Leaflet: information for the user

Rosuvastatina/Ezetimiba Teva 5 mg/10 mg film-coated tablets

Rosuvastatina/Ezetimiba Teva 10 mg/10 mg film-coated tablets

Rosuvastatina/Ezetimiba Teva 20 mg/10 mg film-coated tablets

Read this 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; do not give it to others even if they have similar symptoms to 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.

1. What is Rosuvastatina/Ezetimiba Teva and what it is used for

2. What you need to know before starting to take Rosuvastatina/Ezetimiba Teva

3. How to take Rosuvastatina/Ezetimiba Teva

4. Possible side effects

5. Storage of Rosuvastatina/Ezetimiba Teva

6. Contents of the pack and additional information

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

Rosuvastatina/Ezetimiba Teva is a medication 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 medication increases the concentrations of the "good" cholesterol (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, elevated 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 who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet. Your doctor may prescribe Rosuvastatina/Ezetimiba Teva if you are already taking rosuvastatina and ezetimiba at the same dose level.

Rosuvastatina/ezetimiba is used if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease, this medication reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

This medication does not help with weight loss.

Do not take Rosuvastatina/Ezetimiba Teva if

• 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 pain and cramps (myopathy),
• you are taking a medicine called ciclosporin (used for example after an organ transplant),
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina/Ezetimiba Teva, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method (see Pregnancy and breastfeeding).
• you have ever had a severe skin reaction or skin peeling, blisters and/or mouth sores after taking this medicine or other medicines containing rosuvastatin.
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat a viral liver infection called hepatitis C).

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 Teva if:

• you have kidney problems,
• you have liver problems,
• 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 medicines to lower cholesterol. Tell your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness,
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness in the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• 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 are taking medicines to treat infections, including HIV (the virus that causes AIDS) or hepatitis C, such as lopinavir/ritonavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir. See “Other medicines and Rosuvastatina/Ezetimiba Teva”,
• you have severe respiratory failure,
• you are taking other medicines called fibrates to lower cholesterol, see “Other medicines and Rosuvastatina/Ezetimiba Teva”,
• you are going to have an operation. You may need to stop taking Rosuvastatina/Ezetimiba Teva for a short time
• you regularly consume large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• you are over 70 years old, (as your doctor must 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) by mouth or injection. The combination of fusidic acid and rosuvastatin/ezetimibe can cause severe muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medicine to treat cancer)

If you find yourself in any of these situations mentioned above (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 detects increased levels of liver enzymes in the blood. For this reason, your doctor will regularly perform blood tests (liver function test) during treatment with this medicine. It is essential that you go to the doctor for the tests.

While taking this medicine, 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 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 suitable for children and adolescents under 18 years of age.

Other medicines and Rosuvastatina/Ezetimiba Teva

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

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

• Ciclosporin (used for example after an organ transplant to prevent organ rejection. The effect of rosuvastatin is increased with its use together).Do not take Rosuvastatina/Ezetimiba Teva 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 together), ticagrelor or clopidogrel.
• Other medicines to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g. gemfibrozil and other fibrates).
• Colestiramine (a medicine to lower cholesterol), because it affects how ezetimibe works.
• Regorafenib (used to treat cancer).
• Darolutamida (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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Medicines for indigestion containing aluminium and magnesium (used to neutralise stomach acid).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely take rosuvastatin/ezetimibe again. Taking this medicine with fusidic acid can cause rare muscle weakness, pain or tenderness (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

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

Pregnancy and breastfeeding

Do not take rosuvastatin/ezetimibe if you are pregnant, think you may be pregnant or intend to become pregnant. If you become pregnant while taking this medicine,stop taking it immediatelyand tell your doctor. Women should use an appropriate contraceptive method during treatment with this medicine.

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

Driving and operating machinery

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

Rosuvastatina/Ezetimiba Teva contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine.

Rosuvastatina/Ezetimiba Teva contains sodium

This medicine 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. If in doubt, consult your doctor or pharmacist again.

You should continue to maintain a low-cholesterol diet and exercise while taking Rosuvastatina/Ezetimiba Teva.

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.

Try to take the tablets every day at the same time, to help you remember.

