Rosvera

Leaflet accompanying the packaging: patient information

Roswera, 5 mg, film-coated tablets

Roswera, 10 mg, film-coated tablets

Roswera, 15 mg, film-coated tablets

Roswera, 20 mg, film-coated tablets

Roswera, 30 mg, film-coated tablets

Roswera, 40 mg, film-coated tablets

Rosuvastatin

Read the leaflet carefully 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 doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Roswera and what is it used for

Roswera belongs to a group of medicines called statins.
The doctor prescribed Roswera because:

• The patient has high cholesterol levels. This means that they are at risk of a heart attack or stroke. Roswera is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.

The doctor recommended taking a statin because diet changes and increased physical activity
have proven insufficient to achieve normal cholesterol levels in the blood. Patients taking Roswera should also follow a low-cholesterol diet and exercise regularly.
Or

• The patient has other factors that increase the risk of a heart attack, stroke, or other similar health problems.

A heart attack, stroke, or other health problems can be caused by a disease called atherosclerosis. Atherosclerosis is the result of lipid deposits accumulating in the arteries.

Why is it important to continue taking Roswera?

Roswera is used to achieve normal blood levels of fatty substances called lipids, including cholesterol.
There are different types of cholesterol in the blood, namely "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Roswera can lower "bad" cholesterol levels and increase "good" cholesterol levels.
• Roswera helps to slow down the production of "bad" cholesterol in the body and improve the body's ability to remove cholesterol from the blood.

In most people, high cholesterol levels do not affect their well-being, as they do not cause any symptoms. However, if left untreated, lipid deposits can accumulate in the blood vessel walls, causing them to narrow.
In some cases, narrowed blood vessels can become blocked, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of a heart attack, stroke, or other similar health problems associated with high cholesterol levels can be reduced.
Roswera should be continuedeven if normal cholesterol levels have been achieved, as the medicine prevents cholesterol levels from rising againand causing lipid deposits to form. Treatment should be discontinued if the doctor advises it or if the patient becomes pregnant.

2. Important information before taking Roswera

When not to take Roswera

• if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6);
• in pregnancy or during breastfeeding. If the patient becomes pregnant while taking Roswera, the medicine should be stopped immediately and the doctor consulted. Women of childbearing age taking Roswera should use effective methods of contraception;
• if the patient has liver disease;
• if the patient has severe kidney disease;
• if the patient has recurring or unexplained muscle pain;
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called 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 in case of doubt), the doctor should be consulted again.

In addition, Roswera should not be taken in a dose of 30 mg or 40 mg (the highest dose):

• if the patient has moderate kidney disease (in case of doubt, the doctor should be consulted);
• if the patient has thyroid function disorders;
• if the patient has a history of recurring or unexplained muscle pain or muscle problems or similar problems in relatives or muscle problems when taking other cholesterol-lowering medicines in the past;
• if the patient regularly consumes large amounts of alcohol;
• if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India),
• if the patient is taking other medicines called fibrates, which lower cholesterol levels. If any of the above situations apply to the patient (or in case of doubt), the doctor should be consulted again.

Warnings and precautions

Before starting Roswera, the patient should consult their doctor or pharmacist:

• if the patient has kidney problems;
• if the patient has liver problems;
• if the patient has a history of recurring or unexplained muscle pain or muscle problems or similar problems in relatives or muscle problems when taking other cholesterol-lowering medicines in the past. In case of unexplained muscle pain, especially if accompanied by a feeling of illness or fever, the doctor should be consulted immediately. The doctor should also be informed if the patient experiences persistent muscle weakness;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has thyroid function disorders;
• if the patient is taking other medicines called fibrates, which lower cholesterol levels. The patient should carefully read the leaflet, especially if they have taken other cholesterol-lowering medicines in the past;
• if the patient is taking medicines used to treat HIV, such as ritonavir with lopinavir and/or atazanavir, see "Roswera 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 - see also "Warnings and precautions" and "Roswera and other medicines");
• if the patient is over 70 years old (because the doctor needs to choose the right dose of Roswera for the patient);
• if the patient has severe respiratory failure;
• if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India). The doctor will choose the right starting dose of Roswera for the patient;
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth, throat, nose, genitals, and eyes after taking rosuvastatin or other statins;
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes worsen the symptoms of the disease or cause myasthenia (see section 4).

