Rosuvastatina teva-ratiopharm 10 mg comprimidos recubiertos con pelicula efg

Patient Information Leaflet

Rosuvastatina Teva-ratiopharm 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking the 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 pass it on to others even if their symptoms are the same. It may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. See section 4.

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

2.What you need to know before taking 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 additional information

Rosuvastatin belongs to a group of medicines 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 Teva-ratiopharm 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 reduce cholesterol and continue exercising while on treatment with rosuvastatin Teva-ratiopharm.

Or

• You present other factors that increase the risk of suffering a heart attack, stroke, or other health-related problems.

A heart attack, stroke, and other health-related problems may 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-ratiopharm

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 the risk of having a heart attack, stroke, or other health-related 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-ratiopharm

• If you areallergicto the active ingredientrosuvastatinaor to any of the other components of this medication. (see section 6)
• If you are pregnantor inlactation. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Teva-ratiopharm using an appropriate contraceptive method.
• 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/voxilaprevir medications(used to treat a liver infection called hepatitis C)
• If you are taking a medication calledciclosporina(used, for example, after an organ transplant).

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

Do not takethe highest dose (40 mg)

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glanddoes 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 medications.
• If you have or have had myasthenia(a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)or myasthenia gravis(a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• 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 medications 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 Teva-ratiopharm

• 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 medications. 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 constant muscle weakness.
• If you have or have had myasthenia(a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)or myasthenia gravis(a disease that causes weakness of the eye muscles), as statins can 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 medications.
• if you regularly consumelarge amounts of alcohol.
• if yourthyroid glanddoes not function correctly.
• if you are takingother medicationscalledfibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.
• if you are takingmedicationsto treat HIV (AIDS virus),such as ritonavir with lopinavir and/or atazanavir, seeUse of Rosuvastatina Teva-ratiopharm with other medications.
• If you are taking or have taken within the last 7 days a medication called fusidic acid, (a medication for bacterial infection), orally or by injection. The combination of fusidic acid and rosuvastatina can cause severe muscle problems (rhabdomyolysis), please see “Other medications and rosuvastatina”. If you are over 70 years old, (
• 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 appropriate starting dose of rosuvastatina for you.

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

• Do not take Rosuvastatina Teva-ratiopharm 40 mg (the highest dose of this medication) 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 treatment. 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 elevated 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 medication, 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: It is not recommended to administer Rosuvastatina 40 mg tablets to children and adolescents under 18 years of age.

Use of Rosuvastatina Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take other medications, even those purchased without a prescription.

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

• ciclosporina (used after an organ transplant),
• warfarina, ticagrelor or clopidogrel (or any other blood thinner),
• fibrates (such as gemfibrozilo, fenofibrato) or any other medication used to lower cholesterol (such as ezetimiba),
• medications for indigestion (used to neutralize stomach acid),
• eritromicina (an antibiotic),
• fusidic acid (an antibiotic – please see “Warnings and precautions”)oral contraceptives (the pill), hormone replacement therapy
• 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 medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosvuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medications 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 temporarily stop taking this medication. Your doctor will indicate when it is safe to start taking rosuvastatina again. Taking rosuvastatina with fusidic acid can 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 medication.

Driving and operating machinery

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-ratiopharm 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 medication.

Sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult with your doctor or pharmacist if you have any doubts.

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment withRosuvastatinashould start witha 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 having a heart attack or stroke.
• If you have factors that make you more vulnerable to potential side effects.

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

Your doctor may decide to start treatment with the lower dose (5 mg) if:

• You are ofAsian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You have a risk of developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the appropriate dose ofRosuvastatina 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 later to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose ofRosuvastatinais 40 mg. This dose is only for patients with high cholesterol levels 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, a stroke, 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 dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The usual recommended starting dose is 5 mg. Your doctor may increase your dose gradually to reach the appropriate dose of Rosuvastatina Teva-ratiopharm for you. The maximum recommended daily dose is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take the dose indicated by your doctor once a day.Do not administer Rosuvastatina Teva-ratiopharm 40 mg tablets to 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 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 ofRosuvastatina.

If you take more Rosuvastatina Teva-ratiopharm 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 Toxicology 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 takingRosuvastatina.

If you forget to take Rosuvastatina Teva-ratiopharm

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-ratiopharm

Consult your doctor if you want to stop treatment withRosuvastatina.Your cholesterol levels may increase again if you stop takingRosuvastatina.

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

Like all medicines, Rosuvastatina may 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 will disappear within a short period of time.

Stop taking Rosuvastatina 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 may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Reddish patches on the trunk, 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 Rosuvastatina 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 side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolisis.
• if you experience muscle rupture
• if you experience a syndrome with symptoms similar to lupus(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
• 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 taking this medication
• An increase in the amount of protein in 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).

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 interrupt treatment with Rosuvastatina tablets (rare side effect with daily doses of 5 mg, 10 mg, and 20 mg of Rosuvastatina).

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 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

• 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
• 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 the Pharmacovigilance of Medicinal Products 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.

Expiration date after the first opening of the bottle 6 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rosuvastatina Teva-ratiopharm 10 mg

- The active ingredient is rosuvastatin.

Rosuvastatina Teva-ratiopharm 10 mg film-coated tablets contain rosuvastatin calcium equivalent to 10 mg of rosuvastatin.

- The other components (excipients) are:

Tablet core: 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 iron oxide red (E172)

Appearance of the product and contents of the package

Rosuvastatina Teva-ratiopharm 10 mg film-coated tablets are pink, round, biconvex, marked with “10” on one face and with a notch on the other, approximate diameter 7 mm.

The tablets can be divided into two equal halves.

Rosuvastatina Teva-ratiopharm 10 mg film-coated tabletsare presented 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 compartment with a desiccant containing silica gel. DO NOT remove it from the bottle. DO NOT ingest the compartment containing silica gel.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strassee 3,

D-89143 Blaubeuren (Germany)

Or

Pliva Croatia, Ltd.

Prilaz baruna Filipovica 25

10.000 Zagreb

Croatia

Or

Teva Pharma, S.L.U.

Industrial Estate Malpica, c/C, nº 4,

50016 Zaragoza

Spain

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

Austria:Rosuvastatin ratiopharm 10 mg Filmtabletten

Bulgaria:???????????? ???? 10 mg ????????? ????????

Czech Republic:Rosuvastatin-Teva Pharma10 mg

Finland:Rosuvastatin ratiopharm 10 mg tabletti, kalvopäällysteinen

Island:Rosuvastatin Teva

Norway:Rosuvastatin Teva

Portugal:Rosuvastatina ratiopharm

Romania:Rosuvastatina ratiopharm 10 mg comprimate filmate

Spain:Rosuvastatina Teva-ratiopharm 10 mg comprimidos recubiertos con película EFG

Last review date of this leaflet:February 2024

Detailed information about this medicineis available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74734/P_74734.html