Package Leaflet: Information for the User

Rosuvastatina/Ezetimiba Krka 10 mg/10 mg Film-Coated Tablets

Rosuvastatina/Ezetimiba Krka 20 mg/10 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Rosuvastatina/Ezetimiba Krka contains two different active principles. One of the active principles is rosuvastatina, which belongs to the group of medicines called statins, the other active principle is ezetimiba.

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

This medicine acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract as well as the cholesterol produced by the body itself.

This medicine is used in patients who cannot control their cholesterol levels solely with a diet. While taking this medicine, you must follow a cholesterol-reducing diet.

Your doctor may prescribe this medicine if you are already taking rosuvastatina and ezetimiba at the same dosage level.

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

This medicine does not help you lose weight.

You must continue taking this medicine, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from increasing and causing the formation of fatty deposits. However, you should interrupt treatment if your doctor instructs you to do so or if you become pregnant.

Do not take Rosuvastatina/Ezetimiba Krka

• If you are allergic to rosuvastatina, ezetimiba, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unjustified muscle pain and cramps.
• If you are taking a combination of medications such as sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called ciclosporina (used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking this medication or other related medications.

If you find yourself in any of the above situations (or are unsure), consult your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina/Ezetimiba Krka:

• If you have kidney problems,
• If you have liver problems,
• If you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other medications to lower cholesterol levels. Inform your doctor immediately if you experience unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you experience constant muscle weakness,
• If you regularly consume large amounts of alcohol,
• If your thyroid gland does not function correctly,
• If you take other medications called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have taken other cholesterol-lowering medications before,
• If you are taking medications to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir. Please see “Other Medications and Rosuvastatina/Ezetimiba Krka”,
• If you are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic medication) orally or injectable. The combination of fusidic acid and rosuvastatina/ezetimiba may cause severe muscle problems (rhabdomyolysis),
• If you are over 70 years old, (since your doctor must choose the appropriate dose of rosuvastatina/ezetimiba for you),
• If you have severe respiratory insufficiency,
• If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the appropriate dose for you,
• 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 myasthenia gravis (a disease that causes eye muscle weakness), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

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

Your doctor will closely monitor you while taking this medication if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and during treatment with this medication.

Children and Adolescents

This medication is not recommended for children and adolescents under 18 years old.

Other Medications and Rosuvastatina/Ezetimiba Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Ciclosporina (used, for example, after an organ transplant).
• Anticoagulants, e.g. warfarin, acenocoumarol, or fluindione (their anticoagulant effect and risk of bleeding may increase if taken with this medication), ticagrelor, or clopidogrel.
• Other medications to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (such as gemfibrozil, fenofibrate). Treatments for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatina in the blood).
• Erythromycin (an antibiotic).
• Oral contraceptive (the pill).
• Hormone replacement therapy (increased hormone levels in the blood)
• Regorafenib (used to treat cancer).
• Darolutamida (used to treat cancer).
• Any of the following medications 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.
• Colestiramina (a medication to lower cholesterol), as it affects how ezetimiba works.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will tell you when you can safely take this medication again. Taking this medication with fusidic acid may occasionally cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.

If you visit a hospital or receive treatment for another condition, inform the medical staff that you are taking this medication.

Taking Rosuvastatina/Ezetimiba Krka with Food and Drinks

You can take this medicationwith or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not takethis medicationif you are pregnant, think you may be pregnant, or intend to become pregnant. If you become pregnant while taking this medication,stop taking it immediatelyand inform your doctor. Women should use contraceptive methods during treatment with this medication.

Do not take this medication if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Driving and Operating Machinery

This medication is not expected to interfere with your ability to drive or operate machinery. However, some people may feel dizzy after taking this medication. If you feel dizzy, do not drive or operate machinery.

Rosuvastatina/Ezetimiba Krka contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult your doctor before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Before starting to take this medication, you must start a diet to reduce your cholesterol levels and start the treatment with rosuvastatina and ezetimiba at the same dose level. This medication is not suitable for initiating treatment.

• You must continue to maintain a low-cholesterol diet while taking this medication.

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

If your doctor has prescribed rosuvastatina/ezetimiba together with another cholesterol-lowering medication that contains the active ingredient colestiramina or any other medication that contains a bile acid sequestrant, you must take rosuvastatina/ezetimiba at least 2 hours before or 4 hours after these medications.

