Crosuvo

Leaflet accompanying the packaging: patient information

Crosuvo, 5 mg, film-coated tablets

Crosuvo, 10 mg, film-coated tablets

Crosuvo, 20 mg, film-coated tablets

Crosuvo, 40 mg, film-coated tablets

Rosuvastatinum

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Crosuvo and what is it used for
• 2. Important information before taking Crosuvo
• 3. How to take Crosuvo
• 4. Possible side effects
• 5. How to store Crosuvo
• 6. Package contents and other information

1. What is Crosuvo and what is it used for

Crosuvo belongs to a group of medicines called statins.

Crosuvo is recommended for use because:

• The patient has been found to have high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Crosuvo is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.
• The doctor has recommended taking a statin because diet changes and increased physical activity have proven insufficient to achieve normal cholesterol levels in the blood. The patient taking Crosuvo should also follow a low-cholesterol diet and engage in physical activity.

or

• Crosuvo is also recommended if the patient has other factors that increase the risk of heart attack (myocardial infarction), stroke, or similar diseases.

Heart attack, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in blood vessels.

Why is it essential to take Crosuvo regularly

Crosuvo is used to achieve normal levels of fatty substances in the blood. 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).

• Crosuvo may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Crosuvo involves inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not change their well-being because they do not cause any symptoms. However, if the patient does not receive treatment, it leads to the deposition of fatty substance deposits in the walls of blood vessels and their narrowing.
Sometimes, it may lead to the blockage of a narrowed blood vessel, disruption of blood flow to the heart or brain, and consequently, a heart attack or stroke. Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.
Even if the cholesterol level is normal after taking Crosuvo, the patient should continue taking it. This prevents the cholesterol level from increasing again, which causes the deposition of fatty substances.
The patient should stop taking Crosuvo if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Crosuvo

When not to take Crosuvo:

• if the patient is allergic 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 Crosuvo becomes pregnant, she should stop taking the medicine immediately and consult a doctor. Women taking Crosuvo 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 discomfort or pain,
• if the patient is taking a 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 the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers in the mouth after taking Crosuvo or other medicines from the same group (other statins).

If any of the above situations apply to the patient, or if the patient has doubts, they should consult their doctor again.
Additionally, do not take Crosuvo 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubts, consult a doctor),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle discomfort or pain, or if the patient or their family members have had muscle diseases, or if muscle disorders have occurred while taking cholesterol-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 fibrate medicines, i.e., other cholesterol-lowering medicines.

If any of the above situations apply to the patient (or if the patient has doubts), they should consult their doctor again.

Warnings and precautions

Before starting to take Crosuvo, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has liver disease,
• if the patient experiences frequent or unexplained muscle discomfort or pain, or if the patient or their family members have had muscle diseases, or if the patient has had muscle disorders while taking cholesterol-lowering medicines. The patient should contact their doctor immediately if they experience muscle discomfort or pain of unknown origin, especially if it is accompanied by general malaise and fever. The patient should inform their doctor if they experience persistent muscle weakness.
• if the patient has myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness, including eye muscles), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has thyroid disease,
• if the patient is taking cholesterol-lowering medicines from the fibrate group. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before.
• if the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and (or) atazanavir, they should consult the information in the section: "Crosuvo and other medicines",
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (an antibiotic). Taking fusidic acid at the same time as Crosuvo can lead to severe muscle damage (rhabdomyolysis); see the section "Crosuvo and other medicines".
• if the patient is over 70 years old (as the doctor must choose an appropriate initial dose of Crosuvo for the patient),
• if the patient has severe respiratory failure,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In such patients, the doctor will determine the appropriate initial dose of Crosuvo.

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

Do not take Crosuvo 40 mg (the highest dose), and before taking Crosuvo in any other dose, consult a doctor or pharmacist.

In a small group of patients, statin medicines can affect liver function. To confirm such an effect, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends performing a liver enzyme activity test in the blood before starting and during treatment with Crosuvo.
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 fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking Crosuvo. If any of the symptoms described in section 4 occur, the patient should stop taking Crosuvo and consult their doctor immediately.

Children and adolescents

• if the patient is under 6 years old:Crosuvo should not be used in children under 6 years old.
• if the patient is under 18 years old:Crosuvo 40 mg is not suitable for use in children and adolescents under 18 years old.

Crosuvo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor if they are taking:

• cyclosporine (used, for example, after organ transplantation),
• a fibrate medicine (such as gemfibrozil, fenofibrate), or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used to treat indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and the section "Warnings and precautions"),
• oral contraceptives,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• camptothecin (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, 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 anemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• blood thinners, e.g., warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken with this medicine), ticagrelor, or clopidogrel.

Crosuvo may affect the action of these medicines, or these medicines may affect the action of Crosuvo.

If the patient needs to take fusidic acid orally for a bacterial infection, they should temporarily stop taking Crosuvo. The doctor will inform the patient when it is safe to start taking Crosuvo again. Taking Crosuvo with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

If the patient is taking fusidic acid orally for a bacterial infection, they should temporarily stop taking Crosuvo. The doctor will inform the patient when it is safe to start taking Crosuvo again. Taking Crosuvo with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Crosuvo with food and drink

Crosuvo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Crosuvo should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant while taking Crosuvo, they should stop taking the medicine immediately and consult their doctor. While taking Crosuvo, the patient should avoid pregnancy and use effective methods of contraception.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Most people can drive and operate machines while taking Crosuvo without any problems. However, some patients may experience dizziness while taking Crosuvo. If the patient experiences such symptoms, they should consult their doctor before driving or operating machines.

