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Simvastatin 80Mg Tablets Package leaflet: Information for the patient Simvastatin 80mg Tablets Read all of this leaflet carefully before you • if you are due to have an operation. You may need start taking this medicine because it contains to stop taking Simvastatin tablets for a short time important information for you. • if you are Asian, because a different dose may be • Keep this leaflet. You may need to read it again. applicable to you • If you have any further questions, ask your • if you are taking or have taken in the last 7 days doctor or pharmacist. a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The • This medicine has been prescribed for you only. combination of fusidic acid and Simvastatin can Do not pass it on to others. It may harm them, lead to serious muscle problems (rhabdomyolysis). even if their signs of illness are the same as yours. Your doctor should do a blood test before you start • If you get any side effects, talk to your doctor taking Simvastatin and if you have any symptoms of or pharmacist. This includes any possible side liver problems while you take Simvastatin. This is to effects not listed in this leaflet. See section 4. check how well your liver is working. What is in this leaflet Your doctor may also want you to have blood tests to check how well your liver is working after you 1 What Simvastatin is and what it is used start taking Simvastatin. for 2 What you need to know before you take While you are on this medicine your doctor will Simvastatin monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of 3 How to take Simvastatin developing diabetes if you have high levels of sugars 4 Possible side effects and fats in your blood, are overweight and have high 5 How to store Simvastatin blood pressure. 6 Contents of the pack and other Tell your doctor if you have severe lung disease. information Contact your doctor immediately if you 1 What Simvastatin is and what it is used experience unexplained muscle pain, tenderness for or weakness. This is because on rare occasions, Simvastatin contains the active substance muscle problems can be serious, including simvastatin. Simvastatin is a medicine used to lower muscle breakdown resulting in kidney damage; levels of total cholesterol, “bad” cholesterol (LDL and very rare deaths have occurred. cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin raises levels of The risk of muscle breakdown is greater at higher “good” cholesterol (HDL cholesterol). Simvastatin is a doses of Simvastatin, particularly the 80mg dose. The member of the class of medicines called statins. risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following Cholesterol is one of several fatty substances found applies: in the bloodstream. Your total cholesterol is made up • you consume large amounts of alcohol mainly of LDL and HDL cholesterol. • you have kidney problems • you have thyroid problems LDL cholesterol is often called “bad” cholesterol • you are 65 years old or older because it can build up in the walls of your arteries • you are female forming plaque. Eventually this plaque build-up can • you have ever had muscle problems during lead to a narrowing of the arteries. This narrowing treatment with cholesterol-lowering medicines can slow or block blood flow to vital organs such as called “statins” or fibrates the heart and brain. This blocking of blood flow can • you or a close family member have a hereditary result in a heart attack or stroke. muscle disorder. HDL cholesterol is often called “good” cholesterol Also tell your doctor or pharmacist if you have a because it helps keep the bad cholesterol from muscle weakness that is constant. Additional tests building up in the arteries and protects against heart and medicines may be needed to diagnose and treat disease. this. Triglycerides are another form of fat in your blood Children and adolescents that may increase your risk for heart disease. Safety and effectiveness of Simvastatin have been studied in 10-17 year old boys and in girls who had You should stay on a cholesterol-lowering diet while started their menstrual period (menstruation) at taking this medicine. least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied Simvastatin is used in addition to your cholesterol- in children under the age of 10 years. For more lowering diet if you have: information, talk to your doctor. • a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia) Other medicines and Simvastatin Tell your doctor or pharmacist if you are taking, have • a hereditary illness (homozygous familial recently taken or might take any other medicine(s) hypercholesterolaemia) that increases the with any of the following active ingredients. Taking cholesterol level in your blood. You may also Simvastatin with any of the following medicines can receive