Coralium D3 Forte

Calcium, Magnesium, Lysine, Zinc, Manganese, Copper, Boron, Selenium & Vitamin D3 Tablets

Each tablet contains:

Coral calcium (elemental Calcium) …….............500mg

Magnesium (elemental)……..................................75mg

As Magnesium carbonate

L-Lysine HCL............…………….........................30mg

Zinc (elemental)………...………………………...12mg

As zinc sulphate

Manganese (elemental)………………………….....4mg

As Manganese chloride

Copper (elemental)…………..................................1.7mg

As copper sulphate

Boron………………………………..........................1mg

Selenium (elemental)……………………………..40mcg

As Sodium selenite

Vitamin D3……......................................................400IU

(from lichen source)

Tablet.

Calcium 500mg, Magnesium 75mg, Lysine 30mg, Zinc 12mg, Manganese 4mg, Copper 1.7mg, Boron 1mg, Selenium 40mcg, Vitamin D3 400IU

4.1 Therapeutic Indication

Calcium supplementation & Supports immunity

4.2 Posology and Method of Administration

One tablet daily after meal for adult

4.3 Contraindications 

• Hypersensitivity to the active substance or to any of the excipients listed in the formulation.
• Diseases and/or conditions resulting in hypercalcemia and/or hypercalciuria (e.g. myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism).
• Nephrolithiasis/nephrocalcinosis
• Severe renal impairment and renal failure
• Hypervitaminosis D
• Hypersensitivity to the active substances or to any of the excipients present in this tablet.
• Relative contra-indications are osteoporosis due to prolonged immobilization, renal stones, and severe hypercalciuria.

4.4 Special warnings and precautions for use 

• Patients who are already taking thiazide diuretics and/or cardiac glycosides should be referred to their doctor prior to concomitant use (i.e. not suitable for pharmacy supply). Concomitant use should be prescribed with caution due to the increased risk of hypercalcemia.
• During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. 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 the treatment discontinued. It is advisable to reduce or interrupt treatment temporarily if urinary calcium exceeds 7.5 mmol/24 h (300 mg/24 h).
• 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. 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.
• Coralium-D3 forte tablets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.
• Coralium-D3 forte tablets should be used with caution in immobilized patients with osteoporosis due to the increased risk of hypercalcemia.
• The content of vitamin D (500 IU) in Coralium-D3 forte tablets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases, it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. Milk-alkali syndrome (Burnett's syndrome), i.e. hypercalcemia, alkalosis, and renal impairment can develop when large amounts of calcium are ingested with absorbable alkali.
• Allowances should be made for calcium and vitamin D supplements from other sources.
• Whilst taking Coralium-D3 forte tablets, both protein and energy are also required to provide complete nutrition in the daily diet. No other vitamins, minerals or supplements with or without vitamin A should be taken with this preparation except under medical supervision.
• Do not take Coralium-D3 forte tablets on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor.

4.5 Drugs interactions 

• Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcemia, serum calcium should be regularly monitored during the concomitant use of thiazide diuretics.
• Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Coralium D3 forte tablets.
• Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
• Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.
• Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
• If a bisphosphonate or sodium fluoride is used concomitantly with Coralium D3 forte tablets, these medicinal products should be administered at least three hours before the intake of Coralium D3 forte tablet since gastrointestinal absorption may be reduced.
• Rifampicin, phenytoin, or barbiturates may reduce the activity of vitamin D3, since they increase the rate of its metabolism.
• The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.
• Calcium salts may decrease the absorption of iron, zinc or strontium. Consequently, the iron, zinc or strontium preparation should be taken at a distance of two hours from the calcium preparation.
• Calcium salts may reduce the absorption of the estramustin or thyroid hormones. It is recommended that taking CoraliumD3 forte tablets be spaced at least 2 hours from these medicines.
• Oxalic acid (found in spinach, sorrel and rhubarb), phosphate, and phytic acid (found in whole cereals) may inhibit calcium absorption through the formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
• Zinc Sulphate reduce the absorption of tetracyclines

4.6 Use in special populations

Pregnancy

Coralium-D3 forte tablets may be given during pregnancy in cases of calcium and vitamin D3 deficiency.

During pregnancy the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D. Animal studies have shown toxic effects on reproduction at high doses of vitamin D. In pregnant women, all calcium or vitamin D overdose must be avoided as prolonged hypercalcemia in pregnancy may lead to retardation of physical and mental development, supravalvular aortic stenosis and retinopathy in the child. There are no indications that Vitamin D3 at therapeutic doses is teratogenic in humans.

