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 pack and other information

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

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

• The patient has high cholesterol levels. This means that they are 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 taking a statin because diet changes and increased physical activity have not been enough to achieve the correct cholesterol level 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 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 the accumulation of lipid deposits in the arteries.

Why it is important to continue taking Rosuvastatin Krka

Rosuvastatin Krka is used to achieve the correct level of fatty substances in the blood, called lipids, which include 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 the level of bad cholesterol and increase the level of good cholesterol.
• 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 their well-being, as they do not cause any symptoms. However, without treatment, lipid deposits can accumulate in the walls of blood vessels, causing them to narrow.
It happens that narrowed blood vessels can become blocked, which can disrupt 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.
You should continue taking Rosuvastatin Krkaeven if you have achieved the correct cholesterol levels, because the medicine prevents the cholesterol level from rising againand causing lipid deposits. Treatment should be discontinued if the doctor recommends it or if you become pregnant.

2. Important information before taking Rosuvastatin Krka

When not to take Rosuvastatin Krka

• during pregnancy or breastfeeding. If you become pregnant while taking Rosuvastatin Krka, you should stop taking the medicine immediately and consult a doctor. Women of childbearing age taking Rosuvastatin Krka should use effective methods of contraception.
they should consult a doctor again.

In addition, you should not take Rosuvastatin Krka 30 mg and 40 mg (the highest dose):

they should consult a doctor again.

Warnings and precautions

Before starting to take Rosuvastatin Krka, you should consult a doctor or pharmacist:

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

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

You should 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 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 Rosuvastatin Krka.
Patient with diabetes or 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 you experience any of the symptoms described in section 4, you should stop taking Rosuvastatin Krka and consult a doctor immediately.

Children and adolescents

Rosuvastatin Krka and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those available without a prescription.
You should inform your 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 section "Warnings and precautions"),
• 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 also section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, 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 you need to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking Rosuvastatin Krka. Your doctor will tell you when you can safely 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

You should not take Rosuvastatin Krka during pregnancy or while breastfeeding. If you become pregnant while taking Rosuvastatin Krka, you should stop taking the medicine immediately and consult a doctor. Women of childbearing age should use effective methods of contraception while taking Rosuvastatin Krka.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Rosuvastatin Krka is unlikely to affect your ability to drive or use machines. However, some patients may experience dizziness. If you experience dizziness, you should consult a doctor before driving or using machines.

Rosuvastatin Krka contains lactose (a type of sugar)

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

3. How to take Rosuvastatin Krka

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should consult a doctor or pharmacist.

Usual doses for adults

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 you have 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.
You should consult a doctor or pharmacist to determine the correct starting dose.
The doctor may prescribe the lowest dose (5 mg) if:

• you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India),
• you are over 70 years old,
• you have moderate kidney problems,
• you are at risk of muscle pain and muscle problems (myopathy).

Increasing the dose and maximum daily dose
To achieve the correct cholesterol level, the doctor may decide to gradually increase the dose up to a maximum dose of 40 mg once a day. 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 a day. However, the doctor may prescribe a lower dose if you have 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 to 17 years is 5 to 20 mg once a day. The usual starting dose is 5 mg, and the doctor may gradually increase the dose to the level that is right 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 a day. 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 a day. Rosuvastatin Krka can be taken at any time of the day.
To help you remember to take the medicine, you should take it at the same time every day.

Regular medical check-ups to monitor cholesterol levels

It is important to regularly visit your doctor to check if your cholesterol levels are under control.
The doctor may increase the dose of Rosuvastatin Krka to the dose that is right for you.

Taking a higher dose of Rosuvastatin Krka than recommended

You should consult a doctor or the nearest hospital.
If you go to the hospital or are treated for other illnesses, you should inform the medical staff that you are taking Rosuvastatin Krka.

Missing a dose of Rosuvastatin Krka

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

Stopping treatment with Rosuvastatin Krka

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important that you are aware of what side effects the medicine may cause. Side effects are usually mild and temporary.

If you experience any of the following side effects, you should stop taking Rosuvastatin Krka and consult 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 skin itching (with hives).

You should also stop taking Rosuvastatin Krka and consult a doctor immediately if you experience any of the following side effects:

• unusual muscle pain or muscle problems that last 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.
• Stevens-Johnson syndrome (a severe skin rash with blisters, peeling, and mouth sores),
• muscle rupture.
• red, flat, round, or oval patches on the trunk, often with blisters in the center, skin peeling, mouth sores, genital sores, and/or eye sores. 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 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 without the need to stop taking Rosuvastatin Krka (only with a dose of 40 mg).
• diabetes - there is a higher risk of diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are 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 without the need to stop taking 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 skin itching (with hives). If you experience an allergic reaction, you should stop taking Rosuvastatin Krka and consult a doctor immediately.
• muscle injury in adults. If you experience unusual muscle pain or muscle problemsthat last longer than expected, as a precaution, you should stop taking Rosuvastatin Krka and consult a 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 blisters, peeling, and mouth sores).

Very rare side effects (may affect up to 1 in 10,000 people):

• jaundice (yellowing of the skin and eyes).
• liver inflammation.
• 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).
• myasthenic syndrome (a disease that causes muscle weakness in the eyes). You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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
e-mail: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin Krka

The medicine should be stored 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, as 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 (diameter 7 mm), slightly convex film-coated tablets with beveled edges and with "5" embossed on one side.
Rosuvastatin Krka, 10 mg: white, round (diameter 7.5 mm), slightly convex film-coated tablets with beveled edges and with "10" embossed on one side.
Rosuvastatin Krka, 15 mg: white, round (diameter 9 mm), slightly convex film-coated tablets with beveled edges and with "15" embossed on one side.
Rosuvastatin Krka, 20 mg: white, round (diameter 10 mm) film-coated tablets with beveled edges.
Rosuvastatin Krka, 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 into equal doses.
Rosuvastatin Krka, 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 the medicinal products in other EU member states, you 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