Rosucard

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Rosucard
10 mg, coated tablets
Rosuvastatin
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

1. What Rosucard is and what it is 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 Rosucard is and what it is used for

Rosucard belongs to a group of medicines called statins.
Rosucard is recommended for use because:

• The patient has been diagnosed with high cholesterol levels. This indicates an increased risk of heart attack (myocardial infarction) or stroke. Rosucard is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol levels.

Your doctor has prescribed a statin because changes in diet and increased physical activity
have proven insufficient to achieve normal blood cholesterol levels.
Patients taking Rosucard should also follow a cholesterol-lowering diet and engage in regular
physical exercise.
or

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

Myocardial infarction, stroke, and other complications may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why is it important to take Rosucard consistently
Rosucard is used to achieve normal blood levels of fatty substances known as lipids.
The most common of these is cholesterol.
There are different types of cholesterol in the blood, commonly referred to as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosucard may reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.

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

In most people, elevated cholesterol does not cause any noticeable symptoms or changes in well-being. However, if left untreated, fatty deposits may accumulate in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, resulting in a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels become normal after using Rosucard, treatment should be continued. This prevents cholesterol levels from rising again, which could lead to further accumulation of fatty deposits. Treatment should be discontinued only if advised by your doctor or if the patient becomes pregnant.

2. Important information before using Rosucard

When not to use 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 the medicine immediately and inform her doctor. Women taking Rosucard should use effective contraception methods,
• if the patient has liver disease,
• if the patient has severe kidney disease,
• if the patient experiences frequent or unexplained muscle pain or discomfort,
• if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral hepatitis C infection),
• 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 if the patient has any doubts,
the patient should contact their doctor again.
Additionally, do not use Rosucard 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubt, consult the doctor),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or family members have previously had muscle disorders, or if muscle-related side effects occurred during previous treatment with lipid-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 medicines from the fibrate group, i.e. other cholesterol-lowering drugs.

If any of the above situations apply to the patient (or if the patient has any doubts),
the patient should contact their doctor again.
Warnings and precautions
Before starting Rosucard, consult a doctor or pharmacist:

• if the patient has kidney disease,

• if the patient has liver disease,

• if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or family members have previously had muscle disorders, or if the patient previously experienced muscle-related side effects while taking lipid-lowering medicines. The patient should contact their doctor immediately if unexplained muscle pain or discomfort occurs, especially if accompanied by general malaise or fever. The patient should also inform their doctor or pharmacist if persistent muscle weakness occurs,

• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers 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 insufficiency,

• if the patient is taking fibrate-class cholesterol-lowering medicines. Read the leaflet carefully, even if the patient has previously taken other cholesterol-lowering medicines,

• if the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir, refer to the section "Rosucard with other medicines",

• if the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used for bacterial infections). Concurrent use of fusidic acid with Rosucard may lead to severe muscle damage (rhabdomyolysis); see section "Rosucard with other medicines",

• if the patient is over 70 years of age (because the doctor must select an appropriate starting dose of Rosucard),

• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In these patients, the doctor will determine the appropriate starting dose of Rosucard.

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

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

When to exercise special caution when using Rosucard:
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Rosucard. If any of the symptoms described in section 4 occur, stop taking Rosucard and contact a doctor immediately.
In a small number of patients, statins may affect liver function. To confirm this effect, blood tests to assess liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme activity in blood before 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 lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.
Children and adolescents

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

Rosucard with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform the doctor if the patient is taking:

• cyclosporine (used, for example, after organ transplantation),
• darolutamide (used in cancer treatment),
• regorafenib (used in cancer treatment),
• warfarin or clopidogrel (or any other anticoagulant),
• a fibrate-class medicine (such as gemfibrozil, fenofibrate) or any other medicine that lowers blood cholesterol levels (e.g., ezetimibe),
• medicines used for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see below and section "Warnings and precautions"),
• oral contraceptives ("the pill"),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, administered 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 alter the effect of these medicines or these medicines may alter the effect of Rosucard.

If the patient needs to take oral fusidic acid for bacterial infection treatment, Rosucard should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Rosucard. Concurrent use of Rosucard with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
Further information on rhabdomyolysis can be found in section 4.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Rosucard must not be used during pregnancy or breastfeeding. If a woman becomes pregnant while taking Rosucard, she should stop taking the medicine and consult her doctor immediately. Women should avoid becoming pregnant while taking Rosucard by using appropriate contraceptive methods.
Driving and operating machinery
Most people can drive vehicles and operate machinery while taking Rosucard

• as it does not impair their ability. However, some patients may experience dizziness during treatment with Rosucard. If this symptom occurs, the patient should contact their doctor before driving or operating machinery.

Rosucard contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rosucard

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Recommended dose for adults
Use of Rosucard to lower cholesterol levels
Starting dose
Treatment should be initiated with a dose of 5 mg or 10 mg of Rosucard, even if the patient has previously
used higher doses of other statins.
The 5 mg dose can be obtained by splitting a 10 mg tablet along the score line marked on it.
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The choice of starting dose depends on:

• cholesterol levels,
• the patient's risk level for heart attack or stroke,
• the presence of factors increasing the patient's susceptibility to adverse effects.

Ask your doctor or pharmacist which starting dose of rosuvastatin is most appropriate for the patient.
Your doctor may decide to use the lowest dose (5 mg) if:

• the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea or India),
• the patient is over 70 years of age,
• the patient has moderate kidney impairment,
• the patient is at risk of muscle disorders and muscle pain (myopathy).

