Prescribing Information
Fultium-D3 800 IU Capsules
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentation: 800 IU Colecalciferol (equivalent to 20 micrograms vitamin D3).
Indication(s): Treatment and prophylaxis of vitamin D deficiency in adults and adolescents over 12 years. In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency.
Dosage and administration: 1 capsule (800 IU) daily. (see SmPC for full details). Higher doses can be necessary in treatment of vitamin D deficiency, where the dose 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. The daily dose should not exceed 4,000 IU (5 capsules per day). For oral use. Swallow capsules whole with water. Not recommended for use in children under 12 years.
Contraindications: Hypersensitivity to vitamin D or any of the excipients in the product, hypervitaminosis D, nephrolithiasis, nephrocalcinosis, diseases or conditions resulting in hypercalcaemia and/or hypercalciuria, severe renal impairment.
Warnings and precautions: Patients with pseudohypoparathyroidism, sarcoidosis or taking thiazides diuretics or cardiac glycosides must be referred to their doctor and not supplied this as a Pharmacy medicine. Use with caution in patients with impaired renal function. The effect on calcium and phosphate levels should be monitored in these patients. Renal function and serum calcium should be monitored during long term treatment. Additional monitoring is important in patients taking cardiac glycosides or diuretics (especially the elderly), in patients with a high tendency to calculus formation and patients with sarcoidosis.
Fertility, pregnancy and breastfeeding: The recommended daily intake for pregnant women in the United Kingdom is 400 IU, however, in women who are vitamin D deficient a higher dose may be required. Vitamin D is excreted in breast milk, when prescribing additional vitamin D to a breast-fed child consider the dose of any additional vitamin D given to the mother.
Undesirable effects: Allergic reactions are possible. Serious side effects: Hypersensitivity reactions. Uncommon side effects: hypercalcaemia and hypercalciuria. Rare side effects: pruritus, rash and urticaria. For full list of side effects, consult SmPC.
Legal Category: P
Pack size and price: 30 x capsules (£3.60)
MA number(s): PL 00240/0624
MA Holder: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK
Date of Preparation: December 2024
Unique ID number/Job bag number: UK-FULT-92
Fultium-D3 3,200 IU & 20,000 IU Capsules
Please refer to the Summary of Product Characteristics (3,200 IU SmPC, 20,000 IU SmPC) before prescribing.
Presentation: 3,200 IU Colecalciferol (equivalent to 80 micrograms vitamin D3), 20,000 IU Colecalciferol (equivalent to 500 micrograms vitamin D3).
Indication(s): Fultium-D3 3,200 IU: The treatment of vitamin D deficiency in adolescents, adults and the elderly. Fultium-D3 20,000 IU: Treatment and prevention of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency. Indicated for use in adolescents, adults and the elderly.
Dosage and administration: 3,200 IU: 1 capsule daily for up to 12 weeks dependent upon the severity of the disease and the patient’s response to treatment. 20,000 IU: Paediatric population (12-18 years): Prevention of vitamin D deficiency: 1 capsule (20,000 IU) every 6 weeks. Treatment of vitamin D deficiency: 1 capsule (20,000 IU) once every 2 weeks for 6 weeks. Adults: Prevention of vitamin D deficiency: 1 capsule (20,000 IU/month). Treatment of vitamin D deficiency: 2 capsules/week (40,000 IU) for 7 weeks, followed by maintenance therapy. Certain populations are at high risk of vitamin D deficiency and may require higher doses and monitoring of serum 25(OH)D (see SmPC for full details). For oral use. Swallow capsules whole with water. Fultium-D3 should not be used in children under the age of 12.
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 impairment.
Warnings and precautions: Use with caution in patients with impaired renal function. The effect on calcium and phosphate levels should be monitored in these patients. The risk of soft tissue calcification should be considered. 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. Renal function and serum calcium should be monitored. Use with caution in patients receiving treatment for cardiovascular disease, and patients suffering from sarcoidosis. Patients taking cardiac glycosides or treatment to prevent hypercalcemia should be monitored.
