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FULTIUM-D3 800 IU CAPSULES

Active substance(s): COLECALCIFEROL

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Fultium-D3 800 IU Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
800IU Colecalciferol (equivalent to 20 micrograms vitamin D3)
For a full list of excipients see section 6.1

3

PHARMACEUTICAL FORM
Capsule, soft (Capsule)
Blue translucent Capsule

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
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.
Fultium-D3 is indicated in adults, the elderly and adolescents.

4.2

Posology and method of administration
Posology
Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml))
1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of
the disease and the patient’s response to treatment.
Vitamin D insufficiency in adults and the elderly (serum levels 25 – 50 nmol/l (10-20
ng/mL))
AND
long term maintenance therapy following treatment of deficiency in adults and the
elderly
AND
Prevention of vitamin D deficiency

1-2 Capsules (800-1600 IU) daily
Vitamin D deficiency or insufficiency in children over 12 years – 1 capsule daily
depending on the severity of the disease and the patient’s response to treatment.
Should only be given under medical supervision.
As an adjunct to specific therapy for osteoporosis
1 capsule daily
During pregnancy and breast-feeding
Treatment of vitamin D deficiency
1 – 5 capsules (800 – 4000 IU) daily.
Long term maintenance therapy following treatment of deficiency
1 – 2 capsules (800 – 1600 IU) daily.
Fultium-D3 should not be used in children under 12 years
Method of administration
Oral
The capsules should be swallowed whole (not chewed) with water

4.3

Contraindications
Hypersensitivity to vitamin D or any of the excipients in the product
Hypervitaminosis D
Nephrolithiasis
Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria
Severe renal impairment

4.4

Special warnings and precautions for use
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 colecalciferol is not
metabolised normally and other forms of vitamin D should be used (see
section 4.3, contraindications).

Caution is required in patients receiving treatment for cardiovascular disease
(see Section 4.5 - cardiac glycosides including digitalis).
Fultium-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
hypercalcaemia.

is

required

whilst

on

treatment

to

prevent

During long-term treatment with a daily dose exceeding 1,000 IU vitamin D
the serum calcium values must be monitored.
Fultium-D3 should not be given to children.

4.5

Interaction with other medicinal products and other forms of interaction
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 1,25dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.

4.6

Fertility, pregnancy and lactation
There are no or limited amount of data from the use of colecalciferol in
pregnant women. Studies in animals have shown reproductive toxicity (see
section 5.3). 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.

4.7

Effects on ability to drive and use machines
Fultium-D3 has no influence on the ability to drive and use machines.

4.8

Undesirable effects
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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.

4.9

Overdose
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 intake of vitamin D and rehydration.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
The pharmacokinetics of vitamin D is well known. Vitamin D is well absorbed from
the gastro-intestinal 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.

5.3

Preclinical safety data
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.
Colecalciferol 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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Capsule content
Maize Oil, refined
Butylated hydroxytoluene (BHT) (E321)
Capsule shell
Glycerol (E422)
Purified Water
Brilliant Blue W.S (E133)
Gelatin (E441)

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store below 25°C.

Store blister foil in original container in order to protect from light.

6.5

Nature and contents of container
Opaque, white PVC/PVdC blister tray with aluminium foil
Pack sizes: 28, 30, 56, 60, 90
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Any unused product should be disposed of in accordance with local requirements.

7

MARKETING AUTHORISATION HOLDER
Internis Pharmaceuticals Ltd.
Linthwaite Laboratories
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 40861/0002

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/10/2011

10

DATE OF REVISION OF THE TEXT
09/01/2018

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