Rosuvastatin 40mg Film-Coated Tablets
Out of date information, search anotherCRESTOR®
CRESTOR 40mg film-coated tablets
(rosuvastatin calcium)
Read all of this leaflet carefully before you start taking CRESTOR
• 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.
The name of your medicine is CRESTOR 40mg film-coated tablets but will be referred to as CRESTOR throughout this leaflet. Please note that the leaflet also contains information about other strengths CRESTOR 5mg, 10mg and 20mg film-coated tablets.
In this leaflet:
1) What is CRESTOR and what is it used for?
2) Before you take CRESTOR
3) How to take CRESTOR
4) Possible side effects
5) How to store CRESTOR
6) Further information
1) WHAT IS CRESTOR AND WHAT IS IT USED FOR?
CRESTOR belongs to a group of medicines called statins.
You have been prescribed CRESTOR 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. You should continue with your cholesterol-lowering diet and exercise while you are taking CRESTOR.
Or
• You have other factors that increase your risk of having a heart attack, stroke or related health problems.
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.
Why is it important to keep taking CRESTOR? CRESTOR 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).
• CRESTOR can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
• It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your blood.
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 CRESTOR, 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.
2) BEFORE YOU TAKE CRESTOR
Do not take CRESTOR:
• If you have ever had an allergic reaction to CRESTOR,
or to any of its ingredients.
• If you are pregnant or breast-feeding. If you become pregnant while taking CRESTOR stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking CRESTOR 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 (or you are in doubt), please
go back and see your doctor.
In addition, do not take CRESTOR 40mg (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 or Indian).
• If you take other medicines called fibrates to lower your cholesterol.
If any of the before applies to you (or you are in doubt), please
go back and see your doctor.
Take special care with CRESTOR:
• 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 under 10 years old: CRESTOR should not be given to children younger than 10 years.
• If the patient is below 18 years of age: The CRESTOR 40mg tablet is not suitable for use in children and adolescents below 18 years of age.
• If you are over 70 (as your doctor needs to choose the right start dose of CRESTOR to suit you)
• If you have severe respiratory failure.
• If you are of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor needs to choose the right start dose of CRESTOR to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take CRESTOR 40mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of CRESTOR.
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 CRESToR.
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.
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 CRESTOR’). The effects of these medicines could be changed by CRESTOR or they could change the effects of CRESTOR.
Taking CRESTOR with food and drink You can take CRESTOR with or without food.
Pregnancy and breast-feeding
Do not take CRESTOR if you are pregnant or breast-feeding.
If you become pregnant while taking CRESTOR stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking CRESTOR 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 CRESTOR - it will not affect their ability. However, some people feel dizzy during treatment with CRESTOR. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Important information about some of the ingredients of CRESTOR
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 CRESTOR.
For a full list of ingredients please see ‘Further information’ overleaf.
3) HOW TO TAKE CRESTOR
Always take CRESTOR as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking CRESTOR for high cholesterol:
Starting dose
Your treatment with CRESTOR must start with the 5mg or the 10mg 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 CRESTOR will best suit you.
Your doctor may decide to give you the lowest dose (5mg) if:
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or 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 CRESTOR that is right for you.
If you started with a 5mg dose, your doctor may decide to double this to 10mg, then 20mg and then 40mg if necessary.
If you started on 10mg, your doctor may decide to double this to 20mg and then 40mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of CRESTOR is 40mg. 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 CRESTOR to reduce your risk of having a heart attack, stroke or related health problems:
The recommended dose is 20mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.
Usual doses in children aged 10-17 years
The usual start dose is 5mg. Your doctor may increase your dose to find the right amount of CRESTOR for you. The maximum daily dose of CRESTOR is 20mg. Take your dose once a day. CRESTOR 40mg tablet should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take CRESTOR 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 CRESTOR that is right for you.
If you take more CRESTOR 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 CRESTOR.
If you forget to take CRESTOR
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 CRESTOR
Talk to your doctor if you want to stop taking CRESTOR. Your cholesterol levels might increase again if you stop taking CRESTOR.
A translation of the days of the week as they appear on the blister strip is as follows:
Italian: LUN MAR MER GIO VEN SAB DOM
English: MON TUE WED THU FRI SAT SUN
4) POSSIBLE SIDE EFFECTS
Like all medicines, CRESTOR 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 CRESTOR 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 CRESTOR 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. Muscle symptoms are more common in children and adolescents than in adults. 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 CRESTOR tablets (only CRESTOR 40mg)
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
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 CRESTOR tablets (only CRESTOR 5mg, 10mg and 20mg).
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 CRESTOR and seek medical help immediately
• Muscle damage in adults - as a precaution, stop taking CRESTOR 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)
• 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)
• Traces of blood in your urine
• Damage to the nerves of your legs and arms (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia)
Side effects of unknown frequency may include:
• Diarrhoea (loose stools)
• Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disturbances, including insomnia and nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE CRESTOR
• Keep out of the sight and reach of children.
• Do not use CRESTOR after the expiry date which is stated on the box/blisters/label after ‘Exp’. The expiry date refers to the last day of the month.
• Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist.
• Do not store above 30°C.
• If your tablets come in a plastic bottle, keep the lid tightly closed.
• Keep your tablets in the container you received them in.
