Rosuvastatin Viso Farmaceutica 5 mg film-coated tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Rosuvastatin Viso Farmacéutica 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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 should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rosuvastatin Viso Farmacéutica is and what it is 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. How to store Rosuvastatin Viso Farmacéutica
6. Contents of the pack and other information

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

Rosuvastatina belongs to a group of medicines called statins.

You have been prescribed Rosuvastatina because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Rosuvastatina is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been advised to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue regular physical exercise while taking Rosuvastatina.

Or

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

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

Why is it important that you continue taking Rosuvastatina?

Rosuvastatina is used to correct 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 (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatina lowers the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how you feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, cutting off blood supply to the heart or brain and leading to 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 rosuvastatina, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

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

Do not take Rosuvastatina Viso Farmacéutica

• If you are allergic to rosuvastatin or to 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 must avoid becoming pregnant during treatment with Rosuvastatin by using an appropriate contraceptive method.

• If you have liver disease.

• If you have severe kidney problems.

• If you have unexplained, repeated muscle pain or cramps.

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

• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

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

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 gland is not working properly.
• If you have unexplained, repeated muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines.
• 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 medicines called fibrates to lower cholesterol.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Rosuvastatin

• If you have kidney problems.

• If you have liver problems.

• If you have unexplained, repeated muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also have general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.

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

• If you regularly consume large amounts of alcohol.

• If your thyroid gland is not working properly.

• 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 fusidic acid (a medicine for bacterial infections) orally or by injection within the last 7 days. The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis); please see “Other medicines and Rosuvastatin”.

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

• If you have severe respiratory failure.

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of rosuvastatin for you.

If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

Do not take the highest dose of 40 mg and consult your doctor or pharmacist before starting 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 immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function test) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely 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 must not be given to children under 6 years of age.

•If the patient is under 18 years of age: Rosuvastatin 40 mg tablets must not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Viso Farmacéutica

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

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

• cyclosporine (used, for example, after organ transplantation),

• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant),

• fibrates (such as gemfibrozil, fenofibrate), or any other medicine 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 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 blood uric acid levels),
  • 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 amyloidosis).

The effects of these medicines may be altered by rosuvastatin, or they may alter the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart rosuvastatin. Taking rosuvastatin with fusidic acid may, in rare cases, cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatin if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while taking rosuvastatin, as 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 machinery.

Rosuvastatina Viso Farmacéutica contains lactose.

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

Rosuvastatina Viso Farmacéutica contains sodium

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

For a complete list of ingredients, see Contents of the pack and other information.

3. How to take Rosuvastatin Viso Farmacéutica

Follow exactly the instructions for administration of this medicine given 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 be initiated with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin.

The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level of having a heart attack or stroke.
• Whether you have any factors that make you more susceptible to possible adverse effects.

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

Your doctor may decide to start treatment with 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 developing muscle pain and 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 your condition. If you started with a 5 mg dose, 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 10 mg dose, 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 levels and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of heart attack, stroke, or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the previously mentioned 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 until reaching the appropriate rosuvastatin dose needed 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 prescribed by your doctor once daily. Rosuvastatin 40 mg tablets must not be administered to children and adolescents.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once daily. You may 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 monitoring

It is important 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 appropriate 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you are admitted to hospital or receive treatment for another condition, inform healthcare staff that you are taking rosuvastatin.

If you forget to take rosuvastatin

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

If you stop taking rosuvastatin

Consult your doctor if you wish to discontinue treatment with rosuvastatin. Your cholesterol levels may rise again if you stop taking rosuvastatin.

If you have any further 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 everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek immediate medical attention if 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.
• Severe skin itching (with hives).
  • Reddish, flat, non-elevated circular or target-shaped rashes on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
  • Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking rosuvastatin and consult your doctor immediately:

• If you experience unexplained muscle pain or cramps that 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 experienced unpleasant muscle effects, which very rarely have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you develop lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Frequent adverse effects (may affect between 1 in 10 and 1 in 100 patients)

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (frequent adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you closely 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.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop 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, and severe skin itching (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 (inflammation of the pancreas).
• Increased liver enzymes in 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 adverse effects (may affect fewer 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 arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Adverse effects with unknown frequency (frequency cannot be estimated from available data), which may include:

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Persistent muscle weakness.
  • Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
  • Ocular myasthenia (a disease causing 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton/blister/label after EXP. The expiry date refers to the last day of the month indicated.

Store in the original container to protect from light.

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

Keep the tablets in the container in which they were supplied.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Viso Farmacéutica

The active substance is rosuvastatin. Rosuvastatin 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 red iron oxide (E-172).

Appearance of Rosuvastatin Viso Farmacéutica and contents of the pack

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 pack sizes are available in all countries).

Tablets packed in plastic containers include a desiccant which protects the tablets from moisture. The desiccant must not be swallowed.

Rosuvastatin Viso Farmacéutica 5 mg film-coated tablets are pink, round, film-coated tablets of 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

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
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

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