Rosuvastatin 40mg Film-Coated Tablets
0866 / 0867 / 0868 1197 / 1198 / 1204 1199 / 1200 / 1205 05.11.07[9]
Rosuvastatin® 10mg Film-Coated Tablets Rosuvastatin® 20mg Film-Coated Tablets Rosuvastatin® 40mg Film-Coated Tablets
(rosuvastatin calcium)
This product is available by using any of the above names but will be referred to as Rosuvastatin throughout this leaflet.
Read all of this leaflet carefully before you start taking Rosuvastatin
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What is Rosuvastatin and what is it used for?
2) Before you take Rosuvastatin
3) How to take Rosuvastatin
4) Possible side effects
5) How to store Rosuvastatin
6) Further information
1) WHAT IS Rosuvastatin AND WHAT IS IT USED FOR?
Rosuvastatin belongs to a group of medicines called statins. It 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). Rosuvastatin can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
You have been prescribed Rosuvastatin because you have a high cholesterol level. This means you are at risk from a heart attack or stroke.
You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. Rosuvastatin works by helping to block your body’s production of ‘bad’ cholesterol and improves your body’s ability to remove it from your blood. Why is it important to keep taking Rosuvastatin?
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. However, you should stop if your doctor tells you to do so, or you have become pregnant.
You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin.
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. If you correct your cholesterol levels, you can reduce your risk of having a heart attack or stroke.
2) BEFORE YOU TAKE Rosuvastatin Do not take Rosuvastatin:
• If you have ever had an allergic reaction to Rosuvastatin, or to any of its
ingredients.
• 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.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains.
• If you take a drug called ciclosporin (used, for example, after organ transplants)
If any of the above applies to you, please go back and see your doctor.
In addition, do not take Rosuvastatin 40 mg (the highest dose):
• If you have moderate kidney problems (if in doubt, please ask your doctor).
• If your thyroid gland is not working properly.
• If you have had any repeated or unexplained muscle aches or pains, a
personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see your doctor.
Take special care with Rosuvastatin:
• If you have problems with your kidneys.
• If you have problems with your liver.
• If you have had repeated or unexplained muscle aches or pains, a
personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not working properly.
• If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other medicines for high cholesterol before.
• If you take medicines used to fight the HIV infection e.g. lopinavir/ritonavir, please see Taking other medicines.
• If the patient is a child: Rosuvastatin should not be given to children
• If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin to suit you)
• If you are of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of Rosuvastatin to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take Rosuvastatin 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin.
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines including any you bought without a prescription.
Tell your doctor if you are taking any of the following: ciclosporin (used for example, after organ transplants), warfarin (or any other drug used for thinning the blood), fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe), indigestion remedies (used to neutralise acid in your stomach), erythromycin (an antibiotic) an oral contraceptive (the pill), hormone replacement therapy or lopinavir/ ritonavir (used to fight the HIV infection -please see Take special care with Rosuvastatin). The effects of these medicines could be changed by Rosuvastatin or they could change the effects of Rosuvastatin.
Taking Rosuvastatin with food and drink
You can take Rosuvastatin with or without food.
Pregnancy and breast-feeding
Do not take Rosuvastatin if you are pregnant or breastfeeding.
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.
Driving and using machines
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. Important information about some of the ingredients of Rosuvastatin
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.
For a full list of ingredients please see Further information below.
3) HOW TO TAKE Rosuvastatin
Always take Rosuvastatin as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
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:
• Your cholesterol level.
• The level of risk you have of experiencing a heart attack or stroke.
• Whether you have a factor that may make you more sensitive to possible side effects.
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:
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• You are over 70 years of age.
• You have moderate kidney problems.
• You are at risk of muscle aches and pains (myopathy).
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 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 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 20 mg.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin once daily. You can take it at any time of the day.
Try to take your tablet at the same time every day to help you to remember it.
Regular cholesterol checks
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.
If you take more Rosuvastatin than you should
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.
If you forget to take a dose
Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Rosuvastatin
Talk to your doctor if you want to stop taking Rosuvastatin. Your cholesterol levels might increase again if you stop taking Rosuvastatin.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Rosuvastatin 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:
• Difficulty in 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 in swallowing
• Severe itching of the skin (with raised lumps).
