5 mg, 10 mg, 20 mg and 40 mg film-coated tablet
rosuvastatin
What Rosuvastatin STADA is and what it is used for
Rosuvastatin Stada contains the active substance rosuvastatin, which belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Stada because:
- you have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Stada 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 Stada.
Or
- You have other factors that increase the risk of having a heart attack, stroke, or other related health problems.
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’s important to continue taking Rosuvastatin Stada
Rosuvastatin Stada is used to correct the concentration of certain fats in the blood, so-called lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood, the “bad” cholesterol ( LDL-C ) and the “good” cholesterol ( HDL-C ).
- Rosuvastatin Stada can lower 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. However, if left untreated, 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 Stada 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 Stada 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 STADA
Do not use Rosuvastatin STADA
- if you have ever had an allergic reaction 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 Stada, stop taking it immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Stada by using appropriate contraception
- if you have 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 in organ transplantation).
If any of the above apply to you (or you are not sure) contact your doctor.
Note that you should not take 40 mg of rosuvastatin (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
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 this medicine.
- 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 Stada
- if you are taking or have been taking a medicine called fusidic acid (medicine for bacterial infection ) in the last 7 days, either by mouth or as an injection. The combination of fusidic acid and Rosuvastatin Stada can lead to severe muscle problems ( rhabdomyolysis ), See “Other medicines and Rosuvastatin Stada”.
- if you are over 70 years old (then your doctor needs to choose the right starting dose of Rosuvastatin Stada 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 Stada 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 Stada or other medicines containing rosuvastatin.
Severe skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Rosuvastatin Stada. Stop using Rosuvastatin Stada and see a doctor 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 40 mg rosuvastatin (the highest dose one) and talk to your doctor or pharmacist before taking any dose of Rosuvastatin Stada.
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 Stada.
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.
Children and young people
- if the patient is under 6 years of age: Rosuvastatin Stada should not be given to children under 6 years of age.
- if the patient is under 18 years of age: Rosuvastatin Stada 40 mg tablet is not suitable for children and adolescents under 18 years of age.
Other medicines and Rosuvastatin STADA
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 in organ transplantation)
- warfarin , ticagrelor or clopidogrel (or other blood thinners)
- fibrates (eg gemfibrozil, fenofibrate), 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,
- 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, Graz, elbasvir, glekaprevir, pibrentasvir.
The effects of these medicines may be affected by Rosuvastatin Stada or they may affect the effect of Rosuvastatin Stada.
If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop using this medicine. Your doctor will tell you when it is safe to start taking Rosuvastatin Stada again. Ingestion of Rosuvastatin Stada with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information on rhabdomyolysis in section 4.
Pregnancy, breastfeeding, and fertility
Do not take Rosuvastatin Stada if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Stada, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Stada by using appropriate contraception.
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.
Driving and using machines
Rosuvastatin Stada does not affect the ability to drive or use machines of most people. However, some people feel dizzy while using Rosuvastatin Stada. 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 STADA 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.
For a complete list of ingredients, see Package Contents and Other Information.
How to use Rosuvastatin STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults
If you are taking Rosuvastatin Stada for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Stada should start with 5 mg or 10 mg dose one, even if you have taken a higher dose of another statin before. The choice of starting dose for you depends on:
- your cholesterol levels.
- 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 dose of Rosuvastatin Stada 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 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 Stada 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 Stada 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 Stada to reduce the risk of 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.
Tablet intake
Swallow each tablet whole with a glass of water.
Take Rosuvastatin Stada 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 Stada 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 Stada for you. The maximum daily dose of Rosuvastatin Stada is 10 mg or 20 mg for children aged 6-17 years, depending on the underlying condition you are being treated for. Take a dose once a day. Rosuvastatin Stada 40 mg tablet should not be used in children.
If you use more Rosuvastatin STADA 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 professional that you are taking Rosuvastatin Stada.
