ROSUVASTATIN TEVA-RATIOPHARM 20 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Rosuvastatina Teva-ratiopharm 20 mg film-coated tabletsEFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Rosuvastatina Teva-ratiopharm and what is it used for
2. What you need to know before you take Rosuvastatina Teva-ratiopharm
3. How to take Rosuvastatina Teva-ratiopharm
4. Possible side effects
5. Storage of Rosuvastatina Teva-ratiopharm
6. Contents of the pack and other information

1. What is Rosuvastatina Teva-ratiopharm and what is it used for

Rosuvastatina belongs to a group of medicines called statins.

You have been prescribed rosuvastatina because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke.

Rosuvastatina Teva-ratiopharm is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should keep to a cholesterol-lowering diet and exercise while you are taking Rosuvastatina Teva-ratiopharm.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatina Teva-ratiopharm

Rosuvastatina is used to correct the levels of fatty substances in the blood called lipids, the most well-known of which is cholesterol.

There are different types of cholesterol in the blood, "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatina decreases the amount of "bad" cholesterol and increases the "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improving the body's ability to remove it from the blood.

In most people, high cholesterol does not affect how they feel because it does not produce any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You need to keep taking rosuvastatina, even if you have already achieved the correct cholesterol levels, because it prevents your cholesterol levels from rising again and causing the buildup of fatty deposits.However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Rosuvastatina Teva-ratiopharm

Do not take Rosuvastatina Teva-ratiopharm

• If you are allergicto the active substance rosuvastatinaor any of the other ingredients of this medicine (see section 6).
• If you are pregnantor breast-feeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatina Teva-ratiopharm using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C)
• If you are taking a medicine called ciclosporin(used, for example, after an organ transplant).

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

Also, do not takethe highest dose (40 mg)

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pains, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you have or have had myasthenia(a disease that causes general muscle weakness, which can affect 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 to appear (see section 4).
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibratesto lower cholesterol.

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 Rosuvastatina Teva-ratiopharm

• if you have kidney problems
• if you have liver problems
• If you have repeated or unexplained muscle pains, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain, especially if you have a high temperature or feel generally unwell. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you have or have had myasthenia(a disease that causes general muscle weakness, which can affect 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 to appear (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rosuvastatina or other related medicines.
• if you regularly drink large amounts of alcohol.
• if your thyroid glandis not working correctly.
• if you are taking other medicinescalled fibratesto lower cholesterol.
• if you are taking medicinesto treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see Using Rosuvastatina Teva-ratiopharm with other medicines.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid, (an antibiotic), by mouth or by injection. The combination of fusidic acid and rosuvastatina can cause muscle problems (rhabdomyolysis), please see “Other medicines and rosuvastatina”. If you are over 70 years old, (as your doctor will need to choose the right starting dose of rosuvastatina for you).
• If you have severe respiratory problems.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatina for you.

If you are in any of the above situations (or are unsure):

• Do not take Rosuvastatina Teva-ratiopharm 40 mg (the highest dose of this medicine) and consult your doctor or pharmacist before starting to take any dose of Rosuvastatina.

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

In a small number of people, statins can affect the liver. This can be detected by a simple blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests (liver function tests) before and after starting you on rosuvastatina.

While you are on this medicine, your doctor will monitor you if you have diabetes or are at risk of getting diabetes. You may be at risk of getting diabetes if you have high levels of sugar or fat in your blood, are overweight, or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatina should notbe given to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatina 40 mg tabletsshould not be given to children and adolescents under 18 years of age.

Using Rosuvastatina Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

• ciclosporin (used after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other blood thinner),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion medicines (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic – see “Warnings and precautions”), oral contraceptives (the pill), hormone replacement therapy
• regorafenib (used to treat cancer)
• darolutamide (used to treat cancer)
• capmatinib (used to treat cancer)
• hormone replacement therapy
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis), 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.

The effects of these medicines can be altered by Rosuvastatina or they can alter the effect of Rosuvastatina.

If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop taking this medicine temporarily.Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breast-feeding

Do not takeRosuvastatinaif you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatina, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatina as it is unlikely to affect their ability to do so. However, some people may feel dizzy while taking rosuvastatina. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Teva-ratiopharm contains lactose and sodium.

Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sodium

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

3. How to take Rosuvastatina Teva-ratiopharm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Usual dose in adults

If you are taking rosuvastatina for high cholesterol:

Starting dose

Your treatment with Rosuvastatina should start with a dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin before. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk of having a heart attack or stroke.
• Whether you have factors that make you more sensitive to the possible side effects.

Consult your doctor or pharmacist to determine the best starting dose of Rosuvastatina for you.

Your doctor may decide to start you on the lowest dose (5 mg) if:

• you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• you are over 70 years old.
• you have moderate kidney problems.
• you are at risk of muscle pains(myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the dose of Rosuvastatina that is right for you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then to 20 mg, and later to 40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be a 4-week interval between each dose adjustment.

The maximum daily dose of Rosuvastatina is 40 mg. This dose is only for patients with very high cholesterol and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking Rosuvastatina Teva-ratiopharm to reduce the risk of having a heart attack, stroke, or related health problems:

The recommended dose is 20 mg once daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose for treatment is 5 mg. Your doctor may gradually increase your dose to the dose of Rosuvastatina Teva-ratiopharm that is right for you. The maximum recommended daily dose is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take the dose prescribed by your doctor once daily. Do notgive Rosuvastatina Teva-ratiopharm 40 mg tabletsto children.

