T00115-01 Malta Zejtun 190x500 PIL Package leaflet: Information for the user Rosuvastatin 5mg, 10mg, 20mg and 40mg Film-coated Tablets Read all of this leaflet carefully before you start Warnings and precautions taking this medicine because it contains important Talk to your doctor or pharmacist before taking information for you. Rosuvastatin Tablets: • Keep this leaflet. You may need to read it again. • If you have problems with your kidneys. • If you have any further questions, ask your doctor or • If you have problems with your liver. pharmacist. • If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, • This medicine has been prescribed for you only. Do or a previous history of muscle problems when taking not pass it on to others. It may harm them, even if other cholesterol-lowering medicines. Tell your doctor their signs of illness are the same as yours. immediately if you have unexplained muscle aches or • If you get any side effects, talk to your doctor or pains especially if you feel unwell or have a fever. Also tell pharmacist. This includes any possible side effects your doctor or pharmacist if you have a muscle weakness not listed in this leaflet. See section 4. that is constant. • The full name of this medicine is Rosuvastatin 5mg, • If you are taking or have taken in the last 7 days a 10mg, 20mg and 40mg Film-coated Tablets but medicine called fusidic acid, (a medicine for bacterial within the leaflet it will be referred to as Rosuvastatin infection) orally or by injection. The combination of fusidic Tablets. acid and Rosuvastatin Tablets can lead to serious muscle problems (rhabdomyolysis). • If you regularly drink large amounts of alcohol. What is in this leaflet: • If your thyroid gland is not working properly. • If you take other medicines called fibrates to lower your 1 What Rosuvastatin Tablets are and what they cholesterol. Please read this leaflet carefully, even if you are used for have taken other medicines for high cholesterol before. 2 What you need to know before you take • If you take medicines used to fight the HIV infection e.g. Rosuvastatin Tablets ritonavir with lopinavir and/or atazanavir, please see “Other medicines and Rosuvastatin Tablets”. 3 How to take Rosuvastatin Tablets 4 Possible side effects Children and adolescents 5 • If the patient is under 6 years old: Rosuvastatin Tablets How to store Rosuvastatin Tablets should not be given to children younger than 6 years. 6 Contents of the pack and other information • If the patient is below 18 years of age: The Rosuvastatin 40mg Tablet is not suitable for use in children and 1 What Rosuvastatin Tablets are and what they adolescents below 18 years of age. are used for • If you are over 70 (as your doctor needs to choose the Rosuvastatin Tablets belong to a group of medicines called right start dose of Rosuvastatin Tablets to suit you). statins. • If you have severe respiratory failure. • If you are of Asian origin – that is Japanese, Chinese, You have been prescribed Rosuvastatin Tablets Filipino, Vietnamese, Korean and Indian. Your doctor needs because: to choose the right start dose of Rosuvastatin Tablets to - You have a high cholesterol level. This means you are at suit you. risk from a heart attack or stroke. Rosuvastatin Tablets are used in adults, adolescents and children 6 years or older If any of the above applies to you (or if you are not sure): to treat high cholesterol. • Do not take Rosuvastatin 40mg Tablets (the highest dose) and check with your doctor or pharmacist before you You have been advised to take a statin, because changing actually start taking any dose of Rosuvastatin Tablets. your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with In a small number of people, statins can affect the liver. This your cholesterol-lowering diet and exercise while you are is identified by a simple test which looks for increased levels taking Rosuvastatin Tablets of liver enzymes in the blood. For this reason, your doctor will usually carry out this blood test (liver function test) Or before and during treatment with Rosuvastatin Tablets. - You have other factors that increase your risk of having a heart attack, stroke or related health problems. Heart While you are on this medicine your doctor will monitor attack, stroke and other problems can be caused by a you closely if you have diabetes or are at risk of developing disease called Atherosclerosis. Atherosclerosis is due to a diabetes. You are likely to be at risk of developing diabetes build up of fatty deposits in your arteries. if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Why it is important to keep taking Rosuvastatin Tablets Other medicines and Rosuvastatin Tablets Rosuvastatin Tablets are used to correct the levels of fatty Tell