CRESTOR 5MG FILM COATED TABLETS
Active substance: ROSUVASTATIN CALCIUM
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CRESTOR
rosuvastatin
P033484
Read all of this leaflet carefully before you start taking CRESTOR Keep this leaflet. You may need to read itagain. 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 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 bodys production of bad cholesterol. It also improves your bodys 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 (ifin 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 cholesterollowering 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 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. Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this. 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.
CRESTOR 5mg, 10mg, 20mg and 40mg tablets (rosuvastatin)
If you take medicines used to fight the HIV infection e.g. lopinavir/ritonavir, please see Taking other medicines. If the patient is under 10years old: CRESTOR should not be given to children younger than 10years. If the patient is below 18years of age: The CRESTOR 40mg tablet is not suitable for use in children and adolescents below 18years 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 and 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 below. 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 and Indian). You are over 70years 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 fourweeks between every dose adjustment. The maximum daily dose of CRESTOR is40mg. 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 with20mg. 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 10-17years 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 youre taking CRESTOR. If you forget to take CRESTOR Dont 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. 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 1in 10and 1in 100patients): 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 1in 100and 1in1,000patients): 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 1in 1,000and 1in 10,000patients): 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 1in 10,000patients): 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 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 CRESTOR Keep out of the reach and sight 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. Store your tablets below 30C. If your tablets come in a plastic container, keep the lid tightly closed. Keep your tablets in the container you received them in.
6) FURTHER INFORMATION What CRESTOR contains: The active substance in CRESTOR is rosuvastatin. CRESTOR film-coated tablets contain rosuvastatin calcium equivalent to 5mg, 10mg, 20mg or 40mg of rosuvastatin. The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171). CRESTOR 10mg, 20mg and 40mg film-coated tablets also contain red iron oxide (E172). CRESTOR 5mg film-coated tablets also contain yellow iron oxide (E172). What CRESTOR looks like and contents of the pack CRESTOR comes in blister packs containing 7,14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90,98 and 100tablets and plastic containers with 30 and 100tablets (Not all packs are available in every country). CRESTOR comes in four tablet strengths: CRESTOR 5mg film-coated tablets are yellow, round and marked with ZD4522and 5on one side and plain on the reverse. CRESTOR 10mg film-coated tablets are pink, round and marked with ZD4522and 10on one side and plain on the reverse. CRESTOR 20mg film-coated tablets are pink, round and marked with ZD4522and 20on one side and plain on the reverse. CRESTOR 40mg film-coated tablets are pink, oval and marked with ZD4522on one side and 40on the reverse. Marketing Authorisation Holder and Manufacturer The Marketing Authorisations for CRESTOR are held by AstraZeneca UK Ltd, 600Capability Green, Luton, LU13LU, UK. Manufacturers responsible for batch release: AstraZeneca UK Ltd., SilkRoadBusinessParkMacclesfield, Cheshire, SK102NA, UK Telephone: +441625582828 Brecon Pharmaceuticals Ltd, 2-7WyeValleyBusiness Park, Brecon Road, Hay-on-Wye, Hereford, HR35PG, UK Telephone: +441497820829 Corden Pharma GmbH, Otto-Hahn-Strasse, 68723Plankstadt, Germany Telephone: +4962029900 AstraZeneca GmbH, Tinsdaler Weg 183, 22880Wedel, Germany Telephone: +4941037080 AstraZeneca Reims, Parc Industriel Pompelle, Chemin de Vrilly, Box 1050, Reims Cedex 2, France Telephone: +33326616868 AstraZeneca AB, S-15185Sdertlje, Sweden Telephone: +46855326000 This product is authorised in the Member States of the EEA under the following name(s): CRESTOR 5mg, 10mg, 20mg and 40mg (NL, AT, BE, DK, GR, FI, IC, IE, IT, LU, NO, MT, PL, PT, SE, UK), and 5mg, 10mg and 20mg (DE, ES, FR).
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Reference number Crestor 5mg Film-coated Tablets 17901/0243 Crestor 10mg Film-coatedTablets 17901/0201 Crestor 20mg Film-coated Tablets 17901/0202 Crestor 40mg Film-coated Tablets 17901/0203 This is a service provided by the Royal National Institute of Blind People.
This leaflet was last updated in 04/2012. CV 120050a 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 ahelpline 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 7North Road Maidenhead Berkshire SL61PE Helpline number: 08454505988open 1000-1600from Mon-Fri.
