GLUCO-GAP Package Insert

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME AND DOSAGE FORM:

GLUCO-GAP (CAPSULE)

COMPOSITION:

Each capsule contains:
HydroQsorb (Co-enzyme Q10) 50 mg
Chromium 0,025 mg
Vitamin D3 800 IU
Vitamin B1 5 mg
Vitamin B12 0,1 mg
List of excipients: Colloidal anhydrous silica, magnesium stearate.

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHAMRMACOLOGICAL ACTION:

Co-enzyme Q10 (Q10) is an electron carrier in the mitochondria and acts as a primary antioxidant. It is present in all membranes and it appears to exceed other antioxidants in quantity and efficiency. Q10 levels, can be used as a marker of antioxidant capacity, and is decreased in diabetic patients. Q10 also seems to have a positive effect on the immune system in patients with diabetes i.e. it induced changes in activation markers in peripheral natural killer cells.

A study measuring trace elements in blood and scalp hair of diabetic patients confirmed that chromium, as well as other minerals were significantly decreased.
Several clinical studies have documented a beneficial effect of chromium in insulin resistance and Type 2 diabetes.
There is a high prevalence of vitamin D deficiency in patients with diabetes mellitus and an independent association between vitamin D deficiency and the presence of nephropathy.

The vitamin B12 deficiency is found to be associated with the dosage and duration of metformin use. Evidence from early clinical observations, indicates a prevalence of 30 % of vitamin B12 malabsorption among patients undergoing long-term metformin treatment. Subsequent studies reported that metformin decreased serum vitamin B12 level by 14 % to 30 %.
A study with a large dose of 1500 g vitamin B12 administered as supplementation without discontinuation of metformin for approximately 2 months, showed a restoration of normal serum vitamin B12 concentration in the vast majority of the vitamin B12-deficient patients.

Thiamine (vitamin B1) is an essential cofactor in most organisms. Its active form, thiamine diphosphate (TDP), is essential in several stages of anabolic and catabolic intermediary metabolism, e.g. the intracellular glucose metabolism (glycolysis, Krebs cycle, pentose-phosphate cycle), and TDP is also a modulator of neuronal and neuro- muscular transmission. A deficiency of thiamine or defects in its intracellular transport can cause a number of severe disorders. Thiamine (vitamin B1) is marginally deficient in patients with diabetes mellitus.

INDICATIONS:

GLUCO-GAP capsules assist in the maintenance of the essential nutrients that may be depleted as a result of diabetes and the treatment thereof.

CONTRAINDICATIONS:

GLUCO-GAP capsule is contraindicated in individuals allergic or sensitive to any of the listed ingredients.

WARNINGS and SPECIAL PRECAUTIONS:

GLUCO-GAP has not been evaluated by the Medicines Control Council. This product is not intended to diagnose, treat, cure or prevent any disease. Health supplements are intended only to complement health or supplement the diet. Doses in excess of the prescribed amount may lead to hypervitaminosis and/or mineral toxicity.

INTERACTIONS:

There is an increased risk of hypercalcemia if vitamin D is given with thiazide diuretics or calcium. Cholestyramine or colestipol hydrochloride administration may result in decreased intestinal absorption of vitamin D analogs.
No other known interactions have been established. If you suspect any interactions please consult your healthcare practitioner immediately.

PREGNANCY AND LACTATION:

Safety during pregnancy and lactation has not been established. Please consult your healthcare practitioner prior to use.

DOSAGE AND DIRECTIONS FOR USE:

Adult: Take one (1) capsule daily.
Do not exceed the recommended daily dosage.

SIDE EFFECTS:

Excessive intake of vitamin D may lead to the development of hyperphosphataemia or hyperkalaemia. No other known side effects have been established. If any side effects occur please consult your healthcare practitioner immediately.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

The acute or chronic administration of excessive amounts of vitamin D or enhanced responsiveness to normal amounts of the vitamin leads to a number of clinical syndromes that are the result of deranged calcium metabolism.
If suspected overdose occurs please consult your healthcare practitioner immediately. Treatment should be symptomatic and supportive.

IDENTIFICATION:

GLUCO-GAP are white and dark blue hard gelatin capsules.

PRESENTATION:

GLUCO-GAP capsules are packed in PVC/PVDC/Aluminium blister packs of 30 capsules.

STORAGE INSTRUCTIONS:

Store at or below 25 ̊C.
KEEP OUT OF REACH OF CHILDREN
Store in unit carton until before use.

REGISTRATION NUMBER:

To be allocated.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:

Adcock Ingram Limited
1 New Road
Erand Gardens
Midrand,1685
www.adcock.com

DATE OF PUBLICATION OF THE PACKAGE INSERT:

To be allocated

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