5 mg, 10 mg, 20 mg, 40 mg film-coated tablets
What Rosuvastatin Mylan is and what it is used for
Rosuvastatin Mylan contains the active substance rosuvastatin which belongs to a group of medicines called statins.
You have been prescribed this medicine because:
- You have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Mylan 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 Mylan.
- 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 related 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 Mylan:
- Rosuvastatin Mylan 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 Mylan 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, as 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 Mylan, 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 Mylan 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 Mylan
Do not take Rosuvastatin Mylan if you
- is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
- is pregnant or breastfeeding. If you become pregnant during treatment with Rosuvastatin Mylan, stop taking the medicine and contact a doctor immediately. Women should avoid becoming pregnant during treatment with Rosuvastatin Mylan by using a suitable contraceptive.
- have a liver disease
- have severe kidney problems
- have repeated or unexplained weakness, aches, or pains in the muscles
- takes a drug combination of sofosbuvir, velpatasvir, and voxilaprevir (used to treat a viral infection in the liver called hepatitis C).
- take a medicine that contains cyclosporine (used for example after organ transplants).
If any of the above conditions apply to you (or you are not sure), consult your doctor.
Note that you should not take rosuvastatin 40 mg tablets (the highest dose one):
- if you have moderate kidney problems (ask your doctor if you are unsure).
- if your thyroid gland is not functioning normally.
- if you have had repeated or unexplained muscle aches or pains, if you or your family have previously had muscle problems or if you have previously had muscle problems in connection with the possible use of other cholesterol-lowering drugs.
- if you regularly drink large amounts of alcohol.
- if you are of Asian descent (Japan, China, Philippines, Vietnam, Korea, or India).
- if you are using a type of medicine called fibrates and is used to lower your cholesterol levels.
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 Mylan
- if you have problems with your kidneys
- if you have a problem with your liver
- if you or someone in your family has had recurrent or unexplained muscle problems or has previously had muscle problems associated with the use of cholesterol-lowering drugs.
- if you have ever developed a severe rash or skin rash, blisters, and/or sores in your mouth after taking Rosuvastatin Mylan or other related medicines.
- if you regularly consume large amounts of alcohol
- if you have problems with your thyroid gland
- if you use other drugs, called fibrates, to lower your cholesterol levels. Read this leaflet carefully, even if you have used other medicines to treat high cholesterol levels before.
- if you are taking medicines to treat HIV infection such as lopinavir/ritonavir and/or atazanavir (see section “Other medicines and Rosuvastatin Mylan”).
- if you are taking or within the last 7 days have taken a medicine called fusidic acid (a medicine for bacterial infection) by mouth or as an injection. Concomitant treatment with fusidic acid and Rosuvastatin Mylan may lead to severe muscle problems ( rhabdomyolysis ), see Other medicines and Rosuvastatin Mylan.
- if you have severe respiratory failure
- if you are of Asian descent (Japan, China, Philippines, Vietnam, Korea, or India). Your doctor needs to choose the right starting dose of Rosuvastatin Mylan that is right for you.
If any of the above applies to you (or you are not sure):
Do not take Rosuvastatin Mylan 40 mg tablets (the highest dose one) and consult your doctor or pharmacist before taking any dose of Rosuvastatin Mylan.
Tell your doctor or pharmacist immediately if you have recurrent or unexplained muscle aches or pains, especially if you feel unwell or have a fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness. More tests and medications may be needed to diagnose and treat this.
Talk to your doctor or pharmacist if you experience persistent cough, shortness of breath, or difficulty breathing. This medicine can cause scarring of the lungs and you may need a medical examination.
Take special care with Rosuvastatin Mylan:
Severe skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Rosuvastatin Mylan. Stop using Rosuvastatin Mylan and see a doctor immediately if you notice any of the symptoms described in section 4.
In a small number of people, statins can affect the liver. This is detected by a simple blood 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 Mylan.
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 high blood fat levels, are overweight and have high blood pressure.
Children and young people
- if the patient is under 6 years of age: Rosuvastatin Mylan should not be given to children under 6 years of age.
- if the patient is under 18 years of age: Rosuvastatin 40 mg tablets are not suitable for children and adolescents under 18 years of age.
