Consumer medicine information

1. Why am I using SIMVAR?

SIMVAR contains the active ingredient simvastatin. SIMVAR is used to help lower cholesterol and triglyceride levels, its used in people who have coronary heart disease (CHD) and it is used in people with a high risk of CHD (e.g. diabetes, a history of stroke, or other blood vessel disease).
For more information, see Section 1. Why am I using SIMVAR? in the full CMI.

2. What should I know before I use SIMVAR?

Do not use if you have ever had an allergic reaction to simvastatin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use SIMVAR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SIMVAR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SIMVAR?

• Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

• If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

• Take this medicine only when prescribed by your doctor.

5. What should I know while using SIMVAR?

6. Are there any side effects?

Tell your doctor and pharmacist as soon as possible if you do not feel well while you are taking SIMVAR.
This medicine helps most people but may cause unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Simvastatin.

2 Qualitative and Quantitative Composition

Simvastatin is a lipid-lowering agent derived synthetically from a fermentation product of Aspergillus terreus.
Simvastatin is a white crystalline powder, practically insoluble in water and freely soluble in chloroform, methanol and ethanol.
Each tablet contains simvastatin 10 mg, 20 mg, 40 mg or 80 mg.
Excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

10 mg tablet. Light pink coloured, oval, biconvex film-coated tablets, marked "SVN 10" on one and 'NEO' on the other side.
20 mg tablet. Tan coloured, oval, biconvex film-coated tablets, marked with "SVN 20" on one side and 'NEO' on the other side.
40 mg tablet. Pink coloured, oval, biconvex film coated tablets, marked "SVN 40" on one side 'NEO' on the other side.
80 mg tablet. Pink coloured, capsule-shaped, biconvex film-coated tablets marked with "SVN 80" on one side and 'NEO' on the other side.

4 Clinical Particulars

4.9 Overdose

A few cases of overdosage have been reported; all patients recovered without sequelae. The maximum dose taken was 3.6 g. General measures should be adopted, and liver function should be monitored.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Genetic toxicology studies of simvastatin showed no evidence of mutagenic activity in bacteria or in mammalian cells in vitro, or of clastogenic activity in vitro or in mice in vivo. In vitro and in vivo assays showed that simvastatin does not cause DNA damage in rat hepatocytes.
Carcinogenicity. In animal studies. Carcinogenicity studies have been conducted in mice at oral doses ranging from 1 to 400 mg/kg/day and in rats at doses of 1 to 100 mg/kg/day. Hepatocellular adenomas and carcinomas were observed in both sexes of both species at doses greater than 25 mg/kg/day. Plasma drug levels in rats at this no effect dose level, expressed as the AUC for enzyme inhibitory activity, were 3 to 11 times greater than in humans at the maximum recommended dose, whereas serum levels at the no effect level in mice were similar to those in humans. Additional findings in mice were increased incidences of pulmonary adenomas at doses greater than 25 mg/kg/day, and of Harderian gland adenomas at 400 mg/kg/day. In rats, the incidence of thyroid follicular adenoma was increased in females at dose greater than 5 mg/kg/day and in males at doses greater than 25 mg/kg/day. These thyroid tumours were associated with focal cystic follicular hyperplasia and may be a secondary effect reflective of a simvastatin mediated enhancement of thyroid hormone clearance by the liver.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSIMVAS.gif Chemical name: [1S-[1α, 3α, 7β, 8β (2S*,4S*), 8αβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl) ethyl]-1-naphthalenyl 2,2-dimethylbutanoate.
Molecular formula: C₂₅H₃₈O₅.
Molecular weight: 418.57.
CAS number. 79902-63-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SIMTIHST.gif