Rosuvastatin krka

Package leaflet: Information for the user

Rosuvastatin Krka, 5 mg, film-coated tablets
Rosuvastatin Krka, 10 mg, film-coated tablets
Rosuvastatin Krka, 15 mg, film-coated tablets
Rosuvastatin Krka, 20 mg, film-coated tablets
Rosuvastatin Krka, 30 mg, film-coated tablets
Rosuvastatin Krka, 40 mg, film-coated tablets
rosuvastatinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist.
See section 4.

Contents of this leaflet

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

1. What Rosuvastatin Krka is and what it is used for

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

• You have high cholesterol levels. This means you are at increased risk of heart attack or stroke. Rosuvastatin Krka 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 cholesterol levels in your blood. While taking Rosuvastatin Krka, you should continue to follow a cholesterol-lowering diet and engage in regular physical exercise.
Or

• You have other risk factors that increase your risk of heart attack, stroke, or other similar health problems. Heart attack, stroke, or other health problems may be caused by a disease called atherosclerosis. Atherosclerosis results from the buildup of fatty deposits (plaques) in the arteries.

Why is it important to keep taking Rosuvastatin Krka continuously?
Rosuvastatin Krka 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, commonly referred to as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin Krka can reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
• Rosuvastatin Krka helps reduce the body's production of "bad" cholesterol 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 build up in the walls of blood vessels, causing them to narrow.
In some cases, narrowed blood vessels may become completely blocked, interrupting blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, Rosuvastatin Krka reduces the risk of heart attack, stroke, or other health problems associated with high cholesterol.
You should continue taking Rosuvastatin Krka even if your cholesterol levels have returned to normal, because the medicine prevents cholesterol levels from rising again and stops further buildup of fatty deposits. Treatment should only be stopped if your doctor advises it, or if you become pregnant.

2. Important information before using Rosuvastatin Krka

When not to use Rosuvastatin Krka

• 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 Rosuvastatin Krka, the medicine must be stopped immediately and the doctor contacted. Women of childbearing age taking Rosuvastatin Krka should use effective methods of contraception.
• if the patient has liver disease;
• if the patient has severe kidney disease;
• if the patient has 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 to the patient (or if in doubt), the patient should contact their doctor again.

Additionally, do not take Rosuvastatin Krka 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 dysfunction;
• if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in family members or muscle problems occurred while 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 that lower cholesterol levels. If any of the above situations apply to the patient (or if in doubt), the patient should contact their doctor again.

Warnings and precautions
Before starting Rosuvastatin Krka, 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 muscle problems occurred while taking other cholesterol-lowering medicines in the past. 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 of the disease 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 dysfunction;
• if the patient is taking other medicines called fibrates that lower cholesterol levels. The patient should read the leaflet carefully, even if other cholesterol-lowering medicines have been taken in the past.
• when taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, see section "Rosuvastatin Krka 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 (a medicine used for bacterial infections). Taking fusidic acid together with Rosuvastatin Krka may lead to severe muscle damage (rhabdomyolysis);
• if the patient is over 70 years of age (as the doctor must select the appropriate dose of Rosuvastatin Krka for the patient);
• 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 Rosuvastatin Krka for the patient.

If any of the above situations apply to the patient (or if in doubt):
Do not take Rosuvastatin Krka 30 mg and 40 mg (the highest dose).
Contact a doctor or pharmacist before taking any dose of Rosuvastatin Krka.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, stop taking Rosuvastatin Krka and contact a doctor immediately.
In a small number of patients, taking statins may affect liver function. This effect can be detected by a simple blood test checking whether liver enzyme activity has increased. Therefore, the doctor will usually recommend blood tests (liver enzyme activity test) before starting and during treatment with Rosuvastatin Krka.
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.

Children and adolescents

• if the patient is under 6 years of age: Rosuvastatin Krka should not be used in children under 6 years of age.
• if the patient is under 18 years of age: Rosuvastatin Krka 30 mg and 40 mg is not suitable for use in children and adolescents under 18 years of age.

Rosuvastatin Krka and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, 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 hydrochloric 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),
• cemiplimab (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).

Rosuvastatin Krka may alter the effect of these medicines or the above medicines may alter the effect of Rosuvastatin Krka.
If the patient needs to take oral fusidic acid to treat a bacterial infection, Rosuvastatin Krka should be temporarily discontinued. The doctor will inform the patient when it will be safe to restart taking Rosuvastatin Krka. Taking Rosuvastatin Krka with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Rosuvastatin Krka with food and drink
Rosuvastatin Krka can be taken independently of meals.

