Rosucard

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Rosucard

10 mg, film-coated tablets

Rosuvastatinum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any further doubts, the patient 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 any side effects occur, including those not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Rosucard and what is it used for

Rosucard belongs to a group of medicines called statins.

Rosucard is recommended for use because:

• The patient has been found to have high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Rosucard is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.

The doctor has prescribed a statin because diet changes and increased physical activity have proven insufficient to achieve normal cholesterol levels in the blood. The patient taking Rosucard should also follow a low-cholesterol diet and exercise regularly. Alternatively,

• Rosucard is also recommended if the patient has other factors that increase the risk of heart attack (myocardial infarction), stroke, or similar diseases.

Heart attack, stroke, and other problems can be caused by atherosclerosis of the arteries. Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in the blood vessels.

Why is it important to take Rosucard constantly

Rosucard is used to achieve normal levels of fatty substances in the blood, called lipids. The most common of these is cholesterol. There are different types of cholesterol in the blood, so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosucard may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.

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• The action of Rosucard involves inhibiting the production of "bad" cholesterol in the body. It also helps to remove "bad" cholesterol from the blood.

In most people, increased cholesterol levels do not change their well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, fatty deposits accumulate in the walls of blood vessels and their narrowing. Sometimes, the narrowed blood vessel may become blocked, disrupting blood flow to the heart or brain, and consequently leading to a heart attack or stroke. Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases. Even if the cholesterol level is normal after taking Rosucard, the patient should continue to take it. This prevents the cholesterol level from increasing again, which causes the accumulation of fatty substances. The patient should stop taking the medicine if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Rosucard

When not to take Rosucard

• if the patient has been found to be allergic (hypersensitive) to rosuvastatin or any of the other ingredients of the medicine (listed in section 6),
• if the patient is pregnant or breastfeeding. If a woman taking Rosucard becomes pregnant, she should stop taking it immediately and inform her doctor. Women taking Rosucard should use effective methods of contraception,
• if the patient has liver disease,
• if the patient has severe kidney disease,
• if the patient has frequent or unexplained muscle pains or weaknesses,
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used in viral hepatitis C infection),
• if the patient is taking cyclosporin (a medicine used, for example, after organ transplantation).

If any of the above situations apply to the patient or the patient has doubts, they should contact their doctor again.

In addition, do not take Rosucard, 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubt, the patient should ask their doctor),
• if the patient has thyroid disease,
• if the patient has frequent or unexplained muscle pains or weaknesses, or if the patient or their family members have had muscle diseases or previously experienced muscle disorders while taking cholesterol-lowering medicines,
• if the patient regularly consumes large amounts of alcohol,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• if the patient is taking fibrate medicines, i.e., other cholesterol-lowering medicines.

If any of the above situations apply to the patient (or the patient has doubts), they should contact their doctor again.

Warnings and precautions

Before starting to take Rosucard, the patient should consult their doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has liver disease,
• if the patient has frequent or unexplained muscle pains or weaknesses, or if the patient or their family members have had muscle diseases or previously experienced muscle disorders while taking cholesterol-lowering medicines,

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The patient should immediately contact their doctor if they experience unexplained muscle pains or weaknesses, especially if accompanied by general malaise and fever. The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness,

• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and (or) ulcers in the mouth after taking Rosucard or other similar medicines,
• if the patient regularly consumes large amounts of alcohol,
• if the patient has thyroid disease,
• if the patient has severe respiratory failure,
• if the patient is taking cholesterol-lowering medicines from the fibrate group. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before,
• if the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and (or) atazanavir, the patient should refer to the information in the section: "Rosucard and other medicines",
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (an antibiotic used in bacterial infections). Taking fusidic acid with Rosucard may lead to severe muscle damage (rhabdomyolysis); see the section "Rosucard and other medicines",
• if the patient is over 70 years old (because the doctor must choose the appropriate initial dose of Rosucard for the patient),
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor will determine the appropriate initial dose of Rosucard.

