Colecalciferol 20,000 IU Soft Gel Capsules - Summary of Product Characteristics (SmPC) (2023)

This information is intended for use by health professionals

1. Name of the medicinal product

Colecalciferol 20,000 IU Soft Capsules

2. Qualitative and quantitative composition

Each soft capsule contains:

20,000 IU colecalciferol (equivalent to 500 micrograms vitamin D3)

For a full list of the excipients, see section 6.1.

3. Pharmaceutical form

Soft capsule

Translucent soft gelatin capsules containing a clear liquid.

4. Clinical particulars

4.1 Therapeutic indications

Treatment and prevention of vitamin D deficiency.

As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency.

The capsules are indicated for use in adolescents, adults and the elderly.

4.2 Posology and method of administration

Posology

Paediatric population

- 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

Not recommended for children under 12 years due to risk of choking.

Adults:

- Prevention of vitamin D deficiency: 20,000 IU/month (1 capsule), higher doses may be required in certain situations, see below

- Treatment of vitamin D deficiency: 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.

Follow-up serum 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved.

Certain populations are at high risk of vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D:

- Institutionalised or hospitalised individuals

- Dark skinned individuals

- Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens

- Obese individuals

- Patients being evaluated for osteoporosis

- Use of certain concomitant medications (e.g., anticonvulsant medications, glucocorticoids, anti-retrovirals)

- Patients with liver or renal disease

- Patients with malabsorption, including inflammatory bowel disease and coeliac disease

- Those recently treated for vitamin D deficiency, and requiring maintenance therapy.

Pregnancy and breastfeeding

Colecalciferol capsules are not recommended during pregnancy unless the clinical condition of the woman requires treatment.

Colecalciferol and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed but allowance for any maternal dose should be made when prescribing vitamin D products to a breast-fed child.

Method of administration

This medicine is taken orally.

The capsule should be swallowed whole with water, preferably with the main meal of the day.

4.3 Contraindications

Colecaliciferol capsules should not be used in patients with:

- 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

This medicinal product contains traces of soya bean lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

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).

Colecalciferol capsules 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.

During long-term treatment with an equivalent daily dose exceeding 1,000 IU vitamin D the serum calcium values must be monitored. Renal function should also be checked by measuring serum creatinine. It is recommended to reduce the dose or interrupt treatment if the calcium content in the urine exceeds 7.5 mmol / 24 hours (300 mg / 24 hours).

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.

Colecalciferol capsules should not be given to children under 12 years.

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 administration of benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcaemia.

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

Studies have shown safe use of doses up to 4000IU during pregnancy although studies in animals have shown reproductive toxicity (see section 5.3). Adequate vitamin D intake is essential for maternal and fetal health during pregnancy, and epidemiological data indicate that many pregnant women have sub-optimal vitamin D levels. Notably, vitamin D deficiency correlates with preeclampsia, gestational diabetes mellitus, and bacterial vaginosis, and an increased risk for C-section delivery.

Due to their high strength, Vitamin D3 20,000IU soft capsules are not recommended during pregnancy.

Breastfeeding

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.

Fertility

In studies in female rats the estrous cycle was disturbed. The changes were reversible and recovery was observed after the administration was discontinued. (see section 5.3). There are no data in humans concerning a possible effect of Vitamin D on fertility.

4.7 Effects on ability to drive and use machines

Colecalciferol capsules have 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.

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

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 overdose conditions where hypercalcaemia could result.

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. In addition, it has been demonstrated that some animal species (e.g., rats) may be too sensitive for results to be relevant to human risk assessment.

In studies in female rats the estrous cycle was disturbed with significantly lower estrogen levels being observed after more than 1 week of administration. The changes were reversible and recovery was observed in week 2 after the administration was discontinued.In both rats and rabbits, implantation and maintenance of the pregnancy were adversely affected by high doses of 1,25-dihydroxycholecalciferol due to histopathological changes to the reproductive organs and biochemical parameters.

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.

Vitamin D has no mutagenic potential. Carcinogenicity studies have not been reported, however carcinogenic risk is very low at physiological concentrations and at therapeutic concentrations intended to treat vitamin D deficiencies.

6. Pharmaceutical particulars

6.1 List of excipients

Capsule content: refined sunflower oil, all-rac-α-tocopherol

Capsule shell: gelatin, glycerol, purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25°C.