your doctor or pharmacist if you are taking, have substances in the blood called lipids, the most common of recently taken or might take any other medicines. which is cholesterol. Tell your doctor if you are taking any of the following: There are different types of cholesterol found in the blood – ciclosporin (used for example, after organ transplants), “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C). warfarin or clopidogrel (or any other drug used for thinning - Rosuvastatin Tablets can reduce the “bad” cholesterol and the blood), fibrates (such as gemfibrozil, fenofibrate) or increase the “good” cholesterol. any other medicine used to lower cholesterol (such as - It works by helping to block your body’s production of ezetimibe), indigestion remedies (used to neutralise acid “bad” cholesterol. It also improves your body’s ability to in your stomach), erythromycin (an antibiotic), an oral remove it from your blood. contraceptive (the pill), hormone replacement therapy For most people, high cholesterol does not affect the way or anti-viral medications such as ritonavir with lopinavir they feel because it does not produce any symptoms. and/or atazanavir or simeprevir (used to treat infections, However, if it is left untreated, fatty deposits can build up in including HIV or hepatitis C infection – please see “Warnings the walls of your blood vessels causing them to narrow. and precautions”), dronedarone (an antiarrhythmic) and Sometimes, these narrowed blood vessels can get blocked itraconazole (an antifungal drug). If you need to take oral which can cut off the blood supply to the heart or brain fusidic acid to treat a bacterial infection you will need to leading to a heart attack or a stroke. If you correct your temporarily stop using this medicine. Your doctor will tell cholesterol levels, you can reduce your risk of having a you when it is safe to restart Rosuvastatin Tablets. Taking heart attack or stroke. Rosuvastatin Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See You need to keep taking Rosuvastatin Tablets, even if it has more information regarding rhabdomyolysis in section 4. got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing The effects of these medicines could be changed by build up of fatty deposits. However, you should stop if your Rosuvastatin Tablets or they could change the effect of doctor tells you to do so, or if you have become pregnant. Rosuvastatin Tablets. Rosuvastatin Tablets with food and drink 2 What you need to know before you take You can take Rosuvastatin Tablets with or without food. Rosuvastatin Tablets Pregnancy and breast-feeding Do not take Rosuvastatin Tablets: Do not take Rosuvastatin Tablets if you are pregnant or • If you are allergic to rosuvastatin or any of the other breast-feeding. If you become pregnant while taking ingredients of this medicine (listed in section 6). Rosuvastatin Tablets stop taking them immediately and • If you are pregnant or breast-feeding. If you become tell your doctor. Women should avoid becoming pregnant pregnant while taking Rosuvastatin Tablets stop taking while taking Rosuvastatin Tablets by using suitable them immediately and tell your doctor. Women should contraception. avoid becoming pregnant while taking Rosuvastatin Tablets by using suitable contraception. Ask your doctor or pharmacist for advice before taking any • If you have liver disease. medicine. • If you have severe kidney problems. Driving and using machines • If you have repeated or unexplained muscle aches or Most people can drive a car and operate machinery while pains. using Rosuvastatin Tablets – it will not affect their ability. • If you take a drug called ciclosporin (used for example, However, some people feel dizzy during treatment with after organ transplants). Rosuvastatin Tablets. If you feel dizzy, consult your doctor If any of the above applies to you (or you are in doubt), before attempting to drive or use machines. please go back and see your doctor. Rosuvastatin Tablets contain lactose In addition, do not take Rosuvastatin 40mg If you have been told by your doctor that you have an Tablets (the highest dose): intolerance to some sugars (lactose or milk sugar), contact • If you have moderate kidney problems (if in doubt, please your doctor before taking Rosuvastatin Tablets. ask your doctor). For a full list of ingredients please see “Contents of the pack • If your thyroid gland is not working properly. and other information” below. • If you have had any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, Rosuvastatin Tablets contain Allura red AC (E129) or a previous history of muscle problems when taking May cause allergic reactions. other cholesterol-lowering medicines. • If you regularly drink large amounts of alcohol.