Rosucard

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Rosucard(Rosuvacard)

10 mg, coated tablets

Rosuvastatinum
Rosucard and Rosuvacard are different trade names for the same medicine.

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

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, you should 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 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. Or

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

Myocardial infarction, stroke, and other problems can be caused by atherosclerosis of the arteries. Atherosclerosis is the result of the deposition of atherosclerotic plaques in 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.
• 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, high 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 narrow them. Sometimes, a narrowed blood vessel can 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 can lead to the accumulation of fatty deposits. The patient should stop taking Rosucard if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Rosucard

When not to take Rosucard

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 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 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.

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 attention immediately.
In a small group of patients, statin medicines may affect liver function. 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 who have high blood sugar and fat levels, are overweight, and have high blood pressure may be at risk of developing diabetes.

Children and adolescents

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 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 used to treat indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also above and "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, given alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Rosucard may affect the action of these medicines or these medicines may affect the action 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).
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 child, they should consult a 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 a doctor immediately. Women should avoid becoming pregnant while taking Rosucard, using appropriate 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 monohydrate and sodium

If the patient has been found to be intolerant to some sugars (lactose, i.e., milk sugar), they should inform their doctor before taking Rosucard.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Rosucard

This medicine should always be taken as directed by a doctor or pharmacist. If the patient has any doubts, they should consult a doctor or pharmacist.

Recommended dose for adults

Taking Rosucard to lower cholesterol levels The initial dose The 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.
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 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 and pain (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 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 so that it is suitable for 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 consult a 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 treatment with Rosucard

The patient should tell their doctor if they want to stop taking Rosucard. Cholesterol levels may increase again if treatment with Rosucard is stopped.
If the patient has any further doubts about taking this medicine, they should consult a 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. They are usually mild and disappear shortly after starting treatment.
The patient should stop taking Rosucard immediately and seek medical attentionif they experience any of 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, 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 discomfort or painthat lasts 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 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 discontinuation of 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 doctor will monitor the patient while they are 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 (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 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 other muscle symptoms 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). -
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).
• The patient should talk to their doctor if they experience weakness in their arms or legs, 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, 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
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 coated tablet contains 10 mg of rosuvastatin in the form of rosuvastatin calcium.
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, silicon dioxide, 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

Rosucard, 10 mg, coated tablets: light pink, 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.
Pack size
30 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

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
Zentiva Romania S.A
Theodor Pallady Bvd, no 50
3 district, 032266, Bucharest
Romania

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, the country of export:
LT/1/10/1961/002
LT/1/10/1961/004
Parallel import authorization number: 13/21

Date of leaflet approval: 12.06.2023

[Information about the trademark]
This medicine is authorized for use in the European Economic Area member states under the following names:
Bulgaria: РОСУКАРД
Czech Republic, Estonia, Poland, Romania, Slovakia: Rosucard
Latvia, Lithuania: Rosuvacard
[Information about the trademark]