Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

* Keep this leaflet. You may need to read it again.

* If you have any further questions, ask your doctor or

pharmacist.

* This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

* If you get any side effects talk to your doctor or pharmacist.

• Active Ingredient: Vitamin D3 (Cholecalciferol): 10,000 IU.

• Excipients: Refined Corn Oil, Butylated Hydroxyanisole, Butylated

Hydroxytoluene, Methyl Paraben, Propyl Paraben.

Capsule shell: Gelatin, Glycerin, Sorbitol 70% solution, Methyl Paraben,

Propyl Paraben, Sunset Yellow, Ponceau 4R.

3-THERAPEUTIC INDICATIONS:

UBSA-D 10,000 IU is a high-dose supplement commonly used to

address or prevent vitamin D deficiency, especially in individuals

with limited sun exposure or those at risk for bone health issues. This

dosage provides a significantly higher amount of the nutrient than

The capsules are indicated for use in adolescents, adults and

elderly.

4-PHARMACOLOGICAL PROPERTIES:

ATC code: A11CCOS

In its biologically active form, vitamin D3 stimulates intestinal

absorption of calcium, incorporation of calcium into osteoid and

release of calcium from bone tissue. In the small intestine, it

promotes rapid and delayed absorption of calcium. Passive and

active phosphate transport is also stimulated. In the kidney, it inhibits

the excretion of calcium and phosphate by promoting tubular

Vitamin D is well absorbed from the gastrointestinal tract in the

presence of bile, it’s hydroxylated in the liver form 25-hydroxycole-

calciferol and then undergoes further hydroxylation in the kidney to

form the active metabolite 1,25 dihydroxycholecalciferol (calcitriol).

Metabolites circulate in the blood bound to a specific α-globin,

vitamin D and its metabolites are excreted mainly in bile and feces.

6-CONTRAINDICATIONS:

Cholecalciferol capsules should not be used in patients with:

-Hypersensitivity to vitamin D or any of the excipients contained in the

product.

peanut or soy, do not use this medication.

7- POSOLOGY:

Dose and duration of treatment depend on the severity of the

deficiency and the level of Vitamin D in blood. Always take this

medicine exactly as your doctor has told you.

Use in adults

The usual dose for the prevention of Vitamin D deficiency is 1 capsule

(10 000IU) taken orally, once a week for a duration specified by your

doctor.

In case of malabsorption syndrome or hepatobiliary disease, the

Follow-up serum 25(OH)D measurements should be performed

approximately three to four months after initiation of maintenance

therapy to confirm that the target level has been achieved.

Certain populations are at high risk of vitamin D deficiency and may

require higher doses and monitoring of serum 25(OH)D:

-Institutionalized or hospitalized people.

- Dark-skinned individuals.

-People with limited effective exposure to the sun due to protective

clothing or regular use of sunscreens.

- Obese people.

- Those recently treated for vitamin D deficiency and requiring

maintenance treatment.

Use in children and adolescents

The usual dose for the treatment of vitamin D deficiency is 1 to 2

capsule (10 000IU) orally once a day, for a duration specified by your

doctor.

For the prevention of vitamin D deficiency, for a child under 12years as

they not be able to swallow the capsules, its recommended to empty

the capsule content in a full glass of water or juice and drink

immediately.

D. Strict medical supervision is necessary and, if necessary, ECG and

calcium monitoring.

Simultaneous administration of benzothiadiazide derivatives (thiazide

diuretics) increases the risk of hypercalcemia.

Concurrent 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

the form of cholecalciferol l is not metabolized normally and other

forms of vitamin D must be used.

Caution is required in patients receiving treatment for

cardiovascular disease.

Cholecalciferol capsules should be prescribed with caution to

patients with sarcoidosis due to the risk of increased metabolism of

vitamin D in its active form. These patients should be monitored for

calcium content in serum and urine.

During long-term treatment with an equivalent daily dose greater

than 1,000 IU of vitamin D, serum calcium values should be

considered for individual patients. Calcium supplements should be

administered under close medical supervision.

Medical supervision is necessary during treatment to prevent

hypercalcemia, Cholecalciferol capsules should not be given to

children under 12 years of age.

9-SPECIFIC PATIENT POPULATIONS:

Pregnancy:

Studies have shown safe use of doses up to 4000 IU during

pregnancy, although animal studies have shown reproductive

toxicity. Adequate vitamin D intake is essential for maternal and