If any of the above situations apply to the patient (or in case of doubt):

• Roswera 30 mg and 40 mg (the highest dose) should not be taken. The doctor or pharmacist should be consulted before taking any dose of Roswera

Roswera.

In a small number of patients, taking statins may affect liver function. This effect can be detected by a simple blood test that checks if liver enzyme activity has increased. Therefore, the doctor usually recommends blood tests (liver enzyme tests) before starting and during treatment with Roswera.
Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor 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 with Roswera. If any of the symptoms described in section 4 occur, Roswera should be discontinued and the doctor consulted immediately.
Children and adolescents

• if the patient is under 6 years old: Roswera should not be used in children under 6 years old.
• if the patient is under 18 years old: Roswera 30 mg and 40 mg are not suitable for use in children and adolescents under 18 years old.

Roswera and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
The doctor should be informed about the following medicines:

• cyclosporine (a medicine used, for example, after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medicine),
• fibrates (e.g., gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• antacids (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see also "Warnings and precautions" and above),
• oral contraceptives,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer)
• hormone replacement therapy,
• 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, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Roswera may affect the action of these medicines or these medicines may affect the action of Roswera.

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

Roswera with food and drink

Roswera can be taken with or without food.

Pregnancy and breastfeeding

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

Driving and using machines

For most patients, Roswera does not affect the ability to drive or use machines. However, some patients may experience dizziness. If dizziness occurs, the patient should consult their doctor before driving or using machines.

Roswera contains lactose (a type of sugar)

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Roswera.

3. How to take Roswera

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.

Usual doses for adult patients

Taking Roswera to lower high cholesterol levels:

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

• cholesterol levels,
• the risk of a heart attack or stroke,
• the presence of a factor that may increase the risk of side effects.

Not all doses of Roswera may be available.
The doctor or pharmacist should be consulted to determine the appropriate initial dose.
The doctor may prescribe the lowest dose (5 mg) if:

• the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India),
• the patient is over 70 years old,
• the patient has moderate kidney disease,
• there is a risk of muscle pain and muscle problems (myopathy).

Dose increase and maximum daily dose
To achieve normal cholesterol levels, the doctor may decide to gradually increase the dose up to a maximum dose of 40 mg once daily. Each dose increase will be done at 4-week intervals.
The maximum daily dose of Roswera is 40 mg. This dose is used only in patients with very high cholesterol levels who are at high risk of a heart attack or stroke and whose cholesterol levels have not decreased sufficiently with lower doses.

Taking Roswera to reduce the risk of a heart attack, stroke, or other similar health problems:

The recommended initial dose is 20 mg once daily. However, the doctor may prescribe a lower dose if the patient has any of the above-mentioned factors.

Taking Roswera 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, and the doctor may gradually increase the dose as needed. The maximum daily dose of Roswera is 10 mg or 20 mg in children aged 6-17 years, depending on the condition. The medicine should be taken once daily. Roswera 30 mg and 40 mg film-coated tablets should not be used in children.

How to take the tablets

The tablet should be swallowed whole with water.
Roswera should be taken once daily. Roswera can be taken at any time of day.
To help remember to take the medicine, it should be taken at the same time every day.

Regular medical check-ups to monitor cholesterol levels

It is essential to regularly visit the doctor to check if cholesterol levels are under control.
The doctor may increase the dose of Roswera to the dose suitable for the patient.

Taking a higher dose of Roswera than recommended

The doctor or the nearest hospital should be consulted.
If the patient goes to the hospital or is treated for other illnesses, the medical staff should be informed about taking Roswera.

Missing a dose of Roswera

The patient should not worry if they miss a dose. The next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping Roswera

Before stopping Roswera, the doctor should be consulted. Stopping Roswera may cause cholesterol levels to rise again.
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, Roswera can cause side effects, although not everybody gets them.
It is essential for the patient to be aware of the possible side effects of Roswera. Side effects are usually mild and temporary.