If any of the above situations apply to the patient (or the patient has doubts):

• the patient should not take Rosucard at a dose of 40 mg (the highest dose), and before taking Rosucard at any other dose, they should consult their doctor or pharmacist.

When to exercise special caution when taking Rosucard:

In connection with the use of Rosucard, severe skin reactions have been reported, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, the patient should stop taking Rosucard and seek medical help immediately.

A small group of patients taking statins may experience liver function disorders. To confirm such an effect, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends performing a liver enzyme activity test in the blood before starting and during treatment with Rosucard.

Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

• if the patient is under 6 years old: Rosucard should not be used in children under 6 years old.
• if the patient is under 18 years old: Rosucard at a dose of 40 mg is not suitable for use in children and adolescents under 18 years old.

Rosucard 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 tell their doctor if they are taking:

• cyclosporin (used, for example, after organ transplantation),
• darolutamide (used in the treatment of cancer),
• regorafenib (used in the treatment of cancer),
• warfarin or clopidogrel (or any other blood-thinning medicine),
• a medicine from the fibrate group (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also the section "Warnings and precautions" and the section "Rosucard and other medicines"),
• oral contraceptives ("the pill"),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, given alone or in combination with other medicines (see also the section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Rosucard may change the effect of these medicines or these medicines may change the effect of Rosucard.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Rosucard. The doctor will inform the patient when they can safely start taking Rosucard again. Taking Rosucard with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis); see the section "Rosucard and other medicines".

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Rosucard should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant while taking Rosucard, they should stop taking it and consult their doctor immediately. Women should avoid becoming pregnant while taking Rosucard, using effective methods of contraception.

Driving and using machines

Most people can drive and use machines while taking Rosucard

• without it affecting their ability. However, some patients may experience dizziness while taking Rosucard. If this symptom occurs, the patient should consult their doctor before driving a vehicle or operating machinery.

Rosucard contains lactose monohydrate and sodium

If the patient has previously been found to be intolerant to some sugars, they should consult their doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Rosucard

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

Recommended dose for adults

Taking Rosucard to lower cholesterol levels

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg of Rosucard, even if the patient has previously taken higher doses of other statins.

A dose of 5 mg can be obtained by dividing a 10 mg tablet along the marked line.

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The size of the initial dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke in the patient,
• the presence of factors that increase the patient's susceptibility to adverse effects.

The patient should ask their doctor or pharmacist which initial dose of rosuvastatin is most suitable for them.

The doctor may decide to use the smallest dose (5 mg) if:

• the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderately severe kidney disease,
• the patient is at risk of muscle diseases (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose so that it is suitable for the patient's needs.

If the patient started treatment with a dose of 5 mg, the doctor may decide to increase it to 10 mg, then to 20 mg, or to 40 mg if necessary. If the patient started treatment with a dose of 10 mg, the doctor may decide to increase it to 20 mg, then to 40 mg if necessary.

The treatment period with the established dose between each increase is 4 weeks.

The maximum daily dose of Rosucard is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom a dose of 20 mg was insufficient to lower cholesterol levels.

Taking Rosucard to reduce the risk of heart attack or stroke or similar health problems

The recommended daily dose is 20 mg, but the doctor may decide to reduce it if the patient has the factors described above.

Use in children and adolescents aged 6-17 years

The dose range for children and adolescents is 5 to 20 mg. The doctor may decide to increase the dose of Rosucard so that it is suitable for the patient's needs. The maximum daily dose of Rosucard is 10 mg or 20 mg for children aged 6 to 17 years, depending on the type of disease being treated. The medicine should be taken once a day. Rosucard at a dose of 40 mg should not be used in children.

How to take the medicine

The tablet should be swallowed whole, with a glass of water.

Rosucard should be taken once a dayat any time, with or without food.

It is recommended to take the medicine at the same time every day to make it easier to remember.

Cholesterol control tests

To ensure that cholesterol levels have decreased and are normal, the patient should regularly undergo check-ups and blood tests.

The doctor may decide to increase the dose of Rosucard so that it is suitable for the patient's needs.

Taking a higher dose of Rosucard than recommended

In case of taking a higher dose of Rosucard than recommended, the patient should contact their doctor or go to the nearest hospital.

