Rosuvastatin 5Mg, 10Mg, 20Mg and 40Mg Film-Coated Tablets

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. 1 What Rosuvastatin Tablets are and what they • If you take other medicines called fibrates to lower your 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. • 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.

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Rosuvastatin 5mg, 10mg, 20mg & 40mg Tablets PIL - UK

approved for print/date Item no: BBBA0465 Colours Non Printing Colours 1. Black 1. Originator: S.Anson Dimensions: 190 x 500 Origination Date: 20.01.17 Min Body Text Size: 9pts 2. 2. Revision Date: 08.02.17 Supplier: Actavis Malta Zejtun 3. 3. Revised By: Proof Round S.Anson 4. 5. 6 Date sent: 20.01.17 + 07.02.17 Technical 6. [email protected] Approval Date received: 08.02.17

* Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. T00115-01 Malta Zejtun 190x500 PIL

3 How to take Rosuvastatin Tablets • Diabetes. This is more likely if you have high levels of Always take this medicine exactly as your doctor has told sugars and fats in your blood, are overweight and have you. Check with your doctor or pharmacist if you are not high blood pressure. Your doctor will monitor you while sure. you are taking this medicine. You should stay on a cholesterol-lowering diet while taking Uncommon possible side effects (may affect up to 1 in Rosuvastatin Tablets. 100 people): • Rash, itching or other skin reactions Recommended dose in adults • An increase in the amount of protein in the urine – this usually returns to normal on its own without having to If you are taking Rosuvastatin Tablets for high stop taking your Rosuvastatin Tablets (only Rosuvastatin cholesterol: 5mg, 10mg and 20mg Tablets). Starting dose: Your treatment with Rosuvastatin Tablets must start with Rare possible side effects (may affect up to 1 in 1,000 the 5mg or the 10mg dose, even if you have taken a higher people): dose of a different statin before. The choice of your start • Severe allergic reaction – signs include swelling of the dose will depend upon: face, lips, tongue and/or throat, difficulty in swallowing • Your cholesterol level. and breathing, a severe itching of the skin (with raised • The level of risk you have of experiencing a heart attack or lumps). If you think you are having an allergic reaction, stroke. then stop taking Rosuvastatin Tablets and seek medical • Whether you have a factor that may make you more help immediately sensitive to possible side effects. • Muscle damage –as a precaution, stop taking Rosuvastatin Tablets and talk to your doctor immediately if you have Please check with your doctor or pharmacist which start any unusual aches or pains in your muscles which go on dose of Rosuvastatin Tablets will best suit you. for longer than expected Your doctor may decide to give you the lowest dose (5mg) • A severe stomach pain (inflamed pancreas) if: • Increase in liver enzymes in the blood • You are of Asian origin (Japanese, Chinese, Filipino, • Reduction in platelets in the blood. Vietnamese, Korean and Indian). Very rare possible side effects (may affect up to 1 in • You are over 70 years of age. 10,000 people): • You have moderate kidney problems. • Jaundice (yellowing of the skin and eyes) • You are at risk of muscle aches and pains (myopathy). • Hepatitis (an inflamed liver) Increasing the dose and maximum daily dose • Traces of blood in your urine • Damage to the nerves of your legs and arms (such as Your doctor may decide to increase your dose. This is so numbness) that you are taking the amount of Rosuvastatin Tablets that • Joint pain is right for you. If you started with a 5mg dose, your doctor • Memory loss may decide to double this to 10mg then 20mg and then • Gynecomastia (breast enlargement in men). 40mg if necessary. If you started on 10mg, your doctor may decide to double this to 20mg and then 40mg if necessary. Side effects of unknown frequency (frequency cannot There will be a gap of four weeks between every dose be estimated from the available data): adjustment. • Diarrhoea (loose stools) • Stevens-Johnson syndrome (serious blistering condition of The maximum daily dose of Rosuvastatin Tablets is 40mg. It the skin, mouth, eyes and genitals) is only for patients with high cholesterol levels and a high • Cough risk of heart attacks or stroke whose cholesterol levels are • Shortness of breath not lowered enough with 20mg. • Oedema (swelling) If you are taking Rosuvastatin Tablets to reduce • Sleep disturbances, including insomnia and nightmares your risk of having a heart attack, stroke or • Sexual difficulties related health problems: • Depression The recommended dose is 20mg daily. However, your • Breathing problems, including persistent cough and/or doctor may decide to use a lower dose if you have any of shortness of breath the factors mentioned above. • Tendon injury • A disorder of the nerves which can cause weakness, Use in children and adolescents aged 6-17 years tingling or numbness (peripheral neuropathy) The usual start dose is 5mg. Your doctor may increase • Muscle weakness that is constant (immune-mediated your dose to find the right amount of Rosuvastatin Tablets necrotizing myopathy). for you. The maximum daily dose of Rosuvastatin Tablets is 10mg for children aged 6 to 9 years and 20mg for Reporting of side effects