ROSUVASTATIN VISO FARMACEUTICA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin Viso Farmacéutica 5 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Rosuvastatin Viso Farmacéutica and what is it used for
2. What you need to know before you take Rosuvastatin Viso Farmacéutica
3. How to take Rosuvastatin Viso Farmacéutica
4. Possible side effects
5. Storage of Rosuvastatin Viso Farmacéutica
6. Contents of the pack and further information

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

Rosuvastatin belongs to a group of medicines 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 aged 6 years or older to treat high cholesterol.

You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps lower cholesterol and continue to exercise while you are on treatment with Rosuvastatin.

Or

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

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why is it important to keep taking Rosuvastatin?

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

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

• Rosuvastatin lowers the amount of "bad" cholesterol and increases the "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 because they do not produce any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

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

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

Do not take Rosuvastatin Viso Farmacéutica

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine.
• 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 or unexplained muscle pains or cramps.
  • If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C infection).

• If you are taking a medicine 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.

Also, 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 work correctly.
• If you have repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (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 above situations (or are unsure), pleaseconsult your doctor again.

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 or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain or cramp, especially if you also have a high temperature or feel generally unwell. Also, inform your doctor or pharmacist if you have persistent 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 medicines.

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

• If you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), by mouth or by injection. The combination of fusidic acid and rosuvastatin can cause serious muscle problems (rhabdomyolysis), please see “Other medicines and Rosuvastatin”.

• If you are over 70 years old (as your doctor will need to choose the right starting dose of rosuvastatin for you).
• If you have severe respiratory problems.
• If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatin for you.

If you have or have had myasthenia (a disease that causes general 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 make these conditions worse or trigger the onset of myasthenia (see section 4).

If you are in any of these 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. Stop taking 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 carry out a blood test(liver function test) before and after starting treatment with rosuvastatin.

While you are on this medicine, 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 given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg rosuvastatin tablets should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Viso Farmacéutica

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

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

• ciclosporin (used, for example, 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 ezetimibe),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see also under 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 levels of uric acid in the blood),
  • teriflunomide (used to treat multiple sclerosis),

• 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, 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-related amyloidosis).

The effects of these medicines may be altered by rosuvastatinor may alter the effect of rosuvastatin.

If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatin again. Taking rosuvastatin with fusidic acid can, in rare cases, cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about 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 taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatinas it is unlikely to affect their ability. However, some people may feel dizzy while taking 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 some sugars, consult them before taking this medicine.

Rosuvastatin Viso Farmacéuticacontains sodium

This medicine contains less than 1mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”

To get a complete list of ingredients, see the Contents of the pack and further information.

3. How to take Rosuvastatin Viso Farmacéutica

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual dose 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 level of risk you have of having a heart attack or stroke.
• If you have any factors that make you more vulnerable to the 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 you on the lowest 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 muscle pains or cramps (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose 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 then to 40 mg if necessary. There will be a 4-week interval 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 once daily. 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 starting dose is 5 mg. Your doctor may increase your dose to achieve the dose of rosuvastatin that is right for you. The maximum 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 prescribed by your doctor once daily. Do notgive the 40 mg rosuvastatin tablets to children and adolescents.

Taking the tablets

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 your tablets at the same time each day. This will help you remember to take them.

Regular checks of your cholesterol levels

It is important that you see your doctor regularly to have your cholesterol levels checked, to make sure that your cholesterol levels have returned to normal and are being kept at the right 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 the nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking Rosuvastatin.

If you forget to take Rosuvastatin

Do not worry, just take your next scheduled dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rosuvastatin

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 medicine, 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 rosuvastatina 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 patches 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 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 rosuvastatina and consult your doctor immediately:

• If you experience unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent 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 fatal muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you experience a syndrome similar to lupus (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 rosuvastatina tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatina).
• 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 rosuvastatina tablets (only for rosuvastatina 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, severe skin itching (with hives). If you think you are having an allergic reaction, stop taking rosuvastatina and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatina and consult your doctor immediately if you have unjustified 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.
• Increased breast size 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 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 Medicines Surveillance System for Human Use: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina 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 you received them.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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 Rosuvastatina Viso Farmacéutica

The active ingredient is rosuvastatina. Rosuvastatina Viso Farmacéutica contains 5 mg of rosuvastatina (as rosuvastatina 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 Rosuvastatina Viso Farmacéutica and Package Contents

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 swallowed.

Rosuvastatina Viso Farmacéutica 5 mg film-coated tablets are pink, circular, film-coated tablets, approximately 4.50 mm in size, with "G" engraved on one side and "C" 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 under 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/