Rosuvastatin Krka dd - Rosuvastatin uses, dose and side effects

You have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Krka dd is used in adults, adolescents, and children from 6 years of age to treat high cholesterol.

You have been advised to take a statin because dietary changes and increased exercise were not enough to correct your cholesterol levels. You should continue with a cholesterol-lowering diet and exercise while taking Rosuvastatin Krka dd

You have other factors that increase the risk of having a heart attack, stroke, or other health problems related to cardiovascular disease.

Myocardial infarction, stroke, and other cardiovascular health problems can be caused by a disease called atherosclerosis (atherosclerosis). The cause of atherosclerosis is that fat accumulates in the arteries.

Why it is important to continue taking Rosuvastatin Krka dd:

Rosuvastatin Krka dd is used to correct the concentration of certain fats in the blood, so-called lipids. The most common of these is cholesterol.

There are different types of cholesterol in the blood, the “bad” cholesterol ( LDL-C ) and the “good” cholesterol ( HDL-C ).

Rosuvastatin Krka dd can reduce the “bad” cholesterol and increase the “good” cholesterol.
It works by helping your body reduce the production of “bad” cholesterol and improve your body’s ability to remove it from your blood.

For most people, high cholesterol levels do not affect how they feel because high cholesterol levels do not cause any symptoms. If left untreated, however, fat deposits can settle on the walls of your blood vessels and make them narrower.

Sometimes these narrow blood vessels can be blocked and then shut off the blood supply to the heart or brain, which can lead to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to continue taking Rosuvastatin Krka dd, even if your cholesterol has reached the right level because it prevents your cholesterol levels from rising again so that fat accumulates. However, you should stop if your doctor advises you to do so, or if you have become pregnant.

Rosuvastatin contained in Rosuvastatin Krka dd may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Rosuvastatin Krka dd

Do not use Rosuvastatin Krka dd

if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6)
if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Krka dd, stop taking Rosuvastatin Krka dd immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Krka dd by using appropriate contraception.
if you have the liver disease
if you have severe kidney problems
if you have repeated or unexplained muscle aches or pain
if you are taking a combination therapy with sofosbuvir / velpatasvir / voxilaprevir (used to treat a viral infection in the liver called hepatitis C).
if you are taking a medicine called ciclosporin (used for example after an organ transplant).If any of the above apply to you (or you are not sure) contact your doctor.

Please note that you should not take Rosuvastatin Krka dd in doses of 30 mg or 40 mg (the highest dose):

if you have moderate kidney problems (ask a doctor if you are unsure)
if you have thyroid problems
if you have had repeated or unexplained muscle aches or pains, previous muscle disease, heredity for muscle disease, or have had muscle pain when using other cholesterol-lowering medicines.
if you regularly drink large amounts of alcohol
if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
if you are taking another type of cholesterol-lowering drug called fibrates any of the above apply to you (or you are not sure) contact your doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Rosuvastatin Krka dd

if you have problems with your kidneys
if you have a problem with your liver
if you have had repeated or unexplained muscle aches or pains, previous muscle disease, heredity for muscle disease, or have had muscle pain when using other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pain, especially if you feel sick or have a fever. Also, tell your doctor or pharmacist if you have long-term muscle weakness.
if you regularly drink large amounts of alcohol
if you have thyroid problems
if you are taking other cholesterol-lowering drugs called fibrates. Read all of this leaflet carefully even if you have taken other medicines for high cholesterol before.
if you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see “Other medicines and Rosuvastatin Krka dd”
if you are taking or have taken a medicine called fusidic acid (used to treat bacterial infections ) by mouth or by injection over the last 7 days. The combination of fusidic acid and Rosuvastatin Krka dd can lead to severe muscle problems ( rhabdomyolysis ).
if you are over 70 years old (then your doctor needs to choose the right starting dose of Rosuvastatin Krka dd that is right for you)
if you suffer from severe respiratory failure
If you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian) your doctor will need to choose the right starting dose of Rosuvastatin Krka dd that is right for you.
if you have ever developed a severe rash or skin rash, blisters, and/or sores in your mouth after taking rosuvastatin or other statins.

If any of the above is true for you (or if you are unsure):

Do not take Rosuvastatin Krka dd in doses of 30 mg or 40 mg (the highest dose) and talk to your doctor or pharmacist before taking any dose of Rosuvastatin Krka dd

In a small number of people, statins can affect the liver. This is detected by a simple test that examines increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin Krka dd

During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at high risk for diabetes. You are more likely to get diabetes if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure.

