Fultium D3

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Fultium D3 is a brand of colecalciferol (vitamin D3) capsules used to treat and prevent vitamin D deficiency.

It is manufactured by Internis Pharmaceuticals and is one of the most widely prescribed vitamin D preparations in the United Kingdom.

Fultium D3 is available as soft gel capsules in strengths of 800 IU (20 micrograms) and 3,200 IU (80 micrograms).

Vitamin D plays a fundamental role in maintaining healthy bones, muscles, and immune function, and deficiency is extremely common in the UK due to limited sunlight exposure, particularly during the autumn and winter months.

This page provides a comprehensive clinical overview of Fultium D3, including what vitamin D does, who needs supplementation, dosing guidance, potential side effects, safety warnings, and how to obtain it in the United Kingdom.

Important safety information about Fultium D3

• Follow the dose prescribed by your healthcare professional. Do not take more than recommended without medical advice.
• Fultium D3 3,200 IU capsules are prescription-only (POM); Fultium D3 800 IU is a pharmacy (P) medicine.
• Do not take Fultium D3 if you have hypercalcaemia (raised blood calcium), kidney stones, or hypervitaminosis D.
• If you take thiazide diuretics or digoxin, inform your prescriber before starting vitamin D supplements.
• Vitamin D toxicity, though rare, can occur with prolonged intake of very high doses.

Understanding vitamin D and its role in the body

Vitamin D is a fat-soluble vitamin that functions as a hormone once activated in the body.

It exists in two main forms: vitamin D2 (ergocalciferol), derived from plant sources, and vitamin D3 (colecalciferol), produced in the skin when exposed to ultraviolet B (UVB) radiation from sunlight and also found in animal-source foods.

Vitamin D3 is the form used in Fultium D3 and is generally considered more effective at raising and maintaining blood levels of vitamin D than vitamin D2.

Once colecalciferol enters the body, whether from sunlight, food, or supplements, it undergoes two activation steps.

The first takes place in the liver, where the enzyme CYP2R1 converts it to 25-hydroxyvitamin D (also called calcifediol or 25(OH)D).

This is the main circulating form of vitamin D and is the marker measured in blood tests to assess vitamin D status.

The second activation step occurs primarily in the kidneys, where the enzyme CYP27B1 converts 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D (calcitriol), the biologically active hormonal form.

Calcitriol acts through the vitamin D receptor (VDR), which is found in nearly every tissue in the body.

Its primary physiological role is to maintain calcium and phosphate homeostasis.

It increases intestinal absorption of calcium and phosphate from food, promotes renal reabsorption of calcium, and when dietary calcium is insufficient, mobilises calcium from bone to maintain serum calcium within the narrow range required for normal cellular function, nerve transmission, and muscle contraction.

Without adequate vitamin D, the body absorbs only 10 to 15% of dietary calcium; with sufficient vitamin D, absorption increases to 30 to 40%.

Vitamin D deficiency in the United Kingdom

Vitamin D deficiency is a major public health issue in the UK.

The National Diet and Nutrition Survey (NDNS) has consistently found that a significant proportion of the UK population has serum 25-hydroxyvitamin D levels below 25 nmol/L, the threshold defined as deficiency by the Scientific Advisory Committee on Nutrition (SACN).

This is particularly prevalent during winter and spring, in people with darker skin tones, in people who spend little time outdoors, and in those who cover most of their skin with clothing.

The UK lies at a latitude of 50 to 60 degrees north.

Between October and March, the angle of the sun is too low for UVB radiation to reach the Earth's surface in sufficient quantities to trigger vitamin D synthesis in the skin.

Even during summer months, cloud cover, sunscreen use, and indoor lifestyles limit the amount of vitamin D produced.

People with darker skin pigmentation require several times more UVB exposure to produce the same amount of vitamin D as people with lighter skin, placing Black African, African-Caribbean, and South Asian populations at particularly high risk of deficiency.

Risk groups identified by SACN and Public Health England include all infants and children under 5 years, adults over 65 years, pregnant and breastfeeding women, people with limited sun exposure (housebound individuals, care home residents, night-shift workers), people who habitually cover most of their skin outdoors, people with darker skin, and patients with conditions that impair fat absorption such as coeliac disease, Crohn's disease, and cystic fibrosis.

Consequences of vitamin D deficiency

Prolonged vitamin D deficiency leads to impaired calcium and phosphate absorption, resulting in secondary hyperparathyroidism and accelerated bone turnover.

In children, this causes rickets, characterised by soft, weak bones, skeletal deformities (bowed legs, thickened wrists and ankles), delayed growth, and muscle weakness.

In adults, the equivalent condition is osteomalacia, which presents with diffuse bone pain (often mistaken for fibromyalgia or chronic fatigue), proximal muscle weakness (difficulty rising from a chair or climbing stairs), and an increased risk of fractures.

Vitamin D insufficiency (levels between 25 and 50 nmol/L) is also associated with reduced bone mineral density and an increased risk of osteoporotic fractures, particularly in postmenopausal women and older adults.

