ROSUVASTATIN SANDOZ 20 mg FILM-COATED TABLETS

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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rosuvastatin Sandoz and what is it used for
2. What you need to know before you take Rosuvastatin Sandoz
3. How to take Rosuvastatin Sandoz
4. Possible side effects

5 Storage of Rosuvastatin Sandoz

1. Contents of the pack and other information

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

Rosuvastatin belongs to a group of medicines called statins.

You have been prescribed rosuvastatin because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke. Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking 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 can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why is it important to keep taking Rosuvastatin Sandoz?

Rosuvastatin is used to correct the levels of fatty substances in the blood called lipids, the most well-known of which is 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 the "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 they feel because they do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, cutting off the 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 related health problems.

You need to keep taking rosuvastatin, even if you have already achieved the correct cholesterol levels, because it prevents your cholesterol levels from rising againand causing the buildup of fatty deposits. However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Rosuvastatin Sandoz

Do not take Rosuvastatin Sandoz:

• if you are allergic to rosuvastatinor any of the other ingredients of this medicine (listed in section 6 and at the end of section 2),
• if you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women must 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 unexplained muscle pains,
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat hepatitis C infection),
• 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 the highest dose (Rosuvastatin 40 mg):

• 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 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(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• if you are taking other medicines called fibratesto lower your 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 Rosuvastatin Sandoz.

• 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 pains, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have 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) because statins can sometimes make the disease worse or cause myasthenia (see section 4),

• if you have ever developed a skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatin 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 your 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, atazanavir, and/or tipranavir), see "Taking Rosuvastatin Sandoz with other medicines",
• if you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), see "Other medicines and Rosuvastatin Sandoz",
• if you are over 70 years old(because your doctor will need to choose the right starting dose of rosuvastatin 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 rosuvastatin for you.

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

• Do not take the highest dose of 40 mg 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. Stop taking 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 can be 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 you on rosuvastatin.

While you are on 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 levels of sugar in your blood, are overweight, or 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:the 40 mg rosuvastatin 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 take any other medicines.

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

• ciclosporin (used, for example, after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant), fibrates, and other medicines that lower lipid levels (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 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),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• 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 affected by rosuvastatin or may affect the effect of rosuvastatin.

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

Pregnancy and breast-feeding

Do not takerosuvastatin if you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Most people can drive and use machines while taking rosuvastatin as it will not affect their ability. However, some people may feel dizzy while taking rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin Sandoz contains lactose and sodium.

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

The complete list of ingredients is found 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 Rosuvastatin Sandoz

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking rosuvastatin for high cholesterol:

Starting dose

Your treatment with rosuvastatin 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,
• your level of risk of having a heart attack or stroke,
• whether you have factors that make you more vulnerable to possible side effects.

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

Your doctor may decide to start you on the lowest dose (5 mg) if:

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

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose so that 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 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 having a heart attack or stroke, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking rosuvastatin to 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 to 17 years

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

The recommended starting dose for treatment is 5 mg once daily, and your doctor may gradually increase your dose to the dose of rosuvastatin that is right 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 notgive the 40 mg rosuvastatin tablets to children.

Taking the tablets

Swallow each tablet whole with a glass of water.

Take rosuvastatin once a day.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 your cholesterol levels

It is important that you see your doctor regularly to have your cholesterol levels checked, to make sure 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 rosuvastatin for you.

If you take more Rosuvastatin Sandoz 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 rosuvastatin.

If you have taken more Rosuvastatin Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used.

If you forget to take Rosuvastatin Sandoz

Do not worry, just take the next scheduled dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatin Sandoz

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

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 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 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 rosuvastatin and consult your doctor immediately if you experience:

• Unjustified muscle pain or crampsthat last 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 suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis,
• Syndrome with symptoms similar to lupus (including hives, joint disorders, and effects on blood cells),
• Muscle rupture.

Common Adverse Effects (may affect up to 1 in 10 people and 1 in 100 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 (common adverse effect only with the daily dose of 40 mg 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 closely monitor you 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.
• 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 (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, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking rosuvastatinand seek immediate medical attention.
• Muscle injury in adults. As a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (inflamed pancreas).
• Increased liver enzymes in the blood.
• Unusual bruising and bleeding due to low platelet count in the blood,
• Syndrome with 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 the urine.
• Nerve damage in the legs and arms (with numbness and tingling).
• Joint pain.
• Memory loss.
• Increased breast size in men (gynecomastia).

Adverse Effects of 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 resulting in rupture.
• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which 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 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 Medicines and Health Products Agency (AEMPS) website: 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 Sandoz

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

Do not use this medicine after the expiration date shown on the box and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Validity period after first opening:

Bottles: 100 days.

Store in the original packaging to protect it from moisture.

This medicine does not require special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Rosuvastatin Sandoz Composition

• The active ingredient is rosuvastatin.

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

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

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

• Other ingredients are:

Core: lactose, anhydrous colloidal silica, microcrystalline cellulose, cornstarch, talc, stearic acid fumarate, and sodium.

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

Product Appearance and Package Contents

Rosuvastatin Sandoz 5 mg

Brown, round, film-coated tablets, approximately 5 mm in diameter.

Rosuvastatin Sandoz 10 mg

Brown, round, film-coated tablets, approximately 6 mm in diameter, marked with "RSV 10" on one side.

Rosuvastatin Sandoz 20 mg

Brown, round, film-coated tablets, approximately 8 mm in diameter, marked with "RSV 20" on one side.

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

Package sizes

Blister: 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.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

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 Last Revision of this Leaflet:February 2025

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