Rosuvastatin

Package leaflet: information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rosucard (Rosuvacard), 20 mg, film-coated tablets
Rosuvastatinum
Rosucard and Rosuvacard are different trade 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 you experience any adverse reactions, including those not listed in this leaflet, tell 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 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 levels.

Your doctor has prescribed a statin because dietary changes and increased physical activity
have proven insufficient to achieve normal blood cholesterol levels.
Patients taking Rosucard should also follow a cholesterol-lowering diet and engage in regular physical activity.
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 other related problems 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 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: 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, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off 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 diseases.
Even if cholesterol levels become normal after taking Rosucard, you must continue taking the medicine. This prevents cholesterol levels from rising again, which could lead to further fatty deposits.
You should stop taking the medicine 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 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 in 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 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 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 previously experienced a 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 (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, orally or by injection, a medicine containing fusidic acid (used in bacterial infections). Concurrent 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). The doctor will determine the appropriate starting dose of Rosucard for these patients.

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:
Severe 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 and contact a doctor immediately.
In a small number of patients, statins may affect liver function. To confirm such effects, 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 (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, 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.

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. Concurrent 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 operating machinery
Most people can drive vehicles 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 the medicine 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,
you should consult your 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 score 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 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 to 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 a 5 mg dose, your doctor may decide to increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If the patient started treatment with a 10 mg dose, your doctor may decide to increase it to 20 mg, then to 40 mg, if necessary.
The treatment period at a fixed 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 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, 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. Your 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 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 are within the normal range, regular check-ups and blood tests should be performed.
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 Rosucard than recommended, 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.
If you forget to take Rosucard
There is no need to 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 tell 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 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 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 swallowing;
• Severe skin itching (with hives);
• Red, flat, disc-shaped or round rashes on the trunk, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genital organs, and around the eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

You should stop taking Rosucard and contact your doctor immediately:

• If unexpected muscle pain or discomfort occurs and 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 adverse muscle effects, which very rarely may progress to a potentially life-threatening muscle damage known as rhabdomyolysis (rare adverse effect).
• 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 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;
• 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 risk of developing diabetes is higher if the patient has high 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 (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 skin itching (with hives). If an allergic reaction is suspected, the patient 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 discomfort persists longer than expected;
• Severe abdominal pain (pancreatitis);
• Increased liver enzyme levels in blood;
• Easier than usual bleeding or bruising due to low platelet count (thrombocytopenia);
• Lupus-like disease 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 effects
If any adverse effects occur, including those 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to gather 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.
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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Rosucard contains
The active substance is rosuvastatin.
One coated tablet contains 20 mg of rosuvastatin as 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
Pink, coated, oval, biconvex tablets approximately 11.1 mm in length and 5.6 mm in width.
Pack sizes:
30, 90 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Latvia, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Latvia, country of export: 10-0008
Parallel import authorisation number: 455/21