- if you are over 70 years old, doctors need to choose the right starting dose of Rosuvastatin Mylan that is right for you).
Other medicines and Rosuvastatin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as these medicines:
- ciclosporin (used for example after organ transplants)
- warfarin, ticagrelor, or clopidogrel (or any other medicine used to make the blood thinner)
- fibrates (eg gemfibrozil or fenofibrate; used to lower cholesterol levels) or any other drug used to lower cholesterol levels (eg ezetimibe)
- medicines for heartburn and acid reflux (used to neutralize stomach acid)
- erythromycin (an antibiotic )
- fusidic acid (an antibiotic, see below and Warnings and Precautions)
- oral contraceptives ( birth control pills )
- 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 infection, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grasp, elbasvir, glekaprevir, pibrentasvir.
The above medicines may be affected by Rosuvastatin Mylan or affect the effect of Rosuvastatin Mylan.
If you need to take fusidic acid by mouth for the treatment of a bacterial infection, you should temporarily stop using this medicine. Your doctor will tell you when it is safe to start using Rosuvastatin Mylan again. Ingestion of Rosuvastatin Mylan with fusidic acid may in rare cases lead to muscle weakness, muscle soreness, and muscle pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.
Pregnancy and breastfeeding
Do not use Rosuvastatin Mylan if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Mylan, stop using the medicine immediately and tell your doctor. Women should avoid getting pregnant while taking Rosuvastatin Mylan by using a suitable contraceptive.
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 any medicine.
Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatin Mylan – it does not affect their ability. Nevertheless, some people may experience dizziness during treatment with Rosuvastatin Mylan. If you feel dizzy, talk to a doctor before driving or handling machinery.
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 Mylan contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
For a full list of ingredients, see section 6 of this leaflet.
How to use Rosuvastatin Mylan
Always use 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 Mylan for high cholesterol:
Treatment with Rosuvastatin Mylan should be started with a 5 mg or 10 mg dose even if you have previously taken a higher dose of another statin. The choice of your starting dose depends on:
- tin cholesterol level
- how much you are at risk of having a heart attack or stroke
- if you have any risk factor that makes you more sensitive to any side effects.
Ask your doctor or pharmacist for advice on which dose of Rosuvastatin Mylan is best for you.
Your doctor may prescribe you the lowest dose of one (5 mg) if:
- you are of Asian descent (Japan, China, Philippines, Vietnam, Korea, or India)
- 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 Mylan 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 40 mg if necessary. If you started with 10 mg, your doctor may decide to double the dose to one 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 Mylan is 40 mg and is only prescribed for patients with high cholesterol and a high risk of heart attack or stroke, whose cholesterol levels are not lowered sufficiently by 20 mg.
If you are taking Rosuvastatin Mylan to reduce the risk of having a heart attack, stroke, or other 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.
Use for children and adolescents aged 6–17 years
For children and adolescents aged 6–17 years, the dose varies from 5 to 20 mg once a day. The usual starting dose is 5 mg daily. Your doctor may increase the dose gradually to find the right dose of Rosuvastatin Mylan for you. The maximum daily dose of Rosuvastatin Mylan is 10 mg or 20 mg for children aged 6-17 years, depending on the underlying condition being treated. Take a dose once a day. Rosuvastatin Mylan 40 mg tablets should not be given to children.
Taking the tablet
Swallow the tablet whole with a glass of water.
Take Rosuvastatin Mylan once daily. You can take the tablet at any time of the day with or without food.
Try to take the tablet at the same time each day, it will help you remember to take it.
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 amount of Rosuvastatin Mylan that is right for you.
If you take more Rosuvastatin Mylan 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 using Rosuvastatin Mylan.
If you forget to take Rosuvastatin Mylan
Do not worry, take your next scheduled dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop using Rosuvastatin Mylan
Talk to your doctor if you want to stop using Rosuvastatin Mylan. Your cholesterol levels may rise again if you stop using Rosuvastatin Mylan.
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, but some side effects can be serious and require medical attention.
Stop taking Rosuvastatin Mylan and seek medical attention immediately if you get any of the following allergic or skin reactions:
- difficulty breathing, with or without swelling of face, lips, tongue, and/or throat
- swelling of the face, lips, tongue, and/or throat which may cause difficulty in 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, 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).
