ROSUVASTATIN/EZETIMIBE TEVA 5 mg/10 mg FILM-COATED TABLETS

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

Do not take Rosuvastatin/Ezetimibe 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 pains or 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 Rosuvastatin/Ezetimibe Teva, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method (see section Pregnancy and breastfeeding).
• 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 medicines containing rosuvastatin.
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used for hepatitis C virus infection).

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 starting to take Rosuvastatin/Ezetimibe Teva if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pains or cramps, 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 or cramp, especially if you also feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness,
• you have or have had myasthenia (a disease that causes general muscle weakness, which 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 (e.g., 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 (AIDS virus) or hepatitis C, such as lopinavir/ritonavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See "Other medicines and Rosuvastatin/Ezetimibe Teva",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and Rosuvastatin/Ezetimibe Teva",
• you are going to have surgery. You may need to stop taking Rosuvastatin/Ezetimibe Teva for a short time
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• 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). The combination of fusidic acid and rosuvastatin/ezetimibe can cause serious muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medicine to treat cancer)

If you are in any of the above situations (or if you 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 blood test that checks for increased levels of liver enzymes in the blood. For this reason, your doctor will regularly perform blood tests (liver function tests) during treatment with this medicine. It is important that you go to the doctor to have these tests done.

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 taking this medicine and seek medical attention immediately if you notice any of the symptoms described in section 4.

Children and adolescents

The use of this medicine is not suitable for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Inform 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 its combined use). Do not take Rosuvastatin/Ezetimibe 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), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates).
• Colestyramine (a medicine to lower cholesterol), because it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (indicated for the treatment of 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.
• Treatments for indigestion that contain aluminum and magnesium (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Fusidic acid. If you have to take oral fusidic acid 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 rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• An oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels 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.

Pregnancy and breastfeeding

Do not take rosuvastatin/ezetimibe if you are pregnant, think you may be pregnant, or are planning to become pregnant. 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 rosuvastatin/ezetimibe if you are breastfeeding, 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, some people may feel dizzy after taking this medicine. If you feel dizzy, do not drive or use machines.

Rosuvastatin/Ezetimibe Teva contains lactose

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.

Rosuvastatin/Ezetimibe Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Rosuvastatin/Ezetimibe Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You should continue to follow a cholesterol-lowering diet while taking Rosuvastatin/Ezetimibe Teva.

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.

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

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

If your doctor has prescribed rosuvastatina/ezetimiba along 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 taking the bile acid sequestrant.

Regular checks of cholesterol levels

It is important that you go to your doctor regularly 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 Teva than you should

Contact your doctor or the nearest hospital emergency department immediately because 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 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 make up for missed doses.

If you stop taking Rosuvastatin/Ezetimibe Teva

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 know what these adverse effects can be.

Stop taking Rosuvastatin/Ezetimibe Teva 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 the destruction of muscle fibers that damage the kidneys, can be severe and could lead to a potentially life-threatening disorder (rhabdomyolysis). This is rare (may affect up to 1 in 1000 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 1000 people);
• if you have a syndrome similar to lupus (which includes skin rash, joint disorders, and effects on blood cells). This is rare (may affect up to 1 in 1000 people).
• if you experience muscle rupture. This is rare (may affect up to 1 in 1000 people).
• red, non-raised patches, target-shaped or circular on the torso, often with central blisters, skin peeling, mouth, throat, nose, genitals, and eye ulcers. 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 skin rash, high body temperature, and swelling of 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;
• constipation;
• general discomfort;
• 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;
• stomach pain;
• diarrhea;
• flatulence (excess gas in the intestinal tract);
• feeling tired;
• high levels in some blood test results of liver function (transaminases).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• skin rash, itching, hives;
• 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;
• tingling sensation;
• dry mouth;
• stomach inflammation;
• 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 Adverse Effects (may affect up to 1 in 1000 people)

• pancreatitis, which causes severe stomach pain that can spread to the back
• decrease in the number of platelets 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);
• 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;
• hives and target-shaped lesions (erythema multiforme).
• gallstones or gallbladder inflammation (which can cause abdominal 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 the 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 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 Teva

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

Do not use this medicine after the expiration date that appears on the packaging or on the blister after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, 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 Teva

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

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

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

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

• Other ingredients are:

Tablet core

Lactose monohydrate (see section 2 "Rosuvastatin/Ezetimibe Teva contains lactose"), sodium croscarmellose, sodium lauryl sulfate (see section 2 "Rosuvastatin/Ezetimibe Teva contains sodium"), povidone K29/32, microcrystalline cellulose 102, hypromellose 2910, anhydrous colloidal silica, magnesium stearate

Tablet coating

Rosuvastatin/Ezetimibe Teva 5 mg/10 mg:

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

Rosuvastatin/Ezetimibe Teva 10 mg/10 mg:

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

Rosuvastatin/Ezetimibe Teva 20 mg/10 mg:

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

Appearance of the Product and Package Contents

Rosuvastatin/Ezetimibe Teva 5 mg/10 mg film-coated tablets Film-coated, biconvex, round, light yellow in color, with a diameter of approximately 10 mm and with the inscription "EL 5" on one side.

Rosuvastatin/Ezetimibe Teva 10 mg/10 mg film-coated tablets Film-coated, biconvex, round, beige in color, with a diameter of approximately 10 mm and with the inscription "EL 4" on one side.

Rosuvastatin/Ezetimibe Teva 20 mg/10 mg film-coated tablets Film-coated, biconvex, round, yellow in color, with a diameter of approximately 10 mm and with the inscription "EL 3" on one side.

OPA/Al/PVC//Al blisters.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5. Haarlem, 2031 GA,

Netherlands

Manufacturer

ELPEN Pharmaceutical Co. Inc.

95 Marathonos Ave.,

19009, Pikermi Attica,

Greece

You can request more information about this medicine by contacting 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

This medicine is authorized in the Member States of the European Economic Area with the following names:

Czech Republic: 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

Date of the Last Revision of this Leaflet:November 2021.

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/)