Properties
What is it?
Composition: Calcium carbonate 1250 mg (equivalent to 500 mg elemental calcium), Cholecalciferol 5.5 mcg (Vitamin D3 200 IU) in the form of 2.20 mg Cholecalciferol concentrate*. Excipients: Xylitol 225 mg, Orange flavour granules 55.9 mg (containing 55.1 mg isomalt, 0.839 mg orange flavouring substance, mono- and diglycerides of fatty acids 0.000727 mg), Povidone 15.75 mg, Magnesium stearate 6.00 mg, Sucralose 0.25 mg. *Cholecalciferol concentrate contains, including 10% excess: 0.00550 mg cholecalciferol, 0.0220 mg DL-α-tocopherol, 0.0660 mg medium-chain triglycerides, 1.61 mg modified corn starch, 0.385 mg sucrose, 0.0880 mg sodium ascorbate, 0.0264 mg silicon dioxide. Description Round, biconvex, white tablets without coating with orange flavour. Minor inclusions and irregular edges may be present. Pharmacotherapeutic group Mineral supplements. Calcium preparations. Calcium preparations in combination with other agents. Indications - Prevention and treatment of calcium and vitamin D deficiency; - Additional therapy for osteoporosis in patients at risk of calcium and vitamin D deficiency. Method of administration and dosage Calcium and vitamin D deficiency: - Adults: one tablet 1-3 times daily. - Children: one tablet 1-2 times daily. Additional therapy for osteoporosis: - Adults and elderly: one tablet 2-3 times daily. Renal insufficiency Calcium-D3 Nicomed is not recommended for patients with severe renal insufficiency. The tablet can be chewed and dissolved. Contraindications - Hypersensitivity to the active substances or excipients - Severe renal insufficiency (glomerular filtration rate ˂30 ml/min/1.73m2) - Diseases and/or conditions leading to hypercalcemia or hypercalciuria - Urolithiasis (nephrolithiasis) - Vitamin D hypervitaminosis - Calcium-D3 Nicomed contains isomalt (E953) and sucrose. Therefore, it is not recommended for use in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, and sucrose-isomaltase deficiency. Pregnancy and lactation Pregnancy Calcium-D3 Nicomed can be used by women during pregnancy in case of calcium and vitamin D deficiency. The daily dose during pregnancy should not exceed 2500 mg of calcium and 4000 IU of vitamin D. However, excessive intake of calcium and vitamin D should be avoided in pregnant women, as persistent hypercalcemia can negatively affect the developing fetus. Vitamin D has no teratogenic effect at therapeutic doses. Lactation Calcium-D3 Nicomed can be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account if additional vitamin D is prescribed for the infant. Storage conditions Store in a tightly closed bottle at a temperature not exceeding 30°C, in a dry place. Keep out of reach of children! Pharmacy dispensing conditions: Pharmaceutical product group III, available without prescription