Roswera

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking the medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Roswera is and what it is used for
2. Important information before taking Roswera
3. How to take Roswera
4. Possible side effects
5. How to store Roswera
6. Contents of the pack and other information

1. What Roswera is and what it is used for

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

• You have high cholesterol levels. This means you are at risk of heart attack or stroke. Roswera is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol levels.

Your doctor has recommended a statin because changes in diet and increased physical activity have not been sufficient to achieve normal blood cholesterol levels. While taking Roswera, you should also follow a cholesterol-lowering diet and engage in regular physical exercise.
Or

• You have other risk factors increasing the likelihood of heart attack, stroke, or other similar health problems.

Heart attack, stroke, or other health problems may be caused by a condition called atherosclerosis. Atherosclerosis results from the buildup of fatty deposits (plaques) in the arteries.
Why is it important to take Roswera continuously?
Roswera is used to achieve normal blood levels of fatty substances called lipids, the most common of which is cholesterol. There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Roswera can reduce levels of bad cholesterol and increase levels of good cholesterol.
• Roswera helps inhibit the production of bad cholesterol in the body and improves the body's ability to remove 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 can accumulate in the walls of blood vessels, leading to narrowing.
In some cases, narrowed blood vessels may become completely blocked, interrupting blood flow to the heart or brain, which can result in a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other health problems associated with high cholesterol can be reduced.
You should continue taking Roswera even if normal cholesterol levels are achieved, because the medicine prevents cholesterol levels from rising again, which could lead to further fatty deposits. Treatment should only be stopped on the advice of your doctor or if you become pregnant.

2. Important information before using Roswera

When not to use Roswera

• if the patient has ever had an allergic reaction to rosuvastatin or any of the other ingredients of this medicine (listed in section 6);
• during pregnancy or breastfeeding. If pregnancy occurs while taking Roswera, the medicine must be stopped immediately and the doctor contacted. Women of childbearing potential taking Roswera should use effective contraceptive methods;
• if the patient has liver disease;
• if the patient has severe kidney disease;
• if the patient experiences recurrent or unexplained muscle pain;
• if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C);
• if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation). If any of the above situations apply (or if in doubt), the patient should contact their doctor again.

Additionally, do not take Roswera at a dose of 30 mg or 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubt, contact the doctor);
• if the patient has thyroid function disorders;
• if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in family members, or if muscle problems occurred during previous use of other cholesterol-lowering medicines;
• 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 (or if in doubt), the patient should contact their doctor again.

Warnings and precautions
Before starting treatment with Roswera, consult a doctor or pharmacist:

• if the patient has kidney problems;
• if the patient has liver problems;
• if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in family members, or if muscle problems occurred during previous use of other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by malaise or fever, contact the doctor immediately. The doctor should also be informed if persistent muscle weakness occurs;
• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or lead to the development of myasthenia (see section 4);
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulcers after taking rosuvastatin or other similar medicines;
• 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, even if other cholesterol-lowering medicines were taken previously;
• if the patient is taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and (or) atazanavir – see section "Roswera and 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 to treat bacterial infections). Taking fusidic acid together with Roswera may lead to severe muscle damage (rhabdomyolysis) – see section "Roswera and other medicines";
• if the patient is over 70 years of age (as the doctor must select the appropriate dose of Roswera);
• if the patient has developed severe respiratory failure;
• if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India). The doctor will select the appropriate starting dose of Roswera.

If any of the above situations apply (or if in doubt):

• Do not take Roswera 30 mg or 40 mg (the highest dose). Contact a doctor or pharmacist before taking any dose of Roswera.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Roswera. If any of the symptoms described in section 4 occur, treatment with Roswera must be discontinued and medical advice sought immediately.

In a small number of patients, statins may affect liver function. This effect can be detected by a simple blood test measuring liver enzyme activity. Therefore, the doctor will usually recommend blood tests (liver enzyme activity) before starting and during treatment with Roswera.

Patients with diabetes or at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and fat levels, obesity, and high blood pressure may be at increased risk of developing diabetes.

Children and adolescents

• if the patient is under 6 years of age: Roswera must not be used in children under 6 years of age.
• if the patient is under 18 years of age: Roswera at doses of 30 mg and 40 mg is not appropriate for use in children and adolescents under 18 years of age.

Roswera and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use, including those available without a prescription.

Inform the doctor if the patient is taking any of 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),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic – see below and section "Warnings and precautions"),
• oral contraceptives,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high blood uric acid levels),
• teriflunomide (used to treat multiple sclerosis),
• leflunomide (used to treat rheumatoid arthritis),
• 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,
• roxadustat (used to treat anaemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• momelotinib (used to treat myelofibrosis in adults with anaemia).

Roswera may alter the effect of these medicines or these medicines may alter the effect of Roswera.

If the patient needs to take oral fusidic acid to treat a bacterial infection, Roswera should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Roswera. In rare cases, taking Roswera with fusidic acid may lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Roswera with food and drink
Roswera can be taken regardless of meals.

Pregnancy and breastfeeding
Do not take Roswera during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Roswera, she should stop taking this medicine immediately and contact her doctor. Women of childbearing potential should use effective contraceptive methods while taking Roswera.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
For most patients, Roswera does not affect the ability to drive or operate machinery. However, some patients may experience dizziness. If dizziness occurs, contact the doctor before attempting to drive or operate machinery.

