MEDITAB SIMVASTATIN

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

Administration route:

Oral

Units in package:

30 tablets, 180 tablets, 100 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:

2010-11-04

Patient Information leaflet

SIMVACOR
1
MEDITAB SIMVASTATIN
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 MEDITAB SIMVASTATIN?
MEDITAB SIMVASTATIN contains the active ingredient simvastatin.
MEDITAB SIMVASTATIN 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 MEDITAB
SIMVASTATIN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MEDITAB SIMVASTATIN?
Do not use if you have ever had an allergic reaction to MEDITAB
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
MEDITAB SIMVASTATIN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MEDITAB SIMVASTATIN 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 MEDITAB SIMVASTATIN?
•
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 MEDITAB
SIMVASTATIN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MEDITAB SIMVASTATIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MEDITAB SIMVASTATIN.
•
Have your blood fats checked when your doctor says, to make sure
MEDITAB SIMVASTATIN is working.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give MEDITAB SIMVASTATIN to anyone else even if they have the
same condition as you.
DRIVING OR USING
MACHINES
•
Be careful dri