- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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 coloured translucent soft gelatin 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
PosologyVitamin 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))ANDlong term maintenance therapy following treatment of deficiency in adults and the elderlyANDPrevention of vitamin D deficiency1-2 Capsules (800-1600 IU) dailyVitamin 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 osteoporosis1 capsule daily During pregnancy and breast-feedingTreatment 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 yearsMethod of administrationOralThe capsules should be swallowed whole (not chewed) with water
Hypersensitivity to vitamin D or any of the excipients in the productHypervitaminosis DNephrolithiasisDiseases or conditions resulting in hypercalcaemia and/or hypercalciuriaSevere 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 is required whilst on treatment to prevent hypercalcaemia.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 1,25-dihydroxyvitamin 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 disordersUncommon: Hypercalcaemia and hypercalciuria. Skin and subcutaneous disordersRare: Pruritus, rash and urticaria.Reporting of suspected adverse reactionsReporting 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.
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, refinedButylated hydroxytoluene (BHT) (E321)Capsule shellGlycerol (E422)Purified WaterBrilliant Blue W.S (E133)Gelatin (E441)
6.3 Shelf life
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions. 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 foilPack sizes: 28, 30, 56, 60, 90Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
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)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Internis Pharmaceuticals Ltd
Carradine House, 237 Regent's Park Road, London, N3 3LF, UK
+44 (0)1271 326 371
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