Stop taking Rosuvastatin Mylan and consult a doctor immediately if you experience unusual weakness, aches, or pains in the muscles that last longer than you expected. Muscle symptoms are more common in children and adolescents than in adults. As with other cholesterol-lowering drugs, a few people have experienced unpleasant muscle damage that in rare cases has developed into a potentially life-threatening muscle injury called rhabdomyolysis.
You may also experience the following side effects that may be signs of serious problems. Seek medical attention immediately if you get any of the following side effects:
- Severe fatigue or thirst, increased need to urinate, especially at night – these signs may indicate diabetes. This is more likely if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
- Severe abdominal pain radiating to the back (may indicate inflammation of the pancreas)
- Bruising and bleeding occur more easily or more often than usual, which may indicate a low platelet count ( thrombocytopenia )
- Yellow skin and eyes (jaundice) as well as fever, stomach pain, light stools, or dark urine (may indicate liver problems)
- Numbness, tingling, or ant crawling on arms and legs (may indicate nerve damage)
- Respiratory problems, including persistent cough and/or shortness of breath or fever (may indicate scarring of the lungs, known as interstitial lung disease).
- Lupus-like disease picture (including rash, joint pain, and effects on blood cells)
- Muscle strain (muscle damage due to rupture of muscle fiber; symptoms may include pain, swelling, bruising, tenderness, and loss of function).
Other possible side effects
Common (may affect up to 1 in 10 users) :
- muscle pain
- feeling weak
- increased content of protein in the urine. This usually goes back to normal without you having to stop taking Rosuvastatin Mylan (Rosuvastatin Mylan 40 mg tablets only)
Uncommon (may affect up to 1 in 100 people) :
- rash, itching, raised itchy rash ( hives )
- increased content of protein in the urine. This usually goes back to normal without you having to stop using Rosuvastatin Mylan. (Rosuvastatin Mylan 5 mg, 10 mg and 20 mg tablets only).
Rare (may affect up to 1 in 1,000 people) :
- increase in liver enzymes in the blood, which is seen in blood tests.
Very rare (may affect up to 1 in 10,000 users ):
- traces of blood in the urine
- joint pain
- memory loss
- enlargement of the mammary glands in men ( gynecomastia )
Has been reported (occurs in an unknown number of users)
- diarrhea (loose stomach)
- shortness of breath
- swelling ( edema )
- sleep disorders, including insomnia and nightmares
- sexual difficulties
- tendon injuries, sometimes with complicated stretch marks and abrasions
How to store Rosuvastatin Mylan
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label, blister, or outer carton. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Store in the original package. Moisture sensitive.
- Rosuvastatin Mylan provided in cans should be used within 3 months of first opening the can.
- 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.
One tablet contains 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as rosuvastatin calcium).
Other ingredients are:
Microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, crospovidone, magnesium oxide, magnesium stearate, red iron oxide (E172)
Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, and yellow iron oxide (E172). Red iron oxide (E172) and black iron oxide (E172) (10 mg, 20 mg, or 40 mg tablets only)
What the medicine looks like and the contents of the pack
Rosuvastatin Mylan 5 mg: a yellow, round, biconvex, film-coated tablet, marked with “M” on one side and “RS” on the other.
Rosuvastatin Mylan 10 mg: pink, round, biconvex, film-coated tablet marked with “M” on one side and “RS1” on the other.
Rosuvastatin Mylan 20 mg: pink, round, biconvex, film-coated tablet marked with “M” on one side and “RS2” on the other.
Rosuvastatin Mylan 40 mg: pink, oval, biconvex, film-coated tablet, marked with “M” on one side and “RS4” on the other.
Rosuvastatin Mylan is available in blister packs of 14, 15, 28, 30, 56, 60, 84, 90 and 98 tablets
or plastic jars with 28, 30, 56, 60, 84 and 90 tablets.
The jars have a screw cap that contains a desiccant. Do not eat the desiccant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
McDermott Laboratories Ltd (T / A Gerard Laboratories, T / A Mylan Dublin), 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics (UK) Limited, Station Close, Potters Bar Hertfordshire, EN6 1TL, UK
Mylan Hungary Ltd, Mylan utca 1., Komárom, 2900, Hungary