Vit.D3-GAP Package Insert

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME AND DOSAGE FORM:

VIT. D3-GAP Capsules

COMPOSITION:

Each capsule contains:
Vitamin D3 800 I.U.
List of Excipients: Colloidal anhydrous silica, magnesium stearate and microcrystalline cellulose

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins

PHARMACOLOGICAL ACTION:

The physiological role of vitamin D is to promote absorption and utilization of calcium and phosphate and for normal calcification of bones. The mechanism by which vitamin D acts to maintain normal concentrations of calcium and phosphate in plasma is to facilitate their absorption in the small intestine, to enhance their mobilization from bone and to decrease their excretion by the kidneys.

Exposure of skin to ultraviolet rays in sunlight results in formation of cholecalciferol (vitamin D3). Calcitriol appears to act by binding to specific receptors in the cytoplasm of the intestinal mucosa and subsequently being incorporated into the nucleus leading to the formation of calcium binding protein that results in increased absorption of calcium from the intestine. Calcitriol may also regulate the transfer of calcium ion from bone and stimulate reabsorption of calcium in the distal renal tubule, thereby effecting calcium homeostasis in the extracellular fluid.

A deficiency of vitamin D results in inadequate absorption of calcium and phosphate. In infants and children, lack of vitamin D results in defects in bone growth known as rickets. In adults vitamin D deficiency results in osteomalacia or adult rickets which is most likely to happen during times of increased need for calcium during pregnancy or lactation.

INDICATIONS:

VIT. D3-GAP capsules assist in the maintenance of vitamin D3 levels. Vitamin D is required to maintain adequate calcium metabolism and good bone health for all ages.

CONTRAINDICATIONS:

VIT.D3-GAP capsule is contra-indicated for individuals allergic or sensitive to any of the listed ingredients.

WARNINGS AND SPECIAL PRECAUTIONS:

VIT.D3-GAP capsule 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 D.

INTERACTIONS:

Cholestyramine or colestipol hydrochloride administration may result in decreased intestinal absorption of vitamin D analogs. There is an increased risk of hypercalcemia if vitamin D is given with thiazide diuretics or calcium.

PREGNANCY AND LACTATION:

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

DOSAGE AND DIRECTION 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. Doses of vitamin D analogues that do not exceed the physiologic requirements are nontoxic. If any side effects occur please consult your healthcare practitioner.

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. Treatment should be symptomatic and supportive.

IDENTIFICATION:

VIT. D3-GAP capsules are green and white hard gelatin capsules.

PRESENTATION:

VIT. D3-GAP capsules are packed in PVC/PVDC/Aluminium blister packs of 30 capsules. Blisters are kept inside a cardboard box.

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 THIS PACKAGE INSERT:

To be allocated

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