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: PL17780/1097 .
Rosuvastatin 15 mg and 30 mg film-coated tablets
Rosuvastatin 15 mg film-coated tablets
Rosuvastatin 30 mg film-coated tablets
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:
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), please go back and see your doctor.
In addition, do not take Rosuvastatin 30 mg or 40 mg (the highest doses) if
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
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 any of the above applies to you (or if you are not sure)
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:
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.
If you are pregnant or breast-feeding, 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 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.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
If you are taking rosuvastatin for high cholesterol
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.
Administration of a 5 mg dose can be achieved by halving a 10 mg tablet with the breakline.
The choice of your starting 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:
Increasing the dose and maximum daily dose
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 increase this to 10 mg, then 15 mg, then 20 mg, then 30 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg, then increase it to 30 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of rosuvastatin is 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 20mg.
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 is 5 – 20 mg. Your doctor may 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 – 17 years depending on your underlying condition being treated. Take your dose once a day. Rosuvastatin 30 mg and 40 mg tablets should not be used by children.
Swallow each tablet whole with a drink of water.
Take rosuvastatin once 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 (rare side effect):
Also, stop taking Rosuvastatin and talk to your doctor immediately:
The following adverse reactions have been reported with rosuvastatin.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.
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 package after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C in the original package in order to protect from light and moisture.
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.
Each film-coated tablet contains 15 mg or 30 mg rosuvastatin, as rosuvastatin calcium.
The other ingredients are:
Core: Lactose monohydrate, Cellulose, microcrystalline, Croscarmellose sodium, Silica colloidal anhydrous, Magnesium stearate. Coating layer: Hypromellose 2910/5, Macrogol 6000, Titanium dioxide (E171), Talc and Iron oxide yellow (E172). Rosuvastatin 15mg also contains Iron oxide red (E172).
Rosuvastatin 15 mg film-coated tablets: Orange to ochre, film-coated, round tablets with diameter approx. 7.1 mm.
Rosuvastatin 30 mg film-coated tablets: Yellow to dark yellow, film-coated, round tablets with diameter approx. 9.7 mm.
Rosuvastatin is available in Alu/Alu blisters in pack sizes of 14, 28, 56, 84, 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
This leaflet was last revised in August 2023.