ROSUVASTATIN VISO FARMACEUTICA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin Viso Farmacéutica 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Rosuvastatin Viso Farmacéutica and what is it used for
2. What you need to know before taking Rosuvastatin Viso Farmacéutica
3. How to take Rosuvastatin Viso Farmacéutica
4. Possible side effects
5. Storage of Rosuvastatin Viso Farmacéutica
6. Package contents and additional information

1. What is Rosuvastatin Viso Farmacéutica and what is it used for

Rosuvastatin belongs to a group of medications called statins.

You have been prescribed Rosuvastatin because:

• You have high cholesterol levels. 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 advised to take a statin because changes in your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You should maintain a diet that helps lower cholesterol and continue to exercise while being treated with Rosuvastatin.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

Heart attacks, strokes, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of deposits of fatty substances 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, the most well-known being cholesterol.

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

• Rosuvastatin decreases the amount of "bad" cholesterol and increases "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, as 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 blood vessels can become blocked, preventing blood from reaching 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 related health problems.

You need to continue taking rosuvastatin, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from rising again and causing the formation of fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

2. What you need to know before taking Rosuvastatin Viso Farmacéutica

Do not take Rosuvastatin Viso Farmacéutica

• If you are allergic to rosuvastatin or any of the other components of this medication.
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, 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 and unexplained muscle pain or cramps.
  • If you are taking a combination of medications such as sofosbuvir/velpatasvir/voxilaprevir (used for 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), pleaseconsult your doctor again.

Additionally, do not take Rosuvastatin Viso Farmacéutica 40 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not function correctly.
• If you have repeated and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a 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 take other medications called fibrates to 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

• If you have kidney problems.
• If you have liver problems.
• If you have repeated and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained 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 peeling of the skin, blisters, and/or sores in the mouth after taking Crestor or other related medications.

• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you take other medications called fibrates to lower cholesterol. Read this package leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you take medications to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, please see Other medications and Rosuvastatina

• If you take or have taken in the last 7 days a medication called fusidic acid(an antibiotic for bacterial infections) orally or by injection. The combination of fusidic acid and rosuvastatin can lead to serious muscle problems (rhabdomyolysis), please see "Other medications and Rosuvastatina".

• If you are over 70 years old (as your doctor will 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 determine the appropriate starting dose of rosuvastatin for you.

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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

If you are in any of the above situations (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 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 test) before and after treatment with rosuvastatin.

While taking this medication, your doctor will closely monitor you if you have diabetesor 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: Rosuvastatin 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Rosuvastatina Viso Farmacéutica

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, clopidogrel, or ticagrelor (or any other anticoagulant medication),
• fibrates (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 - please see below and in Warnings and precautions),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
  • darolutamide (used to treat cancer),
  • capmatinib (used to treat cancer),
  • hormone replacement therapy
  • fostamatinib (used to treat low platelet count),
  • febuxostat (used to treat and prevent high uric acid levels in the blood),
  • teriflunomide (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,
• roxadustat (used to treat anemia in patients with chronic kidney disease),

• tafamidis (used to treat a disease called transthyretin amyloidosis).

These medications may affect the way rosuvastatinworks or may be affected by rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will tell you when it is safe to start taking rosuvastatin again. 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 take rosuvastatinif 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 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 rosuvastatinas 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 Viso Farmacéuticacontains lactose.

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

Rosuvastatin Viso Farmacéuticacontains sodium

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

To obtain a complete list of components, see the Package contents and additional information.

3. How to take Rosuvastatina Viso Farmacéutica

Follow the instructions for taking this medication exactly 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:

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 any 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 (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of having muscle pain or cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the appropriate 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 sufficiently 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 above factors.

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 achieve the appropriate dose of rosuvastatin to treat your condition. The maximum recommended daily dose of rosuvastatin is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose indicated by your doctor once a day. Do notadminister rosuvastatin 40 mgtablets 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 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 to have your cholesterol levels checked, 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 appropriate dose of rosuvastatin for you.

If you take more Rosuvastatina than you should

Contact your doctor or the 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 are hospitalized or receive treatment for another condition, inform the healthcare staff that you are taking Rosuvastatina.

If you forget to take Rosuvastatina

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

If you stop taking Rosuvastatina

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 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.
• 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 unexplained muscle pain and 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.
• If you experience muscle rupture.
• If you experience a lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Common Adverse Effects (may affect between 1 in 10 and 1 in 100 patients)

• 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 between 1 in 100 and 1 in 1,000 patients)

• 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 (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

Rare Adverse Effects (may affect between 1 in 1,000 and 1 in 10,000 patients)

• 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 rosuvastatin and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (pancreatitis).
• Increased liver enzymes in the blood.
• Bleeding or bruising more easily than normal due to a low platelet count in the blood.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very Rare Adverse Effects (may affect less than 1 in 10,000 patients)

• 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.
• Enlargement of the breasts in men (gynecomastia).

Adverse Effects of Unknown Frequency (frequency cannot be estimated from available data) that may include:

• 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.
• Constant muscle weakness.
  • Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
  • Ocular 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 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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatin Viso Farmacéutica

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

Do not use this medicine after the expiration date stated on the carton/blister/label after CAD. The expiration date is the last day of the month indicated.

Store in the original package to protect from light.

If your tablets come in a plastic container, keep the lid tightly closed.

Keep the tablets in the package in which they were received.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatin Viso Farmacéutica

The active ingredient is rosuvastatin. Rosuvastatin Viso Farmacéutica contains 10 mg of rosuvastatin (as rosuvastatin calcium).

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

Appearance of Rosuvastatin Viso Farmacéutica and Package Contents

Rosuvastatin 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 swallowed.

Rosuvastatin Viso Farmacéutica 10 mg film-coated tablets are pink, circular, film-coated tablets, approximately 5.50 mm in size, with "G" engraved on one side and "D" on the other side of the tablet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, Hertfordshire, WD18 8YA

United Kingdom

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Glenmark 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:

Date of the last revision of this leaflet:March 2025

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