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. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 acenocoumarol (anticoagulants) - inflammation of the blood vessels (vasculitis) • fenofibrate (also used to lower cholesterol) - unusual bruising, skin eruptions and swelling • niacin (also used to lower cholesterol) (dermatomyositis), hives, skin sensitivity to the • rifampicin (used to treat tuberculosis). sun, fever, flushing - shortness of breath (dyspnoea) and feeling You should also tell any doctor who is prescribing unwell a new medicine for you that you are taking - lupus-like disease picture (including rash, joint Simvastatin. disorders, and effects on blood cells) • inflammation of the liver with the following Simvastatin with food and drink symptoms: yellowing of the skin and eyes, itching, Grapefruit juice contains one or more components dark-coloured urine or pale-coloured stool, feeling that alter how the body uses some medicinal tired or weak, loss of appetite; liver failure (very products, including Simvastatin. Consuming rare) grapefruit juice should be avoided. • inflammation of the pancreas often with severe abdominal pain. Pregnancy and breast-feeding Do not take Simvastatin if you are pregnant, trying The following very rare serious side effect was to get pregnant or think you may be pregnant. If you reported: get pregnant while taking Simvastatin, stop taking • a serious allergic reaction which causes difficulty in it immediately and contact your doctor. Do not take breathing or dizziness (anaphylaxis). Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk. The following side effects have also been reported rarely: Ask your doctor or pharmacist for advice before • low red blood cell count (anaemia) taking any medicine. • numbness or weakness of the arms and legs • headache, tingling sensation, dizziness Driving and using machines • digestive disturbances (abdominal pain, Simvastatin is not expected to interfere with your constipation, flatulence, indigestion, diarrhoea, ability to drive or to use machinery. However, it nausea, vomiting) should be taken into account that some people get • blurred vision and impaired vision (rare) dizzy after taking Simvastatin. • rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions) (very rare) Simvastatin contains lactose • rash, itching, hair loss If you have been told by your doctor that you have • weakness an intolerance to some sugars, contact your doctor • muscle rupture (very rare) before taking this medicinal product. • trouble sleeping (very rare) • poor memory (very rare), memory loss, confusion 3 • gynaecomastia (breast enlargement in men) (very How to take Simvastatin rare). Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. The following side effects have also been reported but the frequency cannot be estimated from the Always take this medicine exactly as your doctor or available information (frequency not known): pharmacist has told you. Check with your doctor or • erectile dysfunction pharmacist if you are not sure. • depression • inflammation of the lungs causing breathing You should stay on a cholesterol-lowering diet while problems including persistent cough and/or taking Simvastatin. shortness of breath or fever • tendon problems, sometimes complicated by Dosage rupture of the tendon The recommended dose is simvastatin 5mg, 10mg, • muscle pain, tenderness, or weakness that is 20mg, 40mg, or 80mg by mouth once a day. constant that may not go away after stopping Simvastatin tablets. Adults The usual starting dose is 10, 20 or, in some cases, Additional possible side effects reported with some 40mg a day. Your doctor may adjust your dose after statins: at least 4 weeks to a maximum of 80mg a day. • sleep disturbances, including nightmares Do not take more than 80mg a day. • sexual difficulties • Diabetes. This is more likely if you have high levels Your doctor may prescribe lower doses, particularly of sugar and fats in your blood, are overweight and if you are taking certain medicinal products listed have high blood pressure. Your doctor will monitor above or have certain kidney conditions. you while you are taking this medicine. The 80mg dose is only recommended for adult Laboratory Values patients with very high cholesterol levels and at high Elevations in some laboratory blood tests of liver risk of heart disease problems who have not reached function and a muscle enzyme (creatine kinase) have their cholesterol goal on lower doses. been observed.

Use in children and adolescents: Reporting of side effects For children (10-17 years old), the recommended If you get any side effects, talk to your doctor, usual starting dose is 10mg a day in the evening. pharmacist or nurse. This includes any possible side The maximum recommended dose is 40mg a day. effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: The tablet can be divided into equal doses. With www.mhra.gov.uk/yellowcard or search for MHRA simvastatin 80mg tablets, dosages of 80mg and Yellow Card in the Google Play or Apple App Store. 40mg (=half tablet) can be achieved. To achieve By reporting side effects you can help provide more lower dosages, tablets of 5, 10 or 20mg are information on the safety of this medicine. commercially available.

Method of administration 5 How to store Simvastatin Take Simvastatin in the evening. You can take it with Keep this medicine out of the sight and reach of or without food. Keep taking Simvastatin unless your children. doctor tells you to stop. Do not use this medicine after the expiry date which is stated on the packaging after ¨expiry date¨. The If your doctor has prescribed Simvastatin along first 2 digits denote the month, the last digits the with another medicine for lowering cholesterol year. The expiry date refers to the last day of that containing any bile acid sequestrant, you should month. take Simvastatin at least two hours before or four Do not store above 30°C. Store the tablets in the hours after taking the bile acid sequestrant. original package in order to protect from light and moisture. If you take more Simvastatin than you should Do not throw away any medicine via wastewater or Please contact your doctor or pharmacist. household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures If you forget to take Simvastatin will help to protect the environment. Do not take a double dose to make up for a forgotten tablet. Just take your normal amount of 6 Contents of the pack and other Simvastatin at the usual time the next day. information What Simvastatin contains: If you stop taking Simvastatin • The active substance is: Simvastatin, 80mg per Talk to your doctor or pharmacist because your tablet cholesterol may rise again. • The other ingredients are: Tablet core: Lactose monohydrate, cellulose If you have any further questions on the use of this microcrystalline (E460), pregelatinised maize medicine, ask your doctor or pharmacist. starch, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica 4 Possible side effects (E551), talc (E553b), magnesium stearate (E470b). Like all medicines, this medicine can cause side Film-coating: Hypromellose (E464), red iron oxide effects, although not everybody gets them. (E172), triethylcitrate (E1505), titanium dioxide (E171), talc (E553b), povidone K-30. The following terms are used to describe how often side effects have been reported: What Simvastatin looks like and contents of • Rare (may affect up to 1 of 1,000 people) the pack • Very rare (may affect up to 1 of 10,000 people) Simvastatin 80mg is a dark pink-coloured, oblong, • Not known (frequency cannot be estimated from film-coated tablet, scored on one side. The tablets the available data). are packed in blisters in a carton box, containing 10, 20, 28, 30, 40, 50, 56, 60, 98 or 100 tablets. Not all The following rare serious side effects were reported. pack sizes may be marketed. If any of these serious side effects happen, stop taking the medicine and tell your doctor Marketing Authorisation Holder immediately or go to the emergency room at Accord, Barnstaple, EX32 8NS, UK your nearest hospital: • muscle pain, tenderness, weakness, or cramps. Manufacturer On rare occasions, these muscle problems Balkanpharma-Dupnitsa AD can be serious, including muscle breakdown 3, Samokovsko Shosse Str. (rhabdomyolysis) resulting in kidney damage; and 2600 Dupnitsa very rare deaths have occurred Bulgaria • hypersensitivity (allergic) reactions including: - swelling of the face, tongue and throat which This leaflet was last revised in February 2020. may cause difficulty in breathing (angioedema) - severe muscle pain usually in the shoulders and hips - rash with weakness of limbs and neck muscles - pain or inflammation of the joints (polymyalgia rheumatica)

BBBA7601

Simvastatin 80mg Film-coated Tablets PIL - UK