Prospect: Information for the user

Rosuvastatina Krka 15 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Rosuvastatina Krka

4.Possible adverse effects

5.Storage of Rosuvastatina Krka

6.Contents of the package and additional information

Rosuvastatina Krka contains the active ingredient rosuvastatin, which belongs to a group of medicines called statins.

You have been prescribed Rosuvastatina Krka because:

•You havehigh levels of cholesterol. This means you have arisk of suffering a heart attack or a stroke. Rosuvastatina Krka is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

You have been advised to take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to reduce cholesterol and continue to exercise while on treatment with Rosuvastatina.

Or

•You present other factors that increase the risk of suffering a heart attack, stroke, or other health-related problems.

A heart attack, stroke, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why is it important to continue taking Rosuvastatina?

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

There are different types of cholesterol in the blood, "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

•Rosuvastatina reduces the amount of "bad" cholesterol and increases "good" cholesterol.

•It acts by blocking the production of "bad" cholesterol and improves the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form 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, causing a heart attack or stroke. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, stroke, or other health-related problems.

You needto continue taking rosuvastatina, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should interrupt treatment if your doctor advises you to do so or if you become pregnant.

Do not take Rosuvastatina Krka

-If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).

-If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Krka, stop taking it immediately and inform your doctor. Women should 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 unjustified muscle pain and cramps..

• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines (used for a liver virus infection called hepatitis C).(used for a liver virus infection called hepatitis C).

-If you are taking a medicine called ciclosporin (used, for example, after an organ transplant).(used, for example, after an organ transplant).

If you are in any of the situations mentioned above (or are unsure),return to your doctor.

Also, do not take Rosuvastatina Krka 30 mg or 40 mg (the highest dose):

?If you have moderate kidney problems (if in doubt, consult your doctor).

?If your thyroid gland does not function properly.

?If you have repeated or unjustified 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 (for example, 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 return to your doctor.

Warnings and precautions

Consult your doctor orpharmacist before starting to take rosuvastatin

-If you have kidney problems.

-If you have liver problems.

-If you have repeated or unjustified 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 have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have constant muscle weakness.

-If you regularly consume large amounts of alcohol.

-If your thyroid gland does not function properly.

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

-If you are taking medicines to combat HIV (AIDS virus) infection, such as ritonavir with lopinavir and/or atazanavir, see “Other medicines and Rosuvastatina Krka”.

-If you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibacterial medicine) by mouth or by injection. The combination of fusidic acid and Rosuvastatina Krka may cause severe muscle problems (rhabdomyolysis).

-If you are over 70 years old, as your doctor must establish 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 must establish the appropriate starting dose of rosuvastatin for you.

• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking rosuvastatin or other statins.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

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

-Do not take Rosuvastatina Krka 30 mg and 40 mg (the highest dose) and consult your doctor or pharmacist before starting to take any dose of rosuvastatin.

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatin.

If you have diabetes or are at risk of developing diabetes, your doctor will closely monitor you while taking this medicine. You are likely to be at risk of developing diabetes if you have high blood sugar and fat levels, if you are overweight, and if you have high blood pressure.

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 medical attention immediately if you notice any of the symptoms described in section 4.

Children and adolescents

-Ifthe 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 30 mg and 40 mg rosuvastatin tablets should not be administered to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Krka

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

Inform 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 ezetimiba),
• medicines 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),
• darolutamida (used to treat cancer),
• hormone replacement therapy,
• 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 modified by rosuvastatin or may change the effect of rosuvastatin.

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

Taking Rosuvastatina Krka with food and drinks

You can take rosuvastatin with or without food.

Pregnancy and breastfeeding

Do not takerosuvastatinif you are pregnant or breastfeeding. If you become pregnant while takingrosuvastatinstop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment withrosuvastatinusing an appropriate contraceptive method.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Most patients can drive vehicles and use machines during treatment withrosuvastatinas it will not affect their ability. However, some people may feel dizzy during treatment withrosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Krka contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual doses in adults:

If you are taking Rosuvastatina Krka for high cholesterol levels:

Starting dose:

Your treatment withRosuvastatina Krkashould start witha dose of5 mg or 10 mg, even if you have taken a higher dose of another statin previously. The choice of starting dose will depend on:

-Your cholesterol level.

-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 which is the best starting dose ofRosuvastatina Krkafor you.

