Rosuvastatin Krka

Leaflet accompanying the packaging: patient information

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

Rosuvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 Rosuvastatin Krka and what is it 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. Package contents and other information

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

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

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

The doctor has recommended a statin because diet changes and increased physical activity have proven insufficient to achieve normal cholesterol levels. Patients taking Rosuvastatin Krka should also follow a low-cholesterol diet and exercise.
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 may be caused by a disease called atherosclerosis. Atherosclerosis is the result of lipid deposits accumulating in the arteries.

Why it is essential to continue taking Rosuvastatin Krka

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

• Rosuvastatin Krka may lower bad cholesterol and increase good cholesterol levels.
• Rosuvastatin Krka 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 well-being, as they do not cause any symptoms. However, without treatment, lipid deposits may accumulate in the walls of blood vessels, causing them to narrow.
It may happen that narrowed blood vessels can become blocked, disrupting blood flow to the heart or brain, 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.
It is essential to continue taking Rosuvastatin Krkaeven if normal cholesterol levels have been achieved, as the medicine prevents the cholesterol level from rising again and causing lipid deposits. Treatment should be discontinued if the doctor recommends it or if the patient becomes pregnant.

2. Important information before taking Rosuvastatin Krka

When not to take Rosuvastatin Krka

• if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6);
• in pregnancy or breastfeeding. If the patient becomes pregnant while taking Rosuvastatin Krka, the medicine should be stopped immediately and the doctor contacted. Women of childbearing age taking Rosuvastatin Krka should use effective 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 hepatitis C virus infection);
• if the patient is taking cyclosporine (a medicine used, e.g., after organ transplantation). If any of the above situations apply to the patient (or in case of doubt), the doctor should be contacted again.

In addition, Rosuvastatin Krka 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, consult a 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), the doctor should be contacted 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 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 malaise or fever, consult a doctor immediately. Also, inform the doctor if persistent muscle weakness occurs.
• 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. It is essential to read the leaflet carefully, especially when taking other cholesterol-lowering medicines in the past.
• when taking medicines used to treat HIV, e.g., ritonavir with lopinavir and (or) atazanavir, see "Rosuvastatin Krka 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 section "Rosuvastatin Krka and other medicines");
• if the patient is over 70 years old (as the doctor needs to choose the right dose of Rosuvastatin Krka 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 Rosuvastatin Krka for the patient;
• if the patient has ever had a severe skin rash or skin peeling and blistering in the mouth, or if the patient has had a skin rash or skin peeling and blistering in the mouth when taking Rosuvastatin Krka 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 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):

Do not take Rosuvastatin Krka 30 mg and 40 mg (the highest dose).

Consult a doctor or pharmacist before taking any dose of Rosuvastatin Krka.

In a small number of patients, taking statins may affect liver function. This can be detected by a simple blood test to check if liver enzyme activity has increased. Therefore, the doctor usually recommends blood tests (liver enzyme activity test) before starting and during treatment with Rosuvastatin Krka.
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 rosuvastatin. If any of the symptoms described in section 4 occur, stop taking Rosuvastatin Krka and contact a doctor immediately.

Children and adolescents

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

Rosuvastatin Krka and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription.
Inform the doctor about taking the following medicines:

• cyclosporine (a medicine used, e.g., 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 section "Rosuvastatin Krka and other medicines"),
• 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 virus infection, given alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Rosuvastatin Krka may affect the action of these medicines or these medicines may affect the action of Rosuvastatin Krka.

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

Rosuvastatin Krka with food and drink

Rosuvastatin Krka can be taken with or without food.

Pregnancy and breastfeeding

Do not take Rosuvastatin Krka during pregnancy or breastfeeding. If the patient becomes pregnant while taking Rosuvastatin Krka, they should stop taking the medicine immediately and contact a doctor. Women of childbearing age should use effective 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 use machines. However, some patients may experience dizziness. If dizziness occurs, consult a doctor before driving or using machines.

Rosuvastatin Krka contains lactose (a type of sugar)

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

3. How to take Rosuvastatin Krka

Take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, consult a doctor or pharmacist.

Usual doses for adult patients

Taking Rosuvastatin Krka to lower high cholesterol levels:

Starting dose
Treatment with Rosuvastatin Krka 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 starting dose depends on:

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

Not all doses of Rosuvastatin Krka may be available.
Consult a 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).

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 made at 4-week intervals.
The maximum daily dose of Rosuvastatin Krka 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 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, the doctor may prescribe a lower dose if the patient has any of the above-mentioned factors.

Taking Rosuvastatin Krka in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg, and the doctor may gradually increase the dose to the appropriate dose 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 condition. The medicine should be taken once daily. Rosuvastatin Krka 30 mg and 40 mg film-coated tablets should not be used in children.

How to take the tablets

Swallow the tablet whole with water.
Rosuvastatin Krka should be taken once daily.Rosuvastatin Krka can be taken at any time of the day.
To help remember to take the medicine, take it 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 Rosuvastatin Krka to the dose suitable for the patient.

Taking a higher dose of Rosuvastatin Krka than recommended

Consult a doctor or the nearest hospital.
If the patient is hospitalized or treated for other diseases, inform the medical staff about taking Rosuvastatin Krka.

Missing a dose of Rosuvastatin Krka

Do not worry if a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Rosuvastatin Krka treatment

Before stopping Rosuvastatin Krka treatment, consult a doctor.
Stopping Rosuvastatin Krka treatment may cause cholesterol levels to rise again.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin Krka can cause side effects, although not everybody gets them.
It is essential for the patient to be aware of the possible side effects of the medicine. Side effects are usually mild and temporary.

If any of the following side effects occur, stop taking Rosuvastatin Krka and contact a doctor immediately:

Stop taking Rosuvastatin Krka and contact a 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 itching of the skin (with lumps).

Also, stop taking Rosuvastatin Krka and contact a doctor 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-related 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, 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 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).

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 Rosuvastatin Krka (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):

• Rash, itching, or other skin reactions.
• Increased protein in the urine - this parameter usually returns to normal without the need to stop Rosuvastatin Krka (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 itching of the skin (with lumps). If an allergic reaction occurs, stop taking Rosuvastatin Krkaand contact a doctor immediately.
• Muscle damage in adults. If unusual muscle pain or muscle problems occurlasting longer than expected, as a precaution, stop taking Rosuvastatin Krka and contact a doctor immediately.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme activity in the blood.
• Increased tendency to bleed or bruise due to low platelet count (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 damage.
• 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). Consult a doctor 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, tell a 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
email: 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 Rosuvastatin Krka

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
There are no special storage instructions for the medicine.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rosuvastatin Krka contains

• The active substance 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, silicon dioxide 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 Rosuvastatin Krka looks like and contents of the pack

Rosuvastatin Krka, 5 mg: white, round (7 mm in diameter), slightly convex film-coated tablets with a beveled edge and "5" embossed on one side.
Rosuvastatin Krka, 10 mg: white, round (7.5 mm in diameter), slightly convex film-coated tablets with a beveled edge and "10" embossed on one side.
Rosuvastatin Krka, 15 mg: white, round (9 mm in diameter), slightly convex film-coated tablets with a beveled edge and "15" embossed on one side.
Rosuvastatin Krka, 20 mg: white, round (10 mm in diameter) film-coated tablets with a beveled edge.
Rosuvastatin Krka, 30 mg: white, biconvex film-coated tablets in the shape of a capsule 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 into equal doses.
Rosuvastatin Krka, 40 mg: white, biconvex film-coated tablets in the shape of a capsule (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, 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