SIMVACOR 20

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

simvastatin, Quantity: 20 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Simvastatin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; butylated hydroxyanisole; citric acid monohydrate; lactose monohydrate; pregelatinised maize starch; ascorbic acid; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; hyprolose; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

100 tablets, 180 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg 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 CHD (coronary heart disease) (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.

Product summary:

Visual Identification: Tan coloured, oval, biconvex film-coated tablets debossed with 'SVN 20' on one side and 'NEO' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-06-15

Patient Information leaflet

SIMVACOR
1
SIMVACOR
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SIMVACOR?
SIMVACOR contains the active ingredient simvastatin. SIMVACOR is used
to treat people who have coronary heart disease
(CHD) or who are at high risk of CHD (for example, if they have
diabetes, a history of stroke, or other blood vessel disease).
For more information, see Section 1. Why am I using SIMVACOR?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SIMVACOR?
Do not use if you have ever had an allergic reaction to SIMVACOR 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
SIMVACOR?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SIMVACOR 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 SIMVACOR?
•
For adults, the recommended starting dose is 10mg or 20 mg per day,
taken in the evening, which may need to be
increased up to 80 mg daily to have the best effect
More instructions can be found in Section 4. How do I use SIMVACOR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SIMVACOR?
THINGS YOU
SHOULD DO
• Remind any doctor, dentist or pharmacist you visit that you are
using SIMVACOR.
• Have your blood fats checked when your doctor says, to make sure
SIMVACOR is working.
THINGS YOU
SHOULD NOT DO
• Do not stop using this medicine suddenly.
• Do not give SIMVACOR to anyone else even if they have the same
condition as you.
DRIVING OR USING
MACHINES
• Be careful driving or operating machinery until you know how
SIMVACOR affects you.
DRINKING
ALCOHOL
• Drinking large quantities of alcohol may increase your chance of
SIMVACOR c