Package Insert: Information for the Patient

Rosuvastatina Viso Farmacéutica 5 mg Film-Coated Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isRosuvastatina Viso Farmacéuticaand what is it used for

2. What you need to know before starting to takeRosuvastatina Viso Farmacéutica

3. How to takeRosuvastatina Viso Farmacéutica

4. Possible side effects

5. Storage ofRosuvastatina Viso Farmacéutica

6. Contents of the pack and additional information

Rosuvastatin belongs to a group of medications called statins.

They have prescribed Rosuvastatin because:

•You havehigh levels of cholesterol.This means you havea risk of suffering a heart attack or a cerebral infarction.Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

They have indicated that you should 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 perform physical exercise while undergoing treatment with Rosuvastatin.

Or

•You present other factors that increase therisk of suffering a heart attack, cerebral infarctionor other related health problems.

A heart attack, cerebral infarction, and other related health 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 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 (C-LDL) and good cholesterol (C-HDL).

•Rosuvastatin 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 not treated, 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 cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, cerebral infarction, or related health 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 interrupt treatment if your doctor indicates so or if you become pregnant.

Do not take Rosuvastatina Viso Farmacéutica

•If you are allergic to rosuvastatinor to any of the other ingredients of this medication.

•If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor.

•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 (used to treat a viral liver infection called hepatitis C).

•If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

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

Also, do not take Rosuvastatina Viso Farmacéutica 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(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),pleasereturn to 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 constant muscle weakness.

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

•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 infectionsuch as ritonavir with lopinavir and/or atazanavir or simeprevir, please seeOther medications and Rosuvastatina

• If you are taking or have taken within the last 7 daysa medication called fusidic acid(a medication for bacterial infections) by mouth or injection. The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis), please see “Other medications and Rosuvastatina”.

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

If you have or have had myasthenia (a disease that involves generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), since statins may sometimes 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 (the highest dose)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 treatment. Stop using 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 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 havediabetesor 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 Viso Farmacéutica

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, for example, after an organ transplant),

-warfarina, clopidogrel or ticagrelor (or any other anticoagulant),

-fibrates (such as gemfibrozilo, fenofibrato) or,

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

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

-eritromicina (an antibiotic), fusidic acid (an antibiotic - see Warnings and precautions),

-oral contraceptives (the pill),

-regorafenib (used to treat cancer),

• -darolutamida (used to treat cancer),
• capmatinib (used to treat cancer),
• -hormonal replacement therapy
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood),
• teriflunomida (used to treat multiple sclerosis),

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 byrosuvastatinaor may change the effect ofrosuvastatina.

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily discontinue the use of this medication. Your doctor will tell you when it is safe to resume taking rosuvastatina. The combination of rosuvastatina and fusidic acid may cause, in rare cases, muscle weakness, sensitivity or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediately and 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 operating machinery

The majority of patients can drive vehicles and operate machinery during treatment withrosuvastatinasince 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 operate machinery.

Rosuvastatina Viso Farmacéuticacontains lactose.

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

RosuvastatinaViso Farmacéuticacontains sodium

This medication contains less than 1mmolof sodium (23 mg) per tablet; this is, essentially “sodium-free”

To obtain a complete list of components, see theContents of the pack and additional information.

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 treatment with rosuvastatin 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 potential 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 ofAsian origin(Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you areover 70 years old.

•If you have moderate kidney problems.

•If 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 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 earlier.

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 visit your doctor regularly for cholesterol level checks, to ensure 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 Toxicology 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 forget to take Rosuvastatin

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

If you interrupt treatment with Rosuvastatin

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

If you have any other questions 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 or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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 unexplained 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.
• If you experience muscle rupture.
• If you experience a lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).

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

•Headache.

•Stomach pain.

•Constipation.

•Nausea.

•Muscle pain.

•Weakness.

•Dizziness.

•Increased protein in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin (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 in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin (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.

•Adult muscle injury – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected.

•Intense stomach pain (pancreatitis).

•Increased liver enzymes in the blood.

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

•Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare side 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 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).

•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 damage.

•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 the 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.

• Do not use this medication after the expiration date that appears on the box/pouch/label after CAD. The expiration date is the last day of the month indicated.
• Conserve in the original packaging to protect from light.
• If your tablets come in a plastic container, keep the lid tightly closed.
• Keep the tablets in the packaging in which you received them.

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

Composition of Rosuvastatina Viso Farmacéutica

The active ingredient is rosuvastatin. Rosuvastatina Viso Farmacéutica contains 5 mg of rosuvastatin (as rosuvastatin calcium).

The other components are: lactose monohydrate, microcrystalline cellulose, crospovidone, sodium bicarbonate, magnesium stearate, hypromellose, triacetin, titanium dioxide (E-171), and iron oxide red (E-172).

Appearance of Rosuvastatina Viso Farmacéutica and contents of the package

Rosuvastatina Viso Farmacéutica comes in blister packs containing 14, 15, 28, 30, 42, 56, 60, 84, 90, and 98 tablets and plastic containers with 30, 50, 90, and 100 tablets (Not all packages are available in all countries).

The tablets packaged in plastic containers include a desiccant that protects the tablets from moisture. The desiccant should not be taken.

Rosuvastatina Viso Farmacéutica 5 mg film-coated tablets are round, pink-coated tablets of approximately 4.50 mm in size, with "G" on one side and "C" on the other side of the tablet.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, Hertfordshire, WD18 8YA

United Kingdom

Glenmark Pharmaceuticals s.r.o.,

Fibichova 143

56617 Vysoke Myto

Czech Republic

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

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

Last review date of this leaflet:July 2023

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/