Rosuvastatin Krka

Leaflet attached to 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

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 you need to.
In case of any doubts, you should 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. Contents of the packaging 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 a heart attack or stroke. Rosuvastatin Krka is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

The doctor has recommended taking a statin because diet changes and increased physical activity have proven to be insufficient to achieve normal cholesterol levels in the blood. The patient taking Rosuvastatin Krka should also follow a low-cholesterol diet and exercise.
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 may be caused by a disease called atherosclerosis. Atherosclerosis is the result of the accumulation of lipid deposits 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 can lower bad cholesterol levels 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, if left untreated, lipid deposits can accumulate in the walls of blood vessels, causing them to narrow.
It happens that 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 can be reduced.
The patient should continue taking Rosuvastatin Krkaeven if normal cholesterol levels have been achieved, as the medicine prevents the cholesterol level from increasing againand causing lipid deposits to form. 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

• during 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 methods of contraception.
the patient should contact their doctor again.

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

the patient should contact their doctor again.

Warnings and precautions

Before starting to take Rosuvastatin Krka, the patient should consult their doctor or pharmacist:

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

Rosuvastatin Krka 30 mg and 40 mg (the highest dose) should not be taken.

The patient should consult their 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 will usually recommend a blood test (liver enzyme test) before starting and during treatment with Rosuvastatin Krka.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients who have high blood sugar and fat levels, are overweight, and have 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 the patient experiences any of the symptoms described in section 4, they should stop taking Rosuvastatin Krka and contact their doctor immediately.

Children and adolescents

Rosuvastatin Krka 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:

• 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 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 by mouth to treat 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 cause 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

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

3. How to take Rosuvastatin Krka

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 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 risk of a 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.
The patient should consult 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 Rosuvastatin Krka 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 Rosuvastatin Krka to reduce the risk of a 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 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 Rosuvastatin Krka is 10 mg or 20 mg in children aged 6-17 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

The tablet should be swallowed 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, 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 Rosuvastatin Krka to the dose suitable for the patient.

Taking a higher dose of Rosuvastatin Krka 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 Rosuvastatin Krka.

Missing a dose of Rosuvastatin Krka

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

Stopping treatment with Rosuvastatin Krka

Before stopping treatment with Rosuvastatin Krka, the patient should consult their doctor.
Stopping treatment with Rosuvastatin Krka 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, 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 the patient experiences any of the following side effects, they should stop taking Rosuvastatin Krka 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 Rosuvastatin Krka 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-related side effects can rarely develop into a potentially life-threatening muscle injury called rhabdomyolysis.
• Stevens-Johnson syndrome (a severe skin rash with blistering of the skin, mouth, and genitals),
• muscle rupture.
• red, flat, round, or oval 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.
• 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 taking 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):

• 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 taking Rosuvastatin Krka (only 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, the patient should stop taking Rosuvastatin Krka and 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 Rosuvastatin Krka and contact their doctor immediately.
• severe stomach pain (pancreatitis).
• increased liver enzyme activity in the blood.
• increased tendency to bleed or bruise due to low platelet count (thrombocytopenia).
• Stevens-Johnson syndrome (a severe skin rash with blistering of the skin, mouth, and genitals).

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

• jaundice (yellowing of the skin and eyes).
• liver inflammation.
• trace amounts 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 patient should talk to their doctor if they experience muscle weakness in their arms 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
email: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rosuvastatin Krka

The medicine should be stored out of sight and reach of children.
The 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.
The batch number is stated on the packaging after "Lot".
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. Contents of the packaging and other information

What Rosuvastatin Krka contains

• The active substance of the medicine 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 beveled edges and "5" engraved on one side.
Rosuvastatin Krka, 10 mg: white, round (7.5 mm in diameter), slightly convex film-coated tablets with beveled edges and "10" engraved on one side.
Rosuvastatin Krka, 15 mg: white, round (9 mm in diameter), slightly convex film-coated tablets with beveled edges and "15" engraved on one side.
Rosuvastatin Krka, 20 mg: white, round (10 mm in diameter) film-coated tablets with beveled edges.
Rosuvastatin Krka, 30 mg: white, convex film-coated tablets in the shape of a capsule 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.
Rosuvastatin Krka, 40 mg: white, convex 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 the 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