Rosuvastatin 5mg Film-Coated Tablets
4
PACKAGE LEAFLET: INFORMATION FOR THE USER
CRESTOR® 5mg TABLETS
(rosuvastatin calcium)
This product is available in other strengths.
Your medicine is known by either of the above names, but will be referred to as Crestor® Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. What Crestor® Tablets are and what they are used for
2. What you need to know before you take Crestor® Tablets
3. Howto take Crestor® Tablets
4. Possible side effects
5. Howto store Crestor® Tablets
6. Contents of the pack and other information
1. WHAT CRESTOR® TABLETS ARE AND WHAT THEY ARE USED FOR
Crestor® Tablets belong to a group of medicines called statins.
You have been prescribed Crestor® Tablets because:
• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Crestor® Tablets is used in adults, adolescents and children 6 years or older to treat high cholesterol.
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® Tablets.
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® Tablets?
Crestor® Tablets are 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® Tablets 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® Tablets, even if they have got your cholesterol to the right level, because they prevent 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CRESTOR® TABLETS
Do not take Crestor® Tablets:
• If you have ever had an allergic reaction to Crestor® Tablets or to
any of their ingredients.
• If you are pregnant, or breast-feeding. If you become pregnant while taking Crestor® Tablets stop taking them immediately and tell your doctor. Women should avoid becoming pregnant while taking Crestor® Tablets 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® Tablets 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 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Crestor® Tablets.
• 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. Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
• 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 treat the HIV infection e g. ritonavir with lopinavir and/or atazanavir, please see Other medicines and Crestor® Tablets.
• If you take antibiotics containing fusidic acid, please see Other medicines and Crestor® Tablets.
Children and adolescents
• If the patient is under 6 years old: Crestor® Tablets should not be given to children younger than 6 years.
• If the patient is below 18 years of age: The Crestor® 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 Crestor® Tablets 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 Crestor® Tablets to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take Crestor® Tablets 40mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Crestor® Tablets.
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® Tablets. 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.
Continued overleaf
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: ciclosporin (used for example, after organ transplants), warfarin or clopidogrel (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), fusidic acid (an antibiotic - please see Warnings and precautions), an oral contraceptive (the pill), hormone replacement therapy or anti-viral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection - please see Warnings and precautions). The effects of these medicines could be changed by Crestor® Tablets or they could change the effects of Crestor® Tablets.
Pregnancy and breast-feeding
Do not take Crestor® Tablets if you are pregnant or breast-feeding. If you become pregnant while taking Crestor® Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Crestor® Tablets 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® Tablets - it will not affect their ability. However, some people feel dizzy during treatment with Crestor® Tablets. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Crestor® Tablets contain 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 Crestor® Tablets.
For a full list of ingredients please see Contents of the pack and other information.
3. HOW TO TAKE CRESTOR® TABLETS
Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking Crestor® Tablets for high cholesterol:
Starting dose
Your treatment with Crestor® Tablets 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® Tablets 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 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 Crestor® Tablets 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® Tablets 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® Tablets 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.
Use in children and adolescents aged 6-17 years
The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of Crestor® Tablets for you. The maximum daily dose of Crestor® Tablets is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take your dose once a day. Crestor® Tablets 40 mg tablet should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Crestor® Tablets 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.
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® Tablets that is right for you.
If you take more Crestor® Tablets 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® Tablets.
If you forget to take Crestor® Tablets
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.
If you stop taking Crestor® Tablets
Talk to your doctor if you want to stop taking Crestor® Tablets. Your cholesterol levels might increase again if you stop taking Crestor®
Tablets. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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 Crestor® Tablets 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® Tablets 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® Tablets 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.
• 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®Tablets 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® Tablets and seek medical help immediately
• Muscle damage in adults - as a precaution, stop taking Crestor® Tablets 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 (gynaecomastia)
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
• Muscle weakness that is constant Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme
Website: 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® TABLETS
• Do not store above 30°C. Store in the original package.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label. The expiry date refers to the last day of the month.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
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.
Each film-coated tablet contains 5mg rosuvastatin (as rosuvastatin calcium) as the active ingredient.
The tablets also contain crospovidone, calcium phosphate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, glycerol triacetate, hypromellose, titanium dioxide (E171). and yellow iron oxide (E172).
What Crestor® Tablets look like and the contents of the pack
Each round, yellow film-coated tablet is marked ‘ZD4522’ and ‘5’ on one side and plain on the reverse.
Crestor® Tablets are available as blister packs of 15 or 30 tablets.
Who manufactured your medicine
Crestor® Tablets are manufactured by AstraZeneca BV., Postbus 599, 2700 AN Zoetermeer, The Netherlands. Procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance, Alliance Road, London W3 ORB.
PL 16378/0481 |POM|
To listen or request a copy of this leaflet in Braille, large print or audio please call 020 8896 9075.
Please be ready to give the following information:
Product name Reference number
Crestor® 5mg Tablets 16378/0481
H.E.A.R.T UK - The Cholesterol Charity - provides information and advice for patients through a membership magazine, health and diet fact sheets and a helpline manned by nurses and dieticians.
To become a member of H.E.A.R.T UK or for further information contact: H.E.A.R.T UK
7 North Road, Maidenhead, Berkshire, SL6 1PE
Helpline number: 0845 450 5988 open 1000 - 1600 from Mon-Fri.
Revision Date: 02.09.2015 Leaflet Reference: CRE5
Crestor® is a registered trademark of IPR Pharmaceuticals, Inc
4
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN 5mg FILM-COATED TABLETS
(rosuvastatin calcium)
This product is available in other strengths.
Your medicine is known by either of the above names, but will be referred to as Rosuvastatin Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Rosuvastatin Tablets are and what they are used for
2. What you need to know before you take Rosuvastatin Tablets
3. Howto take Rosuvastatin Tablets
4. Possible side effects
5. Howto store Rosuvastatin Tablets
6. Contents of the pack and other information
1. WHAT ROSUVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Rosuvastatin Tablets belong to a group of medicines called statins.
You have been prescribed Rosuvastatin Tablets because:
• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Tablets is used in adults, adolescents and children 6 years or older to treat high cholesterol.
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 Rosuvastatin Tablets.
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 Tablets?
Rosuvastatin Tablets are 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 Tablets 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 Tablets, even if they have got your cholesterol to the right level, because they prevent 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROSUVASTATIN TABLETS
Do not take Rosuvastatin Tablets:
• If you have ever had an allergic reaction to Rosuvastatin Tablets
or to any of their ingredients.
• If you are pregnant, or breast-feeding. If you become pregnant while taking Rosuvastatin Tablets stop taking them immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Tablets 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 Tablets 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 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Tablets.
• 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. Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
• 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 treat the HIV infection e g. ritonavir with lopinavir and/or atazanavir, please see Other medicines and Rosuvastatin Tablets.
• If you take antibiotics containing fusidic acid, please see Other medicines and Rosuvastatin Tablets.
Children and adolescents
• If the patient is under 6 years old: Rosuvastatin Tablets should not be given to children younger than 6 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 Tablets 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 Tablets to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take Rosuvastatin Tablets 40mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin Tablets.
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 Tablets. 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.
Continued overleaf
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: ciclosporin (used for example, after organ transplants), warfarin or clopidogrel (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), fusidic acid (an antibiotic - please see Warnings and precautions), an oral contraceptive (the pill), hormone replacement therapy or anti-viral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection - please see Warnings and precautions). The effects of these medicines could be changed by Rosuvastatin Tablets or they could change the effects of Rosuvastatin Tablets.
Pregnancy and breast-feeding
Do not take Rosuvastatin Tablets if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Tablets 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 Tablets - it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin Tablets. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Rosuvastatin Tablets contain 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 Tablets.
For a full list of ingredients please see Contents of the pack and other information.
3. HOW TO TAKE ROSUVASTATIN TABLETS
Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking Rosuvastatin Tablets for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Tablets 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 Rosuvastatin Tablets 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 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 Tablets 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 Rosuvastatin Tablets 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 Rosuvastatin Tablets 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.
Use in children and adolescents aged 6-17 years
The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of Rosuvastatin Tablets for you. The maximum daily dose of Rosuvastatin Tablets is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take your dose once a day. Crestor® Tablets 40 mg tablet should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin Tablets 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.
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 Tablets that is right for you.
If you take more Rosuvastatin Tablets 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 Tablets.
If you forget to take Rosuvastatin Tablets
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.
If you stop taking Rosuvastatin Tablets
Talk to your doctor if you want to stop taking Rosuvastatin Tablets. Your cholesterol levels might increase again if you stop taking Rosuvastatin Tablets. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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 Tablets 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 Tablets 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 Tablets 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.
• 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 Tablets 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 Rosuvastatin Tablets and seek medical help immediately
• Muscle damage in adults - as a precaution, stop taking Rosuvastatin Tablets 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 (gynaecomastia)
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
• Muscle weakness that is constant Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme
Website: 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 TABLETS
• Do not store above 30°C. Store in the original package.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label. The expiry date refers to the last day of the month.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
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.
Each film-coated tablet contains 5mg rosuvastatin (as rosuvastatin calcium) as the active ingredient.
The tablets also contain crospovidone, calcium phosphate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, glycerol triacetate, hypromellose, titanium dioxide (E171). and yellow iron oxide (E172).
What Rosuvastatin Tablets look like and the contents of the pack
Each round, yellow film-coated tablet is marked ‘ZD4522’ and ‘5’ on one side and plain on the reverse.
Rosuvastatin Tablets are available as blister packs of 15 or 30 tablets. Who manufactured your medicine
Rosuvastatin Tablets are manufactured by AstraZeneca BV., Postbus 599, 2700 AN Zoetermeer, The Netherlands. Procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance, Alliance Road, London W3 ORB.
PL 16378/0481 |POM|
To listen or request a copy of this leaflet in Braille, large print or audio please call 020 8896 9075.
Please be ready to give the following information:
Product name Reference number
Rosuvastatin 5mg Tablets 16378/0481
H.E.A.R.T UK - The Cholesterol Charity - provides information and advice for patients through a membership magazine, health and diet fact sheets and a helpline manned by nurses and dieticians.
To become a member of H.E.A.R.T UK or for further information contact: H.E.A.R.T UK
7 North Road, Maidenhead, Berkshire, SL6 1PE
Helpline number: 0845 450 5988 open 1000 - 1600 from Mon-Fri.
Revision Date: 02.09.2015 Leaflet Reference: ROS5
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