Rosucard

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Rosucard (Rosuvacard)
10 mg, film-coated tablets
Rosuvastatinum
Rosucard and Rosuvacard are different brand 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 share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 to treat high cholesterol levels.

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 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 related conditions may result from atherosclerosis of the arteries.
Atherosclerosis is caused by 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 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 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 how they feel, as it causes no symptoms.
However, without treatment, fatty deposits 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, the medicine should still be taken regularly. This prevents cholesterol levels from rising again and stops further accumulation of fatty deposits.
The medicine 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 this medicine (listed in section 6),
• if the patient is pregnant or breastfeeding. If a woman taking Rosucard becomes pregnant, she should immediately stop taking the medicine and inform her doctor. 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 experiences frequent or unexplained muscle pain or discomfort,
• if the patient is taking the 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 if the patient has any doubts,
they 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 their family members have a history of muscle disorders, or if the patient previously experienced muscle-related problems while taking 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 they experience persistent muscle weakness,
• if the patient has ever developed a severe skin rash, skin peeling, blisters, and/or mouth 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 failure,
• if the patient is taking fibrates (medicines used to lower cholesterol). Please read the package 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; please 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 to treat bacterial infections). Taking fusidic acid together 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 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 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), as statins may occasionally worsen symptoms or trigger myasthenia (see section 4).

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

• before taking Rosucard, consult 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.
Statins may affect liver function in a small number of patients. To monitor this effect, blood tests to check liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme levels 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 blood sugar and lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.
Children and adolescents
Rosucard must not be used in children under 6 years of age.
Rosucard with other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Tell your 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 (such as gemfibrozil, fenofibrate) or any other medicine that lowers blood cholesterol (e.g., ezetimibe),

• medicines used for indigestion (used to neutralize stomach hydrochloric acid),

• erythromycin (an antibiotic),

• fusidic acid (an antibiotic - see below and 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 blood uric acid levels),

• teriflunomide (used to treat 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 to treat a bacterial infection, Rosucard should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Rosucard. Taking 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 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 immediately and consult her doctor. 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 consult their doctor before driving or operating machinery.

Rosucard contains monohydrate lactose 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".

3. How to use Rosucard

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
please 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 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 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.

Please consult your doctor or pharmacist to determine 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 moderately severe kidney disease,
• the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation 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 the dose 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 the dose to 20 mg, then to 40 mg, if necessary.
The treatment period at a given dose between each dose increase should be 4 weeks.
The maximum daily dose of Rosucard is 40 mg. This dose is used in patients with high cholesterol levels
and high risk of heart attack or stroke, in whom the 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, your 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 for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual
starting dose is typically 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 condition being treated.
The medicine should be taken once daily. The 40 mg dose of Rosucard should not be used in children.
How to take 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 the target range, regular check-ups
and blood tests are necessary.
Your doctor may decide to increase the dose of Rosucard as appropriate for the patient.
If you take more Rosucard than you should
If you take more than the prescribed dose of Rosucard, 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 other
healthcare staff that you are taking Rosucard.
If you forget to take 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
Please 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 questions about the use of this medicine, please consult your 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 the possible adverse effects. Usually they are
mild and resolve shortly after starting treatment.
Immediately discontinue use of Rosucard 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 skin itching (with hives);
• Reddish, flat, disc-shaped or round skin lesions on the trunk, often with blisters in the center, peeling skin, and mucosal 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 fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Discontinue use of Rosucard and contact your doctor immediately if the following occur:

• Unexplained muscle pain or discomfort that persists 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 muscle-related adverse effects, which very rarely may progress to a potentially life-threatening condition called rhabdomyolysis (rare adverse effect).
• Symptoms of 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,
• Fatigue,
• Dizziness,
• Diabetes. The risk of developing diabetes is higher in patients with elevated blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor you 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.

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 skin itching (with hives). If an allergic reaction is suspected, discontinue Rosucard immediately and seek medical help,
• Muscle damage in adults – exercise caution; discontinue Rosucard and contact your doctor immediately if muscle pain or other muscle symptoms persist longer than expected,
• Severe abdominal pain (pancreatitis),
• Increased liver enzyme levels in blood,
• Easy or unusual bleeding or bruising due to low platelet count (thrombocytopenia),
• Lupus-like syndrome symptoms (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 (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). Consult your doctor if the patient experiences worsening weakness in hands or legs, especially 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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 to gather additional information on the safety of the medicine.

5. How to store Rosucard

Keep this medicine out of the 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.
Keep in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rosucard contains
The active substance is rosuvastatin.
Each coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
anhydrous colloidal silica, 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
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 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 Romania S.A, Theodor Pallady Bvd, no 50, 3 district, 032266, Bucharest, Romania
Zentiva, k. s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorization Number in Lithuania, country of export: LT/1/10/1961/002
Parallel Import Authorization Number: 253/20

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