Rosuvastatin Msn

Package Leaflet: Information for the Patient

Rosuvastatin MSN, 5 mg, Film-Coated Tablets

Rosuvastatin MSN, 10 mg, Film-Coated Tablets

Rosuvastatin MSN, 20 mg, Film-Coated Tablets

Rosuvastatin MSN, 40 mg, Film-Coated Tablets

Rosuvastatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you; do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Rosuvastatin MSN and what is it used for
• 2. Important information before taking Rosuvastatin MSN
• 3. How to take Rosuvastatin MSN
• 4. Possible side effects
• 5. How to store Rosuvastatin MSN
• 6. Contents of the pack and other information

1. What is Rosuvastatin MSN and what is it used for

Rosuvastatin MSN belongs to a group of medicines called statins.

Rosuvastatin MSN is recommended for use because:

• The patient has high cholesterol levels, which means they are at risk of heart attack (myocardial infarction) or stroke. Rosuvastatin MSN is used in adults, adolescents, and children over 6 years of age to treat high cholesterol levels.
• A statin has been prescribed because diet changes and increased physical activity have not been sufficient to achieve normal cholesterol levels. While taking Rosuvastatin MSN, you should maintain a cholesterol-lowering diet and exercise.

Or

• The patient has other factors that increase the risk of heart attack, stroke, or other similar diseases.

Heart attack, stroke, or other health problems may be caused by a disease called atherosclerosis. Atherosclerosis is the result of the accumulation of atherosclerotic plaques in blood vessels.

Why is it important to take Rosuvastatin MSN

Rosuvastatin MSN is used to achieve normal blood levels of fatty substances called lipids, most commonly cholesterol.

• Rosuvastatin MSN can lower the level of "bad" cholesterol and increase the level of "good" cholesterol.
• The action of Rosuvastatin MSN involves inhibiting the production of "bad" cholesterol in the body and facilitating its removal from the blood.

In most people, high cholesterol levels do not affect well-being, as they do not cause any symptoms. However, if left untreated, fatty deposits can accumulate in blood vessel walls, causing them to narrow.

Sometimes, narrowed blood vessels can become blocked, leading to a heart attack or stroke. By reducing cholesterol levels, the risk of heart attack, stroke, or other similar diseases associated with high cholesterol levels can be reduced.

You should continue taking Rosuvastatin MSNeven if you have achieved normal cholesterol levels, as the medicine prevents the cholesterol level from increasing againand causing the accumulation of fatty deposits.

However, you should stop taking the medicine if your doctor advises you to or if you become pregnant.

2. Important information before taking Rosuvastatin MSN

When not to take Rosuvastatin MSN:

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin MSN, you should stop taking the medicine immediately and consult your doctor. Women of childbearing age taking Rosuvastatin MSN should use effective methods of contraception.
• If you have liver disease.
• If you have severe kidney disease.
• If you have recurring or unexplained muscle pain.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C infection).
• If you are taking cyclosporine (a medicine used, for example, after organ transplants).

If any of the above situations apply to you (or if you are in doubt), you should consult your doctor again.

In addition, you should not take Rosuvastatin MSN at a dose of 40 mg (the highest dose):

• If you have moderate kidney disease (if in doubt, consult your doctor),
• If you have thyroid function disorders,
• If you have had recurring or unexplained muscle pain or muscle problems in the past or similar problems in relatives or muscle problems when taking other cholesterol-lowering medicines,
• If you regularly consume large amounts of alcohol,
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian),
• If you are taking other medicines called fibrates, which lower cholesterol levels.

If any of the above situations apply to you (or if you are in doubt), you should consult your doctor again.

Warnings and precautions

Before starting to take Rosuvastatin MSN, you should discuss it with your doctor or pharmacist:

• If you have kidney problems.
• If you have liver problems.
• If you have had recurring or unexplained muscle pain or muscle problems in the past or similar problems in relatives or muscle problems when taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by malaise or fever, you should contact your doctor immediately. You should also tell your doctor or pharmacist about persistent muscle weakness.
• If you have ever had a severe skin rash or skin peeling, blisters, and (or) ulcers in the mouth, throat, nose, genitals, and eyes after taking Rosuvastatin MSN or other similar medicines.
• If you have myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).
• If you regularly consume large amounts of alcohol.
• If you have thyroid function disorders.
• If you are taking other medicines called fibrates, which lower cholesterol levels. You should carefully read the leaflet, also if you have taken other cholesterol-lowering medicines in the past.
• If you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir (see "Rosuvastatin MSN and other medicines").
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. Taking fusidic acid with Rosuvastatin MSN can lead to serious muscle problems (rhabdomyolysis), see also "Rosuvastatin MSN and other medicines".
• Patient over 70 years old (as the doctor will determine the appropriate initial dose of Rosuvastatin MSN for the patient).
• Patient with severe respiratory failure.
• Patient of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). The doctor will determine the appropriate initial dose of Rosuvastatin MSN for the patient.

If any of the above situations apply to you (or if you are in doubt):

• You should not take Rosuvastatin MSN at a dose of 40 mg (the highest dose) and consult your doctor or pharmacist before taking any dose of Rosuvastatin MSN.

