Composition:

• Orbical-D Tablet: Each tablet contains Calcium Carbonate USP equivalent to 500 mg of elemental Calcium & Cholecalciferol USP equivalent to Vitamin D3 200 IU.

Pharmacology:

• Orbical-D is the preparation of Calcium Carbonate and Vitamin D3 (Colecalciferol). Calcium is necessary for many normal functions of the human body, especially bone formation and maintenance. Vitamin D3 helps with the absorption and reabsorption of calcium and also stimulates bone formation. Clinical studies showed that calcium and vitamin D3 together help in bone growth and in the prevention of osteoporosis and bone fractures.

Indications:

• Orbical-D (Elemental Calcium & Vitamin D3) tablet is indicated for the treatment and prevention of osteoporosis, osteomalacia, rickets, tetany, and pseudohypoparathyroidism. Also suggested for use as a dietary supplement where calcium intake may be inadequate (during pregnancy, lactation, postmenopausal women, and the aged).

Dosage and Administration:

• 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption or as recommended by a physician.

Side Effects:

• It is generally well tolerated. If there are experiences like nausea, vomiting, stomach cramps, dry mouth, increased thirst, or increased urination, a physician should be notified. Constipation may occur.

Contraindications:

• Diseases and conditions resulting in hypercalcemia and hypercalciuria, nephrolithiasis, hypervitaminosis, hypersensitivity to the active substances, or any of the excipients.

Warnings and Precautions:

• During long-term treatment, serum calcium levels should be monitored, and renal function should be assessed through serum creatinine measurement. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics and in patients with a high tendency to calculus formation. In case of hypercalcemia or signs of impaired renal function, the dose should be reduced or treatment discontinued. Vitamin D should be used with caution in patients with renal impairment, and its effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, Vitamin D in the form of cholecalciferol is not metabolized normally, and other forms of Vitamin D should be used.

Drug Interactions:

• Possible interactions with calcium, aluminum, or magnesium-containing antacids and other calcium supplements, calcitriol and other vitamin D3 supplements, digoxin, tetracycline, doxycycline, minocycline, or oxytetracycline.

Overdose:

• Overdose can lead to hypervitaminosis D and hypercalcemia. Symptoms of hypercalcemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, and in severe cases, cardiac arrhythmias. Extreme hypercalcemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Use in Pregnancy and Lactation:

• During pregnancy, the daily intake should not exceed 1500 mg of calcium and 200 IU of cholecalciferol (15 mcg vitamin D). Studies in animals have shown reproductive toxicity with high doses of Vitamin D. In pregnant women, overdoses of Calcium and Vitamin D should be avoided, as permanent hypercalcemia has been linked to adverse effects on the developing fetus. There are no indications that Vitamin D at therapeutic doses is teratogenic in humans. Elemental Calcium & Vitamin D3 tablets can be used during pregnancy in case of a Calcium and Vitamin D deficiency. Elemental Calcium & Vitamin D3 tablets can be used during breastfeeding. Calcium and Vitamin D3 pass into breast milk, so this should be considered when giving additional Vitamin D to the child.

Use in Children:

• Not recommended for children under 12 years.

Storage:

• Store below 30°C, in a cool & dry place. Keep away from light. Keep out of the reach of children.

Pack Size:

• Orbical D Tablet: Each container of Orbical D contains 30 tablets, along with a silica gel desiccant.