Find similar products:
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0135.
Rosuvastatin 5mg-10mg-20mg-40mg Film-coated Tablets
Rosuvastatin 5 mg film-coated tablets
Rosuvastatin 10 mg film-coated tablets
Rosuvastatin 20 mg film-coated tablets
Rosuvastatin 40 mg film-coated tablets
Rosuvastatin
1. What Rosuvastatin is and what it is used for
2. What you need to know before you take Rosuvastatin
3. How to take Rosuvastatin
4. Possible side effects
5. How to store Rosuvastatin
6. Contents of the pack and other information
Rosuvastatin belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin because:
You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin.
Or
Heart attack, stroke and other problems can be caused by a disease called atherosclerosis.
Atherosclerosis is due to build up of fatty deposits in your arteries.
Rosuvastatin is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).
For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems.
You need to keep taking Rosuvastatin, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build-up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have become pregnant.
If any of the above applies to you (or you are in doubt), do not take these tablets and go back and see your doctor.
In addition, do not take Rosuvastatin, (the highest dose):
If any of the above applies to you (or you are in doubt), please go back and see your doctor.
Talk to your doctor or pharmacist before taking Rosuvastatin:
If any of the above applies to you (or if you are not sure):
Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Rosuvastatin treatment. Stop using Rosuvastatin and seek medical attention immediately if you notice any of the symptoms described in section 4.
If you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia (see section 4).
In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will usually carry out this blood test (liver function test) before and during treatment with Rosuvastatin.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following:
The effects of these medicines could be changed by Rosuvastatin or they could change the effect of Rosuvastatin.
If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Rosuvastatin. Taking Rosuvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in Section 4.
Do not take Rosuvastatin if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Most people can drive a car and operate machinery while using Rosuvastatin – it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Rosuvastatin 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 Rosuvastatin.
Rosuvastatin contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.
For a full list of ingredients please see Contents of the pack and other information.
Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you are taking rosuvastatin for high cholesterol:
Starting dose
Your treatment with Rosuvastatin must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:
Please check with your doctor or pharmacist which start dose of Rosuvastatin will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg then 20 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of Rosuvastatinis 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.
If you are taking rosuvastatin to reduce your risk of having a heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.
The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg per day and your doctor may gradually increase your dose to find the right amount of rosuvastatin for you. The maximum daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years depending on your underlying condition being treated. Take your dose once a day. Rosuvastatin 40 mg tablet should not be used by children.
Swallow each tablet whole with a drink of water.
Take Rosuvastatinonce daily. You can take it at any time of the day with or without food.
Try to take your tablet at the same time every day to help you to remember it.
It is important to go back to your doctor for regular cholesterol checks, to make sure your cholesterol has reached and is staying at the correct level.
Your doctor may decide to increase your dose so that you are taking the amount of rosuvastatin that is right for you.
Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another condition, tell the medical staff that you’re taking Rosuvastatin.
Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
Talk to your doctor if you want to stop taking Rosuvastatin. Your cholesterol levels might increase again if you stop taking Rosuvastatin.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.
Stop taking Rosuvastatin and seek medical help immediately if you have any of the following allergic reactions:
Also, stop taking Rosuvastatin and talk to your doctor immediately:
Common possible side effects ( may affect up to 1 in 10 people):
Uncommon possible side effects (may affect up to 1 in 100 people):
Rare possible side effects (may affect up to 1 in 1,000 people):
Very rare possible side effects (may affect up to 1 in 10,000 people):
Not known: frequency cannot be estimated from the available data
Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is rosuvastatin. Rosuvastatin contains either 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as rosuvastatin calcium). The other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone, sodium hydrogen carbonate, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171) and red iron oxide (E172).
Rosuvastatin comes in blister packs containing 14, 15, 28, 30, 42, 56, 60, 84, 90, and 98 tablets and plastic containers with 30, 50, 90 and 100 tablets (Not all packs are available in every country).
The tablets packed in plastic containers include a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.
Rosuvastatin comes in four tablet strengths:
Rosuvastatin 5 mg film-coated tablets are pink coloured film-coated circular tablets approximately 4.50 mm in size, debossed with “G” on one side and “C” on the other side of the tablet.
Rosuvastatin 10 mg film-coated tablets are pink coloured film-coated, circular tablets approximately 5.50 mm in size, debossed with “G” on one side and “D” on the other side of the tablet.
Rosuvastatin 20 mg film-coated tablets are pink coloured film-coated, circular tablets approximately 7.00 mm in size, debossed with “G” on one side and “O” on the other side of the tablet.
Rosuvastatin 40 mg film-coated tablets are pink coloured film-coated, oval shaped tablets approximately 11.6 x 7.0 mm in size, debossed with “G 264” on one side and “40” on the other side of the tablet.
Marketing Authorisation Holder
Manufacturer
or
This leaflet was last revised in 04/2023