Product Information for the Patient

Rosuvastatina/Ezetimiba Sandoz 5 mg/10 mg Film-Coated Tablets

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

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

Rosuvastatina/Ezetimiba Sandoz 40 mg/10 mg Film-Coated Tablets

Read this 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 you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Rosuvastatina/Ezetimiba Sandoz contains two different active principles in one tablet. One of the active principles is rosuvastatina, which belongs to the group of statins, the other active principle is ezetimiba.

Rosuvastatina/Ezetimiba Sandoz is a medication used in adult patients to reduce total cholesterol levels, "bad" cholesterol (LDL cholesterol) and certain fatty substances that circulate in the blood called triglycerides. Additionally, it also increases levels of "good" (HDL cholesterol). This medication 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.

For most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which would cause a heart attack or stroke. By reducing cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

Rosuvastatina/ezetimiba is used in patients whose cholesterol levels cannot be controlled solely with a diet to reduce cholesterol. While taking this medication, you must follow a diet to reduce cholesterol. Your doctor may prescribe Rosuvastatina/Ezetimiba Sandoz if you are already taking rosuvastatina and ezetimiba at the same dose level.

Rosuvastatina/ezetimiba is used if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia).

This medication does not help you lose weight.

Do not take Rosuvastatina/Ezetimiba Sandoz:

• if you are allergic to rosuvastatina, ezetimiba, or any of the other components of this medication (listed in section 6),
• if you have liver disease,
• if you have severe kidney problems,
• if you have repeated or unjustified muscle pain or cramps (myopathy),
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medications 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 are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina/ezetimiba, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method.

Additionally, do not take rosuvastatina/ezetimiba 40 mg/10 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not function correctly (hypothyroidism).
• If you have had repeated or unjustified muscle pain or 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.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibrates to reduce cholesterol (see section “Other medications and Rosuvastatina/Ezetimiba Sandoz”).

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

Warnings and precautions

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

• if you have kidney problems,
• if you have liver problems,
• if you have had repeated or unjustified muscle pain or 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 have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also inform your doctor or pharmacist if you experience constant muscle weakness,
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4),
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the appropriate dose for you,
• if you are taking medications to treat infections, including HIV or hepatitis C, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See “Other medications and Rosuvastatina/Ezetimiba Sandoz”,
• if you have severe respiratory failure,
• if you are taking other medications called fibrates to reduce cholesterol. See “Other medications and Rosuvastatina/Ezetimiba Sandoz”,
• if you are to undergo surgery. You may need to stop taking rosuvastatina/ezetimiba for a short period of time,
• if you regularly consume large amounts of alcohol,
• if you have hypothyroidism, i.e., your thyroid gland has below-normal activity,
• if you are over 70 years old (as your doctor must choose the appropriate dose of rosuvastatina/ezetimiba for you),
• if you are taking or have taken within the last 7 days a medication called fusidic acid (a medication for bacterial infection) by oral or injectable route. The combination of fusidic acid and rosuvastatina/ezetimiba may cause severe muscle problems (rhabdomyolysis),
• if you are taking regorafenib (a medication used to treat cancer),
• if you have ever developed a severe skin rash or skin peeling, blisters, or mouth sores after taking rosuvastatina/ezetimiba or other medications containing rosuvastatina.

If you find yourself in any of the above situations (or are unsure): consult your doctor or pharmacist before starting to take any dose of this medication.

In a reduced number of people, statins can affect the liver. This is detected by a simple test that explores increased levels of liver enzymes in the blood. For this reason, your doctor will perform blood tests (liver function test) regularly during treatment with this medication. It is essential to go to the doctor for the tests.

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

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

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age.

