The prevention and treatment of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk
of vitamin D insufficiency.
Prima D3 is indicated in adults, the elderly and adolescents

Vitamin D should be used with caution in patients with impairment of renal function and the effect
on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of Cholecalciferol is not metabolised normally and other forms of vitamin D should be used Caution
is required in patients receiving treatment for cardiovascular disease.
Prima D3 should be prescribed with caution to patients suffering from sarcoidosis because of the
risk of increased metabolism of vitamin D to its active form. These patients should be monitored
with regard to the calcium content in serum and urine.
Allowances should be made for vitamin D supplements from other sources.
The need for additional calcium supplementation should be considered for individual patients.
Calcium supplements should be given under close medical supervision.
Medical supervision is required whilst on treatment to prevent hypercalcaemia.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because
of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.
The effects of digitalis and other cardiac glycosides may be accentuated with the oral
administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if
necessary monitoring of ECG and calcium.
Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as
paraffin oil may reduce the gastrointestinal absorption of vitamin D.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity
by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney
enzyme, 25-hydroxyvitamin D-1-hydroxylase.

There are no or limited amount of data from the use of Cholecalciferol in pregnant women.
Studies in animals have shown reproductive toxicity. The recommended daily intake for pregnant
women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose
may be required. During pregnancy women should follow the advice of their medical practitioner
as their requirements may vary depending on the severity of their disease and their response to
treatment.

Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing
mothers has not been observed; however, when prescribing additional vitamin D to a breast-fed
child the practitioner should consider the dose of any additional vitamin D given to the mother.

Prima D3 has no influence on the ability to drive and use machines.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined
as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D
toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst
and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of
hypercalcaemia. Treatment should consist of stopping all intakes of vitamin D and rehydration.

Pharmacotherapeutic group: Vitamin D and analogues
ATC code: A11CC05
In its biologically active form vitamin D3 stimulates intestinal calcium absorption, incorporation of
calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes
rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated.
In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption.
The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the
biologically active form of vitamin D3. PTH secretion is inhibited additionally by the increased
calcium uptake in the small intestine under the influence of biologically active vitamin D3.

The pharmacokinetics of vitamin D is well known. Vitamin D is well absorbed from the gastrointestinal
tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycolecalciferol and then undergoes further hydroxylation in the kidney to form the active
metabolite 1, 25 dihydroxycolecalciferol (calcitriol). The metabolites circulate in the blood bound
to a specific α - globin, Vitamin D and its metabolites are excreted mainly in the bile and faeces.

Vitamin D is well known and is a widely used material and has been used in clinical practice for
many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia
could result.
Cholecalciferol has been shown to be teratogenic in high doses in animals (4-15 times the human
dose). Offspring from pregnant rabbits treated with high doses of vitamin D had lesions
anatomically similar to those of supravalvular aortic stenosis and offspring not showing such
changes show vasculotoxicity similar to that of adults following acute vitamin D toxicity.

Gelatin
Glycerol
Soybean Oil
Ponceau 4 R
Sunset Yellow FD and C 6 FCF
Brilliant Blue FD and C 1
Purified Water

Not applicable

Do not store above 30°C.
Protect from heat and moisture.
Do not freeze

HDPE bottle with DUMA twist off cap
Pack sizes: 60’s, 30’s HDPE and 3 X 10’s Blister Pack
Not all pack sizes may be marketed.

Any unused product should be disposed of in accordance with local requirements