children aged 10 to 17 years. Take your dose once a day. If you get any side effects, talk to your doctor, pharmacist Rosuvastatin 40mg Tablets should not be used by children. or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Taking your tablets Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Swallow each tablet whole with a drink of water. By reporting side effects you can help provide more Take Rosuvastatin Tablets once daily. You can take it at any information on the safety of this medicine. time of the day. Try to take your tablet at the same time every day to help you to remember it. 5 How to store Rosuvastatin Tablets Regular cholesterol checks Keep this medicine out of the sight and reach of children. It is important to go back to your doctor for regular Do not use this medicine after the expiry date which is cholesterol checks, to make sure your cholesterol has stated on the box/blisters after EXP. The expiry date refers to reached and is staying at the correct level. the last day of that month. Your doctor may decide to increase your dose so that you This medicinal product does not require any special storage are taking the amount of Rosuvastatin Tablets that is right conditions. for you. Do not throw away any medicines via wastewater or If you take more Rosuvastatin Tablets than you household waste. Ask your pharmacist how to throw away should medicines you no longer use. These measures will help Contact your doctor or nearest hospital for advice. protect the environment. If you go into hospital or receive treatment for another condition, tell the medical staff that you’re taking Rosuvastatin Tablets. 6 Contents of the pack and other information If you forget to take Rosuvastatin Tablets What Rosuvastatin Tablets contain Do not worry; just take your next scheduled dose at the • The active substance in Rosuvastatin Tablets is correct time. Do not take a double dose to make up for a rosuvastatin. Rosuvastatin Film-coated Tablets contain forgotten tablet. rosuvastatin calcium equivalent to 5mg, 10mg, 20mg or 40mg of rosuvastatin. If you stop taking Rosuvastatin Tablets • The other ingredients are: tablet core: lactose Talk to your doctor if you want to stop taking Rosuvastatin monohydrate, microcrystalline cellulose, crospovidone Tablets. Your cholesterol levels might increase again if you type A, sodium carbonate monohydrate, sodium stop taking Rosuvastatin Tablets. laurilsulfate, magnesium stearate, tablet coat 5mg Opadry II 85F62533 Yellow: polyvinyl alcohol part hydrolysed, If you have any further questions on the use of this titanium dioxide (E171), polyethylene glycol, talc, iron medicine, ask your doctor or pharmacist. oxide yellow (E172), 10mg, 20mg, 40mg Opadry II 85F64743 Pink: polyvinyl alcohol part hydrolysed, titanium dioxide (E171), 4 Possible side effects polyethylene glycol, talc, iron oxide yellow (E172), iron Like all medicines, this medicine can cause side effects, oxide red (E172), Allura red AC (E129), Indigo carmine although not everybody gets them. (E132). It is important that you are aware of what these side effects What Rosuvastatin Tablets look like and contents may be. They are usually mild and disappear after a short of the pack time. Rosuvastatin Tablets come in four tablet strengths: Stop taking Rosuvastatin Tablets and seek medical 5mg tablets: Yellow, round, 7mm, biconvex with “RU5” help immediately if you have any of the following allergic engraved on one side and blank on the other side. reactions: 10mg tablets: Pink, round, 7mm, biconvex with “RU10” • Difficulty in breathing, with or without swelling of the face, engraved on one side and blank on the other side. lips, tongue and/or throat 20mg tablets: Pink, round, 9mm, biconvex with “RU20” • Swelling of the face, lips, tongue and/or throat, which may engraved on one side and blank on the other side. cause difficulty in swallowing 40mg tablets: Pink, oval, 15.5mm x 8mm, biconvex with • Severe itching of the skin (with raised lumps). “RU40” engraved on one side and blank on the other side. Also, stop taking Rosuvastatin Tablets and talk to your Rosuvastatin Tablets come in blister packs (Al/Al) containing doctor immediately if you have any unusual aches or 28 tablets. pains in your muscles which go on for longer than you Marketing Authorisation Holder might expect. As with other statins, a very small number Actavis Group PTC ehf. of people have experienced unpleasant muscle effects Reykjavíkurvegi 76-78 and rarely these have gone on to become a potentially life 220 Hafnarfjörður threatening muscle damage known as rhabdomyolysis. Iceland Common possible side effects (may affect up to 1 in 10 Manufacturer people): Actavis Ltd. • Headache BLB016, Bulebel Industrial Estate • Stomach pain Zejtun • Constipation ZTN 3000 • Feeling sick Malta • Muscle pain • Feeling weak This leaflet was last revised in February 2017 • Dizziness • An increase in the amount of protein in the urine – this usually returns to normal on its own without having to If you would like a stop taking your Rosuvastatin Tablets (only Rosuvastatin leaflet with larger text, 40mg Tablets) please contact 01271 385257. Continued top of next column BBBA0465 Actavis, Barnstaple, EX32 8NS, UK

Rosuvastatin 5mg, 10mg, 20mg & 40mg Tablets PIL - UK

* Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes.