Package Insert: Information for the Patient

Rosuvastatina Stada 5 mg Film-Coated Tablets

Rosuvastatina Stada 10 mg Film-Coated Tablets

Rosuvastatina Stada 20 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Rosuvastatina Stada and how is it used

2. What you need to know before starting to take Rosuvastatina Stada

3. How to take Rosuvastatina Stada

4. Possible adverse effects

5. Storage of Rosuvastatina Stada

6. Contents of the package and additional information

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 having 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

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).

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 lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other health problems.

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

Do not take Rosuvastatina Stada:

• If you are allergic to rosuvastatinor to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevirmedicines (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 find yourself in any of the above situations (or are unsure), please consult your doctor.

Also, do not take 40 mg of rosuvastatin (the highest dose)

• 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 medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin(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 Stada.

• If you have kidney problems.
• If you have liver 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 hadmyasthenia(a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) orocular myasthenia(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 rosuvastatin or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medicines called fibratesto lower 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 Stada”.
• 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 androsuvastatinmay cause severe muscle problems (rhabdomyolysis), please see “Other medicines and Rosuvastatina Stada”.

• If you are over 70 years old(as your doctor must establish the appropriate starting dose of rosuvastatin 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 appropriate starting dose of rosuvastatin for you.

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

• Do not take 40 mg of rosuvastatin (the highest dose) and consult your doctor or pharmacist before starting to take any dose of rosuvastatin.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using rosuvastatin 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 blood test that measures elevated liver enzymes (transaminases). For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with rosuvastatina.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar levels, are overweight and 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 40 mg should not be administered to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Stada

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

• ciclosporin (used after an organ transplant)
• warfarin, clopidogrel or ticagrelor (or any other anticoagulant)
• 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 below and in “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 (please 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 this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking Crestor with fusidic acid may rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using 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 Stada contains lactose

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

The complete list of excipients is found in “Contents of the pack and additional information”.

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

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should 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.

Check with your doctor or pharmacist which is the best starting dose of rosuvastatin for you.

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

• If you areof Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you areover 70 years old.
• If you have moderate kidney problems.
• If 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 right dose of rosuvastatin 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 of rosuvastatin is 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 rosuvastatinto 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 in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The usual starting dose is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The maximum daily dose of rosuvastatin is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.Do notadminister rosuvastatin40 mgtablets to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take rosuvastatinonce 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 checks

It is essential that you attend your doctor regularly for cholesterol 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 right dose of rosuvastatin for you.

If you take more Rosuvastatina Stada than you should

Contact your doctor or nearest hospital for advice.

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

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 forget to take Rosuvastatina Stada

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

If you interrupt treatment with Rosuvastatina Stada

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

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

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

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

Stop taking rosuvastatin and seek medical attention immediatelyif you experience any of the following symptoms:

• 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, not elevated, 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 symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking rosuvastatinand consult your doctor immediately

• if you experience unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are morefrequent in children and adolescents than in adults. Like other statins, a very small number ofpeople have experienced unpleasant muscle effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomyolysis.
• if you experience muscle rupture
• if you experience a syndrome with symptoms similar to lupus(including urticaria, 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 interrupt treatment with rosuvastatin tablets (only withrosuvastatina 40 mg)
• Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine

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 rosuvastatin tablets (only withrosuvastatina5 mg, 10 mg, and 20 mg)

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 have unjustified muscle pain or cramps that last longer than expected
• Intense stomach pain (possible sign of pancreatitis)
• Increased liver enzymes (transaminases) in the blood
• Increased bleeding or bruising due to low platelet count in the blood
• Syndrome with symptoms similar to lupus (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), blood in the urine, nerve damage in the legs and arms (such as numbness), joint pain, memory loss, and increased breast size in men (gynecomastia)

Side effects of unknown frequency (frequency cannot be estimated from available data):

• 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, persistent 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 the arms or legs that worsens after periods of activity, double vision or 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 Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

Store in the original packaging to protect it from light.

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

Composition of Rosuvastatina Stada

• The active ingredient is rosuvastatin.

Rosuvastatina Stada 5 mg: Each tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina Stada 10 mg: Each tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina Stada 20 mg: Each tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).

• The other components are:

Tablet core: lactose monohydrate, povidone K 30, crospovidone type A, powdered cellulose, copovidone, anhydrous colloidal silica, magnesium stearate.

Tablet coating: polyvinyl alcohol, macrogol (MW 3350), titanium dioxide (E 171), talc.

Appearance of the product and contents of the package

Rosuvastatina Stada 5 mg film-coated tablets are white, round, biconvex tablets with a diameter of 5 mm.

Rosuvastatina Stada 10 mg film-coated tablets are white, round, biconvex tablets with a diameter of 7 mm.

Rosuvastatina Stada 20 mg film-coated tablets are white, round, biconvex tablets with a diameter of 9 mm.

The tablets are presented in blisters with a sealed oPA-Alu-PVC laminate with an aluminum laminate.

They are presented in packs of 7, 14, 15, 20, 28, 28 x1 (unit dose), 30, 50 x1 (unit dose), 50, 60, 90, 98, 100, 154, 196 or 252 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel, Germany

[email protected]

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna, Austria

[email protected]

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary, Ireland

[email protected]

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

AustriaRosuvastatin Stada 5/10/20/40 mg Filmtabletten

BelgiumRosuvastatine EG 5/10/20/40 mg filmomhulde tabletten

DenmarkRosuvastatin Stada

SpainRosuvastatina Stada 5/10/20 mg film-coated tablets

FinlandRosuvastatin Stada 5/10/20/40 mg tabletti, kalvopäällysteinen

FranceROSUVASTATINE EG 5/10/20 mg, comprimé pelliculé

IrelandRosuvastatin Clonmel 5/10/20/40 mg film-coated tablets

ItalyROSUVASTATINA EG

LuxembourgRosuvastatine EG 5/10/20/40 mg comprimés pelliculés

PortugalRosuvastatina Ciclum

SwedenRosuvastatin Stada 5/10/20/40 mg filmdragerad tablett

Last review date of the leaflet:February 2024

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