Taking the tablets

Swallow each tablet with a glass of water.

Take Rosuvastatina Teva-ratiopharm once a day. You can take it at any time of day, with or without food.

Try to take your tablets at the same time each day. This will help you remember to take them.

Regular checks of your cholesterol levels

It is important that you see your doctor regularly to have your cholesterol levels checked, to make sure that your cholesterol levels have returned to normal and are being kept at the right levels.

Your doctor may decide to increase your dose to make sure that you are taking the dose of Rosuvastatina that is right for you.

If you take more Rosuvastatina Teva-ratiopharm than you should

Contact your doctor or the nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking Rosuvastatina.

If you forget to take Rosuvastatina Teva-ratiopharm

Do not worry, just take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatina Teva-ratiopharm

Consult your doctor if you want to stop taking Rosuvastatina. Your cholesterol levels may rise again if you stop taking Rosuvastatina.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Rosuvastatin may cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects may be. They are usually mild and disappear in a short period.

Stop taking Rosuvastatin Teva-ratiopharm and seek immediate medical attentionif you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• Severe skin itching (with hives).
• Red patches on the torso, often with 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).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatin and consult your doctor immediately

• unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects, which have very rarely resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• (including rash, joint disorders, and effects on blood cells)

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache
• Stomach pain
• Constipation
• Nausea
• Muscle pain
• Weakness
• Dizziness
• Diabetes mellitus It is more common for this to occur if you have high blood sugar and fat levels, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medication
• An increase in the amount of protein in the urine – this usually returns to normal on its own without the need to interrupt treatment with Rosuvastatina (only with Rosuvastatina Teva-ratiopharm 40 mg film-coated tablets EFG).

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

• Hives, itching, and other skin reactions.
• An increase in the amount of protein in the urine – this usually returns to normal on its own without the need to interrupt treatment with Rosuvastatina tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of Rosuvastatina).

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

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe skin itching (with hives). If you think you are having an allergic reaction, stop taking Rosuvastatina and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Rosuvastatina and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to a low platelet count in the blood
• Syndrome that has similar symptoms to lupus (including hives, joint disorders, and effects on blood cells)

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflamed liver).
• Traces of blood in the urine.
• Nerve damage in the legs and arms (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breast in men (gynecomastia)

Adverse Effects of Unknown Frequency that may include:

• Diarrhea (loose stools).
• Cough
• Shortness of breath
• Edema (swelling)

• Sleep disturbances including insomnia and nightmares

• Sexual difficulties
• Depression
• Respiratory problems including persistent cough and/or shortness of breath or fever.
• Tendon injuries
• Constant muscle weakness
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Eye 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 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rosuvastatina Teva-ratiopharm

Keep out of sight and reach of children.

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

For blisters:

Do not store at a temperature above 30 ºC.

For bottles:

This medication does not require special storage conditions.

Expiration after opening the bottle 6 months.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina Teva-ratiopharm 20 mg

• The active ingredient is rosuvastatin.

Rosuvastatina Teva-ratiopharm 20 mg film-coated tablets contain rosuvastatin calcium equivalent to 20 mg of rosuvastatin.

• The other components (excipients) are:

Core of the tablet: microcrystalline cellulose, lactose monohydrate, crospovidone (type B), hypromellose 6 Cp, sodium hydrogen carbonate, magnesium stearate.

Coating: lactose monohydrate, hypromellose 6 Cp, titanium dioxide (E171), triacetin, and red iron oxide (E172)

Appearance of the Product and Package Contents

Rosuvastatina Teva-ratiopharm 20 mg film-coated tablets are pink, round, biconvex tablets, marked with “20” on one side and with a score line on the other, approximately 9 mm in diameter.

The tablets can be divided into two equal halves.

Rosuvastatina Teva-ratiopharm 20 mg film-coated tablets are available in blister packs of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets, and bottles of 28, 30, and 100 tablets.

The bottle contains a separate container with desiccant containing silica gel. DO NOT remove it from the bottle. DO NOT ingest the container that contains silica gel.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strassee 3,

D-89143 Blaubeuren (Germany)

Or

PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

Zagreb 10000 Croatia

Or

Teva Pharma, S.L.U.

Polígono Industrial Malpica, c/C, nº 4,

50016 Zaragoza

Spain

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

Austria: Rosuvastatin ratiopharm 20 mg Filmtabletten

Bulgaria: ???????????? ???? 20 mg ????????? ????????

Czech Republic: Rosuvastatin Teva Pharma 20 mg

Finland: Rosuvastatin ratiopharm 20 mg tabletti, kalvopäällysteinen

Iceland: Rosuvastatin Teva

Norway: Rosuvastatin Teva

Portugal: Rosuvastatina ratiopharm

Romania: Rosuvastatina ratiopharm 20 mg comprimate filmate

Spain: Rosuvastatina Teva-ratiopharm 20 mg comprimidos recubiertos con película EFG

Date of the last revision of this prospectus: February 2024

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

You can access detailed information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74735/P_74735.html