Package Insert: Information for the Patient

Rosuvastatina Teva 15 mg Film-Coated Tablets

Rosuvastatina Teva 30 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you and should not be given to others, even if they have the same symptoms, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacisteven if they are not listed in this package insert. See section 4.

Rosuvastatin belongs to a group of medications called statins.

You have been prescribed rosuvastatin because:

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

Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

You have been advised to take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue to exercise while on treatment with rosuvastatin..

Or

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

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

Why it is important to continue taking Rosuvastatin Teva

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

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

• Rosuvastatin reduces the amount of bad cholesterol and increases good cholesterol.
• It acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

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

You need to continue taking rosuvastatin, even if you have achieved the correct cholesterol levels, as it prevents cholesterol levels from increasing again and forming fatty deposits.However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not takeRosuvastatina Teva

• If you areallergicto the active ingredientrosuvastatinaor to any of the other ingredients of this medicine. (see section 6)
• If you are pregnantor inlactation. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor.
• If you haveliver disease
• If you havesevere kidney problems
• If you haverepeated or unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevirmedicines (used to treat a liver infection called hepatitis C)
• If you are taking a medicine calledciclosporina(used, for example, after an organ transplant).

If you find yourself in any of the above situations (or are unsure), pleaseconsult your doctor.

Do not take Rosuvastatina 30 mg or a higher dose:

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid gland does not function correctly.
• If you have repeated or unjustified muscle pain and cramps,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 consume 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 find yourself 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

• If you havekidney problems
• If you haveliver problems
• If you have repeated or unjustified muscle pain and 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 unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• If you have or have had myasthenia(a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing)or myasthenia gravis(a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatina or other related medicines.
• If you regularly consumelarge amounts of alcohol.
• If yourthyroid glanddoes not function correctly.
• If you are takingother medicines called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are takingmedicines for HIV (AIDS virus) treatment, such as ritonavir with lopinavir and/or atazanavir, see “Other medicines and Rosuvastatina Teva”.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and rosuvastatina may cause severe muscle problems (rhabdomyolysis), please see“Other medicines and Rosuvastatina Teva”.
• If you are over 70 years old, (as your doctor must establish the starting dose of rosuvastatina suitable for you).
• If you have severe respiratory failure.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor must establish the starting dose of rosuvastatina suitable for you.

If you find yourself in any of these situations mentioned above (or are unsure):

• Do not take Rosuvastatina Teva 30 mg or a higher dose 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) associated with rosuvastatina treatment have been reported. Stop using rosuvastatina and seek medical attention immediately if you notice any of the symptoms described in section 4.

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 (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatina.

While taking this medicine, your doctor should 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 blood sugar or fat levels, are overweight or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatina should not be administered to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatina 30 mg tablets or higher doses should not be administered to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Teva

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

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

• ciclosporina (used after an organ transplant),
• warfarin, clopidogrel or ticagrelor (or any other blood thinner),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimiba),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic – please see “Warnings and precautions”)
• oral contraceptives (the pill),
• regorafenib (used to treat cancer)
• darolutamida (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 uric acid levels in the blood),
• teriflunomida (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 may be modified by rosuvastatina or may change the effect of rosuvastatina.

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

Pregnancy and Lactation

Do not takerosuvastatinaif you are pregnant or in lactation. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Most patients can drive vehicles and use machines during rosuvastatina treatment as it will not affect their ability. However, some people may feel dizzy during rosuvastatina treatment. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Teva contains lactose and sodium.

Lactose

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

Sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult again with your doctor or pharmacist.

Usual doses in adults

If you are taking rosuvastatina for high cholesterol levels:

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 previously. The choice of starting dose will depend on:

• Your cholesterol levels.
• The degree of risk you have of suffering a heart attack or cerebral infarction.
• If you have factors that make you more vulnerable to possible adverse effects.

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

Your doctor may decide to start treatment with 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 have a risk of suffering muscle pain and cramps (myopathy).

For dosages not covered by this medication, there are other presentations available on the market.

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the appropriate dose of rosuvastatina 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 four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatina is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking Rosuvastatina Teva to reduce the risk of suffering a heart attack, a cerebral infarction, or related health problems:

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

Use in children and adolescents aged 6-17 years

The dosage range for children and adolescents aged 6 to 17 years is 5 to 20 mg once a day. The usual starting dose is 5 mg per day, and your doctor may gradually increase the dose to find the appropriate amount of rosuvastatina film-coated tablets for you. The maximum daily dose of rosuvastatina is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once a day. Children should not use rosuvastatina 30 mg or higher doses.

