5 mg, 10 mg, 20 mg, 40 mg film-coated tablets
What Rosuvastatin Teva is and what it is used for
Rosuvastatin Teva belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Teva because:
- You have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Teva 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 Teva.
- 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 is it important to continue taking Rosuvastatin Teva?
Rosuvastatin Teva 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 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. 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 Teva, 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 Teva 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 Teva
Do not take Rosuvastatin Teva:
- if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6)
- 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
- if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Teva, stop taking the medicine immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Teva 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 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 Rosuvastatin Teva 40 mg (the highest dose):
- if you have moderate kidney problems (ask a doctor if you are unsure)
- if your thyroid gland is not working properly
- 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 Rosuvastatin Teva
- 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 your thyroid gland is not working properly
- 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 Teva
- if you are taking or within the last 7 days have taken a medicine called fusidic acid (a medicine for bacterial infections ) by mouth or by injection. The combination of fusidic acid and Rosuvastatin Teva can lead to severe muscle problems ( rhabdomyolysis ).
Children and young people
If the patient is under 6 years of age: Rosuvastatin Teva should not be given to children under 6 years of age.
If the patient is under 18 years of age: Rosuvastatin Teva 40 mg is not suitable for children and adolescents under 18 years of age.
- If you are over 70 years of age (because your doctor will have to choose a starting dose of Rosuvastatin Teva that is right for you)
- If you have severe breathing problems
- If you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will then have to choose a starting dose of Rosuvastatin Teva that is right for you.
If any of the above is true for you (or if you are unsure):
- Do not take Rosuvastatin Teva 40 mg (the highest dose one) and talk to your doctor or pharmacist before taking any dose of Rosuvastatin Teva.
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 Teva.
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 Teva and see a doctor immediately if you notice any of the symptoms described in section 4.
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.
Other medicines and Rosuvastatin Teva
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:
- regorafenib (used to treat cancer)
- ciclosporin (used for example in organ transplantation)
- warfarin or clopidogrel (or other blood thinners)
- fibrates (eg gemfibrozil, fenofibrate) or any other cholesterol-lowering drug (eg ezetimibe)
- medicine for indigestion (used to neutralize stomach acid)
- erythromycin (an antibiotic )
- fusidic acid (against bacterial infections ). 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 Teva again. The use of Rosuvastatin Teva with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information regarding rhabdomyolysis in section 4.
- birth control pills
- hormone replacement drugs
- ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glekaprevir, pibrentasvir (used to treat viral infections, including HIV or hepatitis C infection, alone or in combination) (see Warnings and precautions)
The effects of these medicines may be affected by Rosuvastatin Teva or they may affect the effect of Rosuvastatin Teva.
Pregnancy and breastfeeding
Do not take Rosuvastatin Teva if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Teva, stop taking the medicine immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Teva by using appropriate contraception.
Driving and using machines
In most people, Rosuvastatin Teva does not affect your ability to drive or use machines. However, some people may experience dizziness while taking Rosuvastatin Teva. 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 Teva 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 sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.
How to take Rosuvastatin Teva
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 Teva for high cholesterol:
Your treatment with Rosuvastatin Teva 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
- what risk level do you have to have 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 Teva 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 Teva 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 Teva 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 Teva 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.
Swallow each tablet whole with a glass of water.
Take Rosuvastatin Teva 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 Teva that is right for you.
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 amount of Rosuvastatin Teva for you. The maximum daily dose of Rosuvastatin Teva is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take a dose once a day. Rosuvastatin Teva 40 mg tablet should not be used in children.
If you take more Rosuvastatin Teva 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 are hospitalized or receiving treatment for any other condition, tell your healthcare provider that you are taking Rosuvastatin Teva.
If you forget to take Rosuvastatin Teva
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 Teva
Talk to your doctor if you want to stop taking Rosuvastatin Teva. Your cholesterol levels may increase again if you stop taking Rosuvastatin Teva.
