ROSUVASTATIN STADA 10 mg FILM-COATED TABLETS

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

Do not take Rosuvastatina Stada:

• If you are allergic to rosuvastatinaor any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor 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 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(used, for example, after an organ transplant).

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

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

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glandis not working correctly.
• 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(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines 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 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, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia(a disease that causes general 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 medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working 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 and rosuvastatina can cause serious muscle problems (rhabdomyolysis), see "Other medicines and Rosuvastatina Stada".

• If you are over 70 years old(as your doctor will need to choose the right starting dose of rosuvastatina for you).
• If you have severe respiratory problems.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatina for you.

If you are in any of these 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 taking 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 do blood tests (liver function tests) before and after starting treatment with rosuvastatina.

While you are taking this medicine, 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 given to children under 6 years of age.
• If the patient is under 18 years of age:Rosuvastatina 40 mg should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Stada

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

Tell 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 medicine)
• 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 also "Warnings and precautions" and below)
• 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 medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see also "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

These medicines may affect the way rosuvastatina works or increase the risk of side effects. If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatina as it will not affect their ability. However, some people may feel dizzy while taking 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 some sugars, consult them before taking this medicine.

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

3. How to take Rosuvastatina Stada

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Usual dose in adults

If you are taking rosuvastatina for high cholesterol:

Starting dose

Your treatment with rosuvastatina should start with 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.
• 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 you on 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 pains(myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the right 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 4-week interval 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 enough 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 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 mg to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase your dose to the dose of rosuvastatina that is right 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 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 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 to your doctor regularly for cholesterol checks to ensure that your cholesterol levels have returned to normal and are being kept at the right levels.

Your doctor may decide to increase your dose so that you are taking the right 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 hospital or receive treatment for another condition, inform the medical 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rosuvastatina Stada

Do not worry, just take the next scheduled dose at the right 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 taking rosuvastatina. Your cholesterol levels may rise again if you stop taking rosuvastatina.

If you have any other questions about the use of this medicine, 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.
• Severe skin itching (with hives).
• Red patches on the torso, 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, which have very rarely 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 rosuvastatin 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 rosuvastatin 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, severe skin itching (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)
• Ocular myasthenia (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed 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 Rosuvastatin Stada

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

Do not use this medicine after the expiration date stated 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 disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your 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

Rosuvastatin Stada Composition

• The active ingredient is rosuvastatin.

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

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

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

• The other ingredients are:

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

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

Product Appearance and Package Contents

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

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

Rosuvastatin 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/