Your doctor may decide to give you 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 have a risk of developing 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 right dose ofRosuvastatina Krkafor 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 later to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose ofRosuvastatina Krkais 40 mg. This dose is only for patients with high cholesterol levels 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 Rosuvastatina Krka to reduce the risk of having a heart attack, a 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 earlier.

Usual doses in children aged 6-17 years:

The dose range in children and adolescents aged 6 to 17 years is 5mg to 20mg once a day. The usual starting dose for treatment is 5mg per day and your doctor may increase your dose gradually to reach the right dose ofRosuvastatina Krkafor you. The maximum recommended daily dose of Rosuvastatina Krka is 10or 20 mg for children aged 6 to 17years, depending on the underlying disease being treated. Take your dose once a day.Do notadminister Rosuvastatina Krka40 mgtablets to children.

Tablet intake:

Swallow each tablet whole with water.

Take Rosuvastatina Krka once a day.You can take it at any time of the day with or without food.

Try to take the tablets at the same time every 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 your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right dose ofrosuvastatinfor you.

If you take more Rosuvastatina Krka than you should:

Contact your doctor or nearest hospital for advice.

If you enter a hospital or receive treatment for another condition, inform the healthcare staff that you are taking Rosuvastatina Krka.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rosuvastatina Krka:

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

If you interrupt treatment with Rosuvastatina Krka:

Consult your doctor if you want to stop takingRosuvastatina Krka. Your cholesterol levels may increase again if you stop takingRosuvastatina Krka.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Likewise, this medication may produce adverse effects, although not all people may experience them.

It is essential that you know which adverse effects may occur. They are usually mild and disappear within a short period of time.

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 may cause difficulty swallowing.

•Intense skin itching (with rashes).

You should also stop taking rosuvastatin and consult your doctor immediately if you experience any of the following:

•Unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis.

•Syndrome of disease similar to lupus (including skin rash, joint disorders, and effects on blood cells).

•Muscle rupture.

•Reddish patches on the trunk, in the shape of a target or circles, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

•Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

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

•Headache.

•Stomach pain.

•Constipation.

•Nausea.

•Muscle pain.

•Weakness.

•Dizziness.

•Increased protein levels in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin tablets (frequent adverse effect only with a daily dose of 40 mg of rosuvastatin).

•Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medication.

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

•Rash, itching, and other skin reactions.

•Increased protein levels in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

Very 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, intense skin itching (with rashes). 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 experience muscle pain or cramps that last longer than expected.

•Severe stomach pain (possible sign of pancreatitis).

•Increased liver enzymes in the blood.

• Bleeding or bruising more easily than normal due to low platelet count in the blood.

•Syndrome of disease similar to lupus (including skin rash, joint disorders, and effects on blood cells).

Very rare adverse effects (may affect up to 1 in 10,000 people)

•Icterus (yellowish discoloration of the skin and eyes).

•Hepatitis (inflamed liver).

•Traces of blood in the urine.

•Nerve damage in the legs and arms (with numbness or tingling).

•Joint pain.

•Memory loss.

•Enlargement of the breasts in men (gynecomastia).

Adverse effects of unknown frequency (frequency cannot be estimated from available data)

•Diarrhea (loose stools).

•Cough.

•Shortness of breath.

•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.

• Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).
• Myasthenia 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, eyelid drooping, 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 does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Rosuvastatina Krka

- The active ingredient is rosuvastatin.

Cada comprimido recubierto con película contiene 15 mg de rosuvastatina (como rosuvastatina de calcio).

- The other components are: lactose, microcrystalline cellulose, crospovidone (type A), magnesium stearate, and anhydrous colloidal silica in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and iron oxide red (E172) in the tablet coating.

Appearance of the product and contents of the package

Rosuvastatina Krka 15 mg film-coated tablets are pink, round, biconvex, film-coated tablets with beveled edges and marked with the number 15 on one face of the tablet (diameter: 9 mm).

Rosuvastatina Krka is available in blister packs of 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, and 100 film-coated tablets.

Rosuvastatina Krka is also available in perforated single-dose blister packs of 10x1, 14x1, 15x1, 20x1, 28x1, 30x1, 56x1, 60x1, 90x1, 98x1, and 100x1 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer :

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the EEA member states under the following names:

Last review date of this leaflet: October 2023

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ).