Rosuvastatin Sandoz 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin Sandoz 5 mg film-coated tablets EFG

Rosuvastatin Sandoz 10 mg film-coated tablets EFG

Rosuvastatin Sandoz 20 mg film-coated tablets EFG

rosuvastatin calcium

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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Rosuvastatin Sandoz

3. How to take Rosuvastatin Sandoz

4. Possible side effects

5. Storage of Rosuvastatin Sandoz

6. Contents of the pack and other information

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

Rosuvastatin belongs to a group of medicines called statins.

Your doctor has 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 must maintain a cholesterol-lowering diet and continue regular physical exercise while taking rosuvastatin.

Or

• You have other factors that increase your risk of heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems may be caused by a condition called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why is it important that you continue taking Rosuvastatina Sandoz?

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 lowers the amount of "bad" cholesterol and increases "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 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 flow 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 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 stops the formation of fatty deposits. However, you should stop treatment if your doctor advises you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatin Sandoz

Do not take Rosuvastatin Sandoz:

• if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2),
• if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should 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 unexplained, repeated muscle pain or cramps,
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines (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.

In addition, do not take the highest dose (Rosuvastatin 40 mg):

• if you have moderate kidney problems (if in doubt, consult your doctor),
• if your thyroid gland is not functioning properly,
• if you have unexplained, repeated muscle pain or 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 (e.g., 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 listed above (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rosuvastatin Sandoz.

• if you have kidney problems,
• if you have liver problems,
• if you have unexplained, repeated muscle pain or 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 had or currently have myasthenia (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing), or ocular myasthenia (a condition 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 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 for HIV infection (AIDS virus), such as ritonavir with lopinavir, atazanavir, and/or tipranavir; see “Taking Rosuvastatin Sandoz with other medicines”,
• if you are taking or have taken within the last 7 days an oral or injected medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis); please see “Other medicines and Rosuvastatin Sandoz”,
• 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 failure,
• 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 the highest dose of 40 mg 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 should not be given to children under 6 years of age.
• If the patient is under 18 years of age: rosuvastatin 40 mg tablets should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Sandoz

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

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

• cyclosporine (used, for example, after organ transplantation),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant), fibrates, and other lipid-lowering medicines (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; see below and “Warnings and precautions”),
• oral contraceptives (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• fostabatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high blood levels of uric acid),
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• teriflunomide (used to treat multiple sclerosis),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• 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 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 rosuvastatin 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 should avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Rosuvastatin Sandoz contains lactose and sodium.

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

The full list of ingredients is in Contents of the pack and other information.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Rosuvastatina Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 of having a heart attack or stroke,
• whether you have factors that make you more susceptible to possible side 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 lowest dose (5 mg) if:

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

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the rosuvastatin dose appropriate 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels 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 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 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily.

The usual recommended starting dose is 5 mg daily, and your doctor may gradually increase your dose until reaching the rosuvastatin dose appropriate for treating your condition. The maximum recommended 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 the dose prescribed by your doctor once daily. Do not administer the 40 mg rosuvastatin tablets to children.

How to take the tablets

Swallow each tablet whole with a glass of 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 that 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 Rosuvastatina Sandoz 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.

If you have taken more Rosuvastatina Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, stating the medicine and amount taken.

If you forget to take Rosuvastatina Sandoz

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

If you stop taking Rosuvastatina Sandoz

Consult your doctor if you wish to stop 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 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 may cause difficulty swallowing,
• severe skin itching (with hives),
• reddish, flat, non-elevated skin rashes on the trunk, often in a target or circular shape, sometimes with central blisters, skin peeling, and 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 or 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,
• syndrome with symptoms resembling lupus (including hives, joint disorders, and effects on blood cells),
• muscle rupture.

Frequent adverse effects (may affect up to 1 in 10 people and 1 in 100 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 (frequent adverse effect only with the daily 40 mg dose of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, 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 and 1 in 1,000 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 (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Rare adverse effects (may affect up to 1 in 1,000 people and 1 in 10,000 people)

• Severe allergic reaction. Symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and 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 lasting longer than expected.
• Severe stomach pain (inflamed pancreas).
• Increased liver enzymes in blood.
• Unusual bruising and bleeding due to low platelet levels in blood,
• Syndrome with symptoms resembling 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 (with numbness and tingling).
• Joint pain.
• Memory loss.
• Enlargement of breasts in men (gynecomastia).

Adverse effects with unknown 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, sometimes leading to rupture.
• 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 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 kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP/CAD. The expiry date refers to the last day of the month indicated.

Shelf life after first opening:

Bottles: 100 days.

Store in the original packaging to protect from moisture.

This medicine does not require special storage temperature conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Sandoz

• The active substance is rosuvastatin.

Rosuvastatin Sandoz 5 mg: each tablet contains 5 mg of rosuvastatin (as calcium rosuvastatin).

Rosuvastatin Sandoz 10 mg: each tablet contains 10 mg of rosuvastatin (as calcium rosuvastatin).

Rosuvastatin Sandoz 20 mg: each tablet contains 20 mg of rosuvastatin (as calcium rosuvastatin).

• The other components are:

Core: lactose, anhydrous colloidal silica, microcrystalline cellulose, maize starch, talc, sodium stearyl fumarate.

Coating: hypromellose, mannitol (E 421), macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the pack

Rosuvastatin Sandoz 5 mg

Brown, round, film-coated tablets with an approximate diameter of 5 mm.

Rosuvastatin Sandoz 10 mg

Brown, round, film-coated tablets with an approximate diameter of 6 mm, marked with “RSV 10” on one side.

Rosuvastatin Sandoz 20 mg

Brown, round, film-coated tablets with an approximate diameter of 8 mm, marked with “RSV 20” on one side.

The film-coated tablets are packaged in OPA/Alu/PVC/Alu blisters or in HDPE bottles with PP cap and silica gel desiccant, all contained in a cardboard outer carton.

Pack sizes

Blister packs: 7, 10, 14, 20, 21, 28, 30, 40, 42, 50, 60, 70, 84, 90, 98 or 100 film-coated tablets.

Bottles: 28, 30, 50, 84, 90 or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57,

1526 Ljubljana

Slovenia

Or

Lek S.A.

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

Or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

Târgu Mures, Mures,

540472 Romania

Or

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

Or

Lek S.A.
Ul. Podlipie 16
95 010 Strykow
Poland

Date of the most recent revision of this leaflet: February 2025

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