Severe skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with rosuvastatin. Stop using Rosuvastatin Krka dd and see a doctor immediately if you notice any of the symptoms described in section 4.

Children and young people

if the patient is under 6 years of age: Rosuvastatin Krka dd should not be given to children under 6 years of age.
if the patient is under 18 years of age: Rosuvastatin Krka dd in doses of 30 mg and 40 mg is not suitable for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Krka dd

Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

ciclosporin (used for example after organ transplantation)
warfarin or clopidogrel (or other blood thinners)
fibrates (eg gemfibrozil, fenofibrate) or other cholesterol-lowering drugs (eg ezetimibe)
certain medicines for heartburn and acid reflux
erythromycin ( antibiotics ), fusidic acid ( antibiotics – see below and Warnings and Precautions
birth control pills
antiviral drugs such as ritonavir together with lopinavir and/or atazanavir or simeprevir (used to treat infections such as HIV or hepatitis C infection, see Warnings and Precautions).
regorafenib (used to treat cancer)
darolutamide (used to treat cancer)
hormone replacement drugs
any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grasp, elbasvir, glekaprevir, pibrentasvir.

The effect of these medicines may be affected by Rosuvastatin Krka dd or they may affect the effect of Rosuvastatin Krka dd

If you have to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to take Rosuvastatin Krka dd again. Use of Rosuvastatin Krka dd with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information regarding rhabdomyolysis in section 4.

Rosuvastatin Krka dd with food, drink, and alcohol

You can take Rosuvastatin Krka dd with or without food.

Pregnancy, breastfeeding, and fertility

Do not take Rosuvastatin Krka dd if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Krka dd, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Krka dd by using appropriate contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Rosuvastatin Krka dd does not affect the ability to drive or use machines in most people. However, some people feel dizzy while taking Rosuvastatin Krka dd. If you feel dizzy, talk to your doctor before trying to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Rosuvastatin Krka dd contains lactose

If you have been told by your doctor that you have an intolerance to some sugars ( lactose or milk sugar), contact your doctor before taking this medicine.

How to use Rosuvastatin Krka dd

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose for adults

If you are taking Rosuvastatin Krka dd for high cholesterol:

Starting dose

Your treatment with Rosuvastatin Krka dd should start with 5 mg or 10 mg, even if you have taken a higher dose of another statin before. The choice of starting dose for you depends on:

your cholesterol level
the risk level you have for having a heart attack or stroke
if you have a factor that may make you more sensitive to possible side effects ask your doctor or pharmacist for advice on which starting dose of Rosuvastatin Krka dd is best for you.

Your doctor may decide to give you the lowest dose (5 mg) if:

you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
you are over 70 years old
you have moderate kidney problems
you are at risk for muscle aches and pains ( myopathy ).

Increase of dose one and a maximum daily dose

Your doctor may decide to increase your dose. This is so that you can take the dose of Rosuvastatin Krka dd that is right for you. If you started with 5 mg, your doctor may decide to double this dose to 10 mg, then to 20 mg, and then to 40 mg if necessary. If you started with 10 mg, your doctor may decide to double this dose to 20 mg and then to 40 mg if necessary. There will be four weeks between each dose adjustment.

The maximum daily dose of Rosuvastatin Krka dd is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels are not lowered enough by 20 mg.

If you are taking Rosuvastatin Krka dd to reduce the risk of having a heart attack, stroke, or other cardiovascular-related health problems:

The recommended dose is 20 mg/day. However, your doctor may decide that you should use a lower dose if you have any of the factors mentioned above.

Tablet intake

Swallow each tablet whole with a glass of water.

Take Rosuvastatin Krka dd once daily. You can take the tablet any time you want, with or without food. Try to take the same time each day to make it easier to remember.

Regular cholesterol checks

You must see your doctor for regular cholesterol checks that ensure that your cholesterol has reached and stays at the right level.

Your doctor may decide to increase your dose so that you take the dose of Rosuvastatin Krka dd that is right for you.

Use for children and adolescents

Use for children and adolescents aged 6‑17 years

The usual dose range for children and adolescents aged 6-17 years is 5-20 mg once daily. The usual starting dose is 5 mg daily and your doctor may gradually increase the dose to find the right dose of Rosuvastatin Krka dd for you. The maximum daily dose of Rosuvastatin Krka dd is 10- or 20 mg for children aged 6-17 years. Take a dose once a day. Rosuvastatin Krka dd 40 mg tablet should not be used in children.

