FULTIUM-D3 Capsule (2018)
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Περιεχόμενα
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 D
3
).
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Capsule, soft (Capsule).
Blue translucent Capsule.
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-D
3
is...
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 an...
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 im...
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 ...
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.
T...
4.6. 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 preg...
4.7. Effects on ability to drive and use machines
Fultium-D
3
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 ...
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 consti...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Vitamin D and analogues
ATC code:
A11CC05
In its biologically active form vitamin D
3
stimulates intestinal calcium absorption, incorporation of calcium into the oste...
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-hydroxycolecalcifero...
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 coul...
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 and other handling
Any unused product should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Internis Pharmaceuticals Ltd., Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK
8. Marketing authorization number(s)
PL 40861/0002
9. Date of first authorization / renewal of the authorization
28/10/2011
10. Date of revision of the text
09/01/2018
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