Crosuvo contains lactose monohydrate and quinoline yellow (E 104)

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Crosuvo.
Due to the presence of quinoline yellow (E 104), the medicine may cause allergic reactions.
A full list of excipients can be found in the section: "Package contents and other information".

3. How to take Crosuvo

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Adults

Taking Crosuvo to lower cholesterol levels

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg, even if the patient has taken higher doses of other statins before. The size of the initial dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke in the patient,
• the presence of factors that increase the patient's susceptibility to adverse effects.

The patient should ask their doctor which initial dose of Crosuvo is most suitable for them.
The doctor may decide to use a dose of 5 mg as the initial dose if:

• the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderately severe kidney disease,
• the patient is at risk of muscle diseases (myopathy).

Dose increase and maximum daily dose

The doctor may decide to increase the dose to suit the patient's needs. If the patient started treatment with a dose of 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 a dose of 10 mg, the doctor may decide to increase it to 20 mg, then to 40 mg if necessary. The treatment period with the established dose between each dose increase is 4 weeks.
The maximum daily dose of Crosuvo is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom a dose of 20 mg was insufficient to lower cholesterol levels.

Taking Crosuvo to reduce the risk of heart attack or stroke or similar health problems

The recommended daily dose is 20 mg, but the doctor may decide to reduce it if the patient has the factors described above.

Taking Crosuvo in children and adolescents aged 6-17 years

The dose range for children and adolescents aged 6-17 years is 5-20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose to suit the patient's needs. The maximum daily dose of Crosuvo in children aged 6-17 years is 10 mg or 20 mg, depending on the disease being treated.
The medicine should be taken once daily. Crosuvo 40 mg should not be used in children.

Taking the medicine

The tablet should be swallowed whole with water.
Crosuvo can be taken with or without food.
It is recommended to take the medicine at the same time every day to make it easier to remember.

Cholesterol control tests

To ensure that cholesterol levels have decreased and are normal, the patient should regularly visit their doctor and have blood tests.
The doctor may decide to increase the dose of Crosuvo to suit the patient's needs.

Taking a higher dose of Crosuvo than recommended

In case of taking a higher dose of Crosuvo than recommended, the patient should consult their doctor or go to the nearest hospital.
If the patient is in the hospital or being treated for another illness, they should inform their doctor or other medical staff that they are taking Crosuvo.

Missing a dose of Crosuvo

The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Crosuvo

The patient should tell their doctor if they want to stop taking Crosuvo. Cholesterol levels may increase again if treatment with Crosuvo is stopped.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Crosuvo can cause side effects, although not everybody gets them. It is essential for the patient to know what side effects can occur. Usually, they are mild and disappear shortly after starting treatment.
The patient should stop taking Crosuvo immediately and seek medical helpif they experience the following allergic reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue, and (or) throat,
• swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing,
• severe itching of the skin (with hives),
• red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

The patient should stop taking Crosuvo and consult their doctor immediatelyif they experience:

• muscle pain or other muscle symptomsthat last longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a very small number of patients have experienced adverse effects on muscles. Rarely, these patients have developed potentially life-threatening muscle damage (rhabdomyolysis).
• muscle rupture,
• symptoms of lupus-like syndrome(such as rash, joint diseases, and hematological changes).

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 treated patients):

• Headache, abdominal pain, constipation, nausea, muscle pain, weakness, dizziness.
• Increased protein in the urine. This symptom usually resolves on its own and does not require stopping treatment (only applies to a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The treating doctor will monitor patients at risk while they are taking this medicine.

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 treated patients):

• Rash, itching, or other skin reactions.
• Increased protein in the urine. This symptom usually resolves on its own and does not require stopping treatment with Crosuvo (only applies to doses of 5 mg, 10 mg, and 20 mg).

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1,000 treated patients):

• Severe allergic reactions - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with hives).

If the patient suspects they have had an allergic reaction, they should stop taking Crosuvo immediately and seek medical help.

• Muscle damage in adults - the patient should exercise caution, i.e., stop taking Crosuvo and consult their doctor immediately if they experience muscle pain or other muscle symptoms that last longer than expected.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme levels in the blood.
• Increased tendency to bleed or bruise due to low platelet count.
• Symptoms of lupus-like syndrome (such as rash, joint diseases, and hematological changes).

Very rare side effects (occurring in less than 1 in 10,000 treated patients):

• Jaundice (yellowing of the skin and eyes), liver inflammation, blood in the urine, nerve damage in the arms and legs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Diarrhea (loose stools), cough, shortness of breath, swelling, sleep disorders (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and (or) shortness of breath or fever), tendon damage, persistent muscle weakness.
• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• Myasthenia gravis (a disease that causes muscle weakness, including eye muscles).

The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Crosuvo

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Do not use this medicine if visible signs of package damage are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Crosuvo contains

• The active substance of Crosuvo is rosuvastatin. Crosuvo film-coated tablets contain calcium rosuvastatin equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
• Other ingredients are:
• Tablet core: microcrystalline cellulose, type 102, lactose monohydrate, spray-dried, crospovidone, type A, magnesium oxide, heavy, magnesium stearate.
• Coating: OPADRY II 31K34257 Pink: lactose monohydrate, triacetin, hypromellose, titanium dioxide (E 171), quinoline yellow (E 104), iron oxide red (E 172).

The patient should read the leaflet carefully before taking Crosuvo and follow the instructions provided by their doctor or pharmacist.