Regular Cholesterol Checks

It is essential that you visit your doctor regularly for cholesterol checks, in order to check that your cholesterol levels have normalized and are maintained at appropriate levels.

Use in Children and Adolescents

This medication should not be used in children and adolescents.

If You Take More Rosuvastatina/Ezetimiba Krka Than You Should

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

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

If You Forget to Take Rosuvastatina/Ezetimiba Krka

Do not worry, omit the missed dose and take the next scheduled dose at the planned time. Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Rosuvastatina/Ezetimiba Krka

Consult your doctor if you want to interrupt treatment with this medication. Your cholesterol levels may increase again if you stop taking this medication.

If you have any other questions 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.

It is important that you know which side effects may occur. Normally, they are mild and disappear in a short period of time.

Stop taking Rosuvastatina/Ezetimiba Krka and seek medical attention immediately if you experience any of the following side effects:

• Any unexplained muscle pain, tenderness or weakness that lasts longer than expected. This is due to muscle problems, including muscle fiber destruction that can damage the kidneys, which can be severe and potentially life-threatening (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people).
• Severe allergic reactions (angioedema) whose signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and intense itching of the skin (with urticaria). This is rare (may affect up to 1 in 1,000 people).
• Syndrome similar to lupus (which includes skin rash, joint disorders, and effects on blood cells). This is rare (may affect up to 1 in 1,000 people).
• If you experience a muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• Flat red spots on the trunk, often with blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this is unknown (cannot be estimated from available data).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this is unknown (cannot be estimated from available data).

Other side effects

Frequent side effects (may affect up to 1 in 10 people)

• Headache
• Stomach pain
• Constipation
• General discomfort
• Muscle pain
• Weakness
• Dizziness
• Diabetes. This is more likely if you have high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor you while taking this medicine.
• High levels in some blood test results for liver function (transaminases)
• Muscle sensitivity or weakness
• Diarrhea
• Flatulence
• Feeling tired

Rare side effects (may affect up to 1 in 100 people)

• Skin rash, itching, or other skin changes
• An increase in the amount of protein in the urine, which usually normalizes without the need to interrupt treatment with rosuvastatina/ezetimiba Sensation of tingling
• Dry mouth
• Urticaria
• Back pain
• Weakness, muscle pain in the arms and legs
• Swelling, especially of the hands and feet
• High levels in some blood test results for muscle function (Creatine Kinase test)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle spasms
• Neck pain
• Loss of appetite
• Pain
• Chest pain
• Hot flashes
• High blood pressure

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

• Severe stomach pain (pancreatitis)
• Decreased number of blood cells, which can cause bruises or bleeding (thrombocytopenia)

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflammation of the liver)
• Traces of blood in the urine
• Nerve damage in the legs and arms (numbness)
• Memory loss
• Enlargement of breast tissue in men (gynecomastia)

Unknown frequency (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 damage
• Constant muscle weakness
• Liver damage
• Urticaria and target lesions (erythema multiforme)
• Muscle sensitivity
• Gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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 medicine.

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 in the blister pack after CAD. The expiration date is the last day of the month indicated.

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

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Rosuvastatina/Ezetimiba Krka Composition

• The active principles are rosuvastatina and ezetimiba.

Rosuvastatina/Ezetimiba Krka 10 mg/10 mg: Each film-coated tablet contains 10 mg of rosuvastatina (as rosuvastatina calcium) and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Krka 20 mg/10 mg: Each film-coated tablet contains 20 mg of rosuvastatina (as rosuvastatina calcium) and 10 mg of ezetimiba.

• The other components are:

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

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

See section 2 “Rosuvastatina/Ezetimiba Krka contains lactose and sodium”.

Appearance of the product and contents of the package

Rosuvastatina/Ezetimiba Krka 10 mg/10 mg: Film-coated tablets, pale yellow-brown to yellow-brown in color, round, slightly biconvex with beveled edges, marked with the inscription “R2” on one face. Approximate diameter of 10 mm.

Rosuvastatina/Ezetimiba Krka 20 mg/10 mg: Film-coated tablets, pale pink in color, round, slightly biconvex with beveled edges, marked with the inscription “R4” on one face. Approximate diameter of 10 mm.

Rosuvastatina/Ezetimiba Krka is available in blisters containing 30 film-coated tablets, in a box.

Marketing authorization holder and responsible 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

Last review date of thisleaflet: May 2023

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)