Pregnancy and breastfeeding
Do not take Rosuvastatin Krka during pregnancy or while breastfeeding. If the patient becomes pregnant while taking Rosuvastatin Krka, she should immediately stop taking this medicine and contact her doctor. Women of childbearing age should use effective methods of contraception while taking Rosuvastatin Krka.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
For most patients, Rosuvastatin Krka does not affect the ability to drive or operate machinery. However, dizziness may occur in some patients. If dizziness occurs, contact the doctor before attempting to drive or operate machinery.

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

3. How to use Rosuvastatin Krka

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Usual doses for adult patients
Use of Rosuvastatin Krka to lower high cholesterol levels:
Starting dose
Treatment with Rosuvastatin Krka 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 any factor that may increase the risk of adverse effects.

Not all Rosuvastatin Krka dosage strengths 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,
• the patient has moderately impaired kidney function,
• there is a risk of muscle pain or muscle problems (myopathy).

Increasing the dose and maximum daily dose
Your doctor may decide to increase the dose so that the dose of Rosuvastatin Krka is appropriate for your needs. If you started treatment at 5 mg, your doctor may decide to increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If you started treatment at 10 mg, your doctor may decide to increase it to 20 mg, then to 40 mg, if necessary. The treatment period at a given dose between each dose increase is 4 weeks.
The maximum daily dose of Rosuvastatin Krka 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 Rosuvastatin Krka 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 risk factors are present.
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 your doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Rosuvastatin Krka 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. Rosuvastatin Krka tablets in 30 mg and 40 mg strengths should not be used in children.
How to take the tablets
The tablet should be swallowed whole with water.
Rosuvastatin Krka should be taken once daily. Rosuvastatin Krka 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 monitor whether cholesterol levels are maintained at an appropriate level.
Your doctor may increase the dose of Rosuvastatin Krka to a level appropriate for your individual needs.
Taking more than the recommended dose of Rosuvastatin Krka
You should contact your doctor or the nearest hospital immediately.
If you are admitted to hospital or are being treated for other conditions, inform the medical staff that you are taking Rosuvastatin Krka.
If you miss a dose of Rosuvastatin Krka
Do not be concerned 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 Rosuvastatin Krka
Before stopping Rosuvastatin Krka, you should consult your doctor.
Stopping Rosuvastatin Krka 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 the patient to be aware of the possible adverse reactions that may occur. Adverse
reactions are usually mild and short-lived.
You must stop taking Rosuvastatin Krka and seek immediate medical help
if any of the following allergic reactions occur:

• breathing difficulties, 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 rash (with nodules),
• red, flat, disc-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, 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 fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

You should also stop taking Rosuvastatin Krka 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 develop into potentially life-threatening muscle damage called rhabdomyolysis.
• if there is a muscle tear,
• 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 spontaneously without the need to discontinue Rosuvastatin Krka (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 in the risk group 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 spontaneously without the need to discontinue Rosuvastatin Krka (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 nodules). If an allergic reaction occurs, stop taking Rosuvastatin Krka and contact your doctor immediately.
• muscle damage in adults. If unusual muscle pain or muscle problems persist longer than expected, as a precaution stop taking Rosuvastatin Krka 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 less than 1 in 10,000 patients):

• Jaundice (yellowing of skin and eyes), hepatitis, trace amounts of blood in urine, damage to nerves of the upper and lower 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 your arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of 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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Rosuvastatin Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word EXP. The expiry date refers to the last day of the specified month.
The batch number is indicated on the packaging after the abbreviation "Lot".
There are no special storage temperature 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 how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rosuvastatin Krka 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, in the form of rosuvastatin calcium.
• The other ingredients are lactose, microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica in the tablet core; and monohydrate lactose, titanium dioxide (E 171), macrogol 6000 and basic butyl methacrylate copolymer in the tablet coating.

What Rosuvastatin Krka looks like and contents of the pack
Rosuvastatin Krka 5 mg: white, round (7 mm in diameter), slightly biconvex coated tablets with bevelled edges and engraved "5" on one side.
Rosuvastatin Krka 10 mg: white, round (7.5 mm in diameter), slightly biconvex coated tablets with bevelled edges and engraved "10" on one side.
Rosuvastatin Krka 15 mg: white, round (9 mm in diameter), slightly biconvex coated tablets with bevelled edges and engraved "15" on one side.
Rosuvastatin Krka 20 mg: white, round (10 mm in diameter) coated tablets with bevelled edges.
Rosuvastatin Krka 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 breaking the tablet for easier swallowing and does not divide the tablet into equal doses.
Rosuvastatin Krka 40 mg: white, biconvex, capsule-shaped coated tablets (dimensions 16 mm x 8.5 mm).
Pack sizes: 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 or 100 coated tablets in blister packs contained 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
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:

For more detailed information about the medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500