P033484
rosuvastatin
P033484
Read all of this leaflet carefully before you start taking CRESTOR Keep this leaflet. You may need to read itagain. 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 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 bodys production of bad cholesterol. It also improves your bodys 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 (ifin 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 cholesterollowering 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 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. Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this. 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.
CRESTOR 5mg, 10mg, 20mg and 40mg tablets (rosuvastatin)
If you take medicines used to fight the HIV infection e.g. lopinavir/ritonavir, please see Taking other medicines. If the patient is under 10years old: CRESTOR should not be given to children younger than 10years. If the patient is below 18years of age: The CRESTOR 40mg tablet is not suitable for use in children and adolescents below 18years 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 and 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 below. 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 and Indian). You are over 70years 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 fourweeks between every dose adjustment. The maximum daily dose of CRESTOR is40mg. 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 with20mg. 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 10-17years 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 youre taking CRESTOR. If you forget to take CRESTOR Dont 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. 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 1in 10and 1in 100patients): 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 1in 100and 1in1,000patients): 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 1in 1,000and 1in 10,000patients): 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 1in 10,000patients): 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 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 CRESTOR Keep out of the reach and sight 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. Store your tablets below 30C. If your tablets come in a plastic container, keep the lid tightly closed. Keep your tablets in the container you received them in.
6) FURTHER INFORMATION What CRESTOR contains: The active substance in CRESTOR is rosuvastatin. CRESTOR film-coated tablets contain rosuvastatin calcium equivalent to 5mg, 10mg, 20mg or 40mg of rosuvastatin. The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171). CRESTOR 10mg, 20mg and 40mg film-coated tablets also contain red iron oxide (E172). CRESTOR 5mg film-coated tablets also contain yellow iron oxide (E172). What CRESTOR looks like and contents of the pack CRESTOR comes in blister packs containing 7,14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90,98 and 100tablets and plastic containers with 30 and 100tablets (Not all packs are available in every country). CRESTOR comes in four tablet strengths: CRESTOR 5mg film-coated tablets are yellow, round and marked with ZD4522and 5on one side and plain on the reverse. CRESTOR 10mg film-coated tablets are pink, round and marked with ZD4522and 10on one side and plain on the reverse. CRESTOR 20mg film-coated tablets are pink, round and marked with ZD4522and 20on one side and plain on the reverse. CRESTOR 40mg film-coated tablets are pink, oval and marked with ZD4522on one side and 40on the reverse. Marketing Authorisation Holder and Manufacturer The Marketing Authorisations for CRESTOR are held by AstraZeneca UK Ltd, 600Capability Green, Luton, LU13LU, UK. Manufacturers responsible for batch release: AstraZeneca UK Ltd., SilkRoadBusinessParkMacclesfield, Cheshire, SK102NA, UK Telephone: +441625582828 Brecon Pharmaceuticals Ltd, 2-7WyeValleyBusiness Park, Brecon Road, Hay-on-Wye, Hereford, HR35PG, UK Telephone: +441497820829 Corden Pharma GmbH, Otto-Hahn-Strasse, 68723Plankstadt, Germany Telephone: +4962029900 AstraZeneca GmbH, Tinsdaler Weg 183, 22880Wedel, Germany Telephone: +4941037080 AstraZeneca Reims, Parc Industriel Pompelle, Chemin de Vrilly, Box 1050, Reims Cedex 2, France Telephone: +33326616868 AstraZeneca AB, S-15185Sdertlje, Sweden Telephone: +46855326000 This product is authorised in the Member States of the EEA under the following name(s): CRESTOR 5mg, 10mg, 20mg and 40mg (NL, AT, BE, DK, GR, FI, IC, IE, IT, LU, NO, MT, PL, PT, SE, UK), and 5mg, 10mg and 20mg (DE, ES, FR).
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Reference number Crestor 5mg Film-coated Tablets 17901/0243 Crestor 10mg Film-coatedTablets 17901/0201 Crestor 20mg Film-coated Tablets 17901/0202 Crestor 40mg Film-coated Tablets 17901/0203 This is a service provided by the Royal National Institute of Blind People.
This leaflet was last updated in 04/2012. CV 120050a 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 ahelpline 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 7North Road Maidenhead Berkshire SL61PE Helpline number: 08454505988open 1000-1600from Mon-Fri.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
