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Brand name: Simvastatin (AN) TM
Active ingredients: simvastatin
What it is used for
Adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Simvastatin is indicated in patients at high risk of coronary heart disease (CHD) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.
How to take it
The way to take this medicine is: Oral. This medicine is taken by mouth.
- Store below 25 degrees Celsius
- Shelf lifetime is 3 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
Light pink coloured, round shaped, biconvex, film coated tablets, debossed with 'A' on one side and '01' on the other side
Images are the copyright of the Pharmacy Guild of Australia
Food interactions
For the active ingredient simvastatin
- Avoid alcohol.
- Avoid drastic changes in dietary habit.
- Avoid taking with grapefruit juice.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Is this medicine subsidised?
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on March 1, 2019. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy?
For the active ingredient simvastatin
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Need more information?
These trusted information partners have more on this topic.
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Statins for the treatment of Alzheimer's disease | Cochrane
High levels of cholesterol (a fatty substance known as a lipid) in the blood are thought to contribute to the cause of Alzheimer's disease and vascular dementia. The statin family of medications (lovastatin, pravastatin, simvastatin and others) are powerful cholesterol-lowering medications and are first-line treatments for reducing cholesterol in people with, or at risk of, cardiovascular disease. There has been much interest in the possible role of statins in the treatment of dementia.
Read more on Cochrane (Australasian Centre) website
Statins for non-alcoholic steatohepatitis | Cochrane
Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in patients with no or very little alcohol consumption is characterised by hepatic histological changes similar to those associated with alcohol-induced liver injury. A range of histological changes can be seen. Some patients have fat accumulation in hepatocytes without significant inflammation or fibrosis (simple hepatic steatosis or NAFLD), but others have hepatic steatosis with prominent necro-inflammatory changes with or without associated fibrosis (this is NASH). Although NAFLD and NASH are common conditions, no effective medical treatment is available to correct the abnormal liver enzymes and adverse outcomes associated with them. This systematic review identified two randomised clinical trials with very small numbers of participants. One of the trials was a pilot trial and compared simvastatin with placebo, and the other trial assessed atorvastatin versus fenofibrate versus a combination of the two. The small pilot trial (n = 16 patients) assessing simvastatin versus placebo in NASH patients did not show significant effects on liver enzyme activities or liver histology. No adverse events were reported. The other trial compared atorvastatin versus fenofibrate versus a group receiving both interventions in 186 patients with NAFLD. There were no statistically significant differences between any of the three intervention groups regarding the 54 week mean activities of aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, or alkaline phosphatases (liver enzymes) in the blood. The triglyceride levels seemed higher in the fenofibrate group compared with the atorvastatin group. Liver histology was not assessed in this trial. The presence of biochemical and ultrasonographic evidence of NAFLD seemed higher in the fenofibrate group compared with the other two intervention groups. Three patients discontinued treatment due to myalgia and elevated serum creatine kinase activity, one from the atorvastatin group and two from the combination group. Another patient from the atorvastatin group discontinued treatment due to raised alanine aminotransferase activity, over three times the upper normal limit. Both trials were at high risk of bias (that is, overestimation of benefits and underestimation of harms). Furthermore, the groups were small raising the risks of random errors (that is, play of chance). Accordingly, we did not find evidence to support or refute the use of statins for patients with NAFLD or NASH. Further unbiased trials with larger numbers of patients looking explicitly at patient-related outcomes of interest (for example, quality of life, development of cirrhosis, and mortality) are needed to assess the effects of statins on NAFLD or NASH.
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Statins for acute coronary syndrome | Cochrane
Long-term therapy with statins (for at least one year) has been shown to reduce the risk of heart attack, stroke, and all-cause mortality in patients with and without established coronary heart disease. The early period following an acute coronary syndrome is a critical stage of coronary heart disease, with a high risk of recurrent events and death. We aimed to determine if early initiation of statins improves patient-relevant outcomes within the first four months following an acute coronary syndrome. This review is an update of a review previously published in 2011 that included 18 studies, enrolling 14,303 patients. The update of this review did not identify any new studies for inclusion. We did not find a significant risk reduction for all-cause mortality, heart attack, or stroke within the first four months. We had some concerns about risk of bias and imprecision of the results. The risk of unstable angina was reduced by about 25% at four months following acute coronary syndrome. Serious side effects from early treatment with statins were rare (0.1%), and serious muscle toxicity was mostly observed with simvastatin 80 mg.
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Lipid-lowering agents for nephrotic syndrome | Cochrane
Nephrotic syndrome is a relatively rare disease in which the kidneys leak protein into the urine. A common early sign is swelling in the feet and face. Other signs and symptoms of nephrotic syndrome include low levels of protein in the blood, and high levels of fats in the blood, particularly cholesterol and triglycerides.
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