ROSUVASTATIN/EZETIMIBE SANDOZ 40 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatin/Ezetimibe Sandoz

Do not take Rosuvastatin/Ezetimibe Sandozif:

• you are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated or unexplained muscle pains or strains (myopathy),
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat viral hepatitis C infection),
• you are taking a medicine called ciclosporin (used, for example, after an organ transplant),
• you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin/ezetimibe, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method.

Also, 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 does not work properly (hypothyroidism).
• If you have had repeated or unexplained muscle pains or strains, 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 drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other cholesterol-lowering medicines called fibrates (see section "Other medicines and Rosuvastatin/Ezetimibe Sandoz").

If you are 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 Rosuvastatin/Ezetimibe Sandoz if:

• you have kidney problems,
• you have liver problems,
• you have had repeated or unexplained muscle pains or strains, 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 have unexplained muscle pain, tenderness or weakness, especially if you also have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness,
• you have or have had myasthenia (a disease characterized by general muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4),
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the appropriate dose for you,
• you are taking medicines 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 medicines and Rosuvastatin/Ezetimibe Sandoz",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates (see "Other medicines and Rosuvastatin/Ezetimibe Sandoz"),
• you are going to have surgery. You may need to stop taking rosuvastatin/ezetimibe for a short time,
• you regularly drink large amounts of alcohol,
• you have hypothyroidism, i.e., your thyroid gland has lower than normal activity,
• you are over 70 years old (as your doctor should choose the appropriate dose of rosuvastatin/ezetimibe for you),
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and rosuvastatin/ezetimibe can cause serious muscle problems (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4,
• you are taking regorafenib (a medicine used to treat cancer),
• you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rosuvastatin/ezetimibe or other medicines containing rosuvastatin.

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

In a small number of people, statins can affect the liver. This is detected by a simple test that checks for increased levels of liver enzymes in the blood. For this reason, your doctor will perform regular blood tests (liver function tests) during treatment with this medicine. It is important that you go to the doctor for these tests.

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 fats 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 in association with rosuvastatin treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms described in section 4.

Children and adolescents

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

Other medicines and Rosuvastatin/Ezetimibe Sandoz

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 to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with concomitant use with ciclosporin). Do not take rosuvastatin/ezetimibe if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). During concomitant use, the effect of rosuvastatin increases. Do not take rosuvastatin/ezetimibe 40 mg/10 mg in combination with a fibrate.
• Colestiramine (a medicine also used to lower cholesterol), as it affects how ezetimibe works.
• 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Treatments for indigestion that contain aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in the blood). This effect can be mitigated by taking these types of medicines 2 hours after rosuvastatin/ezetimibe.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with concomitant use.
• Fusidic acid. If you need 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 start taking rosuvastatin/ezetimibe again. Concomitant use of this medicine and fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• An oral contraceptive (the pill). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased levels of hormones in the blood).

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

Taking Rosuvastatin/Ezetimibe Sandoz with alcohol

Do not take rosuvastatin/ezetimibe 40 mg/10 mg (the highest dose) if you regularly drink large amounts of alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 take rosuvastatin/ezetimibe if 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 immediately and inform your doctor. Women must use contraceptive methods during treatment with this medicine.

Do not take rosuvastatin/ezetimibe if you are breast-feeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

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

Rosuvastatin/Ezetimibe Sandoz contains lactose and sodium

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 film-coated tablet; this is essentially "sodium-free".

3. How to take Rosuvastatin/Ezetimibe Sandoz

Follow exactly the instructions of administration of this medicine given 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 rosuvastatin/ezetimibe.

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.

Try to take the tablet at the same time each day, this will help you remember it.

This medicine is not suitable for starting treatment. The start of treatment or dose adjustment, if necessary, should only be done by taking the active substances separately, and once the appropriate doses have been adjusted, it is possible to switch to the appropriate dose of rosuvastatin/ezetimibe.

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

Regular checks of cholesterol levels

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

If you take more Rosuvastatin/Ezetimibe Sandoz 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 Sandoz

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

If you stop taking Rosuvastatin/Ezetimibe Sandoz

Consult your doctor if you want to stop taking this medicine. Your cholesterol levels may increase 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 are aware of what these adverse effects may be.

Stop taking rosuvastatin/ezetimibe 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 fiber destruction that damages the kidneys, can be severe and may lead to a potentially life-threatening disorder (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 itching of the skin (with hives). This is rare (may affect up to 1 in 1,000 people),
• severe skin reactions, including reddish patches on the torso, target-shaped or circular, 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 or erythema multiforme [potentially life-threatening adverse reactions that affect the skin and mucous membranes]). The frequency of this is unknown (cannot be estimated from available data),
• widespread rash, high body temperature, and swelling of the lymph nodes (DRESS or drug hypersensitivity syndrome),
• lupus-like syndrome (including rash, joint disorder, and effects on blood cells),
• muscle rupture.

Other known adverse effects

Frequent (may affect up to 1 in 10 people)

• headache
• constipation
• general malaise
• muscle pain
• feeling weak
• 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
• 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 in the urine, which usually reverses on its own without the need to interrupt treatment with rosuvastatin/ezetimibe (only for rosuvastatin doses of 40 mg).

Infrequent (may affect up to 1 in 100 people)

• skin rash, itching, hives, 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
• decreased appetite
• pain
• chest pain
• hot flashes
• 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 in the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin/ezetimibe (only for rosuvastatin doses of 10 mg and 20 mg).

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

• pancreatitis, which causes severe stomach pain that can spread to the back
• reduction of platelet levels in the blood, which can cause bruising/bleeding (thrombocytopenia)
• lupus-like syndrome (including 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)
• 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)

Frequency not known (cannot be estimated from available data)

• difficulty breathing
• edema (swelling)
• sleep disturbances, including insomnia and nightmares
• sexual dysfunction
• depression
• respiratory problems, including persistent cough and/or difficulty breathing or fever
• tendon injuries
• constant muscle weakness
• red, elevated, target-shaped rashes (erythema multiforme)
• muscle sensitivity
• gallstones or gallbladder inflammation (which can cause stomach pain, nausea, vomiting)
• severe myasthenia (a disease that causes generalized muscle weakness that, 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 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 Rosuvastatin/Ezetimibe Sandoz

This medicine does not require any special storage temperature.Store in the original packaging to protect it from light and moisture.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofRosuvastatin/Ezetimibe Sandoz

• The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 10 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 20 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 40 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.

• The other ingredients are:

Tablet core

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

Tablet coating

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg: Opadry Yellow 02F220026, which consists of: hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), macrogol 4000 (E1521).

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

Rosuvastatin/Ezetimibe Sandoz 20 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).

Rosuvastatin/Ezetimibe Sandoz 40 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 package contents

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg

Light yellow, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 5" marked on one side.

Rosuvastatin/Ezetimibe Sandoz 10 mg/10 mg

Beige, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 4" marked on one side.

Rosuvastatin/Ezetimibe Sandoz 20 mg/10 mg

Yellow, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 3" marked on one side.

Rosuvastatin/Ezetimibe Sandoz 40 mg/10 mg

White, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 2" marked on one side.

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

OPA/Al/PVC//Al unit dose blisters containing 30 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Elpen Pharmaceutical Co Inc

Marathonos Ave. 95

Pikermi Attiki, 19009

Greece

Date of the last revision of this leaflet:October 2022

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/).