Store this medicinal product in the original package in order to protect from light and moisture.

6.5 Nature and contents of container

Colecalciferol 20,000 IU Soft Capsules are available in polypropylene pots with an LDPE cap containing 20 capsules

6.6 Special precautions for disposal and other handling

Not applicable

7. Marketing authorisation holder

TOR GENERICS Ltd

Tudor House

Northgate

Northwood HA6 2TH

United Kingdom

8. Marketing authorisation number(s)

PL 20491/0001

9. Date of first authorisation/renewal of the authorisation

9/10/2017

10. Date of revision of the text

9/10/2017

FAQs

What are the characteristics of vitamin D? ›

It is a fat-soluble vitamin that has long been known to help the body absorb and retain calcium and phosphorus; both are critical for building bone. Also, laboratory studies show that vitamin D can reduce cancer cell growth, help control infections and reduce inflammation.

Why have I been prescribed colecalciferol 20000? ›

Treatment and prevention of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency. The capsules are indicated for use in adolescents, adults and the elderly. Not recommended for children under 12 years due to risk of choking.

Can you take 20000 IU of vitamin D daily? ›

Do not take more than 100 micrograms (4,000 IU) of vitamin D a day as it could be harmful. This applies to adults, including pregnant and breastfeeding women and the elderly, and children aged 11 to 17 years. Children aged 1 to 10 years should not have more than 50 micrograms (2,000 IU) a day.

What is HuxD3 colecalciferol 20000IU? ›

HuxD3 Colecalciferol 20000iu capsules are a high strength vitamin D3 supplement that can be used to treat vitamin D deficiencies in adults and children over the age of 12. The capsules are suitable for vegetarians and are compliant with halal and kosher diet requirements.

What is the definition of cholecalciferol? ›

Cholecalciferol, also known as vitamin D3 and colecalciferol, is a type of vitamin D that is made by the skin when exposed to sunlight; it is found in some foods and can be taken as a dietary supplement.

What are 10 benefits of vitamin D? ›

Vitamin D Benefits
  • It strengthens the immune system. ...
  • It might prevent certain types of cancer. ...
  • It boosts your mood. ...
  • It can aid in weight loss. ...
  • It can lower the risk of rheumatoid arthritis. ...
  • It lowers the risk of type 2 diabetes. ...
  • It can help lower blood pressure. ...
  • It might reduce the risk of heart disease.
18 Dec 2020

What is another name for colecalciferol? ›

Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.

What is the difference between vitamin D and cholecalciferol? ›

Vitamin D, also known as cholecalciferol, is a vitamin that your body needs to absorb calcium. Vitamin D is made in the skin when it is exposed to sunlight. It can also be found in some foods like fatty fish and eggs. Your body needs vitamin D to maintain strong bones and muscles.

When is the best time to take colecalciferol? ›

Vitamin D can be taken at any time of day, and most of these supplements should be taken with fat-containing meals or snacks to ensure optimal absorption.

What are the side effects of taking Colecalciferol? ›

Side Effects
  • Cough.
  • difficulty swallowing.
  • fast heartbeat.
  • hives or itching.
  • skin rash.
1 Nov 2022

How often should you take vitamin D3 20000 IU? ›

The dose should not exceed 4,000 IU per day or equivalent weekly [20,000 IU (1 capsule) per week] or monthly dose.

Is it better to take vitamin D every day or once a week? ›

It is not necessary to take vitamin D every day. If you need to take vitamin D because your blood levels are low, you can take it every few days, weekly, or even monthly, because, as you mention, it is fat-soluble and, therefore, stored for future use within the fat in your body.

What is the drug colecalciferol used for? ›

Colecalciferol is a form of vitamin D used in the prevention and treatment of vitamin D deficiency conditions. It may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.

What is the difference between Calciferol and cholecalciferol? ›

Cholecalciferol, unlike calcifediol, guarantees an exact dosage in IU (International Units) of vitamin D and has pharmacokinetic properties that allow either daily or even weekly, fortnightly, or monthly administration in its equivalent doses, which can facilitate adherence to treatment.

Is cholecalciferol the best form of vitamin D? ›

Choosing the Best Vitamin D Supplement for Your Health

If you choose to go the supplement route, Clifford recommends taking around 400 to 800 IU of vitamin D3 (cholecalciferol) per day. “Vitamin D3 is the form that is already stored in the body, so some studies have found it to be more effective,” Clifford says.