If any of the following side effects occur, Roswera should be discontinued and the doctor consulted immediately:

breathing problems, 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 lumps).

Roswera should also be discontinued and the doctor consulted immediately if any of the following side effects occur:

• unusual muscle pain or muscle problems lasting longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adults. As with other statins, muscle side effects occur in a small number of patients and can rarely develop into a potentially life-threatening muscle injury called rhabdomyolysis,
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells),
• muscle rupture,
• red, flat, round patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Common side effects (may affect up to 1 in 10 people):

• headache.
• stomach pain.
• constipation.
• nausea.
• muscle pain.
• weakness.
• dizziness.
• increased protein in the urine - this parameter usually returns to normal on its own without the need to stop Roswera (only with a dose of 40 mg).
• diabetes - there is a higher risk of diabetes if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor patients at risk while taking this medicine.

Uncommon side effects (may affect up to 1 in 100 people):

• skin rash, itching, or other skin reactions.
• increased protein in the urine - this parameter usually returns to normal on its own without the need to stop Roswera (with doses of 5-20 mg).

Rare side effects (may affect up to 1 in 1,000 people):

• severe allergic reaction, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing and breathing, severe skin itching (with lumps). In case of an allergic reaction, Roswera should be discontinuedand the doctor consulted immediately.
• muscle injury in adults. If unusual muscle pain or muscle problems occur, as a precaution, Roswera should be discontinued and the doctor consulted immediately.
• severe stomach pain (pancreatitis).
• increased liver enzyme activity in the blood.
• decreased platelet count, which can increase the risk of bleeding or bruising (thrombocytopenia).
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare side effects (may affect less than 1 in 10,000 people):

• jaundice (yellowing of the skin and eyes).
• hepatitis.
• traces of blood in the urine.
• nerve damage in the arms and legs (numbness).
• joint pain.
• memory loss.
• gynecomastia (breast enlargement in men).

Side effects with unknown frequency may include:

• diarrhea.
• cough.
• shortness of breath (dyspnea).
• swelling.
• sleep disorders, including insomnia and nightmares.
• sexual function disorders.
• depression.
• breathing problems, including persistent cough and/or shortness of breath or fever.
• tendon injury.
• persistent muscle weakness.
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• myasthenic syndrome (a disease that causes muscle weakness in the eyes). The doctor should be consulted if the patient experiences muscle weakness in the hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

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

5. How to store Roswera

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
The medicine should be stored in its original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Roswera contains

The active substance of Roswera is rosuvastatin.
Each film-coated tablet contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, or 40 mg of rosuvastatin, in the form of rosuvastatin calcium.
The other ingredients are lactose, microcrystalline cellulose, crospovidone, magnesium stearate, silica colloidal anhydrous in the tablet core, and lactose monohydrate, titanium dioxide (E 171), macrogol 6000, and methacrylic acid - ethyl acrylate copolymer (1:1) in the tablet coating.

What Roswera looks like and what the package contains

Roswera, 5 mg: white, round (7 mm in diameter), slightly convex film-coated tablets with beveled edges and "5" embossed on one side.
Roswera, 10 mg: white, round (7.5 mm in diameter), slightly convex film-coated tablets with beveled edges and "10" embossed on one side.
Roswera, 15 mg: white, round (9 mm in diameter), slightly convex film-coated tablets with beveled edges and "15" embossed on one side.
Roswera, 20 mg: white, round (10 mm in diameter) film-coated tablets with beveled edges.
Roswera, 30 mg: white, capsule-shaped film-coated tablets with a dividing line on both sides (15 mm x 8 mm). The dividing line on the tablet is only to facilitate breaking and not to divide into equal doses.
Roswera, 40 mg: white, capsule-shaped film-coated tablets (16 mm x 8.5 mm).
Packaging:10, 14, 20, 28, 30, 56, 60, 84, 90, 98, or 100 film-coated tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of medicinal products in other EU member states, the local representative of the marketing authorization holder should be contacted:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:27.07.2023