Rosuvastatin Stada 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin Stada 5 mg film-coated tablets EFG

Rosuvastatin Stada 10 mg film-coated tablets EFG

Rosuvastatin Stada 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rosuvastatin Stada is and what it is used for
2. What you need to know before taking Rosuvastatin Stada
3. How to take Rosuvastatin Stada
4. Possible adverse effects
5. How to store Rosuvastatin Stada
6. Contents of the pack and other information

1. What Rosuvastatina Stada is and what it is used for

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 stroke. Rosuvastatin is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been advised to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You should maintain a cholesterol-lowering diet and continue exercising while being treated with 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 may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important that you continue taking rosuvastatin

Rosuvastatin is used to correct levels of fatty substances in the blood called lipids, the most well-known being cholesterol.

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 works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how you feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up 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, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to keep taking rosuvastatin, even after your cholesterol levels have reached the desired level, because it prevents cholesterol levels from rising again and causing the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

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

Do not take Rosuvastatina Stada:

• If you are allergic to rosuvastatin or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

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

Additionally, 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 gland is not functioning properly.
• If you have repeated or unexplained 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 fibrates to lower cholesterol.

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

Warnings and precautions

Talk to 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 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 experience unexplained muscle pain or cramps, especially if you also have general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.

• If you have or have had myasthenia (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

• If you have ever developed a severe skin rash, 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 gland is not functioning properly.

• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.

• 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 within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Rosuvastatina Stada”.

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

• If you have severe respiratory insufficiency.

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of rosuvastatin for you.

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

• Do not take 40 mg of rosuvastatin (the highest dose) and consult your doctor or pharmacist before starting 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 immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely 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: Rosuvastatin must not be given to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatin 40 mg must not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Stada

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

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

• cyclosporine (used after organ transplantation)
• 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)
• treatments 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 levels of uric acid in blood)
• teriflunomide (used to treat multiple sclerosis)
• any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, 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 altered by rosuvastatin or may change the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin. Taking Crestor with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatin if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin by 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 medicine.

Driving and using machines

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

Rosuvastatina Stada contains lactose

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

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

3. How to take Rosuvastatin Stada

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible adverse effects.

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

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

• If you are of Asian origin (e.g., 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 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 rosuvastatin dose appropriate for you. If you started with a 5 mg dose, 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 10 mg dose, 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of 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 until reaching the rosuvastatin dose appropriate 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. Rosuvastatin 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once daily. You may 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 monitoring of cholesterol levels

It is important that you visit 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 so that you are taking the rosuvastatin dose appropriate for you.

If you take more Rosuvastatin Stada than you should

Contact your doctor or nearest hospital for advice.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rosuvastatin Stada

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Rosuvastatin Stada

Consult your doctor if you wish to discontinue treatment with rosuvastatin. Your cholesterol levels may rise again if you stop taking rosuvastatin.

If you have any further 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 everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek immediate medical attention if 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.
• Severe itching of the skin (with hives).
• Red, flat, non-elevated spots on the trunk, often circular or target-shaped, sometimes with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking rosuvastatin and consult your doctor immediately

• if you experience unexplained muscle pain and cramps lasting 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 experienced unpleasant muscle effects, which very rarely have led to a potentially fatal muscle injury called rhabdomyolysis.
• if you experience muscle rupture
• if you develop a syndrome presenting symptoms similar to lupus (including hives, joint disorders, and effects on blood cells)

Frequent adverse effects (may affect up to 1 in 10 people):

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness
• Increased amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (only with rosuvastatin 40 mg)
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Hives, itching, and other skin reactions
• Increased amount of protein in urine – this usually returns to normal on its own without the need to discontinue 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 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 lasting longer than expected
• Severe stomach pain (possible sign of pancreas inflammation)
• Increased liver enzymes (transaminases) in blood
• Increased tendency to bleed or bruise more easily than normal due to low platelet levels in the blood
• Syndrome presenting 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), traces of blood in urine, nerve damage in arms and legs (such as numbness), joint pain, memory loss, and breast enlargement in men (gynecomastia)

Adverse effects with 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 causing generalized muscle weakness which, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in your arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date which is stated on the packaging and on the blister after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Rosuvastatin Stada

• The active substance 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).

• Other components are:

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

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

Appearance of the product and contents of the container

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 made of oPA-Alu-PVC sealed with an aluminum foil.

They are available in pack sizes 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 certain pack sizes may be commercially available.

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 medicinal product is authorized in the European Economic Area member states 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 most recent review of the package leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/