ROSUVASTATIN STADA 5 mg FILM-COATED TABLETS

2. What you need to know before taking Rosuvastatina Stada

Do not take Rosuvastatina Stada:

• If you are allergic to rosuvastatinaor any of the other ingredients of this medication (listed in section 6).
• If you are pregnantor breastfeeding. 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.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or cramps.
• If you are taking a combination of medications called sofosbuvir/velpatasvir/voxilaprevir(used for a viral liver infection called hepatitis C).
• If you are taking a medication 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 again.

Additionally, do not take 40 mg of rosuvastatina (the highest dose)

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pain or cramps,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibratesto lower cholesterol.

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

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 unexplained muscle pain or cramps,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained 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, which in some cases affects 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 (see section 4).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatina or other related medications.
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this package leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV infection,such as ritonavir with lopinavir and/or atazanavir, see "Other medications and Rosuvastatina Stada".
• If you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic) by mouth or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis), please see "Other medications and Rosuvastatina Stada".

• If you are over 70 years old(as your doctor will need to determine the appropriate starting dose of rosuvastatina 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 will need to determine the appropriate starting dose of rosuvastatina for you.

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

• Do not take 40 mg of rosuvastatina (the highest 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), have been reported with rosuvastatina. 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 blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with rosuvastatina.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to 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 medications and Rosuvastatina Stada

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

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

• ciclosporin (used after an organ transplant)
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant medication)
• fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimibe)
• medications 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)
• 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 uric acid levels in the blood)
• teriflunomide (used to treat multiple sclerosis)
• any of the following medications 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 medications can be altered by rosuvastatina or can change the effect of rosuvastatina.

If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will tell you when it is safe to restart rosuvastatina. Taking Crestor with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

Rosuvastatina Stadacontains lactose

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

The complete list of excipients is found in "Contents of the pack and further information".

3. How to take Rosuvastatina Stada

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual doses 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.
• The degree of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of rosuvastatina is for you.

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

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

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that 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 an interval of four weeks between each dose adjustment.

The maximum daily dose of rosuvastatina 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 rosuvastatinato reduce the risk of having a heart attack, 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 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 is 5 mg per day, and your doctor may gradually increase the dose to the appropriate dose of rosuvastatina for you. The maximum daily dose of rosuvastatina is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notgive rosuvastatina 40 mg tablets to children.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatinaonce daily. You can take it at any time of day, with or without food.

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

Regular checks of cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have normalized and are being maintained at appropriate levels.

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

If you take more Rosuvastatina Stada than you should

Contact your doctor or the nearest hospital for advice.

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

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 taken.

If you forget to take Rosuvastatina Stada

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rosuvastatina Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine 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 rosuvastatin and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red patches on the trunk, not elevated, in a target or circular shape, often with central 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 rosuvastatinand consult your doctor immediately

• that 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 that, very rarely, have resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• (including hives, 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 the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin tablets (only with rosuvastatina 40 mg)
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine

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 reverses on its own without the need to interrupt treatment with rosuvastatin tablets (only with rosuvastatina 5 mg, 10 mg, and 20 mg)

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 itching of the skin (with hives). If you think you are having an allergic reaction, stop taking rosuvastatin and seek immediate medical attention
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected
• Severe stomach pain (possible sign of pancreatitis)
• Increased liver enzymes (transaminases) in the blood
• Increased tendency to bleed or bruise more than usual due to low platelet count in the blood
• Syndrome that has symptoms similar 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), blood in the urine, nerve damage in the legs and arms (such as numbness), joint pain, memory loss, and breast enlargement in men (gynecomastia)

Adverse 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, constant muscle weakness
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Myasthenic 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 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 that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina Stada

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

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

Store in the original package to protect it from light.

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

6. Package Contents and Additional Information

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:

Core of the tablet: lactose monohydrate, povidone K 30, crospovidone type A, cellulose powder, copovidone, colloidal anhydrous silica, magnesium stearate.

Coating of the tablet: polyvinyl alcohol, macrogol (MW 3350), titanium dioxide (E 171), talc.

Appearance of the Product and Package Contents

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 oPA-Alu-PVC laminate sealed with an aluminum laminate.

They are available 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 Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel, Germany

[email protected]

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien, Austria

[email protected]

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary, Ireland

[email protected]

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Rosuvastatin Stada 5/10/20/40 mg Filmtabletten

Belgium Rosuvastatine EG 5/10/20/40 mg filmomhulde tabletten

Denmark Rosuvastatin Stada

Spain Rosuvastatina Stada 5/10/20 mg comprimidos recubiertos con película EFG

Finland Rosuvastatin Stada 5/10/20/40 mg tabletti, kalvopäällysteinen

France ROSUVASTATINE EG 5/10/20 mg, comprimé pelliculé

Ireland Rosuvastatin Clonmel 5/10/20/40 mg film-coated tablets

Italy ROSUVASTATINA EG

Luxembourg Rosuvastatine EG 5/10/20/40 mg comprimés pelliculés

Portugal Rosuvastatina Ciclum

Sweden Rosuvastatin Stada 5/10/20/40 mg filmdragerad tablett

Date of the Last Revision of the Leaflet:February 2024

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