If the patient is in the hospital or is being treated for another illness, they should inform their doctor or other medical staff that they are taking Rosucard.

Missing a dose of Rosucard

There is no need to worry; the patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Rosucard treatment

The patient should tell their doctor if they want to stop taking Rosucard. Cholesterol levels may increase again if Rosucard treatment is stopped.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

It is essential for the patient to know which side effects can occur. They are usually mild and disappear shortly after starting treatment.

The patient should stop taking Rosucard immediately and seek medical helpif they experience the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without;
• swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing;
• severe itching of the skin (with hives);
• red, flat, plate-like, or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence 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 or drug hypersensitivity syndrome).

The patient should stop taking Rosucard and contact their doctor immediately:

• if they experience unexpected muscle pains or weaknessesthat last longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, very rare cases of adverse effects on muscles have been reported in Rosucard, which can very rarely lead to potentially life-threatening muscle damage called rhabdomyolysis (rare side effects).
• if the patient has a lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• if the patient experiences muscle rupture.

The following side effects have been reported in patients taking rosuvastatin (the active substance of Rosucard):

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

• headache,
• abdominal pain,
• constipation,
• nausea,
• muscle pain,
• weakness,
• dizziness,
• increased protein in the urine. This symptom usually resolves on its own and does not require stopping Rosucard (only for 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 attending doctor will monitor the patient while taking this medicine.

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

• skin rash, itching, or other skin reactions,

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• increased protein in the urine. This symptom usually resolves on its own and does not require stopping Rosucard (only for doses of 10 mg and 20 mg).

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

• severe allergic reactions - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with hives). If the patient suspects an allergic reaction, they should stop taking Rosucard immediately and seek medical help,
• muscle damage in adults, the patient should exercise caution, i.e., stop taking Rosucard and contact their doctor immediately if they experience muscle pains or weaknesses that last longer than expected,
• severe abdominal pain (pancreatitis),
• increased liver enzyme levels in the blood,
• easy bruising or bleeding due to low platelet count (thrombocytopenia),
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare (may affect up to 1 in 10,000 people):

• jaundice (yellowing of the skin and eyes),
• hepatitis,
• joint pain,
• blood in the urine,
• nerve damage to the arms and legs (felt as numbness),
• memory loss,
• breast enlargement in men (gynecomastia).

Frequency not known (frequency cannot be estimated from the available data):

• depression,
• persistent muscle weakness,
• tendon damage,
• sleep disorders (including insomnia and nightmares),
• diarrhea (loose stools),
• cough,
• shortness of breath,
• edema,
• sexual dysfunction,
• breathing problems (persistent cough and (or) shortness of breath or fever).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Rosucard

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

Store in a temperature below 25°C in the original packaging to protect from light and moisture.

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Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

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. Contents of the packaging and other information

What Rosucard contains

The active substance of Rosucard is rosuvastatin.

One film-coated tablet contains 10 mg of rosuvastatin in the form of rosuvastatin calcium.

Other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;

Coating: hypromellose 2910/5, macrogol 6000, titanium dioxide (E 171), talc, iron oxide red (E 172).

What Rosucard looks like and contents of the pack

Pale pink, film-coated, oval, biconvex tablets with a marked line on one side, approximately 8.8 mm long and 4.5 mm wide. The tablet can be divided into equal doses.

Pack size

30, 90 film-coated tablets.

To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Zentiva, k. s., U Kabelovny 130, 102 37 Prague 10, Czech Republic

Manufacturer:

Zentiva, k. s., U Kabelovny 130, 102 37 Prague 10, Czech Republic

S.C. Zentiva S.A., B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod032266 Romania

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorization number in the Czech Republic, the country of export: 31/168/10-C

Parallel import authorization number: 41/22

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

Bulgaria:

РОСУКАРД

Czech Republic, Estonia, Poland, Romania, Slovakia:

Rosucard

Latvia, Lithuania:

Rosuvacard

Date of leaflet approval: 18.01.2022

[Information about the trademark]

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