ROSUVASTATIN SANDOZ 5 mg FILM-COATED TABLETS

2. What you need to know before taking Rosuvastatin Sandoz

Do not take Rosuvastatin Sandoz:

• if you are allergic to rosuvastatinor any of the other ingredients of this medication (listed in section 6 and at the end of section 2),
• if you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand 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 repeated or unexplained muscle pains or cramps,
• if you are taking a combination of medications sofosbuvir/velpatasvir/voxilaprevir(used to treat hepatitis C infection),
• 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.

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 properly,
• if you have repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a previous 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(for example, 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.

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 or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pains 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 that can affect the muscles used for breathing), or ocular myasthenia (a disease that causes weakness of the eye muscles) since statins can sometimes worsen the disease or cause myasthenia to appear (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 medications,

• if you regularly drink large amounts of alcohol,
• if your thyroid glandis not working properly,
• if you are taking other medications called fibratesto lower cholesterol. Read this 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, atazanavir, and/or tipranavir), see "Taking Rosuvastatin Sandoz and other medications",
• if you are taking or have taken in the last 7 days a medication called fusidic acid(an antibiotic) orally or by injection. The combination of fusidic acid and rosuvastatin can rarely lead to serious muscle problems (rhabdomyolysis), see more information on rhabdomyolysis in section 4,
• if you are over 70 years old, (since your doctor will need to determine the appropriate starting dose of rosuvastatin 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 rosuvastatin for you.

If you are in any of these situations mentioned above (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 in association 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 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 rosuvastatin.

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:rosuvastatin should not be administered to children under 6 years of age.
• If the patient is under 18 years of age:the 40 mg rosuvastatin tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Rosuvastatin Sandoz

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

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

• ciclosporin (used, for example, after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medication), fibrates, and other medications that lower lipid levels (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic, see above 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 uric acid levels 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 medications 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 medications 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 medication. Your doctor will tell you when it is safe to restart rosuvastatin. Taking rosuvastatin 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 takerosuvastatin if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand 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 medication.

Driving and using machines

Most people can drive vehicles and use machines during treatment with rosuvastatin, 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 machines.

Rosuvastatin Sandoz contains lactose and sodium.

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 ingredients is found in Package contents and additional information.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Rosuvastatin Sandoz

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

Usual doses 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,
• 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 rosuvastatin 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),
• you are over 70 years old,
• you have moderate kidney problems,
• you are at risk of muscle pains and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the correct 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 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 from 6 to 17 years old

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

The recommended starting dose for initiating treatment is 5 mg per day, and your doctor may gradually increase the dose until the dose of rosuvastatin that is suitable for treating your condition is reached. The maximum recommended daily dose of rosuvastatin is 10 mg or 20 mg for children from 6 to 17 years old, depending on the underlying condition being treated. Take the dose indicated by your doctor once daily. Do notadminister the 40 mg rosuvastatin tablets to children.

Taking the tablets

Swallow each tablet whole with a glass of water.

Take rosuvastatin once 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 cholesterol level checks

It is essential that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and are being maintained at adequate levels.

Your doctor may decide to increase your dose so that you are taking the correct 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 the hospital or receive treatment for another condition, inform the healthcare 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, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Rosuvastatin Sandoz

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

If you stop taking Rosuvastatin Sandoz

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

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 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,
• Severe skin itching (with hives).
• Red spots on the torso, not raised, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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 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,
• 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, severe skin itching (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.
• Enlargement of the breasts in men (gynecomastia).

Adverse Effects of Unknown Frequency (cannot be estimated from the 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 that, in some cases, affects the muscles used for breathing).
• Eye 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 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 Rosuvastatin Sandoz

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

Do not use this medicine after the expiration date that appears 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 thrown away through wastewater or household waste. 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

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 components are:

Core: lactose, anhydrous colloidal silica, microcrystalline cellulose, cornstarch, 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).

Product Appearance and Package Contents

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 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/