10 mg, 20 mg, 40 mg film-coated tablets
What Rosuvastatin Sandoz is and what it is used for
Rosuvastatin Sandoz belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Sandoz because:
- You have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Sandoz 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 your cholesterol-lowering diet and exercise while taking Rosuvastatin Sandoz.
- 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 Sandoz :
Rosuvastatin Sandoz is used to correct the concentration of certain fats in the blood, 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 Sandoz 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 Sandoz, 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 Sandoz 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 you take Rosuvastatin Sandoz
Do not take Rosuvastatin Sandoz:
- 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 Sandoz, stop taking Rosuvastatin Sandoz immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Sandoz by using appropriate contraception.
- if you have liver disease.
- if you have severe kidney problems.
- if you have repeated or unexplained muscle aches or pains.
- 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 in organ transplantation).
If any of the above apply to you (or you are not sure) contact your doctor.
Also, note that you should not take Rosuvastatin Sandoz 40 mg (the highest dose):
- if you have moderate kidney problems (ask your doctor if you are unsure).
- if you have thyroid problems.
- if you have had recurrent or unexplained muscle aches or pains, a history of muscle disease, heredity for muscle disease, or muscle aches 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.
If 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 Sandoz
- if you have problems with your kidneys.
- if you have a problem with your liver.
- if you have had recurrent or unexplained muscle aches or pains, a history of muscle disease, heredity for muscle disease, or muscle aches when using other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains, 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, atazanavir, and/or tipranavir, see Other medicines and Rosuvastatin Sandoz.
- if you are taking a medicine called fusidic acid (to treat bacterial infections) by mouth or as an injection or if you have been taking this medicine for the last 7 days. The combination of fusidic acid and rosuvastatin can cause serious muscle problems ( rhabdomyolysis ).
- if you are over 70 years old (then your doctor will need to choose the right starting dose of Rosuvastatin Sandoz that is right for you).
- if you suffer from severe respiratory failure.
- if you are of Asian origin (Japanese, Chinese, Philippines, Vietnamese, Korean, or Indian) your doctor needs to choose the right starting dose of Rosuvastatin Sandoz 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 related medicines.
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 Sandoz and seek medical advice immediately if you notice any of the symptoms described in section 4.
If any of the above is true for you (or if you are unsure):
- Do not take Rosuvastatin Sandoz 40 mg (the highest dose) and talk to your doctor or pharmacist before taking any dose of Rosuvastatin Sandoz.
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, doctors will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin Sandoz.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing 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.
Children and young people
- if the patient is under 6 years of age: Rosuvastatin Sandoz should not be given to children under 6 years of age.
- if the patient is under 18 years of age: Rosuvastatin Sandoz 40 mg tablet is not suitable for children and adolescents under 18 years of age.
Other medicines and Rosuvastatin Sandoz
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
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 start using Rosuvastatin Sandoz again. Concomitant use of Rosuvastatin Sandoz with fusidic acid may in rare cases cause muscle weakness, tenderness, or pain ( rhabdomyolysis ). See section 4 for more information on rhabdomyolysis.
Tell your doctor if you are taking any of the following medicines:
- ciclosporin (used for example in organ transplantation)
- warfarin or clopidogrel (or other blood-thinning drugs), fibrates and other lipid-lowering drugs (for example gemfibrozil, fenofibrate), other cholesterol-lowering drugs (for example ezetimibe)
- certain medicines for heartburn and acid reflux
- erythromycin ( antibiotics )
- birth control pills
- hormone replacement drugs
- regorafenib (used to treat cancer)
- darolutamide (used to treat cancer)
- 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, Graz, elbasvir, glekaprevir, pibrentasvir. The effects of these medicines may be affected by Rosuvastatin Sandoz or they may affect the effect of Rosuvastatin Sandoz.
The effects of these medicines may be affected by Rosuvastatin Sandoz or they may affect the effect of Rosuvastatin Sandoz.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rosuvastatin Sandoz if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Sandoz, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Sandoz by using appropriate contraception.
