Rosuvastatin/ezetimibe Teva 10 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatin/Ezetimibe Teva 5 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Teva 10 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Teva 20 mg/10 mg film-coated tablets

Read the 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rosuvastatin/Ezetimibe Teva is and what it is used for
2. What you need to know before taking Rosuvastatin/Ezetimibe Teva
3. How to take Rosuvastatin/Ezetimibe Teva
4. Possible side effects
5. How to store Rosuvastatin/Ezetimibe Teva
6. Contents of the pack and other information

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

Rosuvastatina/Ezetimiba Teva contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Rosuvastatina/Ezetimiba Teva is a medicine used in adult patients to reduce elevated levels of cholesterol, specifically "bad" cholesterol (LDL cholesterol), and certain fat substances called triglycerides circulating in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol). This medicine works by lowering cholesterol in two ways: it reduces cholesterol absorbed from the gastrointestinal tract as well as cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up 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 could lead to a heart attack or stroke. By lowering cholesterol levels, your 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 with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Your doctor may prescribe Rosuvastatina/Ezetimiba Teva if you are already taking rosuvastatin and ezetimibe at the same dose levels.

Rosuvastatina/ezetimiba is used if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease; this medicine reduces the risk of myocardial infarction, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you lose weight.

2. What you need to know before taking 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 pain and cramps (myopathy),
• you are taking a medicine called cyclosporine (used, for example, after organ transplantation),
• 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 by using an appropriate contraceptive method (see section Pregnancy and breastfeeding).
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking this medicine or other medicines containing rosuvastatin.
• you are taking the combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat the viral liver infection called hepatitis C).

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

Warnings and precautions

Talk to 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 pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness in the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to 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 medicines called fibrates to lower cholesterol; see “Other medicines and Rosuvastatin/Ezetimibe Teva”,
• you are scheduled for surgery. You may need to stop taking Rosuvastatin/Ezetimibe Teva temporarily,
• you regularly consume large amounts of alcohol,
• your thyroid gland is not functioning properly (hypothyroidism),
• you are over 70 years of age (as your doctor must select the appropriate dose of rosuvastatin/ezetimibe for you),
• you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) taken orally or by injection. The combination of fusidic acid and rosuvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis),
• you are taking regorafenib (a medicine used to treat cancer).

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

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will regularly perform blood tests (liver function tests) during treatment with this medicine. It is important that you attend your scheduled appointments 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 may 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 immediate medical attention 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 Rosuvastatin/Ezetimibe Teva

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

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

• Cyclosporine (used, for example, after organ transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take Rosuvastatin/Ezetimibe Teva if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocumarol, or fluindione (their anticoagulant effects and risk of bleeding may increase when taken with 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).
• Colestipol (a medicine 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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Treatments for indigestion containing aluminium and magnesium (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin/ezetimibe. Taking this medicine with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• An oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

If you are admitted to hospital or receiving 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 plan to become pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must use effective contraception 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 using machines

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

Rosuvastatin/Ezetimibe Teva contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain 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 instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

You must continue to maintain a cholesterol-lowering diet and exercise while taking Rosuvastatin/Ezetimibe Teva.

The recommended dose for adults is one tablet daily.

You may take it at any time of day, with or without food. Swallow each tablet whole with water.

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

This medicine is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be performed using the active substances separately. Once the appropriate doses have been established, you may then switch to the appropriate dose of rosuvastatin/ezetimibe.

If your doctor has prescribed rosuvastatin/ezetimibe together with another cholesterol-lowering medicine containing the active ingredient colestyramine or any other medicine containing a bile acid sequestrant, you must take rosuvastatin/ezetimibe at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol level monitoring

It is important that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and remain at appropriate levels.

If you take more Rosuvastatin/Ezetimibe Teva than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rosuvastatin/Ezetimibe Teva

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

If you stop taking Rosuvastatin/Ezetimibe Teva

Consult your doctor if you wish to discontinue treatment with this medicine. Your cholesterol levels may rise again if you stop taking this medicine.

If you have any further questions about 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 everyone will experience them. It is important that you are aware of what these adverse effects may 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 lasting longer than expected. This is because muscle problems, including destruction of muscle fibres that can damage the kidneys, may be serious and could lead to a potentially life-threatening condition (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people);
• severe allergic reactions (angioedema), signs of which include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and intense itching of the skin (with lumps). This is rare (may affect up to 1 in 1,000 people);
• if you develop a lupus-like syndrome (including 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-elevated, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency is unknown (cannot be estimated from available data);
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency 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 levels of blood sugar and lipids, overweight and high blood pressure. Your doctor will monitor you while you are taking this medicine;
• stomach pain;
• diarrhoea;
• flatulence (excess gas in the gastrointestinal tract);
• feeling tired;
• elevated levels in certain blood test results for liver function (transaminases).

Uncommon adverse effects (may affect up to 1 in 100 people)

• skin rash, itching, urticaria;
• elevated levels in certain blood test results for muscle function (Creatine Kinase test);
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure;
• tingling sensation;
• dry mouth;
• stomach inflammation;
• back pain;
• muscle weakness;
• pain in arms and legs;
• swelling, especially of the hands and feet;
• increased amount of protein in the urine – this usually returns to normal on its own without needing to stop taking this medicine (only observed in the 10/10 mg and 20/10 mg strengths).

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

• inflammation of the pancreas, causing severe stomach pain that may spread to the back;
• decreased number of platelets in the blood, which may 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);
• inflammation of the liver (hepatitis);
• traces of blood in the urine;
• nerve damage in arms and legs (such as numbness);
• memory loss;
• enlargement of the breasts in men (gynaecomastia).

Frequency not known (cannot be estimated from available data)

• difficulty breathing;
• oedema (swelling);
• sleep disturbances, including insomnia and nightmares;
• sexual dysfunction;
• depression;
• respiratory problems including persistent cough and/or difficulty breathing or fever;
• tendon injuries;
• persistent muscle weakness;
• urticaria and target-shaped skin lesions (erythema multiforme);
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);
• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects muscles used for breathing), ocular myasthenia (a disease causing weakness of the eye muscles). Consult your doctor if you experience arm or leg weakness 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe Teva

• The active substances 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 components are:

Tablet core

Monohydrate lactose (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, colloidal anhydrous 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 contents of the pack

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

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

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

OPA/Al/PVC//Al blisters.

Pack sizes of 10, 28, 30, 60, and 90 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5, Haarlem, 2031 GA,

The Netherlands

Manufacturer:

ELPEN Pharmaceutical Co. Inc.

95 Marathonos Ave.,

19009, Pikermi Attica,

Greece

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

28108 Alcobendas (Madrid)

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Czech Republic: Rosuvastatin/Ezetimibe Teva CR

Spain: Rosuvastatina/Ezetimiba Teva 5 mg / 10 mg comprimidos recubiertos con película

Rosuvastatina/Ezetimiba Teva 10 mg / 10 mg comprimidos recubiertos con película

Rosuvastatina/Ezetimiba Teva 20 mg / 10 mg comprimidos recubiertos con película

Date of the most recent review of this leaflet: November 2021.

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