Also, stop taking Rosuvastatin and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than you might expect. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.
Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):
• Headache
• Stomach pain
• Constipation
• Feeling sick
• Muscle pain
• Feeling weak
• Dizziness
• An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin tablets (only Rosuvastatin 40 mg).
Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000 patients):
• Rash, itching or other skin reactions
• An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin tablets (only Rosuvastatin 5 mg, 10 mg and 20 mg).
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):
• Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking Rosuvastatin and seek medical help immediately
• Muscle damage - as a precaution, stop taking Rosuvastatin and talk to your doctor immediately if you have any unusual aches or pains in your
• muscles which go on for longer than expected • A severe stomach pain (inflamed pancreas)
• Joint pain
• Increase in liver enzymes in the blood.
Very rare possible side effects (these may affect less than 1 in 10,000 patients):
• Jaundice (yellowing of the skin and eyes)
• Hepatitis (an inflamed liver)
• T races of blood in your urine
• Damage to the nerves of your legs and arms (such as numbness)
• Memory loss
If any of the side effects become troublesome, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5) HOW TO STORE Rosuvastatin
• As with all medicines, KEEP YOUR TABLETS IN A SAFE PLACE
where children cannot see or reach them. Your tablets could harm them.
• Do not store your tablets above 30°C. Store in the original package.
• If your doctor tells you to stop taking your tablets, take any tablets you have left back to your pharmacist.
• Do not take your tablets after the expiry date on the container. Take any tablets that are out of date back to your pharmacist.
• If your tablets show any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
6) FURTHER INFORMATION What Rosuvastatin contains:
The active ingredient in Rosuvastatin is rosuvastatin calcium.
Each Rosuvastatin 10mg contains 10mg rosuvastatin (as rosuvastatin calcium).
Each Rosuvastatin 20mg contains 20mg rosuvastatin (as rosuvastatin calcium).
Each Rosuvastatin 40mg contains 40mg rosuvastatin (as rosuvastatin calcium).
The tablets also contain a number of inactive ingredients, which are used to form them. These are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, glycerol triacetate, titanium dioxide (E171), red ferric oxide (E172).
What Rosuvastatin looks like and contents of the pack Rosuvastatin 10mg tablets are round, pink coloured, film coated tablets marked ‘ZD4522’ and ‘10’ on one side and plain on the reverse.
Rosuvastatin 20mg tablets are round, pink coloured, film coated tablets marked ‘ZD4522’ and ‘20’ on one side and plain on the reverse.
Rosuvastatin 40mg tablets are round, pink coloured, film coated tablets marked ‘ZD4522’ and ‘40’ on one side and plain on the reverse.
Rosuvastatin 10mg tablets and Rosuvastatin 20mg tablets are available in calendar blister packs containing 28 and 98 tablets. Rosuvastatin 40mg tablets are available in calendar blister packs containing 28 tablets.
The following is a translation of the days of the week on the blister strip:
Ma / Lu / Mo or LUN - Monday; Di / Ma / Di or MAR - Tuesday Wo / Me / Mi or MER - Wednesday; Do / Je / Do or GIO - Thursday Vr / Ve / Fr or VEN - Friday; Za / Sa / Sa or SAB - Saturday
Zo / Di / So or DOM - Sunday
Manufacturer
Rosuvastatin is manufactured by AstraZeneca GmbH, Plankstadt, Germany and is procured from within the EU by Parallel Import Product Licence holder Star Pharmaceuticals Ltd, Unit 8, Brember Road, South Harrow, Middlesex HA2 8AX. Repackaged by Servipharm Ltd.
Rosuvastatin 10mg Film-Coated Tablets
p PL 20636/0866, 1197, 1199
POM Rosuvastatin 20mg Film-Coated Tablets PL 20636/0867, 1198, 1200 Rosuvastatin 40mg Film-Coated Tablets
PL 20636/0868, 1204, 1205
Leaflet revision and issue date (Ref.) 05.11.07[9]