6) FURTHER INFORMATION
What CRESTOR contains:
Each CRESTOR film-coated tablet contains rosuvastatin calcium equivalent to 40mg rosuvastatin. The ingredients in the tablet core are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone and magnesium stearate.
The ingredients in the tablet coat are lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171) and red iron oxide (E172).
WARNING: This product contains lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It also contains triacetin which may cause headache, stomach upset and diarrhoea.
What CRESTOR looks like and contents of the pack:
CRESTOR 40mg film-coated tablets are pink, film-coated oval tablet marked “ZD4522” on one side and “40” on the reverse. CRESTOR comes in a blister pack containing 28 tablets Manufactured by: Corden Pharma GmbH,
Otto-Hahn-Strasse, 68723 Plankstadt, Germany.
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK102NA, UK.
AstraZeneca GmbH, Tinsdaler Weg 183, 22880, Wedel,
Germany.
AstraZeneca Reims, Parc Industriel Pompelle,
Chemin de Vrilly, Box 1050, Reims Cedex 2, France.
AstraZeneca aB, S-151 085, Sodertalje, Sweden.
Brecon Pharmaceuticals Ltd, Hereford, UK.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU pom CRESTOR® 40mg film-coated tablets PL No: 18799/0958 To become a member of H.E.A.R.T UK or for further information contact: HEART UK, 7 North Road, Maidenhead, Berkshire, SL6 1PE.
Helpline number: 0845 450 5988 open 1000-1600 from Mon-Fri.
Leaflet date: 10.01.2014
CRESTOR is a registered trademark of the AstraZeneca group of companies
ROSUVASTATIN
ROSUVASTATIN 40mg film-coated tablets
(rosuvastatin calcium)
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.
The name of your medicine is ROSUVASTATIN 40mg film-coated tablets but will be referred to as ROSUVASTATIN throughout this leaflet. Please note that the leaflet also contains information about other strengths ROSUVASTATIN 5mg, 10mg and 20mg film-coated tablets.
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. 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. You should continue with your cholesterollowering diet and exercise while you are taking ROSUVASTATIN. Or
• You have other factors that increase your risk of having a heart attack, stroke or related health problems.
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.
Why is it important to keep taking ROSUVASTATIN?
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).
• ROSUVASTATIN can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
• It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your blood.
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.
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 (or you are in doubt), 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 networking 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 under 10 years old: ROSUVASTATIN should not be given to children younger than 10 years.
• If the patient is below 18 years of age: The ROSUVASTATIN 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
• If you are over 70 (as your doctor needs to choose the right start dose of ROSUVASTATIN to suit you)
• If you have severe respiratory failure.
• 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.
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.
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 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.
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. Usual doses in adults
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:
• 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.
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.
Usual doses in children aged 10-17 years
The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of ROSUVASTATIN for you. The maximum daily dose of ROSUVASTATIN is 20 mg. Take your dose once a day. ROSUVASTATIN 40 mg tablet should not be used by children.
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 ROSUVASTATIN 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.
A translation of the days of the week as they appear on the blister strip is as follows:
Italian: LUN MAR MER GIO VEN SAB DOM
English: MON TUE WED THUR FRI SAT SUN
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. Muscle symptoms are more common in children and adolescents than in adults. 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)
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
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 in adults - 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)
• 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)
• Traces of blood in your urine
• Damage to the nerves of your legs and arms (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia)
Side effects of unknown frequency may include:
• Diarrhoea (loose stools)
• Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disturbances, including insomnia and nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE ROSUVASTATIN
• Keep out of the sight and reach of children.
• Do not use ROSUVASTATIN after the expiry date which is stated on the box/blisters/label after ‘Exp’. The expiry date refers to the last day of the month.
• Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist.
• Store your tablets below 30°C.
• If your tablets come in a plastic bottle, keep the lid tightly closed.
• Keep your tablets in the container you received them in.
6) FURTHER INFORMATION
What ROSUVASTATIN contains:
Each ROSUVASTATIN film-coated tablet contains rosuvastatin calcium equivalent to 40mg rosuvastatin. The ingredients in the tablet core are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone and magnesium stearate.
The ingredients in the tablet coat are lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171) and red iron oxide (E172).
WARNING: This product contains lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It also contains glycerol triacetate which may cause headache, stomach upset and diarrhoea.
What ROSUVASTATIN looks like and contents of the pack:
ROSUVASTATIN 40mg film-coated tablets are pink, film-coated oval tablet marked “ZD4522” on one side and “40” on the reverse.
ROSUVASTATIN comes in a blister pack containing 28 tablets Manufactured by: Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany.
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK102NA, UK.
AstraZeneca GmbH, Tinsdaler Weg 183, 22880, Wedel,
Germany.
AstraZeneca Reims, Parc Industriel Pompelle, Chemin de Vrilly, Box 1050, Reims Cedex 2, France.
AstraZeneca AB, S-151 085, Sodertalje, Sweden.
Brecon Pharmaceuticals Ltd, Hereford, UK.
Procured from within the EU and repackaged by the product licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU
ROSUVASTATIN 40mg film-coated tablets | POM |
PL No: 18799/0958
To become a member of H.E.A.R.T UK or for further information contact: HEART UK, 7 North Road, Maidenhead, Berkshire, SL6 1PE.
Helpline number: 0845 450 5988 open 1000-1600 from Mon-Fri. Leaflet date: 10.01.2014