Driving and using machines
Rosuvastatin Sandoz does not affect the ability to drive or use machines in most people. However, some people feel dizzy while using Rosuvastatin Sandoz. 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 sharpened 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 Sandoz contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Rosuvastatin Sandoz
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 Sandoz for high cholesterol:
Your treatment with Rosuvastatin Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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 Sandoz to reduce the risk of having a heart attack, stroke, or other cardiovascular 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.
Use for children and adolescents aged 6–17 years
The usual starting dose is 5 mg *. Your doctor may increase the dose to find the right dose of Rosuvastatin Sandoz for you. The maximum daily dose of Rosuvastatin Sandoz is 10 mg for children aged 6–9 years and 20 mg for children aged 10–17 years. Take a dose once a day. Rosuvastatin Sandoz 40 mg tablet should not be used in children.
As Rosuvastatin Sandoz 5 mg is not available, other medicines of this strength should be used.
Swallow each tablet whole with a glass of water.
Take Rosuvastatin Sandoz once daily. You can take the tablet any time you want, with or without food.
Try to take it at 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 Sandoz that is right for you.
If you take more Rosuvastatin Sandoz 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 Sandoz.
If you forget to take Rosuvastatin Sandoz
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 taking Rosuvastatin Sandoz
Talk to your doctor if you want to stop taking Rosuvastatin Sandoz. Your cholesterol levels may rise again if you stop taking Rosuvastatin Sandoz.
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 Sandoz 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)
- 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).
Also, talk to your doctor as soon as possible, and stop taking Rosuvastatin Sandoz immediately, if you:
- get any 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 picture (including rash, joint problems, and effects on blood cells )
- muscle strain.
Common side effects (may affect up to 1 in 10 people):
- abdominal pain
- muscle aches
- increased content of protein in the urine. This usually goes back to normal without you having to stop taking Rosuvastatin Sandoz (Rosuvastatin Sandoz 40 mg only).
- 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 on its own without you having to stop taking Rosuvastatin Sandoz (Rosuvastatin Sandoz 10 mg and 20 mg only).
Rare side effects (may affect up to 1 in 1,000 people):
- severe allergic reaction – signs are swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and severe itching of the skin (with raised lumps). If you think you have an allergic reaction, stop taking Rosuvastatin Sandoz and see a doctor immediately.
- muscle damage in adults – as a preventative measure stop taking Rosuvastatin Sandoz immediately and talk to a doctor as soon as possible if you have any unusual pain or pain in your muscles that lasts longer than expected
- severe abdominal pain (inflamed pancreas )
- increased liver enzymes in the blood
- unusual bruising and bleeding due to low platelet counts.
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)
- 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)
- shortness of breath
- edema (swelling)
- sleep disorders, including insomnia and nightmares
- sexual difficulties
- respiratory problems, including persistent cough and/or shortness of breath or fever
- tendon injuries, sometimes tendon rupture
- long-lasting muscle weakness.
How to store Rosuvastatin Sandoz
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 blister and the carton after EXP. The expiration date is the last day of the specified month.
Shelf life after the first opening:
Jars: 100 days
Store in the original package. Moisture sensitive.
This medicine does not require any special temperature instructions.
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
- The active substance is rosuvastatin.
Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium).
- The other ingredients are Tablet core: Lactose, colloidal anhydrous silica, microcrystalline cellulose, corn starch, talc, and sodium stearyl fumarate. Film coating: Hypromellose, mannitol (E421), macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
What the medicine looks like and the contents of the pack
10 mg film-coated tablets:
Brown, round, film-coated tablets with a diameter of approximately 6 mm and with “RSV 10” embossed on one side.
20 mg film-coated tablets:
Brown, round, film-coated tablets with a diameter of approximately 8 mm and with “RSV 20” embossed on one side.
40 mg film-coated tablets:
Brown, round, film-coated tablets with a diameter of approximately 10 mm and with “RSV 40” embossed on one side.
The film-coated tablets are packaged in OPA / Alu / PVC / Alu blister packs or are packaged in HDPE cans with PP lids and silica gel as a desiccant and inserted in a carton.
Blisters: 7, 10, 14, 20, 21, 28, 30, 40, 42, 50, 60, 70, 84, 90, 98, 100 film-coated tablets
Jar: 28, 30, 50, 84, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Lek Pharmaceuticals dd, Verovškova ulica 57, 1526 Ljubljana, Slovenia