1. What this product is and what it is used for 1. What Vasta is and what it is used for Vasta is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Vasta raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Vasta is a member of the class of drugs called statins. Vasta is used along with diet if you have: - A raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia). - A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments. - Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Vasta may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood. In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor. 2. What you need to know before you use this product 2. Before you take Vasta Do not take Vasta - If you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Vasta tablets. - If you currently have liver problems. - If you are pregnant or breast-feeding. - If you are taking one or more of the following drugs at the same time: - Itraconazole, ketoconazole, or posaconazole (medicines for fungal infections). - Erythromycin, clarithromycin, or telithromycin (antibiotics for infections). - HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections). - Nefazodone (a medicine for depression). - Gemfibrozil (a medicine for lowering cholesterol). - Ciclosporin (a medicine often used in organ transplant patients). - Danazol (a man-made hormone used to treat endometriosis). Ask your doctor if you are not sure if your medicine is listed above. Take special care with Vasta - Tell your doctor about all your medical conditions including allergies. - Tell your doctor if you drink large amounts of alcohol. - Tell your doctor if you have ever had liver disease. Vasta may not be right for you. - Tell your doctor if you are due to have an operation. You may need to stop taking Vasta tablets for a short time. - Your doctor should do a blood test before you start taking Vasta. This is to check how well your liver is working. - Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Vasta. - While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. - Tell your doctor if you have severe lung disease. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. The risk of muscle breakdown is greater at higher doses of Vasta, particularly the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies: - You consume large amounts of alcohol. - You have kidney problems. - You have thyroid problems. - You are 65 years or older. - You are female. - You have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates. - You or a close family member have a hereditary muscle disorder. Using other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Vasta with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Vasta”). - Ciclosporin (a medicine often used in organ transplant patients). - Danazol (a man-made hormone used to treat endometriosis). - Medicines like itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections). - Fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol). - Erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections). - HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS). - Nefazodone (a medicine for depression). - Amiodarone (a medicine for an irregular heartbeat). - Verapamil, diltiazem or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions). - Colchicine (a medicine used to treat gout). As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following: - Medicines to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants). - Fenofibrate (another medicine for lowering cholesterol). - Niacin (another medicine for lowering cholesterol). - Rifampicin (a medicine used to treat tuberculosis). Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. You should also tell any doctor who is prescribing a new medicine for you that you are taking Vasta. Taking Vasta with food and drink Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Vasta. Consuming grapefruit juice should be avoided. Pregnancy and Breast-feeding Do not take Vasta if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Vasta, stop taking it immediately and contact your doctor. Do not take Vasta if you are breast-feeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. Children Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see HOW TO TAKE Vasta). Vasta has not been studied in children under the age of 10 years. For more information, talk to your doctor. Driving and using machines Vasta is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking Vasta. Important information about some of the ingredients of Vasta Vasta tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to use this product. 3. How to take Vasta Always take Vasta exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol-lowering diet while taking Vasta. The dose is 1 Vasta 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day. For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day. The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Take Vasta in the evening. You can take it with or without food. The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Vasta unless your doctor tells you to stop. If your doctor has prescribed Vasta along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Vasta at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Vasta than you should Please contact your doctor or pharmacist. If you forget to take Vasta Do not take an extra dose, just take your normal amount of Vasta at the usual time the next day. If you stop taking Vasta Your cholesterol may rise again. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects 4. Possible side effects Like all medicines, Vasta can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: - Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated). - Very rare (occurring in less than 1 of 10,000 patients treated). - Frequency not known. The following rare serious side effects were reported. If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital. - Muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. - Hypersensitivity (allergic) reactions including: - Swelling of the face, tongue and throat which may cause difficulty in breathing. - Severe muscle pain usually in the shoulders and hips. - Rash with weakness of limbs and neck muscles. - Pain or inflammation of the joints. - Inflammation of the blood vessels. - Unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing. - Shortness of breath and feeling unwell. - Lupus-like disease picture (including rash, joint disorders, and effects on blood cells). - Inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare). - Inflammation of the pancreas often with severe abdominal pain. The following side effects have also been reported rarely: - Low red blood cell count (anaemia). - Numbness or weakness of the arms and legs. - Headache, tingling sensation, dizziness. - Digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting). - Rash, itching, hair loss. - Weakness. - Trouble sleeping (very rare). - Poor memory (very rare). The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known): - Erectile dysfunction. - Depression. - Inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever. - Tendon problems, sometimes complicated by rupture of the tendon. Additional possible side effects reported with some statins: - Sleep disturbances, including nightmares. - Memory loss. - Sexual difficulties. - Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine. Laboratory Values Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. 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 this product 5. How to store Vasta Keep out of reach of children. Store below 30°C. Do not use beyond the expiry date or if the product shows any sign of deterioration.