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

2. What you need to know before you take 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 must avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains or cramps.
• If you are taking a combination of medicines such as sofosbuvir/velpatasvir/voxilaprevir (used for hepatitis C virus infection).
• If you are taking a medicine called ciclosporin (used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking this medicine or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Rosuvastatin/Ezetimibe Krka:

Severe 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 medical attention immediately if you notice any of the symptoms described in section 4.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, 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 normally perform blood tests (liver function tests) before and during treatment with this medicine.

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 take any other medicines.

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

• Ciclosporin (used, for example, after an organ transplant).
• Anticoagulants, e.g., warfarin, acenocoumarol, or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (such as gemfibrozil, fenofibrate). Treatments for indigestion that contain aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in the blood).
• Erythromycin (an antibiotic).
• An oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood)
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• 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.
• Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Fusidic acid. If you have to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely take this medicine again. Taking this medicine with fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.

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

Taking Rosuvastatin/Ezetimibe Krka with food and drinks

You can take this medicine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not takethis medicineif you are pregnant, think you may be pregnant, or are planning to have a baby.If you become pregnant while taking this medicine, stop taking it immediatelyand inform your doctor. Women must use contraceptive methods during treatment with this medicine.

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

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 use machines.

Rosuvastatin/Ezetimibe Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some 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 Rosuvastatin/Ezetimibe Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• Before starting to take this medicine, you should start a low-cholesterol diet and start treatment with rosuvastatin and ezetimibe at the same dose level. This medicine is not suitable for starting treatment.

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

The recommended dose for adults is one tablet per day. You can 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.

If your doctor has prescribed rosuvastatin/ezetimibe with another cholesterol-lowering medicine that contains the active substance colestyramine or any other medicine that contains a bile acid sequestrant, you should take rosuvastatin/ezetimibe at least 2 hours before or 4 hours after these medicines.

Regular checks of cholesterol levels

It is important that you regularly visit your doctor to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

Use in children and adolescents

This medicine must not be used in children and adolescents.

If you take more Rosuvastatin/Ezetimibe Krka than you should

Contact your doctor or the nearest hospital emergency department immediately, as you may need medical attention.

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 Rosuvastatin/Ezetimibe Krka

Do not worry, skip the missed dose and take the next scheduled dose at the scheduled time. Do not take a double dose to make up for missed doses.

If you stop taking Rosuvastatin/Ezetimibe Krka

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

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.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop taking Rosuvastatin/Ezetimibe Krka and seek immediate medical attention if you experience any of the following adverse effects:

• Any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including muscle fiber destruction that damages the kidneys, can be severe and potentially lead to a life-threatening disorder (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 hives). This is rare (may affect up to 1 in 1,000 people).
• Lupus-like syndrome (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 muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• Red, non-raised, target-like, or circular patches on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this is unknown (cannot be estimated from available data).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this is unknown (cannot be estimated from available data).

Other Adverse Effects

Frequent 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 blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• High levels in some blood test results 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 disorders
• An increase in the amount of protein in the urine, which usually normalizes without the need to interrupt treatment with rosuvastatin/ezetimibe. Tingling sensation
• Dry mouth
• Hives
• Back pain
• Muscle weakness, pain in the arms and legs
• Swelling, especially of the hands and feet
• High levels in some blood test results of muscle function (Creatine Kinase test)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle spasms
• Neck pain
• Decreased appetite
• Pain
• Chest pain
• Hot flashes
• High blood pressure

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Severe stomach pain (pancreatitis)
• Decreased number of cells in the blood, which can 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)
• Traces of blood in the urine
• Nerve damage in the legs and arms (such as numbness)
• Memory loss
• Enlargement of the breasts in men (gynecomastia)

Unknown Frequency (cannot be estimated from available data)

• Sleep disorders, including insomnia and nightmares
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Tendon injuries
• Constant muscle weakness
• Liver disorders
• Hives and target-like lesions (erythema multiforme)
• Muscle sensitivity
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting)
• 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.

Reporting Adverse Effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear 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 Rosuvastatin/Ezetimibe Krka

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

Do not use this medicine after the expiration date stated on the carton or blister 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 medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE 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 Rosuvastatin/Ezetimibe Krka

• The active ingredients 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.

• The other ingredients are:

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

Tablet coating:lactose monohydrate, 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 "Rosuvastatin/Ezetimibe Krka contains lactose and sodium".

Appearance of the Product and Package Contents

Rosuvastatin/Ezetimibe 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.

Rosuvastatin/Ezetimibe 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.

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

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

Date of the Last Revision of thisLeaflet: May 2023

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