This medication is not suitable for starting treatment. The initiation of treatment or dose adjustments, 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 along with another medication to reduce cholesterol that contains the active ingredient cholestyramine or any other medication that contains a bile acid sequestrant, you should take rosuvastatina/ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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 take more Rosuvastatina/Ezetimiba Teva 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 Teva

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 dose.

If you interrupt treatment with Rosuvastatina/Ezetimiba Teva

Consult your doctor if you want to discontinue 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.

Stop taking Rosuvastatina/Ezetimiba Teva and seek medical help immediately if you experience any of the following symptoms:

• any unexplained muscle pain, tenderness or weakness that lasts longer than expected. This is due to muscle problems, including muscle fibre 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 blisters). This is rare (may affect up to 1 in 1,000 people);
• if you have a 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 a muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• flat, red patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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 skin eruption, elevated body temperature, and lymph node enlargement (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;
• constipation;
• general feeling of being unwell;
• muscle pain;
• weakness;
• 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 you are taking this medicine;
• stomach pain;
• diarrhea;
• flatulence (excess gas in the intestinal tract);
• feeling tired;
• high levels in some blood test results for liver function (transaminases).

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

• skin eruption, itching, urticaria;
• 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;
• angina;
• high blood pressure;
• tingling sensation;
• dry mouth;
• inflammation of the stomach;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.
• An increase in the amount of protein in the urine – this usually returns to normal on its own without having to stop taking this medicine (only seen in the 10/10 mg and 20/10 mg presentations)

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

• inflammation of the pancreas, which causes severe stomach pain that can extend to the back
• decrease in the number of platelets in the blood, 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);
• inflammation of the liver (hepatitis);
• 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)

• 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;
• urticaria and target lesions (erythema multiforme).
• 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 your arms or legs that worsens after periods of activity, double vision, 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 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.

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

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rosuvastatina/Ezetimiba Teva

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

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

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

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

• The other components are:

Core of the tablet

Lactose monohydrate (see section 2 “Rosuvastatina/Ezetimiba Teva contains lactose”), croscarmellose sodium, sodium laurilsulfate (see section 2 “Rosuvastatina/Ezetimiba Teva contains sodium”), povidone K29/32, microcrystalline cellulose 102, hypromellose 2910, anhydrous colloidal silica, magnesium stearate

Coating of the tablet

Rosuvastatina/Ezetimiba Teva 5 mg/10 mg:

Hypromellose 2910, titanium dioxide (E171), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), macrogol 4000 (E1521)

Rosuvastatina/Ezetimiba Teva 10 mg/10 mg:

Hypromellose 2910, titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000 (E1521), talc (E553b)

Rosuvastatina/Ezetimiba Teva 20 mg/10 mg:

Hypromellose 6, titanium dioxide (E171), talc (E553b), macrogol 4000 (E1521), yellow iron oxide (E172)

Appearance of the product and contents of the package

Rosuvastatina/Ezetimiba Teva 5 mg/10 mg film-coated tablets Film-coated, biconvex, round, yellowish, with a diameter of approximately 10 mm and with the inscription "EL 5" on one face.

Rosuvastatina/Ezetimiba Teva 10 mg/10 mg film-coated tablets Film-coated, biconvex, round, beige, with a diameter of approximately 10 mm and with the inscription "EL 4" on one face.

Rosuvastatina/Ezetimiba Teva 20 mg/10 mg film-coated tablets Film-coated, biconvex, round, yellow, with a diameter of approximately 10 mm and with the inscription "EL 3" on one face.

OPA/Al/PVC//Al blisters.

Packages of 10, 28, 30, 60, 90 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva B.V.,

Swensweg 5. Haarlem, 2031 GA,

Netherlands

Responsible manufacturer

ELPEN Pharmaceutical Co. Inc.

95 Marathonos Ave.,

19009, Pikermi Attica,

Greece

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

28108 Alcobendas (Madrid)

Spain

Thismedicinal productis authorized in the member states of the European Economic Area with the following names:

Republic of Czechia:Rosuvastatin/Ezetimibe Teva CR

Spain:Rosuvastatina/Ezetimiba Teva 5 mg / 10 mg film-coated tablets

Rosuvastatina/Ezetimiba Teva 10 mg / 10 mg film-coated tablets

Rosuvastatina/Ezetimiba Teva 20 mg / 10 mg film-coated tablets

Last revision date of thisleaflet:November 2021.

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)