Rosucard

Package Leaflet: Information for the Patient

Rosucard, 10 mg, film-coated tablets

Rosucard, 20 mg, film-coated tablets

Rosuvastatine

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. 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 pack 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 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 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.

• 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 regularly

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.
• Rosucard works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not change their well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, it leads to the deposition of fatty deposits in the walls of blood vessels and their narrowing. Sometimes, it may lead to the blockage of a narrowed blood vessel, disruption of blood flow to the heart or brain, and consequently 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 rising again, which causes the deposition of fatty substances. The patient should stop taking Rosucard if the doctor advises it or if the patient becomes pregnant.

2. Important information before taking Rosucard

When not to take Rosucard

• if the patient has hypersensitivity (allergy) 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 and consult a doctor immediately. 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 disorders or pain,
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C),
• if the patient is taking cyclosporine (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, ask a doctor),
• if the patient has thyroid disease,
• if the patient has frequent or unexplained muscle disorders or pain, 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, and 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 a doctor or pharmacist:

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

The patient should immediately contact their doctor if they experience muscle pain or weakness, 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 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 for indigestion (used to neutralize stomach acid),
• if the patient is taking erythromycin (an antibiotic),
• if the patient is taking fusidic acid (an antibiotic - see also section "Warnings and precautions"),
• if the patient is taking oral contraceptives ("the pill"),
• if the patient is taking hormone replacement therapy,
• if the patient is taking capmatinib (used to treat cancer)
• if the patient is taking fostamatinib (used to treat low platelet count)
• if the patient is taking febuxostat (used to treat and prevent high uric acid levels in the blood)
• if the patient is taking teriflunomide (used to treat multiple sclerosis)
• if the patient is taking any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination with other medicines (see also "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• if the patient is taking roxadustat (used to treat anemia in patients with chronic kidney disease).
• if the patient is taking tafamidis (used to treat transthyretin amyloidosis).

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

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

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosucard. If the patient experiences any of the symptoms described in section 4, they should stop taking Rosucard and seek medical attention immediately.

In a small number of patients, statins may affect liver function. To confirm this 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 sugar and fat levels in the blood, 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

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Tell the doctor if the patient is taking:

• cyclosporine (used, for example, after organ transplantation),
• darolutamide (used to treat cancer),
• regorafenib (used to treat cancer),
• warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medicine),
• a fibrate medicine (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also section "Warnings and precautions"),
• oral contraceptives ("the pill"),
• hormone replacement therapy,
• capmatinib (used to treat cancer)
• fostamatinib (used to treat low platelet count)
• febuxostat (used to treat and prevent high uric acid levels 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 with other medicines (see also "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• roxsadustat (used to treat anemia in patients with chronic kidney disease).
• tafamidis (used to treat transthyretin amyloidosis).

Rosucard may affect the way these medicines work, or these medicines may affect the way Rosucard works.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Rosucard. The doctor will tell the patient when it is safe to start taking Rosucard again. Taking Rosucard with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Pregnancy, breastfeeding, and fertility

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

Rosucard should not be taken during pregnancy or while 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 and use 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 or operating machinery.

Rosucard contains lactose and sodium

If the patient has intolerance to some sugars (lactose or milk sugar), they should tell their doctor before taking Rosucard.

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

3. How to take Rosucard

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they 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 scored line.

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 side 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 lowest 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 to suit 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, and then to 20 mg or 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, and then to 40 mg if necessary. The treatment period with the established dose between each dose 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 aged 6 to 17 years is 5 to 20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose to suit 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 disease being treated. The medicine should be taken once daily. 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 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 checks

To ensure that cholesterol levels have decreased and are normal, the patient should regularly visit their doctor and have blood tests.

The doctor may decide to increase the dose of Rosucard to suit the patient's needs.

Taking a higher dose of Rosucard than recommended

If the patient has taken a higher dose of Rosucard than recommended, they should contact their doctor or go to the nearest hospital.

If the patient is in the hospital or 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 treatment with Rosucard

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

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

It is important for the patient to know what side effects can occur. Usually, they are mild and disappear shortly after starting treatment.

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

• difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without it;
• swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing;
• severe itching of the skin (with lumps).
• red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, 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 swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

The patient should stop taking Rosucard and consult their doctor immediately if they experience:

• unexpected muscle pain or weaknessthat persists 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, which can very rarely lead to life-threatening muscle damage called rhabdomyolysis (rare side effects). symptoms of lupus-like syndrome(such as rash, joint diseases, and effects on blood cells). muscle rupture.

The following side effects have been reported with 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 discontinuation of Rosucard (applies only to a dose of 40 mg),
• diabetes. The risk of developing diabetes is higher if the patient has high sugar and fat levels in the blood, is overweight, and has high blood pressure. The treating 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,
• increased protein in the urine. This symptom usually resolves on its own and does not require discontinuation of Rosucard (applies only to 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 lumps). If the patient suspects an allergic reaction, they should stop taking Rosucard immediately and seek medical attention,
• muscle damage in adults, the patient should exercise caution, i.e., stop taking Rosucard and consult their doctor immediately if they experience muscle pain or weakness,
• severe abdominal pain (pancreatitis),
• increased liver enzyme levels in the blood,
• easy bruising or bleeding due to low platelet count (thrombocytopenia).
• symptoms of lupus-like syndrome (such as rash, joint diseases, 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,
• swelling,
• sexual dysfunction,
• breathing problems (persistent cough and (or) shortness of breath or fever).
• 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 those not listed in the leaflet, they should tell their doctor or pharmacist. 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, phone: +48 22 49-21-301, fax: +48 22 49-21-309,

website: https://smz.ezdrowie.gov.pl

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

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rosucard

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

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

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

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

6. Contents of the pack and other information

What Rosucard contains

The active substance of Rosucard is rosuvastatin.

One film-coated tablet contains 10 mg, 20 mg, or 40 mg of rosuvastatin in the form of rosuvastatin calcium.

Other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, silicon dioxide, magnesium stearate;

Coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide red (E172).

What Rosucard looks like and contents of the pack

Rosucard, 10 mg, film-coated tablets: light pink, film-coated, oval, biconvex tablets with a scored line, approximately 8.8 mm long and 4.5 mm wide. The tablet can be divided into equal doses.

Rosucard, 20 mg, film-coated tablets: pink, film-coated, oval, biconvex tablets, approximately 11.1 mm long and 5.6 mm wide.

Package size

28, 30, 84, 90, 98, 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder:

Zentiva k.s.

U kabelovny 130

Dolní Měcholupy

102 37 Prague 10

Czech Republic

Manufacturer:

Zentiva k.s.

U kabelovny 130

Dolní Měcholupy

102 37 Prague 10

Czech Republic

Regarding Rosucard 10 mg:

S.C. ZENTIVA S.A.

B-dul Theodor Pallady, nr. 50, sector 3

032266 Bucharest

Romania

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

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

phone: +48 22 375 92 00

Date of last revision of the leaflet:October 2024