Roswera contains lactose (a type of sugar)
If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Roswera

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.
Usual doses for adult patients
Use of Roswera to lower high cholesterol levels:
Starting dose
Treatment with Roswera should be initiated at a dose of 5 mg or 10 mg, even if the patient has previously taken other statins at higher doses. The starting dose depends on:

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

Not all Roswera doses may be available.
You should contact your doctor or pharmacist to determine the appropriate starting dose.
Your doctor may prescribe the lowest dose (5 mg) if:

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

Increasing the dose and maximum daily dose
Your doctor may decide to increase the dose so that the Roswera dose is appropriate for the patient's needs. If the patient started treatment at 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 at 10 mg, the 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 is 4 weeks.
The maximum daily dose of Roswera is 40 mg. This dose is used only in patients with high cholesterol levels who are at high risk of heart attack or stroke, and in whom cholesterol levels have not sufficiently decreased with lower doses.
Use of Roswera to reduce the risk of heart attack, stroke, or other similar health problems:
The recommended starting dose is 20 mg once daily. However, your doctor may prescribe a lower dose if any of the above-mentioned factors are present in the patient.
Use in children and adolescents aged 6–17 years
The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is typically 5 mg, and the doctor may gradually increase the dose to suit the patient's needs. The maximum daily dose of Roswera is 10 mg or 20 mg in children aged 6 to 17 years, depending on the medical condition. The medicine should be taken once daily. Roswera tablets in doses of 30 mg and 40 mg 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 each day.
Regular medical check-ups to monitor cholesterol levels
It is important to attend regular medical check-ups to ensure that cholesterol levels remain at an appropriate level.
Your doctor may increase the dose of Roswera to suit the individual patient's needs.
Taking more than the recommended dose of Roswera
You should contact your doctor or the nearest hospital immediately.
If you go to the hospital or are treated for other conditions, you must inform the medical staff that you are taking Roswera.
If you miss a dose of Roswera
Do not worry if you miss a dose; take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Roswera
Before stopping Roswera, you should consult your doctor. Stopping treatment with Roswera may cause cholesterol levels to rise again.
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 patients to be aware of the possible adverse reactions that may occur with this medicine.
Adverse reactions are usually mild and short-lived.

You must stop taking Roswera and seek immediate medical help if any of 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 rash on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, 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 body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

You should also stop taking Roswera and contact your doctor immediately:

• If you experience unusual muscle pain or muscle problems lasting longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adults. As with other statins, muscle-related adverse reactions occur in a small number of patients and rarely may progress to potentially life-threatening muscle damage called rhabdomyolysis.
• If muscle rupture occurs,
• If lupus-like syndrome occurs (including rash, joint disorders, and effects on blood cells).

Common adverse reactions (may occur in 1 in 10 to 1 in 100 patients):

• Headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness.
• Increased protein in urine – this parameter usually returns to normal on its own without the need to discontinue Roswera (only at the 40 mg dose).
• Diabetes – there is an increased risk of diabetes if the patient has high blood sugar and fat levels, overweight, and high blood pressure. The treating physician will monitor patients at risk during treatment with this medicine.

Uncommon adverse reactions (may occur in 1 in 100 to 1 in 1,000 patients):

• Rash, itching, or other skin reactions.
• Increased protein in urine – this parameter usually returns to normal on its own without the need to discontinue Roswera (only at doses of 5–20 mg).

Rare adverse reactions (may occur in 1 in 1,000 to 1 in 10,000 patients):

• Severe allergic reaction involving swelling of the face, tongue and (or) throat, which may cause difficulty swallowing and breathing, severe skin itching (with hives). If an allergic reaction occurs, stop taking Roswera immediately and contact your doctor without delay.
• Muscle damage in adults. If unusual muscle pain or muscle problems persist longer than expected, as a precaution you should stop taking Roswera and contact your doctor immediately.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme activity in blood.
• Increased tendency to bleeding or bruising due to low platelet count.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes), hepatitis, trace amounts of blood in urine, damage to nerves of the lower and upper limbs (numbness), joint pain, memory loss, gynecomastia (enlargement of breasts in men).

Adverse reactions with unknown frequency may include:

• Diarrhea (loose stools), cough, shortness of breath (dyspnea), swelling, sleep disturbances including insomnia and nightmares, sexual dysfunction, depression, breathing problems including persistent cough and (or) shortness of breath or fever, tendon damage, persistent muscle weakness.
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing), ocular myasthenia (a disease causing weakness of eye muscles). You should talk to your doctor if you experience weakness in hands or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Roswera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicine.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines no longer in use. This will help protect the
environment.

6. Contents of the packaging and other information

What Roswera contains
The active substance is rosuvastatin.
Each coated tablet contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, or 40 mg of rosuvastatin, as rosuvastatin calcium.
The other ingredients are lactose, microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal silicon dioxide in the tablet core, and monohydrate lactose, titanium dioxide (E 171), polyethylene glycol 6000, and basic butyl methacrylate copolymer in the tablet coating.

What Roswera looks like and contents of the pack
Roswera 5 mg: white, round (diameter 7 mm), slightly biconvex coated tablets with bevelled edges, imprinted with "5" on one side.
Roswera 10 mg: white, round (diameter 7.5 mm), slightly biconvex coated tablets with bevelled edges, imprinted with "10" on one side.
Roswera 15 mg: white, round (diameter 9 mm), slightly biconvex coated tablets with bevelled edges, imprinted with "15" on one side.
Roswera 20 mg: white, round (diameter 10 mm) coated tablets with bevelled edges.
Roswera 30 mg: white, biconvex, capsule-shaped coated tablets with a breakline on both sides (dimensions 15 mm x 8 mm). The breakline is intended only to facilitate tablet fragmentation for easier swallowing and does not ensure equal dose division.
Roswera 40 mg: white, biconvex, capsule-shaped coated tablets (dimensions 16 mm x 8.5 mm).

Packaging: Blister packs containing 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 or 100 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw, Poland
Tel. 22 57 37 500