OSTOCALCIUM B12 SUSPENSION -
PRODUCT INFORMATION LEAFLET

Ostocalcium B12 Suspension is indicated for Therapeutic Use for:
Correction of combined vitamin D3, Calcium and vitamin B12 deficiencies.

Shake the bottle before Use. Do not take more than the recommended dose.
Dosage for Children below 1 year of age: Please consult your doctor.
Dosage for Children above 1 year of age: 1-2 teaspoonful daily (equivalent to 82- 164 mg of calcium, 200-400 I.U. of Vitamin D3 and 2.5-5 mcg of Vitamin B12).
Dosage for Adults & Elderly: 2-4 teaspoonful (equivalent to 164-328 mg of elemental calcium, 400-800 I.U. of Vitamin D and 2-10 mcg of Vitamin B12) , divided into 1 or 2 doses daily.

Do not use Ostocalcium B12 Suspension if you are allergic to the active substances or to any ingredient or excipient of the product or you have severe renal impairment and renal failure.

Monitoring is especially important in patients on concomitant treatment with cardiac glycosides or thiazide 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 the treatment discontinued. Therapy should be reduced or preliminary interrupted, if urinary calcium level exceeds 7.5 mmol/24 h (300 mg/24 h)
This product contains Vitamin D. Therefore, the risk of soft tissue calcification should be taken into account as 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 (see Section 4.3 Contraindications).
This product should be used in Leher’s disease or tobacco amblyopia since these optic neuropathies may degenerate further due to Cyanocobalamin (vitamin B12).
The content of vitamin D in calcium/cholecalciferol and other sources (Food, dietary supplements) should be considered or estimated before prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. Always read and follow the label
Check with your doctor before use if you:
- Have any medical condition/taking any other medication/pregnant or Lactating.
- Are allergic to any ingredients in the product.
- Have increased calcium levels in blood/urine or Vitamin D3 in blood.
- Have kidney problems/stones
Contact a doctor immediately in case of overdose & discontinue afterwards. Keep out of reach of children

Before taking this medicine, make sure you consult your doctor if you are taking similar medicines or products containing similar ingredients.

Pregnancy: As with the use of any medicine during pregnancy, pregnant women should seek medical advice and overdoses of calcium and vitamin D should be avoided as permanent hypercalcemia has been related to adverse effects on developing foetus. The lowest effective dose and shortest duration of treatment should be considered.
Lactation: Calcium passes slightly into breast milk without having a negative effect on children.
Vitamin D and its metabolites also pass into breast milk. This should be considered when giving additional vitamin D to the child.
Pregnant and nursing mothers should only use doses of Vitamin B12 higher than 12 mcg daily only if recommended by their physician.

None

Stop taking this medicine and tell your doctor immediately if:
- you experience allergic reactions such as skin rash or itching.
- You experience nausea, diarrhea, abdominal pain, constipation, and abdominal distension.
These reactions are rare

For Vitamin B12: Oral Vitamin B12 is well tolerated at high doses. There are occasional reports of hypersensitivity reactions (rash, pruritis, urticaria) in those receiving parenteral Vitamin B12, so those who have experienced these reactions with parenteral B12 may experience similar reactions from Oral Vitamin B12 although there are very few reports of this occurring.

Overdose can lead to hypervitaminosis and hypercalcemia. Symptoms of hypercalcemia may include anorexia, nausea, vomiting, thirst, polydipsia, polyuria, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias In case of over dosage, seek medical advice from a doctor immediately even if you do not have any symptoms as hypercalcemia can result in coma and death.
In the case of intoxication, treatment should be stopped immediately, and the fluid deficiency should be balanced.

ATC code: A12AX
Pharmacotherapeutic group: Mineral supplements; calcium, combinations with vitamin D and/or other drugs.
Mechanism of Action
Vitamin D is involved in calcium-phosphorous metabolism. It allows the active absorption of calcium and phosphorous from the intestine and their uptake by bone. Supplementation with calcium and vitamin D3 corrects latent vitamin D deficiency and secondary hyperparathyroidism.Vitamin B12 (cyanocobalamin) is essential for erythropoiesis, formation with myelin sheet and synthesis of the DNA.
Administration of calcium and vitamin D3 counteracts the increase of parathyroid hormone (PTH) which is caused by calcium deficiency, and which causes increased bone Resorption

Calcium:
Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30 % of the swallowed dose. The bioavailability of calcium can be slightly increased by concomitant intake of food.
- Distribution: 99 % of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1 % is present in the intra- and extracellular fluids.
- Metabolism: About 50 % of the total blood-calcium content is in the physiologically active ionised form with approximately 10 % being complexed to citrate, phosphate or other anions, remaining 40 % being bound to proteins, principally albumin
- Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

Vitamin D:
Absorption: Vitamin D is easily absorbed in the small intestine.
- Distribution: Cholecalciferol and its metabolites circulate in the blood bound to a specific globulin. Vitamin D, which is not metabolised is stored in adipose and muscle tissues
- Metabolism: Cholecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycholecalciferol. It is then further converted in the kidneys to 1,25- dihydroxycholecalciferol. 1,25 dihydroxycholecalciferol is the metabolite responsible for increasing calcium absorption
- Elimination: Vitamin D is excreted in faeces and urine.

Vitamin B12:
Two mechanisms exist for cobalamin absorption. One is passive, occurring equally through buccal, duodenal, and ileal mucositis is rapid but extremely inefficient, with <1% of an oral dose being absorbed by the process. The normal physiologic mechanism is active; it occurs through ileum and is efficient for small oral doses of cobalamin, and it is mediated by gastric intrinsic factor (IF). The dietary cobalamin released from protein complexes by enzymes in the stomach, duodenum and jejunum, combines with the salivary glycoprotein. Then this complex is digested by pancreatic trypsin and the cobalamin is transferred to IF.Between 0.5 and 5g of cobalamin enter the bile each day. This binds to IF and a major portion of biliary cobalamin normally is reabsorbed together with cobalamin derived from sloughed intestinal cells. Because of the appreciable amount of cobalamin undergoing enterohepatic circulation, cobalamin deficiency develops more rapidly in individuals who malabsorb cobalamin than it does in vegans, in whom reabsorption of biliary cobalamin is intact.

Sucrose
Phosphoric acid
Colour Erythrosine
Calcium Hydroxide
Benzoic acid
Sodium methyl Hydroxybenzoate
Polysorbate 80
Propylene Glycol
Flavour Banan or Lemon Lime
Sodium Hydroxide or phosphoric acid
Purified Water