What is colecalciferol made from? ›

What it is: Cholecalciferol is one of the two major forms of vitamin D. It's what your body naturally synthesizes in your skin during exposure to sunlight and it's also a commercially prepared supplement made from the lanolin retrieved from washing lambs' wool.

What are symptoms of low vitamin D? ›

Symptoms of vitamin D deficiency may include:
  • Fatigue.
  • Not sleeping well.
  • Bone pain or achiness.
  • Depression or feelings of sadness.
  • Hair loss.
  • Muscle weakness.
  • Loss of appetite.
  • Getting sick more easily.
19 Jul 2022

Is vitamin D good for hair? ›

Vitamin D stimulates hair follicles to grow, and so when the body does not have enough, the hair may be affected. A vitamin D deficiency may also be linked to alopecia areata, an autoimmune condition that causes patchy hair loss.

Why vitamin D is called Calciferol? ›

A unique aspect of vitamin D as a nutrient is that it can be synthesized by the human body through the action of sunlight. These dual sources of vitamin D make it challenging to develop dietary reference intake values. Vitamin D, also known as calciferol, comprises a group of fat-soluble seco-sterols.

Is colecalciferol toxic? ›

Cholecalciferol has a very narrow margin of safety, which means that even small ingestion of this poison can result in severe clinical signs or death. Toxic ingestions must be treated quickly and appropriately to prevent kidney failure.

Is colecalciferol prescription only? ›

If you are at risk of vitamin D deficiency, you will be recommended to take a vitamin D supplement such as calcium and colecalciferol routinely. These tablets/sachets are available on prescription or you can buy them at pharmacies, without a prescription.

Which vitamin is better D or D3? ›

There are two possible forms of vitamin D in the human body: vitamin D2 and vitamin D3. Both D2 and D3 are simply called “vitamin D,” so there's no meaningful difference between vitamin D3 and just vitamin D.

Is cholecalciferol vitamin D2 or D3? ›

The vitamin comes in two main forms: Vitamin D2 (ergocalciferol) Vitamin D3 (cholecalciferol)

Can you take vitamin D and vitamin D3 together? ›

The two types of vitamin D have no negative interactions with each other, so you can safely take them together. However, the body converts both forms of vitamin D to the same active form, called calcitriol.

Does vitamin D Help sleep? ›

Growing evidence has demonstrated that vitamin D has a role in sleep regulation [12]. Specifically, vitamin D deficiency (VDD) can increase risk of sleep disorders and is associated with sleep difficulties, shorter sleep duration, and nocturnal awakenings in children and adults [13,14,15].

What happens if you take vitamin D on an empty stomach? ›

People can pop a lot at once, even a week's worth at a single sitting, with no adverse effects. And unlike the other fat-soluble vitamins, A, E and K, the sunshine vitamin is absorbed well without food, so it can be taken any time.

Should vitamin D be taken at night? ›

Our only hard recommendation: Avoid supplementing with vitamin D at night. There's evidence that vitamin D can suppress melatonin—which is bad news for your sleep quality.

Do you take colecalciferol with food? ›

Colecalciferol can be taken with or without food. If you forget to take your dose, take it as soon as you remember, even if it is a few days later. But, if it is nearly the day for your next dose, just take the next dose on the right day. Do not double the dose.

Is cholecalciferol a steroid? ›

Six different steroid hormones go by the name vitamin D, with varying degrees of activity: the endogenous precursor, cholecalciferol (D3), which is derived from cholesterol; its hydroxylated derivative, calcidiol (25(OH)D3), which has partial activity; and its hydroxylated derivative, the active dihydroxy-form, ...

Can cholecalciferol cause tiredness? ›

These changes may potentially lead to an improvement of physical function and of depressive symptoms. Furthermore, cholecalciferol therapy increases muscle mitochondrial oxidative phosphorylation in vitamin D deficient individuals, potentially leading to a modulation of fatigue.

What is the maximum vitamin D3 to take daily? ›

Unless your doctor recommends it, avoid taking more than 4,000 IU per day, which is considered the safe upper limit. Choose food over pills.

What happens if you take too much vitamin D? ›

The main consequence of vitamin D toxicity is a buildup of calcium in your blood (hypercalcemia), which can cause nausea and vomiting, weakness, and frequent urination. Vitamin D toxicity might progress to bone pain and kidney problems, such as the formation of calcium stones.