other treatments increase the risk of muscle problems (some of these • coronary heart disease (CHD) or are at high risk have already been listed in the above section “Do not of CHD (because you have diabetes, history of take Simvastatin:”). stroke, or other blood vessel disease). Simvastatin • If you need to take oral fusidic acid to treat a may prolong your life by reducing the risk of heart bacterial infection you will need to temporarily disease problems, regardless of the amount of stop using this medicine. Your doctor will cholesterol in your blood. tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may In most people, there are no immediate symptoms rarely lead to muscle weakness, tenderness or of high cholesterol. Your doctor can measure your pain (rhabdomyolysis). See more information cholesterol with a simple blood test. Visit your doctor regarding rhabdomyolysis in section 4. regularly, keep track of your cholesterol, and discuss • ciclosporin (often used in organ transplant your goals with your doctor. patients) • danazol (a man-made hormone used to treat 2 What you need to know before you take endometriosis, a condition in which the lining of Simvastatin the uterus grows outside the uterus) Do not take Simvastatin: • medicines with an active ingredient like • if you are allergic to simvastatin or any of the other itraconazole, ketoconazole, fluconazole, ingredients of this medicine (listed in section 6) posaconazole or voriconazole (used to treat fungal • if you currently have liver problems infections) • if you are pregnant or breast-feeding • fibrates with an active ingredient like gemfibrozil • if you are taking medicine(s) with one or more and bezafibrate (used to lower cholesterol) than one of the following active ingredients: • erythromycin, clarithromycin or telithromycin - Itraconazole, ketoconazole, posaconazole or (used to treat bacterial infections) voriconazole (used to treat fungal infections) • HIV-protease inhibitors such as indinavir, nelfinavir, - Erythromycin, clarithromycin or telithromycin ritonavir and saquinavir (used to treat AIDS) (used to treat infections) • Hepatitis C antiviral agents such as boceprevir, - HIV-protease inhibitors, such as indinavir, telaprevir, elbasvir or grazoprevir (used to treat nelfinavir, ritonavir and saquinavir (HIV-protease hepatitis C virus infection) inhibitors are used for HIV infections) • nefazodone (used to treat depression) - Boceprevir or telaprevir (used to treat hepatitis C • medicines with the active ingredient cobicistat virus infection) • amiodarone (used to treat an irregular heartbeat) - Nefazodone (used to treat depression) • verapamil, diltiazem, or amlodipine (used to treat - Cobicistat high blood pressure, chest pain associated with - Gemfibrozil (used to lower cholesterol) heart disease, or other heart conditions) - Ciclosporin (used in organ transplant patients) • lomitapide (used to treat a serious and rare genetic - Danazol (a man-made hormone used to treat cholesterol condition) endometriosis, a condition in which the lining of • daptomycin (a drug used to treat complicated the uterus grows outside the uterus). skin and skin structure infections and Do not take more than 40mg Simvastatin if you are bacteraemia). It is possible that side effects taking lomitapide (used to treat a serious and rare affecting the muscles may be higher when genetic cholesterol condition). this medicine is taken during treatment with simvastatin (e.g. Simvastatin tablets). Your doctor Ask your doctor if you are not sure if your medicine is may decide that you stop taking Simvastatin listed above. tablets for a while • colchicine (used to treat gout). Warnings and precautions Talk to your doctor or pharmacist before taking As well as the medicines listed above, tell your Simvastatin. doctor or pharmacist if you are taking or have Tell your doctor: recently taken any other medicines, including those • about all your medical conditions including obtained without a prescription. In particular, tell allergies your doctor if you are taking medicine(s) with any of • if you drink large amounts of alcohol the following active ingredients: • if you have ever had liver disease. Simvastatin may • medicines with an active ingredient to prevent not be right for you blood clots, such as warfarin, phenprocoumon or BBBA7601 Simvastatin 80mg Film-coated Tablets PIL - UK approved for print/date Item number: BBBA7601 Colours Non Printing Colours 1. Black 1. Originator: C Fox Dimensions: 190 x 600 2. 2. Origination Date: 18/02/2020 Min Body Text Size: 11pt Revision Date: 19/02/2020 Supplier: Teva Bulgaria Dupnitsa 3. 3. Revised By: CF 4. 5. Proof Round Technical Date sent: 18/02/2020 6. 2 Approval Date received: 19/02/2020 [email protected] Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork.
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