PACKAGE LEAFLET 1
PACKAGE LEAFLET: INFORMATION FOR THE USER Lovastatin Mylan 20 mg Tablets Lovastatin Mylan 40 mg Tablets lovastatin Read all of this leaflet carefully before you start taking this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Lovastatin Mylan is and what it is used for 2. Before you take Lovastatin Mylan 3. How to take Lovastatin Mylan 4. Possible side effects 5. How to store Lovastatin Mylan 6. Further information 1. WHAT LOVASTATIN IS AND WHAT IT IS USED FOR Lovastatin belongs to a group of medicines know as lipid reducing agents. It is used to lower the high levels of cholesterol in your blood which have not been controlled sufficiently by altering your diet. 2. BEFORE YOU TAKE LOVASTATIN MYLAN Do not take Lovastatin Mylan if you are allergic (hypersensitive) to lovastatin or any of the other ingredients of lovastatin Mylan, if you have liver disease or have continuous elevated liver enzymes in your blood, if you have problems with your bile duct (cholestasis), if you have muscle weakness or tenderness, if you are currently taking any of the following medicines to treat an infection: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin or telithromycin, if you are taking amiodarone or verapamil for a heart condition, if you are taking the anti viral drug delavirdine, if you are taking nefazodone for depression, if you are pregnant or breast feeding, if you regularly drink large amounts of alcohol. Take special care with LOVASTATIN MYLAN Tell your doctor if any of the following apply to you: - if you have any of the following that may increase the risk of you developing muscle disease (unexplained muscle pain, muscle cramps, tenderness or weakness, particularly if associated with a high temperature): if you are over 70 years old if you have kidney problems or an underactive thyroid gland if you have a personal or family history of hereditary muscle disorders or have had muscle problems when taking a medicine to lower your blood cholesterol (statin or fibrate) in the past 2
if you regularly drink a large amounts of alcohol if you suffer a serious injury or need to have surgery If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your treatment with Lovastatin Mylan to predict your risk of muscle related side effects. The risk of muscle related side effects is known to increase when certain medicines are taken at the same time (see section 2 'Taking other medicines'). - if you have had liver problems in the past - if you are a female between 10 and 17 years old - if you are suffering from rare hereditary increased cholesterol in the blood (homozygotic familial hypercholesteraemia) - if you have a serious infection, low blood pressure, a hormone or blood disorder or uncontrolled epilepsy. Exceptional cases of a certain lung disease have been reported with some statins, especially with long term therapy (see section 4. 'Possible side effects'). If you have unexplained muscular pain, tenderness or weakness, particularly if this is associated with a high temperature while taking these tablets please tell your doctor. Taking other medicines Please tell your doctor or pharmacist if you are taking any of the following medicines or have recently taken any other medicines, including those obtained without a prescription: medication for infections, such as erythromycin, clarithromycin, itraconazole, ketoconazole, telithromycin orfusidic acid HIV/AIDS medicine such as HIV protease inhibitors nefazodone to treat depression niacin (nicotinic acid), gemfibrozil, or other fibrates to lower your cholesterol. If taken with lovastatin these may increase the risk of you developing muscle problems. immunosuppressives which lower your body s resistance to disease e.g cyclosporine danazol, used to treat endometriosis medicines used to control a heart condition e.g mibefradil, amiodarone, verapamil anticoagulants to prevent blood clots e.g. warfarin Taking LOVASTATIN MYLAN with food and drink Grapefruit juice contains one or more ingredients that can stop your medicine working properly. Do not drink large amounts of grapefruit juice (more than a litre a day). Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You must not take Lovastatin if you are pregnant or breast-feeding. Driving and using machines Lovastatin does not usually affect the ability to drive and use machines. You may, however, feel a bit dizzy. Avoid driving or operating machines if you feel unwell after taking lovastatin. 3. HOW TO TAKE LOVASTATIN MYLAN Always take lovastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. 3
