Altavita D3 Safety Profile

Altavita D3 Safety Profile

  • 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. Altavita® D3 should not be used in combination with calcium in patients with severe renal impairment. No dose adjustment is required in patients with hepatic impairment1-4
  • Altavita D3 25,000 IU oral solution and Altavita D3 25,000 IU soft capsules are not recommended in pregnancy and breastfeeding. *3,4

Adverse reactions by system organ class and frequency:1-4

Metabolism and nutrition disorders:
Uncommon: Hypercalcaemia and hypercalciuria

Skin and subcutaneous disorders:
Rare: Pruritus, rash and urticaria

Uncommon = >1/1,000, <1/100. Rare = >1/10,000, <1/1,000

Certain populations are at high risk of vitamin D deficiency and may require higher doses and monitoring of serum 25(OH)D:1-4

  • 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)
  • Patients with malabsorption, including inflammatory bowel disease and coeliac disease
  • Those recently treated for vitamin D deficiency and requiring maintenance therapy
  • 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. To report an adverse event or a product complaint about a Consilient Health medicine, please contact Consilient Health at drugsafety@consilienthealth.com or 01 2057766
  • Adverse events and product complaints may also be reported to the Health Products Regulatory Authority. Reporting forms and information can be found at www.hpra.ie then click on “Report an issue”

For full safety information refer to the Altavita® D3 Summary of Product Characteristics

Altavita D3 1000 IU soft capsule SPC Altavita D3 7000 IU soft capsule SPC 

* Note that Altavita D3 1,000 IU soft capsules and Altavita D3 7,000 Iu soft capsules are licensed for prophylaxis of vitamin D deficiency in pregnant and breastfeeding women with an identified risk.1,2

1. Consilient Health Ltd, Altavita D3 1,000 IU soft capsules, Summary of product characteristics – available on medicines.ie

2. Consilient Health Ltd, Altavita D3 7,000 IU soft capsules, Summary of product characteristics – available on medicines.ie

3. Consilient Health Ltd, Altavita D3 25,000 IU soft capsules, Summary of product characteristics – available on medicines.ie

4. Consilient Health Ltd, Altavita D3 25,000 IU oral solution, Summary of product characteristics – available on medicines.ie