Product Information for the Patient

Rosuvastatina Vir 10 mg Film-Coated Tablets

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 product information. See section 4.

1. What isRosuvastatina Virand what is it used for

2. What you need to know before starting to takeRosuvastatina Vir

3. How to takeRosuvastatina Vir

4. Possible side effects

5. Storage ofRosuvastatina Vir

6. Contents of the pack and additional information

Rosuvastatin contains belongs to a group of medications 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 a stroke. Rosuvastatin is used in adults, adolescents, and children 6 years of age 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 lower cholesterol and continue exercising while on treatment with Rosuvastatin.

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 it is important to continue taking Rosuvastatin

Rosuvastatin 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).

•Rosuvastatin decreases 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 levels of cholesterol 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 and prevent blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other health-related problems.

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

Do not take Rosuvastatina

•If you are allergic (hypersensitive) to rosuvastatina or to any of the other components of this medication (listed in section 6).

•If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with Rosuvastatina 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 medication called ciclosporina(used, for example, after an organ transplant).

• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatina Vir or other related medications

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

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

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

•If your thyroid glanddoes not function correctly.

•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 medications.

•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 medications called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina

•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 medications. 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 persistent muscle weakness.

•If you regularly consume large amounts of alcohol.

•If your thyroid glanddoes not function correctly.

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

•If you are taking medications to treat HIV (AIDS virus) or hepatitis C infection,such as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medications and Rosuvastatina

•If you are taking or have taken in the last 7 days a medication calledacid fusidic(a medication to treat bacterial infections), by oral or injectable route. The combination of acid fusidic and Rosuvastatina may cause severe muscle problems (rhabdomyolysis).

•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 rosuvastatina for you.

•If you are over 70 years old(since your doctor must establish the appropriate starting dose of rosuvastatina for you).

• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) associated with Rosuvastatina treatment have been reported. Stop using Rosuvastatina Vir and seek medical attention immediately if you notice any of the symptoms described in section 4.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).

If you find yourself 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 Rosuvastatina.

In a reduced 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 rosuvastatina

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may 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: Rosuvastatina should not be administered to children under 6 years of age.

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

Other medications and Rosuvastatina

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

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

-ciclosporina (used after an organ transplant),

-warfarina, ticagrelor or clopidogrel (or any other anticoagulant, such as acenocoumarol),

-fibrates (such as gemfibrozil, fenofibrate),

-any other medication used to lower cholesterol (such as ezetimiba),

-medications for indigestion (used to neutralize stomach acid),

-erythromycin (an antibiotic),

-oral contraceptives (the pill),

-hormone replacement therapy

-antiviral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir(used to treat infections including AIDS or hepatitis C – see Warnings and Precautions).

-regorafenib (used to treat cancer)

-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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medications may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you must take acid fusidic orally to treat a bacterial infection, you must stop taking this medication temporarily. Your doctor will indicate when it is safe to start taking Rosuvastatina again. Taking rosuvastatina with acid fusidic rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Taking Rosuvastatina with food and drinks

You can take this medication with or without food.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

This medication contains lactose

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

Follow exactly the administration instructions of this medication as indicated 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 rosuvastatin treatment should start witha dose of 5 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 levels.

•The degree of risk you have of having a heart attack or stroke.

•If you have any factor that makes you more vulnerable to possible side effects.

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

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

•If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you are over 70 years old.

•If you have a specific genetic variation (known as a genetic polymorphism), which may cause an increase in rosuvastatin levels.

•If you have moderate kidney problems.

•If you have a risk of developing muscle pain and cramps (myopathy).

•If you are taking rosuvastatin with other medications that may increase the level of rosuvastatin in the blood.

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is 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 later to 40 mg, if necessary. There will be a four-week interval 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 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, 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 above.

Recommended doses in children and adolescents aged 6-17 years

The usual recommended starting dose is 5 mg. Your doctor may increase your dose to reach the right dose of rosuvastatin to treat your condition. The maximum daily recommended dose of rosuvastatin is 10 mg for children aged 6-9 years and 20 mg for children aged 10-17 years. Take the dose indicated by your doctor once a day.Do not administer rosuvastatin 40 mg tablets to children and adolescents.

Tablet intake

Swallow each tablet whole with water.

Take rosuvastatin 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 attend your doctor regularly for cholesterol level checks, to ensure that your cholesterol levels have normalized and are maintained at appropriate 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 than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Rosuvastatina

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

If you interrupt treatment with Rosuvastatina

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Stop taking rosuvastatin and seek medical attention immediatelyif 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).

• Reddish patches on the trunk, flat, in the shape of a target or circles, often with blisters in the center, skin peeling, mouth, 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin and consult your doctor immediately if you experience:

• 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 similar to lupus (which includes skin rash, joint disorders, and effects on blood cells).
• Muscle rupture

Frequent side 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 discontinue treatment with rosuvastatin tablets (frequent side 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, obesity, and high blood pressure. Your doctor will closely monitor you while taking this medicine.

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

•Urticaria, itching, and other skin reactions.

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

Very rare side 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 medical attention immediately.

•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.

•Reduced platelet count in the blood.

• Syndrome similar to lupus (which includes skin rash, joint disorders, and effects on blood cells).
• Muscle rupture

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

•Icterus (yellowing 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.

•Enlarged breasts in men (gynecomastia).

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

•Diarrhea (loose stools).

•Stevens-Johnson syndrome (severe skin rash in the form of blisters on the skin, mouth, eyes, and genitals).

•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.

•Peripheral neuropathy (a disorder of the nerves surrounding the spinal cord).

• 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://wwwnotificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rosuvastatina Vir

- The active ingredient is rosuvastatin (as rosuvastatin calcium). A film-coated tablet contains 10 mg of rosuvastatin (equivalent to 10.40 mg of rosuvastatin calcium).

- The other components are:

Lactose, microcrystalline cellulose, sodium citrate (E331), crospovidone, anhydrous colloidal silica, and magnesium stearate.

The tablet coating: opadry II white 33G28523, in its composition:

hypromellose, lactose monohydrate, macrogol (E1521), triacetin (E1518), and titanium dioxide (E171).

Appearance of the product and content of the container

The Rosuvastatina Vir 10 mg tablets are white or almost white, round, and biconvex film-coated tablets, marked with “10” on one side.

The tablets are presented in aluminum/OPA/PVC-aluminum blister containers containing 28 tablets.

Holder of the marketing authorization and Responsible for manufacturing:

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing:

Pharmaceutical Works POLPHARMA S.A.

19, Pelplinska Street

83-200 Starogard Gdanski

Poland

and

Industria Química y Fca. VIR, S.A.

C/Laguna 66-70. P.I. Urtinsa II

28923 Alcorcón (Madrid) Spain

Last review date of this leaflet: May 2023

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