Rosuvastatin

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rosucard, 10 mg, film-coated tablets
Rosuvastatinum
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 the same.
• If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 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 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 may also be 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 related conditions may result from atherosclerosis.
Atherosclerosis is caused by the buildup of atherosclerotic plaques in blood vessels.
Why consistent use of Rosucard is important
Rosucard is used to achieve normal levels of fatty substances in the blood, 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 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 their narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, which may result 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 using Rosucard, the medicine should still be taken regularly. This prevents cholesterol levels from rising again and stops further accumulation of fatty deposits. You should stop taking the medicine only if your doctor advises you to do so, or if you become 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 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 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, they should consult 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 their family members have previously had muscle disorders or experienced muscle-related side effects 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 fibrates, i.e. other cholesterol-lowering medicines. If any of the above situations apply to the patient (or if the patient has any doubts), they should consult 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 members have previously had muscle disorders or experienced muscle-related side effects during treatment with lipid-lowering medicines. The patient should contact their doctor immediately if they experience 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 had a severe skin rash, skin peeling, blisters, and/or mouth 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 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; 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 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 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 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, consult a doctor or pharmacist.

When to exercise particular caution when using Rosucard:
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, treatment with Rosucard should be stopped immediately and the patient should contact their doctor without delay.

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 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 to be used.

Tell your doctor if you are 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 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 effects of these medicines, or these medicines may alter the effects of Rosucard.
If the patient needs to take oral fusidic acid for bacterial infection, Rosucard should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Rosucard. Rarely, using 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 fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 must stop taking the medicine immediately and consult her doctor without delay. 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 without any problems. 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 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 the medicine is essentially "sodium-free".

3. How to take Rosucard

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Rosucard is available in the following doses: 5 mg, 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 taken 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.
The choice of starting dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke in the patient,
• 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 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 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 with 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 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.
How to take the medicine
The tablet should be swallowed whole with water.
Rosucard should be taken once daily, at any time, 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 normal range, regular
follow-up visits and blood tests are necessary.
Your doctor may decide to increase the dose of Rosucard as appropriate for the patient.
Taking more Rosucard than prescribed
If you have taken 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 other
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.
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 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 not everyone will experience them.
It is important for the patient to know which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
The use of Rosucard must be stopped 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 circular rashes on the trunk, often with blisters in the center, peeling of the 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).

The use of Rosucard must be discontinued and immediate contact made with a doctor:

• If unexpected discomfort or muscle 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, muscle-related adverse effects have been observed in a very small number of patients, which very rarely may progress to potentially life-threatening muscle damage called rhabdomyolysis (a rare adverse reaction).
• If the patient develops a lupus-like 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 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; Rosucard should be discontinued and immediate contact made with a doctor if muscle pain or other muscle-related symptoms occur and 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),
• Lupus-like syndrome (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 (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).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can 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 reactions helps to collect more information on the safety of the medicine.

5. How to store Rosucard

Keep this 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. Keep 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 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,
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 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., B-dul Theodor Pallady nr. 50, sector 3, Bucharest, 032266, Romania

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

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

Marketing Authorisation Number in the Czech Republic, the country of export: 31/168/10-C
Parallel Import Authorisation Number: 187/22

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