NICE guideline CG146 recommends vitamin D supplementation alongside bisphosphonate therapy for the prevention of fragility fractures in patients with osteoporosis.

Beyond bone health, observational studies have linked low vitamin D status to increased susceptibility to respiratory infections, autoimmune conditions, cardiovascular disease, and some cancers.

While these associations are biologically plausible given the widespread distribution of vitamin D receptors, large randomised controlled trials have not consistently confirmed supplementation benefits for non-skeletal outcomes.

Current UK recommendations focus on the well-established skeletal benefits of maintaining adequate vitamin D levels.

Clinical evidence for vitamin D supplementation

The evidence supporting vitamin D supplementation for the prevention and treatment of bone disease is robust.

The SACN report on vitamin D (2016) concluded that a serum 25-hydroxyvitamin D concentration of 25 nmol/L is sufficient to protect bone health in the majority of the population and recommended a reference nutrient intake (RNI) of 400 IU (10 micrograms) daily for all people aged 4 years and older throughout the year.

For treatment of documented deficiency, the Royal Osteoporosis Society and NICE recommend an initial loading regimen to replenish stores rapidly, followed by a daily maintenance dose.

The specific regimen varies, but a common approach is 50,000 IU weekly for 6 weeks, then 800 to 2,000 IU daily for maintenance.

Higher maintenance doses (up to 4,000 IU daily) may be needed in patients with malabsorption syndromes, obesity, or those taking enzyme-inducing medications.

A Cochrane review of vitamin D supplementation in older adults found a reduction in hip fracture risk when vitamin D was combined with calcium supplementation, supporting the practice of prescribing both together for osteoporosis prevention.

The NICE guideline on osteoporosis (CG146) recommends ensuring adequate vitamin D and calcium intake in all patients receiving bisphosphonate therapy.

Dosage and administration of Fultium D3

For prevention of vitamin D deficiency in adults at risk, the recommended dose is 800 IU (one Fultium D3 800 IU capsule) daily.

For treatment of confirmed deficiency, a loading dose is usually given first, followed by daily maintenance.

Your GP or specialist will determine the appropriate regimen based on your blood test results, clinical symptoms, and risk factors.

Swallow the capsules whole with water. They may be taken at any time of day, with or without food.

Taking Fultium D3 with a meal that contains some fat may enhance absorption, as vitamin D is a fat-soluble vitamin.

Choose a consistent time of day to help you remember to take it.

If you miss a dose, take it when you remember.

If it is close to the time of your next dose, skip the missed dose and continue as normal. Do not double up on doses.

If you are unsure about your dosing schedule, consult your pharmacist or GP.

Side effects of Fultium D3

Fultium D3 is very well tolerated at recommended doses. Side effects are uncommon and are almost always associated with excessive dosing or underlying conditions that predispose to hypercalcaemia.

Rare adverse effects include nausea, constipation, abdominal discomfort, and allergic skin reactions.

Hypercalcaemia, the most important potential adverse effect, is very unlikely at daily doses of 800 to 2,000 IU in people with normal calcium metabolism and kidney function.

Symptoms of hypercalcaemia include nausea, vomiting, excessive thirst, frequent urination, muscle weakness, and confusion. If you develop these symptoms, stop taking the supplement and contact your GP.

Report any suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk.

Warnings and precautions

Do not take Fultium D3 if you have hypercalcaemia, hypercalciuria, kidney stones, nephrocalcinosis, or hypervitaminosis D.

Use with caution in sarcoidosis and other granulomatous diseases, where unregulated conversion of vitamin D to calcitriol can cause dangerous hypercalcaemia.

Patients with severe renal impairment should use vitamin D only under specialist supervision.

Inform your prescriber if you take thiazide diuretics, digoxin, orlistat, cholestyramine, or antiepileptic drugs, as interactions may affect calcium levels or vitamin D metabolism. Do not exceed the prescribed dose without medical advice.

How to get Fultium D3 in the UK

Fultium D3 800 IU capsules are available over the counter from pharmacies as a pharmacy (P) medicine.

Fultium D3 3,200 IU capsules require a prescription from a GP or authorised prescriber.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Free vitamin D supplements (Healthy Start vitamins) are available through the Healthy Start scheme for eligible pregnant women, new mothers, and children under 4 in low-income families.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) can prescribe Fultium D3 after an appropriate clinical consultation.

Your GP may order a blood test for serum 25-hydroxyvitamin D before prescribing a treatment dose, particularly if you have symptoms suggestive of deficiency or if you are at high risk.

Sources

• Fultium-D3 800 IU Capsules, Summary of Product Characteristics (EMC)
• Colecalciferol, British National Formulary (BNF)
• NICE CG146: Osteoporosis: assessing the risk of fragility fracture
• SACN Vitamin D and Health Report (2016)
• Vitamin D, NHS
• MHRA Yellow Card Scheme