You should have been placed on a diet to lower your cholesterol. This diet should be continued during your treatment with lovastatin. Adults including the elderly The usual starting dose is 20 mg a day, taken with the evening meal although in some cases your doctor may decide to start with a lower dose of 10 mg lovastatin. After at least 4 weeks your doctor may increase the amount of lovastatin you take up to a maximum dose of 80 mg. This can be taken as a single dose or divided into 2 doses taken with breakfast and the evening meal. If you are taking certain other medicines at the same time as lovastatin you may only need to take a dose of 20 mg a day. Dosage in the event of renal failure: If you have severe kidney problems your doctor may prescribe a lower dose. Children or adolescents Children or adolescents under 18 years old should not take these tablets. Children under 10 years old should not take these tablets. If you take more LOVASTATIN MYLAN than you should Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you. If you forget to take LOVASTATIN MYLAN If you forget to take a dose take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for the one you have missed. If you stop taking LOVASTATIN MYLAN Your doctor will tell you how long you need to take your tablets for. Do not suddenly stop taking this medicine without talking to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, lovastatin Mylan can cause side effects, although not everybody gets them. The side effects are usually mild and do not last very long Rarely an allergic reaction may be severe causing: - swelling of the face, lips or tongue - swelling of large muscles causing pain, tenderness and stiffness - a severe skin rash (red, tender, itchy, burning or peeling skin) - bleeding or bruising more easily than normal - fever, flushing or chills, weakness and generally feeling unwell - breathing problems - painful, swollen joints - itching or sensitivity to sunlight or artificial light - changes to some of the cells or other parts of your blood (seen in a blood test). 4
Stop taking Lovastatin Mylan and contact your doctor or hospital immediately common which may be seen in more than 1 in 100 patients but less than 1 in 10 patients are: wind diarrhoea feeling sick indigestion digestive disorders constipation dizziness rash headache stomach pains abnormal vision. muscle cramps and pain uncommon which may be seen in more than 1 in 1000 patients but less than 1 in 100 patients are: sleeping difficulties tiredness. itching changes in taste dry mouth rare which may be seen in more than 1 in 10,000 patients but less than 1 in 1000 patients are: muscle weakness or pain, abnormal muscle breakdown, which can lead to kidney problems hair loss loss of appetite restlessness or anxiety numbness or weakness of the arms and legs pins and needles sensation epidermal necrolysis liver disease with sickness, loss of appetite, feeling generally unwell, fever, itching yellowing of the skin and eyes and dark coloured urine impotence being sick Not known (cannot be estimated from the available data) depression memory impairment severe skin reactions: reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic blood tests may show increased levels of liver enzymes or an increase in creatine kinase (an enzyme indicating muscle damage) Other possible side effects include: Sleep disturbances, including insomnia and nightmares Memory loss Sexual difficulties Breathing problems including persistent cough and/or shortness of breath or fever If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE LOVASTATIN MYLAN Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use lovastatin after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. 5
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What lovastatin Mylan contains - Lovastatin tablets come in two strengths containing either 20 mg or 40 mg of the active ingredient lovastatin. - The other ingredients are pregelatinised starch, microcrystalline cellulose, magnesium stearate, butylated hydroxyanisole (E320), indigo carmine (E 132) The 40mg tablets also contain quinoline yellow (E104) What lovastatin Mylan looks like and contents of the pack Lovastatin 20 mg tablets are pale blue, eight sided tablets marked LV/20 on one side and G on the other, with score-line on one side. Lovastatin 40 mg tablets are : green, eight sided tablets marked LV/40 on one side and G on the other, with score-line on one side. The tablets come in blister pack containing 10, 28, 30, 50, 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Mylan AB P.O. Box 23033 S 10435 Stockholm Sweden Manufacturer Generics [UK] Ltd Station Close Potters Bar Hertfordshire EN6 1TL England McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Dublin 13 Ireland Only the manufacturer responsible for batch release of the concerned batch will be on the final leaflet This medicinal product is authorised in the Member States of the EEA under the following names: Denmark - Lovastatin Mylan Portugal - Lovastatin Mylan (20 and 40mg) Tablets This leaflet was last approved in 6