Rosuvastatin card

Package leaflet: Information for the patient

Warning! Please keep this leaflet. Information on the immediate packaging is in a foreign language.
Rosucard (Rosuvacard)
10 mg, coated tablets
Rosuvastatinum
Rosucard and Rosuvacard are different brand names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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. Your doctor has prescribed a statin because dietary changes and increased physical activity have not been sufficient to achieve normal blood cholesterol levels. Patients taking Rosucard should continue to 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 it is important to take Rosucard regularly
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: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).
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• Rosucard may reduce the level of "bad" cholesterol and increase the level 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 cause any symptoms and does not affect how a person feels.
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, cutting off blood supply 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 return to normal after starting Rosucard, treatment should be continued. This prevents cholesterol levels from rising again and the re-accumulation of fatty deposits. Treatment should be discontinued only if your doctor advises so, 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 their family members have a history of muscle disorders, or if the patient previously experienced muscle-related side effects while taking 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 fibrates, 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 Rosucard, consult a doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has liver disease,

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• if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or their family has a history of 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 they experience unexplained muscle pain or discomfort, 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 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 fibrates, i.e. other cholesterol-lowering medicines. 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, 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 for 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 old (because 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 (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or lead to the development 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.
  When to exercise particular caution during treatment with Rosucard:
  Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Rosucard. If any of the symptoms described in section 4 occur, treatment with Rosucard should be discontinued and the patient should contact their doctor immediately.

In a small number of patients, statins may affect liver function. To confirm this effect, a blood test assessing liver enzyme activity is performed. Usually, the doctor recommends 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 during treatment with this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at 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.

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• 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 to be used.

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 (such as gemfibrozil, fenofibrate) or any other medicine lowering 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 the treatment of low platelet count),
• febuxostat (used in the treatment and prevention of high blood uric acid levels),
• teriflunomide (used in the treatment of multiple sclerosis),
• 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 fusidic acid orally for bacterial infection treatment, Rosucard should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Rosucard. Rarely, concomitant use of Rosucard with fusidic acid may lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
More information about rhabdomyolysis can be found in section 4.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her 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 abilities. 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 using Rosucard.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

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3. How to use Rosucard

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Rosucard is available in the following doses: 10 mg, 20 mg, 40 mg.
Recommended dose for adults
Use of Rosucard for lowering cholesterol levels
Starting dose
Treatment should begin 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 the 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.

You should ask your doctor or pharmacist which starting dose of rosuvastatin is most appropriate for you.
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 disease,
• the patient is at risk of muscle disorders or 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 5 mg, the doctor may decide to increase it to 10 mg, then to 20 mg or
40 mg, if necessary. If the patient started treatment with 10 mg, the doctor may decide to increase it to 20 mg,
then to 40 mg, if necessary.
The treatment period at a given dose between each dose 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 or stroke or similar health problems
The recommended daily dose is 20 mg; however, the doctor may decide to reduce it if the patient has
any of the risk 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 remember it.
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Cholesterol monitoring tests
To ensure that cholesterol levels have decreased and remain within the normal range, regular check-ups
and blood tests are necessary.
Your doctor may decide to increase the dose of Rosucard as appropriate for the patient.
Accidentally taking more Rosucard than prescribed
If you take more Rosucard than prescribed, contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another condition, you should inform your doctor or medical staff
that you are taking Rosucard.
Missing a dose of Rosucard
Do not be alarmed. Take the next dose at the usual time. Do not take a double dose to make up for a
missed dose.
Stopping Rosucard treatment
You should inform your doctor if you wish to stop taking Rosucard. Cholesterol levels may rise again if
Rosucard is discontinued.
If you have any further questions 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 they do not occur in everyone.
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 patient should immediately stop taking Rosucard and seek medical help 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 in swallowing;
• Severe skin itching (with hives);
• Reddish, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, 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).

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

• If unexpected muscle symptoms or pain occur and persist longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a small number of patients have experienced adverse effects on muscles, which very rarely may progress to a potentially life-threatening muscle damage called rhabdomyolysis (rare adverse reaction).
• If the patient develops a lupus-like disease syndrome (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 affect up to 1 in 10 patients):
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• 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 levels of sugar and lipids, overweight and high blood pressure. The treating physician will monitor patients during treatment with this medicine.

Uncommon (may affect 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 affect 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 the patient suspects an allergic reaction, they should immediately stop taking Rosucard and seek medical help,
• Muscle damage in adults – caution is advised; the patient should stop taking 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 disease syndrome (including rash, joint disorders and effects on blood cells).

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

• Jaundice (yellowing of the skin and eyes),
• Hepatitis (liver inflammation),
• 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 (frequency 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 (edema),
• Sexual dysfunction,
• Breathing problems (persistent cough and/or shallow breathing or fever),
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing),
• Ocular myasthenia (a disease causing weakness of eye muscles).

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The patient should talk to a doctor if they experience weakness in hands or legs, worsening after
periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Reporting of adverse reactions
If any adverse symptoms 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 of 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 collect more information on the safety of the medicine.

5. How to store the medicine Rosucard

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package 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: lactose monohydrate, 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:
28, 30, 84, 90 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Lithuania, the exporting country:
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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

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

Marketing Authorisation numbers in Lithuania, the exporting country:
LT/1/10/1961/001
LT/1/10/1961/002
LT/1/10/1961/003
LT/1/10/1961/004

Parallel import authorisation number: 130/20

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