Rosuvastatin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – 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 medicinal product.
Please read this leaflet carefully before using the 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. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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 known as 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 simultaneously 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.

Heart attack, stroke, and other related problems may be caused by atherosclerosis. Atherosclerosis
results from the buildup of atherosclerotic plaques in blood vessels.
Why continuous use of Rosucard is important
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.
• 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 does not affect well-being, as it causes no symptoms. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes the narrowed 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 a doctor or if the patient becomes pregnant.

2. Important information before using Rosucard

When not to use Rosucard

• if the patient has a known allergy (hypersensitivity) 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,
• 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 sofosbuvir/velpatasvir/voxilaprevir (used to treat 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 (if in 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 a family member has a history of muscle disorders, or if muscle-related side effects occurred previously during 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 medicines.

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 treatment with 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 a family member has a history of muscle disorders, or if the patient previously experienced muscle-related side effects during treatment with lipid-lowering medicines. The patient should contact their doctor immediately if they develop unexplained muscle pain or discomfort, 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 other 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 cholesterol-lowering fibrates. The patient should read the leaflet carefully, even if they have 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; please refer to the section "Rosucard with other medicines",

• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). Concomitant 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 (as the doctor must determine the 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 the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may occasionally worsen symptoms or trigger the onset of myasthenia (see section 4).

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.

Serious 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 immediately and contact a doctor without delay.
In a small number of patients, statins may affect liver function. To monitor this effect, blood tests to assess liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme activity in 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 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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Inform your doctor if the patient is taking:

• cyclosporine (used, for example, after organ transplantation),
• darolutamide (used in cancer treatment),
• regorafenib (used in cancer treatment),
• warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medicine),
• a fibrate medicine (such as gemfibrozil, fenofibrate) or any other medicine that lowers blood cholesterol (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,
• capmatinib (used in cancer treatment),
• fostamatinib (used in treatment of low platelet count),
• febuxostat (used in treatment and prevention of high blood uric acid levels),
• teriflunomide (used in treatment of multiple sclerosis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, used alone or in combination with other medicines (see: "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• roxadustat (used to treat anaemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis).

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 a bacterial infection, Rosucard should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Rosucard. Concomitant use of Rosucard with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
More information about rhabdomyolysis can be found in section 4.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Rosucard during pregnancy or while 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 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 lactose monohydrate and sodium
If the patient has been diagnosed with intolerance to certain 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, meaning it is essentially "sodium-free".

3. How to use Rosucard

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Rosucard is available in the following strengths: 10 mg, 20 mg, 40 mg.
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 scored line marked on it.
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 a doctor or pharmacist which starting dose of rosuvastatin is most appropriate for the patient.
The 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 to severe kidney disease,
• the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation and maximum daily dose
The doctor may decide to increase the dose as appropriate for the patient's needs.
If the patient started treatment at 5 mg, the doctor may decide to increase the dose to 10 mg, then to 20 mg or 40 mg, if necessary. If the patient started treatment at 10 mg, the doctor may decide to increase the dose to 20 mg, then to 40 mg, if necessary. The treatment period with a given dose before any further increase should last 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, the doctor may decide to reduce the dose 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 aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg once daily, and the doctor may gradually increase the dose as appropriate for the patient. 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. The 40 mg strength of Rosucard should not be used in children.
How to take the medicine
Swallow the tablet 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 aid memory.
Cholesterol monitoring tests
To ensure that cholesterol levels have decreased and remain within the target range, regular check-ups and blood tests are necessary.
The doctor may decide to increase the dose of Rosucard as appropriate for the patient.
Accidental overdose of Rosucard
If more than the recommended dose of Rosucard has been taken, contact a doctor or go to the nearest hospital immediately.
If the patient is in hospital or being treated for another condition, they should inform the doctor or medical staff that they are taking Rosucard.
Missed dose of Rosucard
There is no cause for concern. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Rosucard treatment
Inform the doctor if the patient wishes to stop taking Rosucard. Cholesterol levels may rise again if treatment with Rosucard is discontinued.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It is important for the patient to be aware of which adverse effects may occur. Usually they are
mild and resolve shortly after starting treatment.
You must stop taking Rosucard immediately and seek medical help if any of 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 itching of the skin (with lumps);
• Red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genital organs and around the eyes. Such potentially life-threatening 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).

You should stop taking Rosucard and contact your doctor immediately if the following occur:

• Unexpected muscle symptoms or pain that persist longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, in a very small number of patients, adverse effects on muscles have been observed, which very rarely may progress to potentially life-threatening muscle damage called rhabdomyolysis (rare adverse effects).
• Symptoms of a lupus-like syndrome (such as rash, joint disorders and effects on blood cells).
• Muscle rupture.

The following adverse effects 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 1,000 patients):

• 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 a patient suspects an allergic reaction, they should immediately stop taking Rosucard and seek medical help,
• Muscle damage in adults – caution is advised; stop taking Rosucard and contact your 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,
• Easier than usual bleeding or bruising due to low platelet count (thrombocytopenia),
• Symptoms of a lupus-like syndrome (such as 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 (inflammation of the liver),
• Joint pain,
• Blood in urine,
• Nerve damage in the upper and lower limbs (felt as numbness),
• Memory loss,
• Breast enlargement in men (gynecomastia).

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

• Depression,
• Persistent muscle weakness,
• Tendon damage,
• Sleep disturbances (including insomnia and nightmares),
• Diarrhea (loose stools),
• Cough,
• Shallow breathing,
• Swelling,
• Sexual dysfunction,
• Breathing problems (persistent cough and/or shallow breathing or fever),
• Myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing),
• Ocular myasthenia (a disease causing weakness of the eye muscles). You should speak to your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

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

5. How to store the medicine Rosucard

Keep the medicine 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 stated month.
Store below 25°C in the original packaging to protect from light and moisture.
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 the medicine Rosucard contains
The active substance is rosuvastatin.
Each coated tablet contains 10 mg of rosuvastatin in the form of rosuvastatin calcium.
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
Rosucard 10 mg, coated tablets: light pink, coated, oval, biconvex tablets with a division line marked, 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, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Lithuania, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing Authorization numbers in Lithuania, country of export:
LT/1/10/1961/002
LT/1/10/1961/004
Parallel Import Authorization number: 13/21

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