Other medications and Rosuvastatina/Ezetimiba Sandoz

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 to prevent organ rejection. The effect of rosuvastatina increases with its concomitant use with ciclosporina).Do not take rosuvastatina/ezetimiba if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication concomitantly), ticagrelor, or clopidogrel.
• Other medications to reduce cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). During concomitant use, the effect of rosuvastatina increases.Do not take rosuvastatina/ezetimiba 40 mg/10 mg in concomitant use with a fibrate.
• Colestiramina (a medication also used to reduce cholesterol), because it affects how ezetimiba works.
• 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Medications for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatina in plasma). This effect can be mitigated by taking this type of medication 2 hours after rosuvastatina/ezetimiba.
• Eritromicina (an antibiotic). The effect of rosuvastatina decreases with its concomitant use.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily interrupt taking this medication. Your doctor will indicate when you can safely take rosuvastatina/ezetimiba again. The concomitant use of this medication and fusidic acid may rarely cause weakness, pain, or muscle sensitivity (rhabdomyolysis). You can consult more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increase of hormone levels in the blood).

If you visit a hospital or receive treatment for another disease, inform the medical staff that you are taking rosuvastatina/ezetimiba.

Taking Rosuvastatina/Ezetimiba Sandoz with alcohol

Do not take rosuvastatina/ezetimiba 40 mg/10 mg (the highest dose) if you regularly consume large amounts of alcohol.

Pregnancy and breastfeeding

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

Do not take rosuvastatina/ezetimiba if you are pregnant, think you may be pregnant, or intend to become pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medication.

Do not take rosuvastatina/ezetimiba if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and operating machinery

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

Rosuvastatina/Ezetimiba Sandoz contains lactose and sodium

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

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

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

You should continue to maintain a low-cholesterol diet and exercise while taking rosuvastatina/ezetimiba.

The recommended dose in 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 a glass of water.

Make sure to take the tablet at the same time every day, which will help you remember.

This medication is not suitable for starting treatment. The initiation of treatment or dose adjustment, if necessary, should only be done by taking the active ingredients separately, and once the appropriate doses are adjusted, it is possible to switch to the appropriate dose of rosuvastatina/ezetimiba.

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

Regular cholesterol level checks

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

If you takemoreRosuvastatina/Ezetimiba Sandozthan you should

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

In 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 forgot to takeRosuvastatina/Ezetimiba Sandoz

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

If you interrupt treatment withRosuvastatina/Ezetimiba Sandoz

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 essential to be aware of which side effects may occur.

Stop taking rosuvastatina/ezetimiba and seek immediate medical attention if you experience any of the following symptoms:

• any unexplained muscle pain, tenderness or weakness that lasts longer than expected. This is because muscle problems, including muscle fibre destruction that damages the kidneys, can be severe and may lead to a potentially life-threatening condition (rhabdomyolysis) that causes discomfort, fever and kidney failure. This is rare (may affect up to 1 in 1,000 people),
• severe allergic reaction (angioedema) – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and intense skin itching (with blisters). This is rare (may affect up to 1 in 1,000 people),
• severe skin reactions, including flat, red patches on the trunk, often with blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or erythema multiforme [potentially life-threatening reactions affecting the skin and mucous membranes]). The frequency of this is unknown (cannot be estimated from available data),
• generalised rash, elevated body temperature and lymph node enlargement (DRESS syndrome or drug hypersensitivity syndrome),
• condition similar to lupus (includes rash, joint disorder and effects on blood cells),
• muscle rupture.

Other known side effects

Frequent (may affect up to 1 in 10 people)

• headache
• constipation
• general feeling of being unwell
• muscle pain
• feeling weak
• dizziness
• diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight and high blood pressure. Your doctor will monitor you while taking this medicine
• abdominal pain (stomach pain)
• diarrhea
• flatulence (excess gas in the intestinal tract)
• feeling tired
• high levels of certain liver function test results in blood tests (transaminases)
• increased protein levels in urine, which usually returns to normal on its own without the need to stop treatment with rosuvastatina/ezetimiba (only for rosuvastatina doses of 40 mg).

Less frequent (may affect up to 1 in 100 people)

• skin rash, itching, urticaria or other skin reactions
• high levels of certain muscle function test results in blood tests (Creatine Kinase test)
• cough
• indigestion
• heartburn
• joint pain
• muscle spasms
• neck pain
• loss of appetite
• pain
• chest pain
• angina
• high blood pressure
• tingling sensation
• dry mouth
• stomach inflammation
• back pain
• muscle weakness
• pain in the arms and legs
• swelling, especially of the hands and feet
• increased protein levels in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatina/ezetimiba (only for rosuvastatina doses of 10 mg and 20 mg).

