Treatment of:
- vitamin D deficiency or insufficiency
- rickets in infants and children
- osteomalacia caused by vitamin D deficiency
Prophylaxis and treatment of vitamin D deficiency in malabsorption.
Supportive treatment of osteoporosis in combination with calcium and a specific osteoporosis treatment.

Posology
In general, the dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol
(25(OH)D), the severity of the disease and the patient´s response to treatment. Measurement of 25(OH)D and
calcium is recommended 3 months after treatment initiation. Dose, treatment duration and the necessity of
further monitoring shall be individualized, guided by the diagnosis, the severity of the disease and the
patient’s response to treatment.
For treatment of Vitamin D deficiency, the dose in adults and adolescents (age 11-17 years) should not
exceed 4,000 I.U. (5 drops) per day, children (age 1-10 years) 2000 IU/day and infants (age 0-1 year) 1000
IU/day. For adult patients with malabsorption, the daily dose should not exceed 9600 IU.
A regular daily dose of 800 I.U. (one drop) raises serum 25(OH)D in average by approximately 20 nmol/l
within 4-5 months in adults.
The dose can be administered as daily doses or be given once a week.

If Detremin is given together with other vitamin D containing products, the total dose of vitamin D should be
considered. Vitamin D is fat soluble and may accumulate in the body. This may cause toxic effects in case of
overdose and long term treatment with excessive doses. Recommended treatment should therefore not be
exceeded.
At high doses of vitamin D3, the serum calcium levels may be monitored and particular caution is
recommended in patients with a history of renal calculi.
Vitamin D3 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
metabolized normally and another form of vitamin D may therefore be needed.
The active metabolite of vitamin D3 (1,25-dihydroxycholecalciferol) may affect the phosphate balance.
Therefore, in conditions with increased phosphate levels, treatment with a phosphate binder may be
considered.
Vitamin D3 should be prescribed with caution to patients suffering from sarcoidosis or other granulomatous
disorders, due to the risk of increased metabolism of vitamin D into its active form. These patients should be
monitored with regard to the calcium content in serum and urine.

- Phenytoin and barbiturates may diminish the effect of vitamin D3 due to hepatic enzyme induction.
- Rifampicin may also reduce the effectiveness of vitamin D3 due to hepatic enzyme induction.
- Isoniazid may reduce the effectiveness of vitamin D3 due to inhibition of the metabolic activation of
vitamin D.
- Patients treated with cardiac glycosides may be susceptible to high calcium levels and should have
ECG parameters and calcium levels monitored.
- Simultaneous administration of benzothiadiazine derivatives (thiazide diuretics) increases the risk of
hypercalcaemia because they decrease the calcium loss in the urine.
- Vitamin D3 might increase the intestinal absorption of aluminium.
- If vitamin D3 is combined with metabolites or analogues of vitamin D careful monitoring of serum
calcium levels is recommended.
- Drugs leading to fat malabsorption, e.g. orlistat and colestyramin, may impair the absorption of
vitamin D.

Pregnancy
Detremin can be used during pregnancy, in case of a vitamin D deficiency.
Studies in animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). There are
no indications that vitamin D at therapeutic doses is teratogenic in humans.

Breast-feeding
Detremin can be used during breast-feeding. Vitamin D and its metabolites are excreted in human milk. This
should be considered when giving additional vitamin D to the child.
Fertility
There are no data on the effect of Detremin on fertility. However, normal endogenous levels of vitamin D are
not expected to have any adverse effects on fertility.

No studies on the effects on the ability to drive and use machines have been performed. Detremin has no
known side effects which are likely to affect the ability to drive and use machines.

Frequencies of adverse reactions are unknown. The following reactions have been reported:
Metabolism and nutrition disorders:
Frequency unknown: hypercalcaemia, hypercalciuria
Gastrointestinal disorders:
Frequency unknown: constipation, flatulence, nausea, abdominal pain, diarrhoea.
Skin and subcutaneous tissue disorders:
Frequency unknown: hypersensitivity reactions such as pruritus, rash, urticaria.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via.
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
• Other GCC States:
- Please contact the relevant competent authority.

Symptoms:
Acute or chronic overdose of vitamin D can cause hypercalcaemia. Symptoms of hypercalcemia are
tiredness, psychiatric symptoms (e.g., euphoria, dazedness, disturbed consciousness), nausea, vomiting, lack
of appetite, weight loss, thirst, polyuria, formation of renal calculi, nephrocalcinosis, extraosseous
calcification and kidney failure, changes in ECG, arrhythmias, and pancreatitis. In isolated cases their course
has been described as fatal.
Treatment:
If a massive dose has been ingested ventricular emptying may be considered, together with administration of
carbon. Sun light and further administration of vitamin D or calcium should be avoided. Rehydration and

treatment with diuretics, e.g. furosemide to ensure adequate diuresis. In hypercalcemia biphosphonates or
calcitonin and corticosteroids may be given. The treatment is directed to symptoms.

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.

At alimentary doses vitamin D3 is almost completely absorbed. Vitamin D3 requires fat to be absorbed in the
intestine. The fact that Detremin contains oil thus facilitates intestinal absorption, and therefore Detremin
may be taken independently of meals. Vitamin D3 is stored in the fatty tissue and its biological half-life is
approx. 50 days. After a single dose of vitamin D3 maximum serum concentrations of the active metabolite
25-hydroxycholecalciferol are reached after about a week. 25-hydroxycholecalciferol is then slowly
eliminated with an apparent half-life in serum of about 50 days, due to the slow elimination of the parent
compound. 25-hydroxycholecalciferol is metabolised to the active metabolite 1,25-dihydroxycholecalciferol.
After high vitamin D3 doses serum 25-hydroxycholecalciferol concentrations can be increased for a month or
two. Hypercalcaemia resulting from overdose can persist for several weeks

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies.
There is no further information of relevance to the safety assessment in addition to what is stated in other
parts of the SPC.

Medium chain triglycerides (received from coconut oil and palm kernel oil).

Not applicable.

Keep the bottle in the outer carton in order to protect from light.

Dropper container with 10 ml solution (250 drops à 800 IU vitamin D3.)
Container: 10 ml molded glass bottles, brown, glass type III.
Dropper: Dropper made of polyethylene, colourless.
Closure: Screw cap made of polypropylene, white.

No special requirements.