With the use of Rosuvastatin MSN, serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. If you experience any of the symptoms described in section 4, you should stop taking Rosuvastatin MSN and contact your doctor immediately.

In a small number of patients, taking statins may affect liver function. This can be detected by a simple blood test to check if liver enzyme activity has increased. Therefore, your doctor will usually recommend a blood test (liver enzyme test) before and during treatment with Rosuvastatin MSN.

While taking this medicine, your doctor will closely monitor patients with diabetes and patients at risk of developing diabetes. Patients at risk of developing diabetes are those who have high sugar and fat levels in the blood, are overweight, and have high blood pressure.

Children and adolescents

• Patients under 6 years of age: Rosuvastatin MSN should not be used in children under 6 years of age.
• Patients under 18 years of age: Rosuvastatin MSN 40 mg is not suitable for use in children and adolescents under 18 years of age.

Rosuvastatin MSN and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

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

• Cyclosporine (used, for example, after organ transplants),
• Warfarin, ticagrelor, or clopidogrel (or any other medicine used to thin the blood),
• Fibrates (such as gemfibrozil, fenofibrate) or other cholesterol-lowering medicines (e.g., ezetimibe),
• Medicines used to treat indigestion (used to neutralize stomach acid),
• Erythromycin (an antibiotic), fusidic acid (an antibiotic - see also "Warnings and precautions" and below),
• Oral contraceptive (birth control pill),
• Regorafenib (used to treat cancer),
• Darolutamide (used to treat cancer),
• Cabozantinib (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, sofosbuvir, voxilaprevir, 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).

Rosuvastatin MSN may affect the way these medicines work or these medicines may affect the way Rosuvastatin MSN works.

If it is necessary to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely start taking Rosuvastatin MSN again. Taking Rosuvastatin MSN with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Rosuvastatin MSN if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin MSN, you should stop taking the medicine immediately and contact your doctor. Women of childbearing age taking Rosuvastatin MSN should use effective methods of contraception.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Rosuvastatin MSN does not affect the ability to drive or use machines in most patients. However, some patients may experience dizziness while taking Rosuvastatin MSN. If you experience dizziness, you should contact your doctor before driving or using machines.

Rosuvastatin MSN contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

A full list of ingredients is found in the section: "Contents of the pack and other information".

3. How to take Rosuvastatin MSN

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Usual doses for adults

Using Rosuvastatin MSN to lower high cholesterol levels: Initial dose

Treatment with Rosuvastatin MSN should be started with a dose of 5 mg or 10 mg, even if you have taken other statins in higher doses in the past. The initial dose depends on:

• Cholesterol levels,
• The degree of risk of heart attack or stroke,
• The presence of a factor that may increase the risk of side effects.

Consult your doctor or pharmacist to determine the appropriate initial dose.

Your doctor may prescribe the lowest dose (5 mg) if:

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian),
• You are over 70 years old,
• You have moderate kidney disease,
• You are at risk of muscle pain and muscle problems (myopathy).

Increasing the dose and maximum daily dose

To achieve normal cholesterol levels, your doctor may decide to gradually increase the dose, up to the dose of Rosuvastatin MSN that is suitable for you. If you started with a dose of 5 mg, your doctor may decide to increase it to 10 mg, then 20 mg, and then 40 mg if necessary.

If you started with a dose of 10 mg, your doctor may decide to increase the dose to 20 mg, and then to 40 mg if necessary. There will be a 4-week interval between each dose change.

The maximum daily dose of Rosuvastatin MSN is 40 mg. This only applies to patients with very high cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels are not sufficiently lowered by a dose of 20 mg.

Using Rosuvastatin MSN to reduce the risk of heart attack, stroke, or other similar health problems:

The recommended initial dose is 20 mg per day. However, your doctor may decide to reduce the dose if you have any of the above-mentioned factors.

Use in children and adolescents aged 6 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual initial dose is 5 mg per day. Your doctor may gradually increase the dose until the dose suitable for the patient is reached. The maximum daily dose of Rosuvastatin MSN is 10 mg or 20 mg in children aged 6 to 17 years, depending on the patient's condition. The dose should be taken once daily. Rosuvastatin MSN 40 mg should not be usedin children.

How to take the tablets

Swallow the tablet whole with water.

Rosuvastatin MSN should be taken once a day. Rosuvastatin MSN can be taken at any time of day, with or without food.

To help you remember to take your medicine, you should take it at the same time every day.

Regular medical check-ups to monitor cholesterol levels

It is essential to regularly visit your doctor to check if your cholesterol levels are under control.

Your doctor may increase the dose of Rosuvastatin MSN to the dose suitable for you.

Taking a higher dose of Rosuvastatin MSN than recommended

Contact your doctor or the nearest hospital.

If you go to the hospital or are treated for other illnesses, tell the medical staff that you are taking Rosuvastatin MSN.

Missing a dose of Rosuvastatin MSN

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Rosuvastatin MSN

Before stopping treatment with Rosuvastatin MSN, consult your doctor.

Stopping treatment with Rosuvastatin MSN may cause your cholesterol levels to rise again.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is essential to know what side effects the medicine can cause.

Side effects are usually mild and temporary.

If you experience any of the following side effects, stop taking Rosuvastatin MSN and contact your doctor immediately:

• Breathing difficulties, 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 itching of the skin (with hives).
• Red, flat, round, or oval patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The development of this type of severe skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or hypersensitivity syndrome).

You should also stop taking Rosuvastatin MSN and contact your doctor immediately:

• If you experience unusual muscle pain or muscle problems that persist longer than expected.Muscle symptoms are more common in children and adolescents than in adults. As with other statins, muscle side effects can occur in a small number of patients and rarely can develop into a potentially life-threatening muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you experience a lupus-like syndrome(including rash, joint disorders, and effects on blood cells).

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

• Headache, abdominal pain, constipation, nausea, muscle pain, weakness, dizziness.
• Increased protein in the urine - usually resolves on its own without the need to stop taking Rosuvastatin MSN (only at a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if you have high sugar and fat levels in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

• Rash, itching, or other skin reactions.
• Increased protein in the urine - usually resolves on its own without the need to stop taking Rosuvastatin MSN (at doses of 5 mg, 10 mg, and 20 mg).

Rare side effects (may affect up to 1 in 1,000 people):

• Severe allergic reaction, including swelling of the face, lips, tongue, and (or) throat, which may cause difficulty swallowing and breathing, severe itching of the skin (with hives). If you experience an allergic reaction, stop taking Rosuvastatin MSN and contact your doctor immediately.
• Muscle damage in adults. If you experience unusual muscle pain or muscle problems that persist longer than expected, stop taking Rosuvastatin MSN and contact your doctor immediately.

Rosuvastatin MSN and contact your doctor immediately.

• Severe abdominal pain (pancreatitis).
• Increased liver enzyme activity in the blood.
• Increased tendency to bleed or bruise due to low platelet count.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare side effects (may affect less than 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes), liver inflammation, blood in the urine, nerve damage in the arms and legs (numbness), joint pain, memory loss, gynecomastia (breast enlargement in men).

Side effects with unknown frequency:

• Diarrhea (loose stools), cough, shortness of breath (dyspnea), swelling, sleep disorders, including insomnia and nightmares, sexual dysfunction, depression, breathing difficulties, including persistent cough and (or) shortness of breath or fever, tendon damage, persistent muscle weakness.
• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• Myasthenic syndrome (a disease that causes muscle weakness in the eyes). You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Rosuvastatin MSN

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

Do not use this medicine after the expiry date stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rosuvastatin MSN contains

The active substance is rosuvastatin. One film-coated tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium).

The other ingredients are: microcrystalline cellulose (E 460), crospovidone type B, corn starch, meglumine, mannitol, magnesium stearate.

Tablet coating Opadry II 32K580000 White: hypromellose 15 mPas, lactose monohydrate, titanium dioxide (E 171), triacetin.

What Rosuvastatin MSN looks like and contents of the pack

• Rosuvastatin MSN 5 mg is a white or almost white, biconvex, round film-coated tablet, approximately 7 mm in diameter and 4 mm thick, with the inscription "R5" on one side and smooth on the other.
• Rosuvastatin MSN 10 mg is a white or almost white, biconvex, round film-coated tablet, approximately 7 mm in diameter and 4 mm thick, with the inscription "R10" on one side and smooth on the other.
• Rosuvastatin MSN 20 mg is a white or almost white, biconvex, round film-coated tablet, approximately 9 mm in diameter and 5 mm thick, with the inscription "R20" on one side and smooth on the other.
• Rosuvastatin MSN 40 mg is a white or almost white, biconvex, oval film-coated tablet, approximately 12 mm long, 7 mm wide, and 5 mm thick, with the inscription "R" on one side and "40" on the other.

The tablets are packaged in aluminum/aluminum blisters placed in a cardboard box and in HDPE containers with a desiccant (1 g), with a PP child-resistant closure, in a cardboard box.

Package sizes:

Blisters: 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, or 100 tablets.

HDPE containers: 30 tablets (for 40 mg strength) or 90 tablets (for 5 mg, 10 mg, and 20 mg strengths).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Vivanta Generics s.r.o.

Třtinová 260/1, Čakovice

196 00 Prague 9

Czech Republic

tel.: (+48) 699 711 147

Importer:

Pharmadox Healthcare Ltd.

KW20A, Kordin Industrial Park

Paola, PLA 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Rosuvastatin MSN 5 mg/10 mg/20 mg/40 mg film-coated tablets

Czech Republic:

Corvapro Neo

Slovakia:

Provacor

Poland:

Rosuvastatin MSN

Romania:

Rosuvastatină MSN 5 mg film-coated tablets

Rosuvastatină MSN 10 mg film-coated tablets

Rosuvastatină MSN 20 mg film-coated tablets

Rosuvastatină MSN 40 mg film-coated tablets

Hungary:

Rosuvastatin MSN 5 mg/10 mg/20 mg/40 mg

Date of last revision of the leaflet: 06/2024