ROSUVASTATIN TEVA 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin Teva 15 mg film-coated tablets

Rosuvastatin Teva 30 mg film-coated tablets

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

1. What is Rosuvastatin Teva and what is it used for

Rosuvastatin belongs to a group of medicines called statins.

You have been prescribed rosuvastatin because:

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

Rosuvastatin is used in adults, adolescents, and children aged 6 years or 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 continue with your cholesterol-lowering diet and exercise while taking rosuvastatin.

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 build-up of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatin Teva

Rosuvastatin 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, the “bad” cholesterol (LDL-C) and the “good” cholesterol (HDL-C).

• Rosuvastatin reduces the amount of “bad” cholesterol and increases the amount of “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. However, if left untreated, it can lead to the build-up of fatty deposits in the walls of the blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, leading to 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 rosuvastatin, even if you have already lowered your cholesterol levels, as it prevents your cholesterol levels from rising againand causing the build-up 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 Rosuvastatin Teva

Do not take Rosuvastatin Teva

• If you are allergicto the active substance rosuvastatinor to any of the other ingredients of this medicine (see section 6).
• If you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin and should use 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(e.g. after an organ transplant).

If you are in any of these situations (or if you are not sure), please go back to your doctor.

Also, do not take Rosuvastatin Teva 30 mg or a higher dose:

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid gland does not work properly.
• If you have repeated or unexplained muscle pains, 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 drink large amounts of alcohol.
• If you are of Asian origin(e.g. Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibratesto lower your cholesterol.

If you are in any of these situations (or if you are not sure), please consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with rosuvastatin

• 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 previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever. Also, inform your doctor or pharmacist if you have muscle weakness that persists.
• If you have or have had myasthenia(a disease characterized by muscle weakness that 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 condition or trigger the onset of myasthenia (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rosuvastatin or other medicines similar to rosuvastatin.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work properly.
• If you are taking other medicines called fibratesto lower your cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection, 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(an antibiotic), by mouth or by injection. The combination of fusidic acid and rosuvastatin can cause muscle problems (rhabdomyolysis), see “Other medicines and Rosuvastatina Teva”.
• If you are over 70 years old(as your doctor will need to choose the right starting dose of rosuvastatin for you).
• If you have severe respiratory problems.
• If you are of Asian origin(e.g. Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatin for you.

If you are in any of these situations (or if you are not sure), please consult your doctor.

Severe skin reactions have been reported in patients taking rosuvastatin. These include Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking rosuvastatin 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 carry out blood tests (liver function tests) before and after starting treatment with rosuvastatin.

While you are on this medicine, your doctor will 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 or fat in your blood, are overweight, or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin should not be given to children under 6 years of age.
• If the patient is under 18 years of age: It is not recommended to give Rosuvastatin 30 mg or higher doses to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Teva

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

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

• ciclosporin (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 ezetimibe),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic – see “Warnings and precautions”)
• oral contraceptives (the pill),
• 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 rosuvastatin or they can alter the effect of rosuvastatin.

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 rosuvastatin again. Taking rosuvastatin 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 take rosuvastatinif you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin and should use 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 rosuvastatin as it is unlikely to affect their ability to do so. However, some people may feel dizzy while taking rosuvastatin. 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 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

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking rosuvastatin for high cholesterol:

Starting dose

Your treatment with rosuvastatin 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.
• The level of risk you have of having a heart attack or stroke.
• Whether you have factors that make you more vulnerable to possible side effects.

Consult your doctor or pharmacist to determine the best starting dose of rosuvastatin 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).

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

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the dose of rosuvastatin 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking Rosuvastatina Teva 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 to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase the dose to find the right amount of rosuvastatin for you. The maximum daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Children should not use rosuvastatin 30 mgor higher doses.

How to take 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 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 go back to your doctor regularly for cholesterol checks to make sure that your cholesterol levels have normalized and are being kept under control.

Your doctor may decide to increase your dose so that you are taking the dose of rosuvastatin that is right for you.

If you take more Rosuvastatina Teva 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, indicating 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 rosuvastatin.

If you forget to take Rosuvastatina Teva

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

If you stop taking Rosuvastatina Teva

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

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

4. Possible Adverse Effects

Like all medicines, rosuvastatin can cause adverse effects, although not all people suffer from them.

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

Stop taking Rosuvastatina Teva 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.
• Intense skin itching (with hives).
• Red spots on the torso, often with blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions 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 rosuvastatina and consult your doctor immediately

• unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent 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 fatal 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
• 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 40 mg dose).
• Diabetes mellitus It is more frequent if you have high sugar and fat levels in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while taking this medication

Uncommon Adverse 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 (only 5 mg, 10 mg, and 20 mg doses).

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, intense skin itching (with hives). If you think you are having an allergic reaction, stop taking rosuvastatinaand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatina and consult your doctor immediatelyif you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than usual due to a low platelet count in the blood
• Lupus or similar disease (including urticaria, 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, which can affect the muscles used for breathing in some cases).
• Myasthenia gravis (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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. 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

Keep out of sight and reach of children.

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

For blisters:

Do not store above 30 ºC.

For bottles:

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

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:

Core of the tablet:

microcrystalline cellulose,

lactose monohydrate,

crospovidone (type B),

hydroxypropylcellulose,

sodium hydrogen carbonate,

magnesium stearate.

Tablet coating:

lactose monohydrate,

hypromellose 6 Cp,

titanium dioxide (E171),

triacetin,

yellow iron oxide (E172).

Appearance of the Product and Package Contents

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

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Manufacturer

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 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:

Austria: Rosuvastatin ratiopharm 15 / 30 mg Filmtabletten

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

Finland: Rosuvastatin Actavis 15 / 30 mg tabletti, kalvopäällysteinen

Croatia: Epri 15 / 30 mg filmom obložene tablete

Hungary: Rozuva-Teva 15 / 30 mg filmtabletta

Portugal: Rosuvastatina Ratiopharm

Date of the last revision of this leaflet:August 2024

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

You can access detailed and updated information about this medicine 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/89822/P_89822.html

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