Breast-feeding

Coralium-D3 forte tablets can be used during breast-feeding. Calcium and vitamin D pass into breast milk. This should be considered when giving additional vitamin D to the child.

Coralium-D3 forte tablets may be administered during pregnancy and lactation at the recommendation of the physician.

4.7 Effects on ability to drive and use machines

There are no data on the effect of this product on driving capacity and use of machines. An effect is, however, unlikely.

4.8 Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

• Immune system disorders
  • Not known: Hypersensitivity reactions including pruritus, wheezing, urticaria, and oropharyngeal swelling have been reported in the post-marketing environment.
• Metabolism and nutrition disorders
  • Uncommon: Hypercalcaemia and hypercalciuria.
  • Very rare: Seen usually only in overdose, see 4.9: Milk-alkali syndrome
• Gastrointestinal disorders
  • Rare: Constipation, flatulence, nausea, vomiting, abdominal pain, and diarrhea.
  • Very rare: Dyspepsia
• Skin and subcutaneous disorders
  • Rare: Pruritus, rash and urticaria.
• Other special population
  • Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: https://www.zuventus.co.in/drug-safety-reporting

4.9 Overdose

No cases of overdosage due to Calcium-D3 forte therapy have been reported.

If overdose of calcium and vitamin-D3 suspected can lead to hypervitaminosis and hypercalcemia. Symptoms of hypercalcemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi, 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.

Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcemia, alkalosis, and renal impairment.

Treatment of Calcium-D3 forte Overdosage

The following steps are recommended to minimise or prevent further absorption of the medication:

1. Administer an emetic.
2. Gastric lavage may be necessary to remove drug already released into the stomach. Keep the patient under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.
3. A drink of mannitol or sorbitol should be given to induce small bowel emptying.
4. Any fluid or electrolyte imbalance should be corrected.

Treatment of hypercalcemia

The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D, and cardiac glycosides must also be discontinued. Emptying of the stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin, and corticosteroids. Serum electrolytes, renal function, and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

5.1 Pharmacodynamic properties/ Mechanism of Action

Calcium, combination with vitamin D3

Calcium is an essential body electrolyte. It is involved in the maintenance of normal muscle and nerve function and essential for normal cardiac function and the clotting of blood. Calcium is mainly found in the bones and teeth. Deficiency of calcium leads to rickets, osteomalacia in children and osteoporosis in the elderly.

Vitamin D increases the intestinal absorption of calcium. Administration of calcium and vitamin D3 (cholecalciferol) counteracts the increase of parathyroid hormone (PTH), which is caused by calcium deficiency and causes increased bone resorption.

Magnesium Magnesium is essential to the body as a constituent of skeletal structures and in maintaining cell integrity and fluid balance. It is utilised in many of the functions in which calcium is concerned but often exerts the opposite effect. Some enzymes require the magnesium ion as a co-factor.

Lysine

Lysine is an essential amino acid that is primarily used for protein synthesis. Lysine helps in synthesis of connective tissues such as bone, skin, collagen, and elastin; synthesis of carnitine and resultant conversion of fatty acids to energy; support for healthy growth and development in children; and maintenance of healthy immune function. Lysine has been shown to increase iron absorption in vivo.

Zinc

Zinc is an essential trace mineral necessary for the proper function of about 300 different enzymes. Zinc is important for wound healing, immune system support, digestion, energy production, growth, cellular repair, collagen synthesis, bone strength, cognitive function, and carbohydrate metabolism (glucose utilization and insulin production). Zinc not only modulates cell-mediated immunity but is also an antioxidant and anti-inflammatory agent.

Manganese

Manganese is an essential element for humans and is required for growth, development, and maintenance of health. Manganese is necessary for skeletal system development, energy metabolism and immunological system function. It is an antioxidant that protects cells from damage due to free radicals. Manganese also plays an essential role in regulation of cellular energy, bone and connective tissue growth and blood clotting.

Copper

Traces of copper are essential to the body as constituents of enzyme systems involved in oxidation reactions.

Boron

Boron is a trace element which might have beneficial effects on functions such as reproduction and development, calcium metabolism, bone formation, brain function, insulin and energy substrate metabolism, immunity, and the function of steroid hormones (including vitamin D and estrogen).

Selenium

Selenium is an essential trace element, deficiency of which has been reported in man. It is thought to be involved in the functioning of membranes and the synthesis of amino acids. Deficiency of selenium in the diet of experimental animals produces fatty liver followed by necrosis.

