Rosuvastatin

Package leaflet: Information for the patient

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Rosucard (Rosuvacard)
20 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, 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. This medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

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 prescribed 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 or older for the treatment of high cholesterol.

Your doctor has prescribed a statin because changes in diet and increased physical activity
have not been sufficient to achieve normal cholesterol levels in the blood.
Patients taking Rosucard should continue to follow a cholesterol-lowering diet and engage in
regular physical exercise.
or

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

Heart attack, stroke and related conditions may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why consistent 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: 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 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 in the blood reduces the risk of heart attack, stroke or similar conditions.
Even if cholesterol levels return to 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 only be discontinued 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 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 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.
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 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 develop unexplained muscle pain, tenderness or weakness, especially if accompanied by malaise or fever. The patient should also inform their doctor or pharmacist if persistent muscle weakness occurs,
• if the patient has ever had a severe skin rash, skin peeling, blisters and/or oral mucosal 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 lipid-lowering medicines from the fibrate group. 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 currently 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 select an appropriate starting dose of Rosucard),
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, 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):

• before taking Rosucard, the patient should consult their doctor or pharmacist. 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, the patient should stop taking Rosucard and contact their doctor immediately.

In a small number of patients, statins may affect liver function. To confirm such an effect, blood tests are performed to assess liver enzyme activity. 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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
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 tikagrelor (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 to treat cancer),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat 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,
• roxadustat (used to treat anaemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis).

Rosucard may alter the effects of these medicines or these medicines may alter the effects 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. 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.
Rosucard must not be used during pregnancy or breastfeeding. If a woman becomes pregnant while taking Rosucard, she should stop taking the medicine and contact her doctor immediately. Women should avoid becoming pregnant while taking Rosucard by using appropriate contraceptive methods.
Driving and using machines
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 an 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 prescribed 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 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.
A 5 mg dose can be obtained by splitting a 10 mg tablet along the scored line on the tablet.
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).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose as appropriate for your individual needs.
If treatment was initiated at 5 mg, your doctor may decide to increase the dose to 10 mg, then to 20 mg or 40 mg, if necessary. If treatment was initiated at 10 mg, your doctor may decide to increase the dose to 20 mg, then to 40 mg, if necessary.
The treatment period at each dose level between dose increases should last 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 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 the dose 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 5 mg once daily, and your 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 and adolescents aged 6 to 17 years, depending on the condition being treated.
Rosucard should be taken once daily. The 40 mg dose 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 help remember it.
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 your individual needs.
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 worry. Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Rosucard
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 effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
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 immediately stop using 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 swallowing;
• Severe skin itching (with hives);
• Red, 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 inside the eyes. The occurrence of such serious 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 using Rosucard and contact your doctor immediately if:

• Unexpected muscle discomfort or pain that persists 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 into a 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 the use of 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,
• Diabetes. The risk of developing diabetes is higher if the patient has high levels of blood sugar and fats, 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 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 you suspect an allergic reaction, you should immediately stop taking Rosucard and seek medical help,
• Muscle damage in adults – caution is advised; 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,
• Bleeding or bruising more easily than usual due to low platelet count (thrombocytopenia),
• Symptoms of 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,
• 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,
• 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). You should talk to your doctor if you 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 provide more information on the safety of this medicine.

5. How to store Rosucard

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Store 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 wastewater 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 20 mg of rosuvastatin (as rosuvastatin calcium).
The other ingredients are:
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
Pink, film-coated, oval, biconvex tablets with a length of approximately 11.1 mm and a width of approximately 5.6 mm.

Pack size:
28, 30, 84 or 90 film-coated tablets.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation 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

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

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

Marketing Authorisation numbers in Lithuania, country of export:
LT/1/10/1961/006
LT/1/10/1961/005
LT/1/10/1961/007
LT/1/10/1961/008

Parallel import authorisation number: 202/20

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