Summary of Product Characteristics (SmPC) - Cholecalciferol 20 000 IU soft capsules
1 NAME OF THE MEDICINAL PRODUCT
Cholecalciferol 20,000 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.5 mg colecalciferol (vitamin D3, equivalent to 20,000 IU).
Excipient with known effect
Each soft capsule contains 0.02 mg of soya-bean oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft capsule
Light yellow coloured, transparent oval shaped, soft gelatin capsules containing clear colourless liquid fill. Each capsule has bearing the designation “58”. Capsule dimensions are approx. 11 x 6 mm.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention and treatment of vitamin D deficiency in adults and adolescents with an identified risk.
As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
Colecalciferol capsules are indicated in adults, the elderly and adolescents.
4.2 Posology and method of administration
Posology
The dosage of vitamin D depends on severity of the disease, as well as patients response to treatment. Based on patients needs, capabilities and preferences daily, weekly or monthly dosing regimens can be offered. Lower dosage forms (e.g. 400 IU, 500 IU, 800 IU and 1,000 IU) are suitable for daily vitamin D supplementation, while higher dosage forms like 20,000 IU contain amounts equal to the weekly and monthly vitamin D dose requirement, which should be taken into consideration. The dosage and the frequency of administration has to be established individually by a physician.
Not all given recommended doses can be achieved with this product.
Alternatively, national posology recommendations in prevention and treatment of vitamin D deficiency can be followed.
Adults:
Prevention of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis:
Recommended dose is 20,000 IU/month (1 capsule), higher doses may be required in certain situations.
Treatment of vitamin D deficiency:
Recommended dose is 40,000 IU/week (2 capsules) for 7 weeks, followed by maintenance therapy (equivalent to 1,400-2,000 IU/day, such as 2-3 capsules per month, may be required. Higher doses 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.
Adolescents:
Prevention of vitamin D deficiency 12-18 years:
20,000 IU (1 capsule) every 6 weeks
Treatment of vitamin D deficiency 12-18 years:
20,000 IU (1 capsule)once every 2 weeks for 6 weeks
Paediatric population
Cholecalciferol 20,000 IU soft capsules should not be given to children under 12 years of age due to the risk of choking. Instead, it is advisable to use drops or dissolvable tablets.
Hepatic impairment
No dose adjustment is required.
Renal impairment
Patients with mild or moderate renal impairment: no specific adjustment is required. Cholecalciferol must not be used in patients with severe renal impairment.
Pregnancy
The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D3 deficient a higher dose may be required [up to 2,000 IU/day or equivalent weekly or monthly dose (60,000 IU (3 capsules) per month)].
Other conditions
In obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D3 metabolism, higher doses are required for the treatment and prevention of vitamin D3 deficiency.
Method of administration
Oral use
The capsules should be swallowed whole (not chewed) with water. The capsules should not be chewed in order to facilitate the swallowing of the capsule content. In order to enhance absorption, it is recommended to take Vitamin D with a meal.
4.3 Contraindications
- Hypersensitivity to the active substance, peanut or soya, or to any of the excipients listed in section 6.1
- Hypervitaminosis D
- Nephrolithiasis
- Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria
- Severe renal impairment
4.4 Special warnings and precautions for use
In the case of therapeutic treatment, the dose should be established on an individual basis for the patients by regular checking (initially weekly, then once every 2-4 weeks) of plasma calcium levels. During long-term treatment an equivalent daily dose exceeding 1,000 IU vitamin D the serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level (see section 4.5). In case of hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued.
Caution is required in patients receiving treatment for cardiovascular disease (see section 4.5 – cardiac glycosides including digitalis).
Renal impairment
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).
Sarcoidosis
Cholecalciferol 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.
Use of additional supplements
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.
Soya-bean oil
Colecalciferol capsules contain soya-bean oil. Not to be used in case of allergy to peanut or soya.
Paediatric population
Cholecalciferol 20,000 IU soft capsules should not be given to children under 12 years.
4.5 Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
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
Pregnancy
There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies have shown safe use of doses up to 4,000 IU during pregnancy although 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.
Breastfeeding
Vitamin D and its metabolites are excreted in breast milk. No adverse events have been observed in infants.Cholecalciferol can be used at recommended doses during lactation in case of a vitamin D deficiency. This should be considered when giving additional vitamin D to the child.
Fertility
There are no data on the effect of colecalciferol on fertility. However, normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.
4.7 Effects on ability to drive and use machines
Cholecalciferol has no or negligible 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).
Immune system disorders:
Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angio-oedema or laryngeal oedema.
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 Website 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.
Absorption
Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile.
Distribution and biotransformation
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).
Elimination
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
Medium chain triglycerides
D-alpha tocopherol
Soya-bean oil, refined
Capsule Shell
Gelatin
Glycerol
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Packed in PVDC/PVC Aluminium foil blisters
Pack sizes: 7, 10, 14, 15, 20, 28 and 30 soft capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with the local requirements.
7 MARKETING AUTHORISATION HOLDER
Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 17780/1261
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/06/2025
10 DATE OF REVISION OF THE TEXT
09/06/2025