Treatment of vitamin D deficiency in adults.

In the case of therapy via oral route, it is recommended to take Dibasa with meals
(see section 5.2). Therapy via intramuscular route is indicated only in case of
malabsorption syndromes.
Treatment of vitamin D deficiency: vitamin D deficiency must be identified clinically and/or by
laboratory tests. The treatment is designed to replenish vitamin D reserves and will be followed by
maintenance therapy if the risk of deficiency persists, at a dosage of vitamin D suitable for its prevention.
In the majority of cases, during the treatment phase, it is recommended not to exceed a cumulative
dose of 300,000 I.U., unless otherwise advised by a doctor.
As an indication, the following dosage scheme is provided, to be adapted at the judgment of the
doctor on the basis of nature and severity of the deficiency status (see also section 4.4).
Treatment:
Dibasa 100,000 I.U.: 1 ampoule (equivalent to 100,000 I.U. of vitamin D3) once a month for
maximum 3 months.
Instructions for use
Doses may be administered via oral or intramuscular route. The ampoules are equipped with a prebreakage
ring and should be opened as follows:
 hold the base of the ampoule with one hand;
 place the other hand at the top of ampoule, placing your thumb above the white ring;
 to open the ampoule, hold the lower part firmly in one hand, and with the other hand apply
downward pressure on the upper part and simultaneously a rotation.
To avoid the risk of cuts, it is recommended to use finger protection devices (e.g. a clean cloth,
a cotton swab) and not to touch the sharp edges or any roughness generated by the breakage.
Dibasa 300,000 I.U.: 1 ampoule (equivalent to 300,000 I.U. of vitamin D3).

Instructions for use
Doses may be administered via oral or intramuscular route.
The ampoules are equipped with a pre-breakage ring and should be opened as follows:
 hold the base of the ampoule with one hand;
 place the other hand at the top of the ampoule, placing your thumb above the white ring;
 to open the ampoule, hold the lower part firmly in one hand, and with the other hand apply
downward pressure on the upper part and simultaneously a rotation.
To avoid the risk of cuts, it is recommended to use finger protection devices (e.g. a clean cloth,
a cotton swab) and not to touch the sharp edges or any roughness generated by the breakage.
Subsequently, lower doses may be considered, depending on the desired serum levels of 25-
hydroxycholecalciferol (25OHD), the severity of the disease, and the patient's response to
treatment.
Pediatric population
At these dosages, Dibasa is not recommended in neonates, children and adolescents under 18 years of
age, due to a lack of clinical data.
Pregnant women
At these dosages Dibasa is not recommended in pregnancy due to the lack of clinical data (see
section 4.6).

In the event of prolonged administrations at high doses, it is recommended to monitor serum level
of 25-hydroxy-cholecalciferol. Stop using Dibasa when the serum level of 25-hydroxycholecalciferol
exceeds 100 ng/mL (equal to 250 nmol/L).
In elderly patients already undergoing treatment with cardiac glycosides or diuretics, it is
important to monitor calcaemia and calciuria. In the event of hypercalcaemia or renal
insufficiency, reduce the dose or discontinue treatment.
To avoid overdose, take into account the total dose of vitamin D in the event of association
with treatments already containing vitamin D, foods enriched with vitamin D, or if using milk
enriched with vitamin D.
In the following cases, it may be necessary to increase the indicated doses:
 Patients undergoing treatment with anticonvulsants or barbiturates (see section 4.5);
 Patients undergoing treatment with corticosteroid therapy (see section 4.5);
 Patients undergoing treatment with lipid-lowering agents such as colestipol,
cholestyramine and orlistat (see section 4.5);
 Patients undergoing treatment with antacids containing aluminium (see section 4.5);
 Obese patients (see section 5.2);
 Digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
 Liver insufficiency.

The product should be prescribed with caution to patients with sarcoidosis, due to a possible
increase in the metabolism of vitamin D in its active form. It is necessary to monitor serum and
urine calcium levels in these patients.
Patients with renal insufficiency have an altered metabolism of vitamin D, therefore, if they have
to be treated with cholecalciferol, the effects on calcium and phosphate homeostasis should be
monitored.

Concomitant use of anticonvulsants or barbiturates may reduce the effect of vitamin D3 by
metabolic inactivation.
In the case of treatment with thiazide diuretics, which decrease urinary elimination of calcium,
monitoring of serum calcium levels is recommended.
Concomitant use of glucocorticosteroids may reduce the effect of vitamin D3.
In the event of treatment with drugs containing digitalis, oral administration of calcium combined
with vitamin D increases the risk of digitalis toxicity (arrhythmia). Strict medical
supervision is therefore required and, if necessary ECG monitoring and monitoring of serum
calcium levels.
Concomitant use of aluminium-containing antacids may interfere with the efficacy of the
medicinal product, reducing the absorption of vitamin D, while preparations containing
magnesium may lead to a risk of hypermagnesaemia.
Studies on animals have suggested possible strengthening of the action of warfarin when
administered with calciferol. Although there is no similar evidence with the use of
cholecalciferol, it is best to exercise caution when both medicinal products are used
concomitantly.
Cholestyramine, colestipol and orlistat reduce the absorption of vitamin D, while chronic
alcoholism decreases Vitamin D reserves in the liver.