If you use more Rosuvastatin Krka dd than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

If you go to a hospital or receive treatment for any other condition, tell your healthcare provider that you are taking Rosuvastatin Krka dd

If you forget to use Rosuvastatin Krka dd

Do not worry but take the next dose as planned at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop using Rosuvastatin Krka dd

Talk to your doctor if you want to stop taking Rosuvastatin Krka dd Your cholesterol levels may increase again if you stop taking Rosuvastatin Krka dd

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must be aware of what these side effects may be. They are usually mild and disappear after a short time.

Stop taking Rosuvastatin Krka dd and seek medical help immediately if you get any of the following allergic reactions:

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 raised lumps).

Also, talk to your doctor as soon as possible, and stop taking Rosuvastatin Krka dd immediately, if you get any of the following:

unusual aches or pains in your muscles that sit in longer than you expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and in rare cases, these have developed into a life-threatening muscle disease, rhabdomyolysis.
lupus-like disease (includes skin rash, joint problems, and effects on blood cells ).
muscle strain.
reddish, not raised, target-like, or circular spots on the torso, often with blistering in the middle, peeling, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
widespread rash, high body temperature, 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 aches
impotence
dizziness
increased content of protein in the urine. This usually goes back to normal without you having to stop taking Rosuvastatin Krka dd (40 mg dose alone ).
diabetes. This is more likely if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure. Your doctor will check you 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 content of protein in the urine. This usually returns to normal by itself without you having to stop taking Rosuvastatin Krka dd (5-20 mg doses only ).

Rare side effects (may affect up to 1 in 1,000 people):

severe allergic reaction – symptoms may include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and severe skin itching (with raised lumps). If you think you have an allergic reaction, stop taking Rosuvastatin Krka dd and see a doctor immediately.
Muscle damage in adults – as a preventative measure, stop taking Rosuvastatin Krka dd immediately and talk to a doctor as soon as possible if you have any unusual aches or pains in your muscles that sit for longer than expected.
severe abdominal pain (inflamed pancreas )
increased liver enzymes in the blood
bleeding or bruising occur more often than normal due to low platelet levels ( thrombocytopenia ).
lupus-like disease (includes skin rash, joint problems, and effects on blood cells ).

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

jaundice (yellowing of the skin and eyes)
hepatitis (inflammation of the liver)
traces of blood in the urine
damage to nerves in legs and arms (eg numbness)
joint pain
memory loss
enlargement of the mammary glands in men ( gynecomastia ).

Has been reported (occurs in an unknown number of users):

diarrhea (loose stools)
cough
shortness of breath
edema (swelling)
sleep disorders, including insomnia and nightmares
sexual difficulties
Depression
respiratory problems, including persistent cough and/or shortness of breath or fever
tendon injuries
muscle weakness that is long-lasting

How to store Rosuvastatin Krka dd

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

No special temperature instructions.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the packaging and other information

Content declaration

The active substance is rosuvastatin.

Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).

Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).

Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium).

The other ingredients are lactose, microcrystalline cellulose, crospovidone (type A), magnesium stearate, anhydrous colloidal silica in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) (only in 5 mg tablets) and yellow iron oxide E172) (only in 10 mg and 40 mg tablets) in the film coating.

What the medicine looks like and the contents of the pack

Rosuvastatin Krka dd 5 mg are brownish red, round, slightly biconvex, film-coated tablets with beveled edges, embossed with the number 5 on one side (diameter: 6 mm).

Rosuvastatin Krka dd 10 mg are brownish-yellow, round, slightly biconvex, film-coated tablets with beveled edges, embossed with the number 10 on one side (diameter: 8 mm).

Rosuvastatin Krka dd 20 mg are white or almost white, round, slightly biconvex, film-coated tablets with beveled edges, embossed with the number 20 on one side (diameter: 10 mm).

Rosuvastatin Krka dd 40 mg is brownish-yellow, biconvex, capsule-shaped film-coated tablets, debossed with the number 40 on one side (size: 16 mm x 9 mm).

Rosuvastatin Krka is available in cartons containing 10, 14, 15, 20, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets in blisters.

Rosuvastatin Krka is available in cartons containing 10 x 1, 14 x 1, 15 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 and 100 x 1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer