Calcium Savio

Italy
Brand name Calcium Savio
Form granules, effervescent
Active substance / Dosage
CALCIUM CARBONATE
Prescription type Prescription only
ATC code
A12AA04
Registration number 032344
Manufacturer I.B.N. SAVIO S.R.L

CALCIO SAVIO
“2500 mg Effervescent Granules for Oral Use” 30 sachets
Calcium Carbonate
Equivalent medicine
COMPOSITION
Each sachet contains:
Active Substance: Calcium carbonate 2500 mg (equivalent to 1000 mg of Ca)
Excipients: anhydrous citric acid; sucrose; sodium saccharin; orange flavour; cherry flavour.
PHARMACEUTICAL FORM AND PACKAGE
Effervescent granules for oral use. Pack of 30 sachets containing 1000 mg of calcium each.
PHARMACOTHERAPEUTIC CATEGORY
Calcium carbonate-based mineral supplement.
MARKETING AUTHORISATION HOLDER
I.B.N. SAVIO S.r.l. - Via del Mare, 36 – 00071 Pomezia – (Rm)
MANUFACTURED BY

  • I.B.N. Savio S.r.l., via E. Bazzano n° 14, Ronco Scrivia (GE) or
  • Lamp San Prospero, Via della Pace n° 25/A, San Prospero (MO) or
  • Fine Foods, Via Dell’Artigianato 8/10, Brembate (BG)

PACKAGED BY

  • Pulitzer Italiana S.r.l., Via Tiburtina n° 1004, Roma or
  • Lamp San Prospero, Via della Pace n° 25/A, San Prospero (MO) or
  • Fine Foods, Via Dell’Artigianato 8/10, Brembate (BG)

QUALITY CONTROL BY

  • I.B.N. Savio S.r.l., Via E. Bazzano, 14 - Ronco Scrivia (GE) or
  • Lamp San Prospero, Via della Pace n° 25/A, San Prospero (MO) or
  • Fine Foods, Via Dell’Artigianato 8/10, Brembate (BG)

The package leaflet included in the individual package will indicate only the actual manufacturing site(s).
THERAPEUTIC INDICATIONS
Treatment and prevention of calcium deficiency.
Pathological conditions requiring increased calcium intake.
CONTRAINDICATIONS
Individual hypersensitivity to the components of the product or substances closely related from a chemical standpoint. Hypercalcaemia and hypercalciuria. Calcium urolithiasis (kidney stones). Severe renal insufficiency.
In case of prolonged immobilisation associated with hypercalcaemia and/or hypercalciuria, treatment with calcium salts should only be initiated upon resumption of mobilisation.
SUITABLE PRECAUTIONS FOR USE
Calcium salts administered at high doses and/or for prolonged periods may cause hypercalcaemia, especially in patients with renal insufficiency. Therefore, they must be used cautiously and only when strictly necessary in patients with renal or cardiovascular diseases. During prolonged treatment, serum and urinary calcium levels should be monitored periodically and, based on these results, the dose may need to be reduced.
DRUG INTERACTIONS AND OTHER
Unless otherwise directed by a physician, do not combine with products containing vitamin D; if combined, regular monitoring of blood and urinary calcium levels is required.
When concomitantly administered with digitalis glycosides, calcium administration (especially if associated with vitamin D) requires regular monitoring, and the physician will establish a specific schedule for controls.
When concomitantly administered with oral tetracyclines, administration of the two drugs should be separated by at least 3 hours.
When taking sodium fluoride products, it is advisable to take calcium at a different time from sodium fluoride.
To avoid potential interactions with other medications, systematically inform your physician of any concomitant therapies.
WARNINGS
CALCIO SAVIO may be indicated in cases of increased physiological need, such as during the last months of pregnancy and during breastfeeding.
Like all medicines, this product must be kept out of the reach of children.
The medicine is not contraindicated in patients with coeliac disease.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Dissolve the contents of one sachet in a glass of water and drink immediately after dissolution.
Adults: osteoporosis and general calcium deficiency states: 1 g/day, i.e. 1 sachet per day of CALCIO SAVIO. Strictly follow medical prescription.
OVERDOSE
Under conditions of normal metabolism, no intoxication has ever been observed following the intake of high doses and/or long-term administration of calcium salts. However, in patients with renal insufficiency or cardiovascular diseases, alkalosis and hypercalcaemia may occur, manifesting as nausea, vomiting, constipation, abdominal pain, thirst, polyuria, polydipsia, characteristic changes in the ECG trace, arterial hypertension, and vasomotor disturbances.
Treatment: discontinue calcium administration, rehydrate, and, depending on the severity of intoxication, administer diuretics and corticosteroids.
UNDESIRABLE EFFECTS
Gastrointestinal disturbances (constipation, flatulence, nausea) and hypophosphataemia may rarely occur.
In case of hypercalcaemia, symptoms such as nausea, vomiting, constipation, abdominal pain, thirst, polyuria, polydipsia, characteristic changes in the ECG trace, arterial hypertension, and vasomotor disturbances may occur. In children, growth retardation may occur (see overdose).
Following the instructions provided in the package leaflet reduces the risk of undesirable effects.
These undesirable effects are generally transient. However, if they occur, it is advisable to consult a physician.
It is important to inform the physician of any undesirable effects not described in the package leaflet.
KEEP OUT OF THE REACH OF CHILDREN.
STORAGE INSTRUCTIONS AND EXPIRY DATE
CALCIO SAVIO must be stored protected from moisture.
Expiry date: see the date indicated on the packaging.
This expiry date refers to the product in its original, unopened packaging, stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
DATE OF REVISION
May 2011