Swallowing the tablets

Swallow each tablet whole with a glass of water.

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

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

Regular cholesterol level checks

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

Your doctor may decide to increase your dose to ensure you are taking the appropriate dose of rosuvastatina for you.

If you take more Rosuvastatina Teva than you should

Contact your doctor or nearest hospital for advice.

In 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 enter a hospital or receive treatment for another condition, inform the healthcare staff that you are taking rosuvastatina.

If you forget to take Rosuvastatina Teva

Do not worry, simply take the next dose at the usual time.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Rosuvastatina Teva

Consult your doctor if you want to interrupt treatment with rosuvastatina.Your cholesterol levels may increase again if you stop taking rosuvastatina.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, rosuvastatin can cause side effects, although not everyone will experience them.

It is essential that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking Rosuvastatina Teva and seek medical attention immediatelyif 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 may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Rash-like lesions on the trunk, red, flat, in the shape of a target or circles, often with central blisters, 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).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin and consult your doctor immediately

• if you experienceunjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis.
• if you experience muscle rupture
• if you have lupus or a similar disease(including rash, joint disorders, and effects on blood cells)

Frequent side effects (may affect up to 1 in 10 people)

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

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

• Urticaria, itching, and other skin reactions.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop rosuvastatin treatment (only for the 5 mg, 10 mg, and 20 mg doses).

Very rare side 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, intense itching of the skin (with rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience 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 low platelet count in the blood
• Lupus or a similar disease (including urticaria, joint disorders, and effects on blood cells)

Very rare side 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 breasts in men (gynecomastia)

Side effects of unknown frequency that may include:

• Diarrhea (loose stools).
• Cough
• Shortness of breath
• Swelling

• Alterations in sleep, including insomnia and nightmares

• Sexual difficulties
• Depression
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries
• Constant muscle weakness
• 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 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 Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not usethis medicationafter 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 °C.

For bottles:

This medication does not require special storage conditions.

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

Composition of Rosuvastatina Teva

- The active ingredient is rosuvastatin.

Rosuvastatina Teva 15 mg: Each film-coated tablet contains 15 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina Teva 30 mg: Each film-coated tablet contains 30 mg of rosuvastatin (as rosuvastatin calcium).

- The other components (excipients) are:

Tablet core:

Microcrystalline cellulose,

Monohydrate lactose,

Crospovidone (type B),

Hydroxypropyl cellulose,

Sodium hydrogen carbonate,

Magnesium stearate.

Tablet coating:

Monohydrate lactose,

6 cps Hypromellose,

Titanium dioxide (E171),

Triacetin,

Yellow iron oxide (E172).

Appearance of the product and contents of the package

Rosuvastatina Teva 15 mg film-coated tablets are yellow, round, biconvex tablets, marked with “15” on one face and flat on the other.

Rosuvastatina Teva 30 mg film-coated tablets are yellow, round, biconvex tablets, marked with “30” on one face and flat on the other.

Rosuvastatina Tevais available in blister packs of 28, 30, 56, 90, 98, and 100 tablets, and bottles of 30 and 100 tablets.

The bottle may contain a separate desiccant container with silica gel. DO NOT remove it from the bottle. DO NOT ingest the silica gel desiccant.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strassee 3,

D-89143 Blaubeuren (Germany)

Or

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

Prilaz Baruna Filipovica, 25

Zagreb 1000 Croatia

Or

Teva Pharma, S.L.U.

Polígono Industrial Malpica, c/C, nº 4,

50016 Zaragoza

Spain

Or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80.

31-546 Krakow

You can request more information about this medication 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 medication is authorized in the member states of the European Economic Area with the following names:

Austria:Rosuvastatin ratiopharm 15 / 30 mg Filmtabletten

Bélgica:Rosuvastatine Teva 15 / 30 mg filmomhulde tabletten/comprimés pelliculés/ Filmtabletten

Finlandia:Rosuvastatin Actavis 15 / 30 mg tabletti, kalvopäällysteinen

Croacia:Epri 15 / 30 mg filmom obložene tablete

Hungría:Rozuva-Teva 15 / 30 mg filmtabletta

Portugal:Rosuvastatina Ratiopharm

Date of the last review of this prospectus:August 2024

The detailed information about this medication is available on thewebsite of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/