Coralcal Kit 150mg+600mg+400IU (30pcs)

Indication: Coralcal-Kit™ is indicated for the treatment and prevention of Osteoporosis. 

Coralcal Kit : Each kit contains 1 lbandronic Acid (Bonova™) Tablet and 30 Tablets of Calcium & Vitamin D3 (Coralcal-DX®).  Each 1 tablet of lbandronic Acid (BonovalM] contains 168.80mg lbandronate Sodium Monohydrate INN equivalent to 150mg of lbandronic Acid.  30 tablets (Coralcal-DX®) of each containing 1500mg of Calcium Carbonate equivalent to 600mg of elemental Calcium and 400 I U of Vitamin D3 as Cholecalciferol USP. 

Dose & administration:  1. Day (1-1 O): Take one Coralcal-DX® (Blue envelope) tablet daily after meal.

2.  Day 11:  I. Take the Bonova™ (Light yellow envelope) tablet 1 hour before breakfast with a full glass of plain water while sitting or standing in an upright position.  II. After taking Bonova™, patient can usually sit or walk around for 1 hour. 

III. Fruit juice, milk or any other liquids cannot be taken with Bonova.

IV. After taking Bonova™, patient must not take any food or liquid for 1 hour. 

3. Day (11-30): Take one Coralcal-DX® (Blue envelope) tablet daily after meal.  Or as directed by the physician. 

Contra-indication:  lbandronic Acid (Bonova™) tablet: Bonova™ is contraindicated in patients with known hypersensitivity to lbandronic Acid or to any of the excipients. Bonova TM is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Bon ova™. As with several bisphosphonates, Bonova™ is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Bonova™ is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.  Calcium + Vitamin D3 (Coralcal-DX®) tablet: Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc. 

Warning and precaution: 
lbandronic Acid (BonovaTMJ tablet:  Upper Gastrointestinal Adverse Reactions: lbandronic Acid like other bisphosphonates administered orally may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects, caution should be used when lbandronic Acid is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).  Hypocalcaemia and Mineral Metabolism: Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy.  Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking lbandronic Acid and other bisphosphonates.  Jaw Osteonecrosis: Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses.  Calcium & Vitamin D3 (Coralcal-DX®) tablet: In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum calcium level should be monitored in mild to moderate impairment and also in case of long term use. Patients with renal stone or with such previous, history should also take precaution. 

Side effects:  lbandronic Acid (Bonova™) tablet: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia etc.  Calcium & Vitamin D3 (Coralcal-DX®) tablet: Flatulence, Diarrhoea, Constipation, Upper GI Discomfort etc. are rare manifestation. Hyper-calcaemia due to prolong use has rarely been reported. 

Use in pregnancy & lactation:  Pregnant Women: There are no adequate and well-controlled studies in pregnant women. lbandronic Acid should not be used during pregnancy.  Lactating mother: It is not known whether lbandronic Acid is excreted in human milk. lbandronic Acid should not be used during lactation. 

Use in children and adolescents:  Safety and effectiveness in children and adolescents have not been established. 

Overdose: 
lbandronic Acid (Bonova™) tablet: No specific information is available on the treatment of over dosage of lbandronic Acid. However, based on knowledge of this class of compounds, oral over dosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events.  Calcium & Vitamin D3 (Coralcal-DX®) tablet: At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.