Fertility, pregnancy and breastfeeding: The recommended daily intake for pregnant women in the United Kingdom is 400 IU, however, in women who are vitamin D deficient a higher dose may be required. Vitamin D is excreted in breast milk, when prescribing additional vitamin D to a breast-fed child consider the dose of any additional vitamin D given to the mother. Fultium-D3 20,000 IU capsules are not recommended during pregnancy unless the clinical condition of the woman requires treatment.
Undesirable effects: Allergic reactions are possible. Uncommon side effects: hypercalcaemia and hypercalciuria. Rare side effects: pruritus, rash and urticaria. For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: Fultium-D3 3,200 IU capsules x 30 (£13.32), Fultium-D3 3,200 IU capsules x 90 (£39.96), Fultium-D3 20,000 IU capsules x15 (£17.04), Fultium-D3 20,000 IU capsules x 30 (£29.00).
MA number(s): PL 40861/0003, PL 40861/0004
MA Holder: Internis Pharmaceuticals Ltd. Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK
Date of Preparation: December 2024
Unique ID number/Job bag number: UK-FULT-76(2)
Fultium-D3 Drops
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentation: 1 ml oral solution contains: 2740 IU Colecalciferol (equivalent to 68.5 micrograms/ml vitamin D3) 3 drops contain 200 IU Colecalciferol (vitamin D3).
Indication(s): 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.
Dosage and administration:Vitamin D deficiency treatment should be up to 12 weeks dependent upon the severity of the disease and the patient’s response to treatment, followed by the appropriate long term maintenance therapy. Paediatric (0-2yrs): 6 – 15 drops (400 – 1,000 IU) daily. Long term maintenance therapy following treatment of deficiency & Prevention of vitamin D deficiency 3 – 15 drops (200 – 1,000 IU) daily. Children (2-11yrs): 6 – 30 drops (400 – 2,000 IU) daily. Long term maintenance therapy following treatment of deficiency & Prevention of vitamin D deficiency 6 – 15 drops (400 – 1,000 IU) daily. Adolescents (12-18yrs): 6 – 60 drops (400 – 4,000 IU) daily. Long term maintenance therapy following treatment of deficiency & Prevention of vitamin D deficiency 6 – 24 drops (400 – 1,600 IU) daily. Adults and the elderly: 12 – 60 drops (800 – 4,000 IU) daily. Long term maintenance therapy following treatment of deficiency & Prevention of vitamin D deficiency 12 – 24 drops (800 – 1,600 IU) daily. As an adjunct to specific therapy for osteoporosis 12 drops (800 IU) daily. During pregnancy and breast-feeding, treatment of vitamin D deficiency 6 – 60 drops (400 – 4,000 IU) daily. Long term maintenance therapy following treatment of deficiency & Prevention of vitamin D deficiency 6 – 30 drops (400 – 2,000 IU) daily.
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 impairment.
Warnings and precautions: Use with caution in patients with impaired renal function. The effect on calcium and phosphate levels should be monitored in these patients. Use with caution in patients with sarcoidosis. Additional serum calcium and urine monitoring is required. Use with caution in patients receiving treatment for cardiovascular disease.
Fertility, pregnancy and breastfeeding: The recommended daily intake for pregnant women in the United Kingdom is 400 IU, however, in women who are vitamin D deficient a higher dose may be required. Vitamin D is excreted in breast milk, when prescribing additional vitamin D to a breast-fed child consider the dose of any additional vitamin D given to the mother.
Undesirable effects: Allergic reactions are possible. Uncommon side effects: hypercalcaemia and hypercalciuria. Rare side effects: pruritus, rash and urticaria. For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: 1 x 25ml (£10.75)
MA number(s): PL 40861/0005
MA Holder: Internis Pharmaceuticals Ltd. Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK
Date of Preparation: December 2024
Unique ID number/Job bag number: UK-FULT-75(3)
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-FULT-87(1) | January 2025