INVITA D3

Posology Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. InVita D3 1,000 IU soft capsules are suitable for daily supplementation, while InVita D3 7,000 IU soft capsules are suitable for weekly supplementation, which should be taken into consideration and dosage should be established by a physician.

The dose of 1,000 IU/day is considered equivalent to 7,000 IU/week. Paediatric posology - Doses of up to 1,000 IU/day may be required to prevent deficiency in some children. - treatment of deficiency 10-18 years 2,000 IU/day for 6 weeks, followed by maintenance therapy of 400-1,000 IU/day (such as one 1,000 IU soft capsule per day or one 7,000 IU soft capsule per week).

- Pregnancy and breastfeeding - Doses of 1,000 – 2,000 IU/day may be required to prevent deficiency in some women (see below). - Even higher doses may be required during breast-feeding if women choose not to give the infant a vitamin D supplement.

Adults - prevention of vitamin D deficiency 1,000 IU/day. Higher doses may be required in certain situations, see below. - as an adjunct to specific therapy for osteoporosis: 1,000 IU/day. Follow- up 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.

, anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy. Method of administration Oral – The capsules should be swallowed whole with water.

2 Pharmacokinetic properties - “Absorption”).

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 authorization of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Caution is required in patients receiving treatment for cardiovascular disease (see section

Hypersensitivity to the active substance(s) or to any of the excipients. - Hypercalcaemia and/or hypercalciuria. - Nephrolithiasis and/or nephrocalcinosis - Serious renal impairment - Hypervitaminosis D - Pseudohypoparathyroidismas the vitamin D requirement may be reduced due to phases of normal vitamin D sensitivity, involving the risk of prolonged overdose.

Better-regulatable vitamin D derivatives are available for this.