Rosvera

Leaflet attached to 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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.
Your doctor has prescribed Roswera because:

• The patient has high cholesterol levels. This means that they are at risk of heart attack or stroke. Roswera 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. Patients taking Roswera should also follow a low-cholesterol diet and exercise regularly.
Or

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

Heart attack, stroke, or other health problems can be caused by a disease called atherosclerosis. Atherosclerosis is the result of the accumulation of lipid deposits 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, such as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Roswera can lower "bad" cholesterol levels and increase "good" cholesterol levels.
• Roswera helps to inhibit the production of "bad" cholesterol in the body and improves the 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 walls of blood vessels, 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 heart attack, stroke, or other similar health problems associated with high cholesterol levels can be reduced.
Patients should continue taking Rosweraeven if they have achieved normal cholesterol levels, as the medicine prevents the cholesterol level from increasing againand causing lipid deposits to form. Treatment should be discontinued if advised by a doctor 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, they should stop taking the medicine immediately and contact their doctor. 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 cyclosporin (a medicine used, for example, after organ transplantation). If any of the above situations apply to the patient (or in case of doubt), they should contact their doctor again.

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

• if the patient has moderate kidney disease (in case of doubt, they should contact their doctor);
• 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), they should contact their doctor again.

Warnings and precautions

Before starting to take 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 patient should contact their doctor immediately. They should also inform their doctor if they experience 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;
• in case of 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 will need 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 skin peeling, 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 ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).

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

• Roswera should not be taken at a dose of 30 mg or 40 mg. The patient should contact their doctor or pharmacist 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 will usually recommend a blood test (liver enzyme test) before starting and during treatment with Roswera.
Patient 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, being overweight, and having 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 the patient experiences any of the symptoms described in section 4, they should stop taking Roswera and contact their doctor 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 at doses of 30 mg and 40 mg is not suitable for use in children and adolescents under 18 years old.

Roswera and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
The patient should inform their doctor about taking the following medicines:

• cyclosporin (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 below),
• 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 inform the patient when it is safe to start taking Roswera again. Taking Roswera with fusidic acid can rarely lead to 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 contact 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 the patient experiences dizziness, they should contact their doctor before attempting to drive or use machines.

Roswera contains lactose (a type of sugar)

If the patient has been told that they have an intolerance to some sugars, they should consult their doctor before taking Roswera.

3. How to take Roswera

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

Usual doses for adults

Taking Roswera to lower high cholesterol levels:

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

• cholesterol levels,
• the risk of 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 patient should contact their doctor or pharmacist to determine the appropriate starting 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).

Increasing the dose 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 made 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 heart attack or stroke and whose cholesterol levels have not decreased sufficiently with lower doses.

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

The recommended starting 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 starting 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 being treated. The medicine should be taken once daily. Roswera 30 mg and 40 mg 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. The medicine 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 patient should contact their doctor or the nearest hospital.
If the patient goes to the hospital or is treated for other illnesses, they should inform the medical staff that they are 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. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Roswera

Before stopping treatment with Roswera, the patient should contact their doctor. Stopping treatment with 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 the patient experiences any of the following side effects, they should stop taking Roswera and contact their doctor 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).

The patient should also stop taking Roswera and contact their doctor immediately if they experience any of the following side effects:

• unusual muscle pain or muscle problems lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, muscle side effects 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, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The development of this type of severe skin rash can 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.
• Abdominal pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Increased protein in the urine - this parameter usually returns to normal without the need to stop Roswera (only at 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):

• Rash, itching, or other skin reactions.
• Increased protein in the urine - this parameter usually returns to normal without the need to stop Roswera (at 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, the patient should stop taking Rosweraand contact their doctor immediately.
• Muscle injury in adults. If the patient experiences unusual muscle pain or muscle problemslasting longer than expected, as a precaution, they should stop taking Roswera and contact their doctor immediately.
• Severe abdominal 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).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience muscle weakness in their hands 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 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 will help to 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 patient should ask their pharmacist 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 contents of the pack

Roswera, 5 mg: white, round (7 mm in diameter), slightly convex film-coated tablets with beveled edges and engraved with "5" on one side.
Roswera, 10 mg: white, round (7.5 mm in diameter), slightly convex film-coated tablets with beveled edges and engraved with "10" on one side.
Roswera, 15 mg: white, round (9 mm in diameter), slightly convex film-coated tablets with beveled edges and engraved with "15" on one side.
Roswera, 20 mg: white, round (10 mm in diameter) film-coated tablets with beveled edges.
Roswera, 30 mg: white, oval film-coated tablets with a score line on both sides (15 mm x 8 mm). The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses.
Roswera, 40 mg: white, oval 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 patient should contact the local representative of the marketing authorization holder:
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