5.2 Pharmacokinetic properties

Calcium

Absorption:

The bioavailability of coral calcium is approximately 70% as per study in animals by Japanese Dietetic Society. This is higher as compared to other calcium salts. Unlike lime and fossilized calcium which are inert, live coral produces calcium in its ionized form. This calcium is able to bypass the digestive process. Hence, calcium and other trace minerals from coral are immediately available to the systems in the human body.

Distribution and metabolism:

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. About 50% of the total blood-calcium content is in the physiologically active ionized form with approximately 10% being complexed to citrate, phosphate, or other anions, the remaining 40% being bound to proteins, principally albumin.

Elimination:

Calcium is eliminated through feces, urine, and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

Vitamin D

Absorption:

Vitamin D3 is absorbed in the small intestine.

Distribution and metabolism:

Cholecalciferol and its metabolites circulate in the blood bound to a specific globulin. Cholecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxy cholecalciferol. It is then further converted in the kidneys to 1,25hydroxycolecalciferol. 1,25 hydroxy cholecalciferol is the metabolite responsible for increasing calcium absorption. Vitamin D which is not metabolized is stored in adipose and muscle tissues.

Elimination:

Vitamin D is excreted in feces and urine.

Magnesium

Magnesium salts are poorly absorbed from the gastro-intestinal tract; however, sufficient magnesium will normally be absorbed to replace deficiency states. Magnesium is excreted in both the urine and the faeces but excretion is reduced in deficiency states.

Lysine

Lysine absorbed from the lumen of the small intestine into the enterocytes by an active transport process.

Zinc Sulphate

Zinc is poorly absorbed from the gastro-intestinal tract. It is widely distributed throughout the body. It is excreted in the faeces with traces appearing in the urine.

Manganese Sulphate

Manganese salts are poorly absorbed

Copper

Copper is absorbed from the gastro-intestinal tract and its major route of excretion is in the bile.

Boron

Most ingested boron is hydrolyzed to boric acid within the gastrointestinal tract. The body absorbs about 85%–90% of ingested boron. However, very little is known about how or where in the gastrointestinal tract absorption occurs.

Selenium

Although it has been established that selenium is essential to human life, very little information is available on its function and metabolism.

6.1 Animal Toxicology or Pharmacology

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There are further no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the prescribing information.

Coralium D3 forte tablets contain a comprehensive formula of calcium and vitamin D3 with multi-minerals and anti-oxidant specially designed to support health and wellbeing in adults by unlocking energy and strengthening immunity. Most vitamins, minerals and trace elements are not produced by human body and hence are dependent on dietary supply of these nutrients. Since vitamins, minerals and trace elements are involved in many metabolic processes in the body, an adequate supply of these vital substances contribute to physical and mental well-being.

8.1 Incompatibilities

Not applicable.

8.2 Shelf-life

Refer on the pack

8.3 Packaging information

10 tablets per pack

8.4 Storage and handing instructions

Store in a dry place at a temperature not exceeding 30°C, protect from light & moisture.

• Take this tablet with food. Take with a full glass of water.
• This tablet need to be taken as Recommended by Healthcare professional. (Don’t exceed the recommended daily usage).
• This tablet is not intended to diagnose, treat, cure or prevent any disease.
• This tablet is not to be used as a substitute for a varied diet

Do not take Coralium D3 forte tablets: 

• if you are allergic (hypersensitive) to any of the ingredients of Coralium D3 forte tablets
• if you suffer from hypercalcaemia (high level of calcium in the blood)
• Do not give Coralium D3 forte tablets to children aged under 12.

Take special care with Coralium D3 forte tablets

Before you are given Coralium D3 forte tablets tell your doctor, dietician or pharmacist if:

• you are pregnant or thinking of becoming pregnant
• you are a smoker
• you have kidney disease, bone disease, malignancies or calcium disorders

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before taking Coralium D3 forte tablets.

Taking other medicines

Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Coralium D3 forte tablets:

• Phenytoin (used to treat epilepsy)
• Tetracycline antibiotics (used to treat infections) such as doxycycline and minocycline
• Thiazide diuretics

Please tell your doctor if you are taking or have recently taken/used any other medicines including other vitamin or mineral products medicines obtained without a prescription.

Zuventus Healthcare Limited

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CTS No.: 358/A2, Near

Nahur Railway Station,

Nahur (W), Mumbai, 400078

Maharashtra, India

At : Plot No. 33, Pharmacity,

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Uttarakhand.

Registered Trade Mark of Zuventus.

July 2024