Pregnancy
In the first 6 months of pregnancy, vitamin D should be taken with caution due to the risk of
teratogenic effects (see section 4.9). At these dosages Dibasa is not recommended in pregnancy
due to lack of clinical data. However, since vitamin D deficiency is harmful to both the mother
and the fetus, vitamin D can be prescribed during pregnancy at lower doses when needed
Breastfeeding
At these dosages, Dibasa is not recommended during breastfeeding, due to the lack of clinical
data.
If necessary Vitamin D can be prescribed while a patient is breastfeeding using lower
dosages. This supplementation does not replace the administration of vitamin D in the
newborn. Vitamin D and its metabolites are found in breast milk. This should be taken into
consideration when administering additional vitamin D to the child.

There is no data available on the effects of this product on the ability to drive. However, an
effect on this ability is unlikely.

When the posology complies with actual individual requirements, Dibasa is well tolerated, also
thanks to the body’s ability to store cholecalciferol in adipose and muscular tissues (see section
5.2).

The undesirable effects reported with the use of vitamin D are as follows:
Immune system disorders:
hypersensitivity reactions.
Metabolism and nutrition disorders:
weakness, anorexia, thirst.
Psychiatric disorders:
drowsiness, confused state.
Nervous system disorders:
headaches.
Gastrointestinal disorders:
constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth.
Skin and subcutaneous tissue disorders:
rash, pruritus.
Renal and urinary disorders:
nephrocalcinosis, polyuria, polydipsia, renal insufficiency.
Investigations:
hypercalciuria, hypercalcemia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are
asked to report any suspected adverse reactions.
To report any side effect(s):
 Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
- Fax: +966-11-205-7662
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
 Other GCC States:
 Please contact the relevant competent authority.

Discontinue Dibasa when calcaemia exceeds 10.6 mg/dL (2.65 mmol/L) or if calciuria
exceeds 300 mg/24 hours in adults or 4-6 mg/kg/day in children. An overdose is revealed as
hypercalciuria and hypercalcaemia, the symptoms of which are as follows: nausea, vomiting,
thirst, polydipsia, polyuria, constipation and dehydration.
Chronic overdoses may lead to vascular and organ calcification as a result of hypercalcaemia.
An overdose during the first 6 months of pregnancy may have toxic effects on the foetus: there is a
correlation between excess intake or extreme maternal sensitivity to vitamin D during pregnancy
and the delayed mental and physical development of the child supravalvular aortic stenosis and
retinopathy. Maternal hypercalcaemia can also lead to the suppression of parathyroid function in
infants resulting in hypocalcaemia, tetany and convulsions.
Treatment in the event of overdose
Discontinue the administration of Dibasa and proceed with rehydration.

Pharmacotherapeutic group: Vitamin D and analogues, cholecalciferol. ATC code:
A11CC05
Vitamin D corrects vitamin D deficiency and increases the intestinal absorption of calcium.

As with other lipid-soluble vitamins, cholecalciferol absorption in the intestine is assisted by a
concomitant intake of foods containing fats.
Cholecalciferol is present in the bloodstream in association with specific α-globulins which
transport it to the liver, where it is hydroxylated at 25-hydroxycholecalciferol. A second
hydroxylation occurs in the kidneys, where the 25-hydroxycholecalciferol is transformed into
1,25-dihydroxy-cholecalciferol which is the active metabolite of vitamin D responsible for the
effects on the phosphocalcium metabolism.
Non-metabolised cholecalciferol accumulates in adipose and muscular tissues to be made available
according to the body’s needs: this is why Dibasa may be administered also on a monthly or yearly
basis. In obese patients, the bioavailability of vitamin D is reduced due to the excess adipose tissue.
Vitamin D is eliminated through the faeces and urine.

Preclinical studies carried out on various species of animals have demonstrated that toxic effects
occur in animals at doses much higher than those required for therapeutic use in humans.
In repeat-dose toxicity studies, the effects most commonly found were: increased calciuria,
decreased phosphaturia and proteinuria
Hypercalcemia was reported at high doses. In a state of prolonged hypercalcemia the most
frequent histological alterations (calcification) have involved the kidneys, heart, aorta, testicles,
thymus and intestinal mucosa.
Reproductive toxicity studies have shown that cholecalciferol does not have negative effects on
fertility and reproduction.
At doses equivalent to the therapeutic doses, cholecalciferol has no teratogenic activity.
Cholecalciferol has no potential mutagenic and carcinogenic activity.

Dibasa 100,000 I.U./mL solution for injection: refined olive oil for injection.
Dibasa 300,000 I.U./mL solution for injection: refined olive oil for injection.

There are no known incompatibilities with other medicinal products.

Do not store above 30° C. Do not freeze.

Store in the original package in order to protect the product from light.

Dibasa 100.000 I.U./mL solution for injection

Amber glass ampoule. The package contains 6 ampoules.

Dibasa 300.000 I.U /mL solution for injection

Amber glass ampoule. The package contains 2 ampoules.

No special requirements.