INVITA D3

Posology 1 capsule contains 50,000 IU vitamin D3. Paediatric posology - Due to lack of clinical data, InVita D3 is not recommended. Pregnancy and breastfeeding - Due to lack of clinical data, InVita D3 is not recommended. Adults - Higher doses may be required in certain situations, see below.

) Certain populations are at high risk of Vitamin D3 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 (eg, anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for Vitamin D3 deficiency, and requiring maintenance therapy.

Special populations Renal impairment InVita D3 should not be used in combination with calcium in patients with severe renal impairment. Hepatic impairment No posology adjustment is required in patients with hepatic impairment. 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.

Vitamin D3 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. • Pregnancy • Children and adolescents (under 18 years of age)