CALISVIT OS 10FL 12ML 200UI

CALISVIT 500 MG/200 POLVERE AND SOLVENT FOR ORAL SOSPENSION

active ingredients

EACH CONTAINER CAP CONTAINS: Active component: colecalciferol (vitamin D3): UI 200 Active component: calcium phosphate tribasic mg 1290 (equal to calcium ion mg 500). Excipients with known effects: esters of p-hydroxybenzoic acid, sucrose. For the full list of excipients, see paragraph 6.1.

Excellent

In the tank cap: L-lisina hydrochloride, sodium starch, dimeticone. In the solvent bottle: sucrose, esters p-hydroxybenzoic acid, magnesium silicate and aluminum, strawberry aroma, purified water.

Therapeutic indications

Calcium deficiency syndromes.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Renal calculus; hypercalcemia; hypercalciuria; kidney failure.

Population

Population. Adults: 1-2 bottles/die for oral use. Children: half dose. Method of administration: Screw the cap completely until it stops holding the bottle in a vertical position. Shake the bottle repeatedly with force to allow the powder to dissolve in the liquid below. Avoid the cap and take the preparation so obtained such as or diluted with water, milk, juices, etc. Or: insert the cap on the bottle cap and press thoroughly to drop the powder in the liquid. Shake holding the cap for 30" to dissolve the powder in the liquid, and in any case until the solution happened. Remove the cap, the guarantee crown and then the cap and take the preparation directly from the bottle or diluted with water, milk, juices, etc. Once the cap powder is dissolved in the liquid below it is necessary to take the preparation immediately or within 24 hours if stored in the refrigerator.

Conservation

The suspension is stable for 24 hours, if the bottle is stored in the refrigerator.

Warnings

In case of prolonged or high-dose treatments, watch that there are no hypervitamins D phenomena and periodically check calcemia and calciuria. Particular caution is required in treating patients with cardiovascular disease and digitized subjects for which it is necessary to carry out periodic checks of the ECG track. The medicine contains: - p-hydroxybenzoate esters that can cause allergic reactions (also delayed); - sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine; - sodium. This medicine contains less than 1 mmol (23 mg) of sodium per bottle, so it is essentially “without sodium”.

Interactions

The absorption of tetracyclines administered by mouth can be reduced by the simultaneous oral intake of calcium compounds; the administration of the two drugs must be allotted at least three hours. Cholesteramine, corticosteroid and mineral oils interfere, reducing it, with the absorption of vitamins D, while barbiturates and phenytoin promote inactivation. Calcium/digital action synergism on the heart could cause serious heart failure (see also point 4.4)

Effects

High doses or prolonged periods of treatment may cause hypercalcemia that occurs with nausea, vomiting, constipation, abdominal pain, polyuria, alteration of the ECG tract. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Intake of excessive quantity of the product may result in the appearance of signs of hypervitaminosis D. In this case, besides suspending the administration of the drug, it is necessary to limit the dietary intake of calcium and, if necessary, rehydrate the patient and acidify the urine.

In pregnant women the product should be administered in cases of actual need, under the direct control of the doctor.

Source: Farmadati