Simvastatin 80 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Simvastatin 10mg, 20mg, 40mg and 80mg Film-Coated Tablets
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, See section 4.
What is in this leaflet:
J| What Simvastatin is and what it is used for ^ What you need to know before you take Simvastatin 3 How to take Simvastatin
^ Possible side effects
5 How to store Simvastatin
^ Contents of the pack and other information
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What Simvastatin is and what it is used for
Simvastatin belongs to a group of medicines commonly known as statins (HMG-CoA Reductase Inhibitors). It is used to help lower cholesterol and other fats (lipids) in the blood to help reduce the risk of a stroke or heart problems.
Simvastatin is used to treat:
■ High levels of cholesterol in the blood (primary hypercholesterolaemia) if it cannot be adequately lowered by diet and exercise alone
■ High levels of cholesterol and other fats in the blood (mixed dyslipidaemia), if they cannot be adequately lowered by diet and exercise alone
■ An inherited condition that causes high levels of cholesterol in the blood (homozygous familial hypercholesterolaemia), as an addition to diet and other lipid-lowering treatments such as LDL Apheresis (a non-surgical therapy that removes Low-Density Lipoprotein [LDL] cholesterol from the blood) or if such treatments are not appropriate
■ To reduce the risk of death or illness in patients with atherosclerotic cardiovascular disease (where the arteries become clogged by fats [cholesterol] causing the arteries to harden and narrow, restricting blood flow) or diabetes, in addition to use of other preventative/protective treatments/measures of other possible risks
What you need to know before you take Simvastatin
Do not take Simvastatin if:
■ You are allergic (hypersensitive) to Simvastatin, statins or any of the other ingredients of this medicine (See Section 6 "Contents of the pack and other information")
■ You suffer from liver disease or an unexplained, persistent elevation of certain liver enzymes in the blood (transaminases)
■ You are pregnant or breast-feeding (see "Pregnancy and Breast-feeding" section)
■ You are currently taking any of the following medicines: (see "Other medicines and Simvastatin")
o Itraconazole, ketoconazole, fluconazole, posaconazole, voriconazole (antifungals), used to treat fungal infections o Nelfinavir, used to treat HIV infection (HIV-protease inhibitors)
o Boceprevir, telaprevir, used to treat hepatitis C (protease inhibitors)
o Erythromycin, clarithromycin, telithromycin (antibiotics), used to treat infections o Nefazodone (antidepressant), used to treat depression
o Gemfibrozil (fibrates), used to treat high cholesterol levels
o Ciclosporin (immunosuppressants), used to reduce the body's immunity when receiving organ transplant
o Danazol (synthetic steroid hormone), used to treat endometriosis (condition where small pieces of the womb lining are found outside the womb causing symptoms such as painful periods, persistent pain in the pelvic area and infertility) and to relieve severe pain and tenderness associated with non-cancerous breast lumps
o You are taking or have taken in the last 7 days fusidic acid (used to treat bacterial infections)
Warnings and precautions
Talk to your doctor before taking Simvastatin:
■ If you experience unexplained muscle pain, cramps, tenderness or weakness during treatment with Simvastatin as these could be symptoms of myopathy/rhabdomyolysis (muscle disorders). As with other statins, the risk of myopathy/rhabdomyolysis is dose related and the risk is increased by high levels of statins in the blood. The risk is greater in patients on Simvastatin 80mg compared with other similar statin-based treatments. (See Section 3 "How to take"). 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 are at risk of developing a muscle disorder (myopathy/rhabdomyolysis) due to the following:
o you are older than 65 years of age o you are female
o you suffer from kidney problems o you have an untreated underactive thyroid o you have a personal or family history of inherited muscle disorders o you have a previous history of muscle problems whilst being treated with a statin or fibrate
o you suffer from or have a history of alcohol abuse
o you are due to have major surgery as treatment with Simvastatin should be temporarily stopped a few days before o you are Asian, because a different dose may be applicable to you
o you are currently taking any of the following medicines: (see "Other medicines and Simvastatin")
■ Other fibrates such as bezafibrate (except fenofibrate), used to lower cholesterol levels
■ Amiodarone (antiarrhythmic agent), used to treat irregular heartbeats
■ Verapamil, diltiazem, amlodipine (calcium-channel blockers), used to treat high blood pressure and to control angina (chest pain)
■ you are currently taking large doses (1g or more daily) of niacin (nicotinic acid), used to treat high cholesterol levels, especially if you are chinese
■ Colchicine, (used to treat gout) if you suffer from kidney problems
■ It is recommended that liver function tests be performed before treatment begins and throughout the first year of treatment
■ If you develop serious liver damage (symptoms include: feeling and/or being sick [nausea, vomiting], abdominal pain, weakness, and weight loss), a condition in which there is too much bilirubin in the blood (hyperbilirubinaemia) or yellowing of the skin or whites of the eyes (jaundice) during treatment with Simvastatin
■ If you develop a shortness of breath or difficulty in breathing (dyspnoea), a cough or deterioration in general health (tiredness, weakness or lack energy, weight loss, fever) as you may have developed an inflammation of the lungs (interstitial lung disease)
■ If you are diabetic
Other medicines and Simvastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which may interact with or be affected by Simvastatin:
Itraconazole, ketoconazole, fluconazole, posaconazole, voriconazole (antifungals), used to treat fungal infections
Nelfinavir, used to treat HIV infection (HIV-protease inhibitors)
Boceprevir, telaprevir, used to treat hepatitis C (protease inhibitors)
Erythromycin, clarithromycin, telithromycin (antibiotics), used to treat infections Nefazodone (antidepressant), used to treat depression
Gemfibrozil (fibrates), used to treat high cholesterol levels
Other fibrates such as bezafibrate (except fenofibrate), used to lower cholesterol levels Ciclosporin (immunosuppressants), used to reduce the body's immunity when receiving organ transplant Danazol (synthetic steroid hormone), used to treat endometriosis (condition where small pieces of the womb lining are found outside the womb causing symptoms such as painful periods, persistent pain in the pelvic area and infertility) and to relieve severe pain and tenderness associated with non-cancerous breast lumps
■ Amiodarone (antiarrhythmic agent), used to treat irregular heartbeats
■ Verapamil, diltiazem, amlodipine (calcium-channel blockers), used to treat high blood pressure and to control angina (chest pain)
■ Fusidic acid (antibacterial agent), used to treat bacterial skin infections
■ Niacin or nicotinic acid in large doses (1g or more daily), used to treat high cholesterol levels
■ Colchicine, used to treat gout
■ Rifampicin (antibiotic) used to treat infections such as tuberculosis
■ Medicines used to thin the blood (anticoagulants) such as warfarin
Simvastatin with food and drink and alcohol
■ During treatment with Simvastatin, a low-fat diet should be followed.
■ These tablets may be taken with or without food.
■ During treatment with Simvastatin, it is advisable not to drink alcohol.
■ Grapefruit juice should be avoided during treatment with Simvastatin.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
■ Do not take Simvastatin if you are pregnant, trying to become pregnant or think you may be pregnant.
■ If you become pregnant while taking Simvastatin, treatment with Simvastatin should be suspended for the duration of pregnancy.
Breast-feeding
Do not take Simvastatin if you are breast-feeding as it is not known if Simvastatin is passed into breast milk.
Driving and using machines
Although unlikely, you may experience dizziness whilst taking this medicine. If this is experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.
Simvastatin contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Simvastatin
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
■ These tablets are to be taken orally as single dose in the evening.
■ The score line is only there to help you break the tablet if you have difficulty swallowing it whole and not to divide into equal doses.
■ The recommended daily dose ranges between 5mg and 80mg.
■ Dosage may be adjusted, if required, up to a maximum of 80mg daily, at intervals of at least 4 weeks.
■ The 80mg dose is only recommended for patients with very high cholesterol levels (severe hypercholesterolaemia) who are at high risk of heart complications, where treatment on lower doses has not been adequate and the benefits are expected to outweigh the potential risks.
■ No dose adjustment is necessary for elderly patients.
Treatment
Very high levels of cholesterol in the blood
(Hypercholesterolaemia)
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