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 Teva and seek medical attention immediately if you get any of the following allergic reactions:
- Breathing difficulties, 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 itching of the skin (with raised lumps).
- Reddish, not raised, target-like, or circular spots on the torso, often with blistering in the middle, skin peeling, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may 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, stop taking Rosuvastatin Teva and contact your doctor immediately if you
- have any unusual aches or pains in the muscles that sit in longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a few people have experienced unpleasant muscle effects and in rare cases, these have developed into the life-threatening muscle disease rhabdomyolysis.
- lupus-like syndrome (which includes rash, joint problems, and effects on blood cells)
- muscle strain
Common side effects (may affect up to 1 in 10 people):
- abdominal pain
- muscle pain
- the increased amount of protein in the urine. This is usually normalized on its own without the need to stop taking Rosuvastatin Teva (Rosuvastatin Teva 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 monitor 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
- the increased amount of protein in the urine. This is usually normalized on its own without the need to stop taking Rosuvastatin Teva tablets (Rosuvastatin Teva 5 mg, 10 mg, and 20 mg only).
Rare side effects (may affect up to 1 in 1,000 people):
- severe allergic reaction. Signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and difficulty breathing, and severe itching of the skin (with raised lumps). If you think you have an allergic reaction, stop taking Rosuvastatin Teva and see a doctor immediately
- muscle damage in adults. As a precautionary measure, stop taking Rosuvastatin Teva and contact a doctor immediately if you have any unusual pain or soreness in your muscles that lasts longer than expected.
- severe abdominal pain (inflamed pancreas )
- elevated liver enzymes in the blood
- unexpected bleeding and bruising ( thrombocytopenia )
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)
- shortness of breath
- edema (swelling)
- sleep disorders, including insomnia and nightmares
- sexual problems
- respiratory problems, including persistent cough and/or shortness of breath or fever
- tendon injuries
- persistent muscle weakness
How to store Rosuvastatin Teva
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.
Do not store above 30 ° C.
No special storage 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.
- Rosuvastatin Teva 5, 10, 20 and 40 mg film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin.
- Other ingredients are:
- Tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone (type B), hydroxypropylcellulose, sodium bicarbonate, magnesium stearate.
- Film coating: lactose monohydrate, hypromellose 6 Cp, titanium dioxide (E171), triacetin, yellow iron oxide (E172) in Rosuvastatin Teva 5 mg film-coated tablets, red iron oxide (E172) in Rosuvastatin Teva 10, 20 and 40 mg film-coated tablets.
What the medicine looks like and the contents of the pack
Rosuvastatin Teva 5 mg film-coated tablets: round, biconvex, yellow tablet, approximately 5.5 mm in diameter.
Rosuvastatin Teva 10 mg film-coated tablets: a round, biconvex, pink tablet with a scored score, approximately 7 mm in diameter.
Rosuvastatin Teva 20 mg film-coated tablets: a round, biconvex, pink tablet with a scored score, approximately 9 mm in diameter.
Rosuvastatin Teva 40 mg film-coated tablets: an oval, biconvex, pink tablet with a score line, approximately 11.5 mm x 7 mm.
Rosuvastatin Teva 10 mg, 20 mg, and 40 mg film-coated tablets: The tablet can be divided into two equal doses.
Rosuvastatin Teva is supplied in blisters of 7, 14, 15, 20, 28, 28 ( calendar pack), 30, 30×1, 42, 50, 50×1, 56, 60, 84, 90, 90×1, 98, 100 and 100×1 film-coated tablets and HDPE jars containing 28, 30, 100, 250 film-coated tablets.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
Merckle GmbH, Blaubeuren, Germany
PLIVA Hrvatska doo (PLIVA Croatia Ltd.), Zagreb, Croatia
TEVA PHARMA SLU, Zaragoza, Spain
Teva Pharma BV, Haarlem, The Netherlands
HBM Pharma sro, Martin, Slovakia