Rosuvastatin Msn

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents 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. This means that 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 and increased physical activity have been insufficient to achieve normal cholesterol levels. While taking Rosuvastatin MSN, the patient 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 can be caused by a disease called atherosclerosis. Atherosclerosis is the result of the deposition 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 the walls of blood vessels, 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.

The patient should continue taking Rosuvastatin MSNeven if normal cholesterol levels have been achieved, as the medicine prevents the cholesterol level from rising againand causing the accumulation of fatty deposits.

However, the patient should stop taking the medicine if their doctor advises them to do so or if they become pregnant.

2. Important information before taking Rosuvastatin MSN

When not to take Rosuvastatin MSN:

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

If any of the above situations apply to the patient (or in case of doubt), they should consult their doctor again.

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

• If the patient has moderate kidney disease (in case of doubt, they should consult their doctor),
• If the patient has thyroid function disorders,
• If the patient has a history of recurring or unexplained muscle pain or muscle problems, or similar problems in relatives, or muscle problems while taking other cholesterol-lowering medicines in the past,
• If the patient regularly consumes large amounts of alcohol,
• If the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian),
• If the patient is taking other medicines called fibrates, which lower cholesterol levels.

If any of the above situations apply to the patient (or in case of doubt), they should consult their doctor again.

Warnings and precautions

Before starting to take Rosuvastatin MSN, the patient should discuss it with their doctor or pharmacist:

• If the patient has kidney problems.
• If the patient has liver problems.
• If the patient has a history of recurring or unexplained muscle pain or muscle problems, or similar problems in relatives, or muscle problems while taking other cholesterol-lowering medicines in the past. In case of unexplained muscle pain, especially if accompanied by a feeling of illness or fever, the patient should consult their doctor immediately. They should also tell their doctor or pharmacist about persistent muscle weakness.
• If the patient has 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 the patient has myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• If the patient regularly consumes large amounts of alcohol.
• If the patient has thyroid function disorders.
• If the patient is taking other medicines called fibrates, which lower cholesterol levels. The patient should carefully read the leaflet, especially if they have taken other cholesterol-lowering medicines in the past.
• If the patient is taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir (see "Rosuvastatin MSN and other medicines").
• If the patient is taking or has 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".
• Patients over 70 years old (as the doctor will determine the appropriate initial dose of Rosuvastatin MSN for the patient).
• Patients with severe respiratory failure.
• Patients 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 the patient (or in case of doubt):

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

Rarely, serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking Rosuvastatin MSN. If the patient experiences any of the symptoms described in section 4, they should stop taking Rosuvastatin MSN and consult their 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, the doctor will usually recommend a blood test (liver enzyme test) before starting and during treatment with Rosuvastatin MSN.

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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient should inform their doctor if they are taking any of the following medicines:

• Cyclosporin (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, velpatasvir, 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 action of these medicines or these medicines may affect the action of Rosuvastatin MSN.

If it is necessary to take oral fusidic acid to treat a bacterial infection, the patient should temporarily stop taking Rosuvastatin MSN. The doctor will inform the patient when it is safe to 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

Rosuvastatin MSN should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant while taking Rosuvastatin MSN, they should stop taking the medicine immediately and consult their doctor. Women of childbearing age taking Rosuvastatin MSN should use effective methods of contraception.

The patient should consult their doctor or pharmacist 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 the patient experiences dizziness, they should consult their doctor before driving or using machines.

Rosuvastatin MSN contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

A full list of ingredients can be found in the section: "Package contents and other information".

3. How to take Rosuvastatin MSN

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Usual doses for adult patients

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 the patient has 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.

The patient should consult their doctor or pharmacist to determine the appropriate initial dose.

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

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

Increasing the dose and maximum daily dose

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

If the patient starts with a dose of 10 mg, the doctor may decide to increase it 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, who have not achieved sufficient cholesterol reduction with 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, the doctor may decide to reduce the dose if the patient has any of the above-mentioned factors.

Using Rosuvastatin MSN 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. The doctor may gradually increase the dose until the appropriate dose for the patient is reached. The maximum daily dose of Rosuvastatin MSN is 10 mg or 20 mg for children aged 6 to 17 years, depending on the patient's health. The dose should be taken once daily. Rosuvastatin MSN 40 mg should not be usedin children.

How to take the tablets

The tablet should be swallowed 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.

In order to remember to take the medicine, it should be taken at the same time every day.

Regular medical check-ups to monitor cholesterol levels

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

The doctor may increase the dose of Rosuvastatin MSN to a dose suitable for the patient.

Taking a higher dose of Rosuvastatin MSN than recommended

The patient should consult their doctor or the nearest hospital.

If the patient goes to the hospital or is treated for other illnesses, they should inform the medical staff that they are taking Rosuvastatin MSN.

Missing a dose of Rosuvastatin MSN

If a dose is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Rosuvastatin MSN

Before stopping treatment with Rosuvastatin MSN, the patient should consult their doctor.

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

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin MSN can cause side effects, although not everybody gets them.

It is essential for the patient to know what side effects of Rosuvastatin MSN may occur.

Side effects are usually mild and temporary.

If the patient experiences any of the following side effects, they should stop taking Rosuvastatin MSN and consult their 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 lumps).
• 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 occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or hypersensitivity syndrome).

The patient should also stop taking Rosuvastatin MSN and consult their doctor immediately:

• If they experience unusual muscle pain or muscle problems that persist longer than expected.Muscle symptoms occur more frequently in children and adolescents than in adults. As with other statins, muscle side effects can rarely develop into a potentially life-threatening muscle injury called rhabdomyolysis.
• If they experience muscle rupture.
• If they 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 with a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient while they 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 (with 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 lumps). In case of an allergic reaction, the patient should stop taking Rosuvastatin MSN and consult their doctor immediately.
• Muscle damage in adults. If the patient experiences unusual muscle pain or muscle problems that persist longer than expected, they should stop taking Rosuvastatin MSN and consult their doctor immediately.

Rosuvastatin MSN and consult their 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 may include:

• Diarrhea (loose stools), cough, shortness of breath (dyspnea), swelling, sleep disorders, including insomnia and nightmares, sexual function disorders, 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).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience muscle weakness in their hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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

Reporting side effects can also be done to the marketing authorization holder.

5. How to store Rosuvastatin MSN

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the packaging, bottle, and blister after: EXP. The expiry date refers to the last day of the specified month.

There are no special storage instructions for the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rosuvastatin MSN contains

The active substance of the medicine is rosuvastatin. One film-coated tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin ( Rosuvastatinum) (in the form of 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, are white or almost white, biconvex, round film-coated tablets, with a diameter of 7 mm and a thickness of 4 mm (approximately), with the inscription "R5" on one side and smooth on the other side.
• Rosuvastatin MSN, 10 mg, are white or almost white, biconvex, round film-coated tablets, with a diameter of 7 mm and a thickness of 4 mm (approximately), with the inscription "R10" on one side and smooth on the other side.
• Rosuvastatin MSN, 20 mg, are white or almost white, biconvex, round film-coated tablets, with a diameter of 9 mm and a thickness of 5 mm (approximately), with the inscription "R20" on one side and smooth on the other side.
• Rosuvastatin MSN, 40 mg, are white or almost white, biconvex, oval film-coated tablets, with a length of 12 mm, width of 7 mm, and thickness of 5 mm (approximately), with the inscription "R" on one side and "40" on the other side.

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 cap with a 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 package 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