Increasing the dose and maximum daily dose
Your doctor may decide to increase the dose as appropriate for the patient's needs.
If the patient started treatment with a 5 mg dose, the doctor may decide to increase it to 10 mg, then
to 20 mg or up to 40 mg, if necessary. If the patient started treatment with a 10 mg dose, the doctor may
decide to increase it to 20 mg and then to 40 mg, if necessary.
The treatment period at a fixed dose between each dose increase is 4 weeks.
The maximum daily dose of Rosucard is 40 mg. This dose is used in patients with high cholesterol levels
and a high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol levels.
Use of Rosucard to reduce the risk of heart attack, stroke or similar health problems
The recommended daily dose is 20 mg; however, your doctor may decide to reduce it if the patient has
any of the factors described above.
Use in children and adolescents aged 6–17 years
The dose range used in children and adolescents is 5 to 20 mg. The doctor may decide to increase
the dose of Rosucard as appropriate 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 daily. Rosucard 40 mg should not be used in children.
Taking the medicine
The tablet should be swallowed whole with water.
Rosucard should be taken once daily, at any time of day, with or without food.
It is recommended to take the medicine at the same time each day to help with remembering.
Cholesterol monitoring tests
To ensure that cholesterol levels have decreased and remain within normal limits, regular check-ups
and blood tests should be performed.
Your doctor may decide to increase the dose of Rosucard as appropriate for the patient.
Taking more Rosucard than recommended
If you take more Rosucard than recommended, contact your doctor or go to the nearest hospital.
If you are in hospital or being treated for another illness, you should inform your doctor or medical staff
that you are taking Rosucard.
Missing a dose of Rosucard
There is no need to worry; take the next dose at the usual time. Do not take a double dose to make up
for a missed dose.
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Stopping Rosucard
You should inform your doctor if you wish to stop taking Rosucard. Cholesterol levels may rise again
if treatment with Rosucard is stopped.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
The medicine Rosucard must be discontinued immediately and medical help sought if the
following allergic reactions occur:

• Difficulty breathing, 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 skin itching (with hives);
• Reddish, flat, disc-shaped or round skin lesions on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genital organs and around the eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The medicine Rosucard should be discontinued and immediate contact made with a doctor:

• If unexpected muscle discomfort or pain occurs and persists longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, adverse effects on muscles have been observed in a very small number of patients, which very rarely may progress to potentially life-threatening muscle damage known as rhabdomyolysis (rare adverse reaction).
• If the patient develops a lupus-like illness (including rash, joint disorders and effects on blood cells).
• If muscle rupture occurs.

The following adverse reactions have been reported with rosuvastatin (the active substance in
Rosucard):
Common (may occur in up to 1 in 10 patients):

• Headache,
• Abdominal pain,
• Constipation,
• Nausea,
• Muscle pain,
• Weakness,
• Dizziness,
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Rosucard (applies only to the 40 mg dose),
• Diabetes. The likelihood of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight and high blood pressure. The treating physician will monitor patients during treatment with this medicine.

Uncommon (may occur in up to 1 in 100 patients):

• Rash, itching or other skin reactions,
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Rosucard (applies only to the 10 mg and 20 mg doses).

Rare (may occur in up to 1 in 1000 patients):

• Severe allergic reactions – symptoms include swelling of the face, lips, tongue and (or) throat, difficulty swallowing and breathing, severe skin itching (with hives). If a patient suspects an allergic reaction, they should immediately stop taking Rosucard and seek medical help,
• Muscle damage in adults – caution is advised; discontinue Rosucard and contact a doctor immediately if muscle pain or other muscle symptoms occur and persist longer than expected,
• Severe abdominal pain (pancreatitis),
• Increased levels of liver enzymes in blood,
• Bleeding or bruising more easily than usual due to low platelet count (thrombocytopenia),
• Lupus-like illness (including rash, joint disorders and effects on blood cells).

Very rare (may occur in up to 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes),
• Hepatitis,
• Joint pain,
• Blood in urine,
• Nerve damage in upper and lower limbs (felt as numbness),
• Memory loss,
• Breast enlargement in men (gynecomastia).

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

• Depression,
• Persistent muscle weakness,
• Tendon damage,
• Sleep disorders (including insomnia and nightmares),
• Diarrhea (loose stools),
• Cough,
• Shallow breathing,
• Swelling,
• Sexual dysfunction,
• Breathing problems (persistent cough and/or shallow breathing or fever).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their
doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rosucard

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must 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 packaging and other information

What Rosucard contains
The active substance is rosuvastatin.
Each coated tablet contains 10 mg of rosuvastatin in the form of rosuvastatin calcium.
The other ingredients are:
Core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;
Coating: hypromellose 2910/5, macrogol 6000, titanium dioxide (E 171), talc, red iron oxide (E 172).

What Rosucard looks like and contents of the pack
Light pink, coated, oval, biconvex tablets with a division line, approximately 8.8 mm in length and 4.5 mm in width. The tablet can be divided into equal doses.
Pack sizes:
30, 90 coated tablets.
For more detailed information, contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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., Bdul Theodor Pallady no. 50, sector 3, Bucharest, cod 032266, Romania

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

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

Marketing authorisation number in the Czech Republic, the country of export: 31/168/10-C
Parallel import licence number: 41/22

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Bulgaria: РOCYKAPД
Czech Republic, Estonia, Poland, Romania, Slovakia: Rosucard
Latvia, Lithuania: Rosuvacard
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