INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PHYTOCOR

SCHEDULING STATUS:
Not applicable

PROPRIETARY NAME
(and dosage form):

PHYTOCOR
(tablets)

COMPOSITION:
Each tablet contains 10 mg
policosanol.

PHARMACOLOGICAL CLASSIFICATION:
A: 34 Other

PHARMACOLOGICAL ACTION
Policosanol is a natural ingredient derived from the waxy component of sugar cane. It is a natural concentrated form of the long chain aliphatic fatty alcohol (not a sugar) derived from sugar cane. The major component is octacosanol, a potent policosanol.
About 75%-80% of cholesterol is synthesized in the liver and the balance is derived from food sources such as meat and dairy products.
Cholesterol is transported in the blood stream by lipoproteins. AcetylCoA is the enzyme responsible for the synthesis of cholesterol in the cells. There are four main classes of lipoproteins, which are:
•        High-density lipoproteins (HDL)
•        Low-density lipoproteins (LDL)
•        Very low density lipoproteins (VLDL)
•        Chylomicrons.
Various clinical trials using the sugar cane extract have demonstrated that policosanol lowers low-density lipoproteins (LDL or "bad" cholesterol) in the blood. It improves blood cholesterol levels by reducing serum cholesterol levels and increasing HDL levels.
Policosanol exhibits anti-oxidant effect on LDL cholesterol.
It has been suggested that it contributes to the "thinning" of the blood by inhibiting platelet aggregation by reducing blood clots and improving circulation.

INDICATIONS:
PHYTOCOR is indicated in those individuals with elevated cholesterol levels equal to or above 5 mmol.

CONTRA-INDICATIONS
Safety during pregnancy and lactation has not been established.

WARNINGS:
Always consult your Healthcare professional about your cholesterol status. If you are on any cholesterol lowering medication, consult your doctor before taking policosanol.

DOSAGE AND DIRECTIONS FOR USE:
One (1) tablet, with water or any other fluid, after the evening meal or as directed by your Healthcare Professional.
Positive results have been observed within 8 weeks.
It is recommended that you inform your Healthcare Professional that you are taking PHYTOCOR.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
No known side effects have been reported.
Policosanol has been found to be safe and well tolerated in patients with hypercholesterolaemia and concomitant coronary risk factors.
Type II diabetics can use policosanol. Documented studies have demonstrated safety in those with liver and kidney problems.
No liver toxicity has been demonstrated during long-term use at high doses in experimental laboratory studies in Sprague Dawley rats.
Special precautions:
Insulin dependent diabetics should use with caution and sugar levels need to be monitored.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage have been documented.

IDENTIFICATION:
White, round, flat, slightly mottled bevelled-edge tablet with a breakline on one side and plain on the other.

PRESENTATION:
Blister packs containing 30 tablets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.

NAME AND BUSINESS ADDRESS:
Pharma Dynamics (Pty) Ltd
F02 Grapevine House
Steenberg Office Park
Westlake
7945

DATE OF PUBLICATION OF THIS INSERT:
August 2002

New to this site: March 2003
Source: Pharmaceutical Industry

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