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

• pancreatitis, which causes severe stomach pain that may spread to the back
• reduction of platelet levels in blood, which may cause petechiae/bleeding (thrombocytopenia)
• condition similar to lupus (includes rash, joint disorder and effects on blood cells)
• muscle rupture

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

• jaundice (yellowing of the skin and eyes)
• liver inflammation (hepatitis)
• blood in urine
• nerve damage in the legs and arms (such as numbness)
• memory loss
• breast enlargement in men (gynecomastia)

Unknown frequency (cannot be estimated from available data)

• difficulty breathing
• swelling
• 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
• flat, red patches on the skin, sometimes in the shape of a target (erythema multiforme)
• muscle sensitivity
• gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting)
• myasthenia gravis (a disease that causes generalised 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 or eyelid drooping, difficulty swallowing or difficulty breathing.

Reporting of 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 the Vigilance 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.

This medication does not requireany special storage temperature.Store in the original packaging to protect it from light and moisture.

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

Do not use this medication after the expiration date that appears on the blister pack and the carton box after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofRosuvastatina/Ezetimiba Sandoz

• The active ingredients are rosuvastatina (as rosuvastatina calcium) and ezetimiba.

Rosuvastatina/Ezetimiba Sandoz5 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium equivalent to 5 mg of rosuvastatina and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Sandoz10 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium equivalent to 10 mg of rosuvastatina and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Sandoz20 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium equivalent to 20 mg of rosuvastatina and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Sandoz40 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium equivalent to 40 mg of rosuvastatina and 10 mg of ezetimiba.

• The other components are:

Core of the tablet

Lactose monohydrate, sodium croscarmellose (E468), povidone, sodium lauryl sulfate (E487), microcrystalline cellulose 102, hypromellose 2910 (E464), anhydrous colloidal silica, magnesium stearate (E470).

Coating of the tablet

Rosuvastatina/Ezetimiba Sandoz5 mg/10 mg: Opadry Yellow02F220026 which consists of:hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), macrogol 4000 (E1521).

Rosuvastatina/Ezetimiba Sandoz10 mg/10 mg: Opadry Beige 02F270003 which consists of:hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000 (E1521), talc (E553b).

Rosuvastatina/Ezetimiba Sandoz20 mg/10 mg: VIVACOAT PC-2P-308 which consists of: hypromellose 6 (E464), titanium dioxide (E171), talc (E553b), macrogol 4000 (E1521), yellow iron oxide (E172).

Rosuvastatina/Ezetimiba Sandoz40 mg/10 mg: Opadry White OY-L-28900 which consists of:lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), Macrogol 4000 (E1521).

Appearance of the product and contents of the package

Rosuvastatina/Ezetimiba Sandoz5 mg/10 mg

Film-coated tablets of yellowish color, round, biconvex, with an approximate diameter of 10 mm and “EL 5” marked on one face.

Rosuvastatina/Ezetimiba Sandoz10 mg/10 mg

Film-coated tablets of beige color, round, biconvex, with an approximate diameter of 10 mm and “EL 4” marked on one face.

Rosuvastatina/Ezetimiba Sandoz20 mg/10 mg

Film-coated tablets of yellow color, round, biconvex, with an approximate diameter of 10 mm and “EL 3” marked on one face.

Rosuvastatina/Ezetimiba Sandoz40 mg/10 mg

Film-coated tablets of white color, round, biconvex, with an approximate diameter of 10 mm and “EL 2” marked on one face.

PouchesOPA/Al/PVC//Al containing 30 and 90 film-coated tablets.

PouchesOPA/Al/PVC//Al perforated for single-dose containing 30 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Elpen Pharmaceutical Co Inc

Marathonos Ave. 95

Pikermi Attiki,19009

Greece

Last review date of this leaflet:October 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).