If you forget to use Rosuvastatin STADA
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 STADA
Talk to your doctor if you want to stop taking Rosuvastatin Stada. Your cholesterol levels may rise again if you stop taking Rosuvastatin Stada.
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 Stada and seek medical help immediately if you get any of the following symptoms:
- 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 Stada 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.
- if you get muscle strain.
- if you get a lupus-like condition (including skin rash, joint problems, and effects on blood cells ).
Common (may affect up to 1 in 10 people):
- headache, abdominal pain, constipation, nausea, muscle aches, weakness, dizziness
- increased content of protein in the urine. This usually returns to normal on its own without you having to stop taking Rosuvastatin Stada (40 mg rosuvastatin 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 (may affect up to 1 in 100 people):
- skin rash, itching, or other skin reactions
- increased content of protein in the urine. This usually goes back to normal without you having to stop taking Rosuvastatin Stada (only for 5 mg, 10 mg, and 20 mg rosuvastatin).
Rare (may affect up to 1 in 1,000 people):
- severe allergic reaction – swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps). If you think you have an allergic reaction, stop taking Rosuvastatin Stada and see a doctor immediately
- muscle damage in adults – as a preventative measure stop taking Rosuvastatin Stada immediately and talk to a doctor as soon as possible if you have any unusual aches or pains in your muscles that last longer than expected
- severe abdominal pain (inflamed pancreas )
- increased liver enzymes in the blood
- bleeding or bruising occurs more often than normal due to low platelet levels
- lupus-like disease (includes skin rash, joint problems, and effects on blood cells ).
Very rare (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 the legs and arms (for example, numbness), joint pain, memory loss, and enlargement of the mammary glands in men ( gynecomastia ).
No known frequency (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, breathing problems, including persistent cough and/or shortness of breath or fever, tendon damage and muscle weakness that is long-lasting.
How to store Rosuvastatin STADA
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 and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
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
Content declaration
The active substance is rosuvastatin.
5 mg: Each tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).
10 mg: Each tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).
20 mg: Each tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).
40 mg: Each tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium).
Other ingredients are:
Tablet core: Lactose monohydrate; povidone K 30; crospovidone type A; powdered cellulose; crospovidone; silica, colloidal, anhydrous, and magnesium stearate.
Film coating : polyvinyl alcohol, macrogol (MW 3350), titanium dioxide (E171), talc.
What the medicine looks like and the contents of the pack
Rosuvastatin Stada 5 mg film-coated tablets
White, round, biconvex film-coated tablets with a diameter of 5 mm.
Rosuvastatin Stada 10 mg film-coated tablets
White, round, biconvex film-coated tablets 7 mm in diameter.
Rosuvastatin Stada 20 mg film-coated tablets
White, round, biconvex film-coated tablets with a diameter of 9 mm.
Rosuvastatin Stada 40 mg film-coated tablets
White, oval, biconvex film-coated tablets with a length of 16.3 and a width of 7.6 mm.
The tablets are supplied in blisters made of a combined Opa-Alu-PVC foil sealed with aluminum foil.
Pack sizes:
5 mg: 7, 14, 15, 20, 28, 28 x 1 (endosblister), 30, 50 x 1 (endosblister), 50, 60, 90, 98, 100, 154, 196, 252 tablets.
10 mg: 7, 14, 15, 20, 28, 28 x 1 (endosblister), 30, 50 x 1 (endosblister), 50, 60, 90, 98, 100, 154, 196, 252 tablets.
20 mg: 7, 14, 15, 20, 28, 28 x 1 (endosblister), 30, 50 x 1 (endosblister), 50, 60, 90, 98, 100, 154, 196, 252 tablets.
40 mg: 28, 28 x 1 (endosblister), 30, 50 x 1 (endosblister), 90, 98, 100, 154, 196, 252 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria
Centrafarm Services BV, Nieuwe Donk 9, Postal code: 4879 AC Etten-Leur, The Netherlands
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark