10 mg, 20 mg, and 40 mg\u00a0film-coated tablet
simvastatin<\/p>\n\n\n\n
Simvastatin\u00a0Krka contains the active substance\u00a0simvastatin.\u00a0Simvastatin\u00a0Krka is a drug used to lower the levels of total cholesterol in the blood, the “bad”\u00a0cholesterol\u00a0(\u00a0LDL\u00a0–\u00a0cholesterol\u00a0), and blood fats, so-called\u00a0triglycerides.\u00a0Simvastatin\u00a0Krka also increases the levels of the “good”\u00a0cholesterol\u00a0(\u00a0HDL\u00a0–\u00a0cholesterol\u00a0).\u00a0Simvastatin\u00a0Krka belongs to a group of medicines called statins.<\/p>\n\n\n\n
Cholesterol\u00a0is one of several fats found in your blood.\u00a0Your total cholesterol consists mainly\u00a0of\u00a0LDL\u00a0and\u00a0HDL\u00a0cholesterol.<\/p>\n\n\n\n
LDL\u00a0cholesterol\u00a0is often called the “bad”\u00a0cholesterol\u00a0because\u00a0it causes fat storage in your vessel walls and forms\u00a0plaque.\u00a0This\u00a0plaque storage can eventually lead to a narrowing of your\u00a0vessels.\u00a0This narrowing can reduce or block blood flow to important organs such as the heart and brain.\u00a0Blockage of blood flow can result in a heart attack or\u00a0stroke.<\/p>\n\n\n\n
HDL cholesterol is often called the “good” cholesterol because it helps prevent the “bad” cholesterol from being stored in vessels and protects against heart disease.<\/p>\n\n\n\n
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.<\/p>\n\n\n\n
You should continue with a cholesterol-lowering diet while you are taking this medicine.<\/p>\n\n\n\n
Simvastatin Krka is used as a supplement to your cholesterol-lowering diet if you have:<\/p>\n\n\n\n
In most people, high\u00a0cholesterol\u00a0does not cause immediate symptoms.\u00a0Your doctor can measure your cholesterol level with a simple blood test.\u00a0Visit your doctor regularly, monitor your cholesterol levels, and discuss your goals with your doctor.<\/p>\n\n\n\n
Simvastatin contained\u00a0in\u00a0Simvastatin\u00a0Krka may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
<\/p>\n\n\n\n
Do not take more than 40 mg Simvastatin Krka if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).<\/p>\n\n\n\n
Consult a doctor if you are unsure if your medicine is listed above.<\/a><\/p>\n\n\n\n Tell your doctor:<\/p>\n\n\n\n Your doctor should take a blood sample before you start taking Simvastatin Krka, and if you have any symptoms of liver problems during treatment with Simvastatin Krka. This blood test is taken to check your liver function.<\/p>\n\n\n\n Your doctor may also need to take a blood test to check your liver function after you start taking Simvastatin Krka.<\/p>\n\n\n\n During treatment with this medicine, your doctor will closely monitor you if you have\u00a0diabetes\u00a0or are at risk of developing\u00a0diabetes.\u00a0You are more likely to be at risk for\u00a0diabetes\u00a0if you have high blood sugar and blood fat levels, are overweight, and have high\u00a0blood pressure.<\/p>\n\n\n\n Tell your doctor if you have any serious lung disease.<\/p>\n\n\n\n Contact a doctor immediately if you experience unexplained muscle aches, soreness, or weakness.\u00a0The reason for this is that in rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result and in very rare cases, deaths have occurred.<\/strong><\/p>\n\n\n\n The risk of muscle breakdown is greater at higher doses of Simvastatin Krka, this is especially true for a dose of 80 mg. The risk of muscle breakdown is also greater in some patients. Talk to your doctor if any of the following apply to you:<\/p>\n\n\n\n Also, tell your doctor or pharmacist if you have persistent muscle weakness.\u00a0Additional tests and medications may be needed to investigate and treat this.<\/p>\n\n\n\n The safety and efficacy of simvastatin have been studied in boys aged 10-17 years and in girls who have had menstruation for at least one year (see section 3). Simvastatin has not been studied in children under 10 years of age. For further information, consult a doctor.<\/a><\/p>\n\n\n\n It is especially important to tell your doctor if you are taking any of the following active ingredients. Taking Simvastatin Krka with any of these medicines may increase the risk of muscle problems (some of these have already been listed in the section above “Do not use Simvastatin Krka”). <\/p>\n\n\n\n Also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking medicines with any of the following active ingredients:<\/p>\n\n\n\n Tell your doctor who is prescribing a new medicine that you are taking Simvastatin Krka.<\/a><\/p>\n\n\n\n Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain drugs, including Simvastatin Krka. Intake of grapefruit juice should be avoided.<\/a><\/p>\n\n\n\n Do not use\u00a0Simvastatin\u00a0Krka if you are pregnant, trying to conceive, or think you may be pregnant.\u00a0If you become pregnant during treatment with\u00a0Simvastatin\u00a0Krka, stop treatment immediately and contact your doctor.<\/p>\n\n\n\n Do not take\u00a0Simvastatin\u00a0Krka if you are breastfeeding as it is unknown if the medicine passes into breast milk.<\/p>\n\n\n\n Ask your doctor or pharmacist for advice before taking any medicine.<\/a><\/p>\n\n\n\n Simvastatin Krka is not expected to affect your ability to drive or use machines. However, keep in mind that some people get dizzy when they take Simvastatin Krka.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.\u00a0One of the factors that can affect your ability in these respects is the use of drugs, due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Your doctor will decide which\u00a0dose\u00a0is right for you depending on your symptoms, your current treatment, and your risk profile.<\/p>\n\n\n\n Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n You should continue with a cholesterol-lowering diet while taking Simvastatin Krka.<\/p>\n\n\n\n Dosage:<\/strong><\/p>\n\n\n\n The recommended\u00a0dose\u00a0is one\u00a0Simvastatin\u00a0Krka 10 mg, 20 mg, or 40 mg tablet once a day.<\/p>\n\n\n\n Adults:<\/em><\/p>\n\n\n\n The most common starting dose is 10 mg, 20 mg, or in some cases 40 mg daily.\u00a0Your doctor may, after at least 4 weeks, need to adjust your\u00a0dose\u00a0to a maximum of 80 mg per day.\u00a0Do not take more than 80 mg per day.<\/strong><\/p>\n\n\n\n Your doctor may prescribe a lower dose for you, especially if you are taking certain medicines listed above or have certain kidney problems.<\/p>\n\n\n\n A dose\u00a0of 80 mg is only recommended for adult patients with very high cholesterol levels and who are at high risk for cardiovascular disease and who have not achieved their treatment goals at lower\u00a0doses.<\/p>\n\n\n\n Method of administration and duration of treatment:<\/strong><\/p>\n\n\n\n Take Simvastatin Krka in the evening. Simvastatin Krka can be taken with or without food.<\/p>\n\n\n\n Continue to take Simvastatin Krka unless your doctor tells you to stop.<\/p>\n\n\n\n If your doctor has prescribed Simvastatin Krka together with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simvastatin Krka at least 2 hours before or 4 hours after taking the bile acid sequestrant.<\/a><\/p>\n\n\n\n The recommended starting dose for children (10 – 17 years) is usually 10 mg in the evening. The maximum recommended dose is 40 mg daily.<\/a><\/p>\n\n\n\n If you have ingested too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0Just take your usual\u00a0dose of\u00a0Simvastatin\u00a0Krka at the time you usually take the next day.<\/p>\n\n\n\n Talk to your doctor or pharmacist as your cholesterol levels may rise again.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n The following classification is used to describe how often side effects have been reported:<\/p>\n\n\n\n The following rare serious side effects have been reported.<\/p>\n\n\n\n If any of these serious side effects occur, stop taking your medicine and contact your doctor immediately or see an emergency department at the nearest hospital.<\/strong><\/p>\n\n\n\n The following side effects have been reported rarely:<\/p>\n\n\n\n The following very rare serious side effects have been reported:<\/p>\n\n\n\n The following side effects have also been reported, but the frequency cannot be determined with available information (no known frequency):<\/p>\n\n\n\n Additional possible side effects have been reported with certain statins:<\/p>\n\n\n\n Laboratory values<\/em><\/p>\n\n\n\n In some blood tests, elevations in liver function values \u200b\u200band a muscle enzyme (creatinine kinase) have been observed.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not store above 30 \u00b0 C.<\/p>\n\n\n\nWarnings and cautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Simvastatin Krka<\/h2>\n\n\n\n
Simvastatin Krka with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Simvastatin Krka contains lactose<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow to use Simvastatin Krka<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If you use more Simvastatin Krka than you should <\/h2>\n\n\n\n
If you forget to use Simvastatin Krka<\/h2>\n\n\n\n
If you stop using Simvastatin Krka<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Simvastatin Krka<\/h2>\n\n\n\n