetimibe Krka 10 mg/10 mg: Film-coated tablets, pale yellowish-brown to pale brownish-yellow in colour, round, slightly biconvex with bevelled edges, marked with the inscription “R2” on one side. Approximate diameter of 10 mm.

Rosuvastatin/Ezetimibe Krka 20 mg/10 mg: Film-coated tablets, pale pink in colour, round, slightly biconvex with bevelled edges, marked with the inscription “R4” on one side. Approximate diameter of 10 mm.

Rosuvastatin/Ezetimibe Krka is available in blister packs containing 30 film-coated tablets, in a box.

Marketing Authorisation Holder and Manufacturer

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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

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

Date of the latest revision of this leaflet: September 2025

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