How many times vitamin D3 should I take daily? ›

The recommended daily amount of vitamin D is 400 international units (IU) for children up to age 12 months, 600 IU for people ages 1 to 70 years, and 800 IU for people over 70 years.

Can vitamin D be taken long term? ›

Some side effects of taking too much vitamin D include weakness, dry mouth, nausea, vomiting, and others. Taking vitamin D for long periods of time in doses higher than 4000 IU (100 mcg) daily is possibly unsafe and may cause very high levels of calcium in the blood.

How long does vitamin D stay in the body? ›

Furthermore, the traced half-life of serum 25(OH)D is about 15 to 25 days (7, 8), whereas the calculated half-life of serum 25(OH)D after intake of vitamin D is up to 82 days (9).

Can I take vitamin D supplements without consulting a doctor? ›

In case of multi-vitamin pills, one should not take them without diagnosing the vitamin deficiency. In case deficiency is diagnosed by doctor—one shouldn't take more than ten vitamin/multi-vitamin tablets in a month that are prescribed. Advisors say it is harmful to take medicines without prescription.

What characteristics do vitamin D and K share? ›

Vitamins D and K are both fat-soluble vitamins and play a central role in calcium metabolism. Vitamin D promotes the production of vitamin K-dependent proteins, which require vitamin K for carboxylation in order to function properly.

What is the classification of vitamin D? ›

Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.

What role does vitamin D have? ›

Vitamin D is a nutrient your body needs for building and maintaining healthy bones. That's because your body can only absorb calcium, the primary component of bone, when vitamin D is present.

What is the structure of vitamin D? ›

Types
NameChemical composition
Vitamin D1Mixture of molecular compounds of ergocalciferol with lumisterol, 1:1
Vitamin D2ergocalciferol (made from ergosterol)
Vitamin D3cholecalciferol (made from 7-dehydrocholesterol in the skin).
Vitamin D422-dihydroergocalciferol
1 more row

What are 3 characteristics of fat-soluble vitamins? ›

They are present in foods containing fats. The body absorbs these vitamins as it does dietary fats. They do not dissolve in water. Vitamins help the body function effectively.

What are the properties of vitamins? ›

The vitamins are organic, low molecular weight substances that have key roles in metabolism. Few are single substances; most are families of chemically-related substances sharing biological activities. The vitamers comprising a vitamin family may vary in biopotency.

What is a characteristic of vitamin K nutrition? ›

Vitamin K helps to make various proteins that are needed for blood clotting and the building of bones. Prothrombin is a vitamin K-dependent protein directly involved with blood clotting. Osteocalcin is another protein that requires vitamin K to produce healthy bone tissue.

What is the action of cholecalciferol? ›

Vitamin D (ergocalciferol-D2, cholecalciferol-D3, alfacalcidol) is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. Having the right amount of vitamin D, calcium, and phosphorus is important for building and keeping strong bones.

What are the 3 types of vitamin D? ›

There are two forms of vitamin D dietary supplements: vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol), and it is important to understand their differences when choosing which vitamin D supplement to take.

What causes a vitamin D deficiency? ›

In general, the two main causes of vitamin D deficiency are: Not getting enough vitamin D in your diet and/or through sunlight. Your body isn't properly absorbing or using vitamin D.

What is the difference between D and D3? ›

There are quite a few differences between vitamin D and vitamin D3, but the main difference between them is that vitamin D is a fat-soluble vitamin that regulates calcium and phosphorous levels in the body, whereas the vitamin D3 is the natural form of vitamin D produced by the body from sunlight.

Why vitamin D is called calciferol? ›

A unique aspect of vitamin D as a nutrient is that it can be synthesized by the human body through the action of sunlight. These dual sources of vitamin D make it challenging to develop dietary reference intake values. Vitamin D, also known as calciferol, comprises a group of fat-soluble seco-sterols.

What is cholecalciferol made from? ›

What it is: Cholecalciferol is one of the two major forms of vitamin D. It's what your body naturally synthesizes in your skin during exposure to sunlight and it's also a commercially prepared supplement made from the lanolin retrieved from washing lambs' wool.

Why vitamin D is called steroid? ›

Technically, vitamin D is a misnomer. It is not a true vitamin because it can be synthesized endogenously through ultraviolet exposure of the skin. It is a steroid hormone that comes in 3 forms that are sequential metabolites produced by hydroxylases.

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