Cacit - Package Leaflet

Indications Contraindications Precautions for use Interactions Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Calcium Carbonate

CACIT 500 20 effervescent tablets

Cacit package inserts are available for packs:
  • CACIT 500 20 effervescent tablets
  • CACIT 1000 20 effervescent tablets

Why is Cacit used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY:

mineral supplement based on calcium carbonate.

THERAPEUTIC INDICATIONS:

Treatment and prevention of calcium deficiency. Pathological states in which "increased calcium intake is required."

Contraindications When Cacit should not be used

States of hypersensitivity to the components. Hypercalcemia and hypercalciuria (excess calcium in the blood or urine). Calcic lithiasis (kidney stones). Severe renal insufficiency. In case of prolonged immobilization accompanied by hypercalcemia and / or hypercalciuria, calcium treatment should only be started when mobilization is resumed.

Precautions for use What you need to know before taking Cacit

Calcium salts administered in high doses and / or for prolonged periods can cause hypercalcemia especially in subjects with renal insufficiency. They must therefore be used with caution and only when indispensable in carriers of kidney and cardiovascular diseases. In case of prolonged treatments, it is necessary to periodically check the calcium, whose values ​​must be kept within values ​​of 9-10 mg%, and the calcium and depending on these, possibly reduce the dose. If the calcium level exceeds the indicated values ​​and if the calciumuria exceeds 7.5 mmol / 24 h (300 mg / 24 h) in the adult and 0.12-0.15 mmol / kg / 24 h (5-6 mg / kg / 24 h) in the child, treatment should be stopped.

Interactions Which drugs or foods can modify the effect of Cacit

Unless specifically instructed by the doctor, do not combine products containing vitamin D; in case of association, it is necessary to regularly measure the calcium in the blood and urine.

  • In case of concomitant treatment with digitalis: since for the synergism on the heart serious disturbances of cardiac function can occur, the administration of calcium (especially if associated with vitamin D) requires regular surveillance and it will be the same doctor who will impose a precise schedule of controls.
  • In case of concomitant treatment with oral tetracycline, the administration of the two drugs should be separated by at least 3 hours.
  • In case of treatment with sodium fluoride products it is advisable to take the calcium away from the sodium fluoride.

TO AVOID INTERACTIONS WITH OTHER DRUGS, PERIODICALLY REPORT ANY OTHER CONCOMITANT THERAPY TO YOUR DOCTOR.

Dosage and method of use How to use Cacit: Dosage

Dissolve the effervescent tablet in a glass of water and drink immediately after the solution.

Adults: osteoporosis and states of calcium deficiency in general: 1 g / day, i.e. 1 tablet a day of CACITTM 1000.

Children: states of calcium deficiency during the growth period: 500 mg - 1 g / day, ie 1-2 tablets of CACITTM 500 per day, depending on age.

Strictly adhere to the medical prescription.

DURATION OF THE TREATMENT:

Doctor's second opinion

Overdose What to do if you have taken too much Cacit

Symptoms: thirst, polyuria, polydipsia (excessive thirst), nausea, vomiting, dehydration, arterial hypertension, vasomotor disorders, constipation. In the infant and child The symptoms described above may be preceded by stunted growth.

Treatment: interruption of calcium administration, rehydration and, depending on the severity of the intoxication, administration of diuretics and cortisones. If necessary, perform peritoneal dialysis.

Side Effects What are the side effects of Cacit

  • Constipation, flatulence, nausea.
  • Hypecalcemia (in case of prolonged treatment) with nausea, vomiting, constipation, abdominal pain, thirst, polyuria, polydipsia, characteristic changes in the E.C.G.trace, arterial hypertension, vasomotor disorders. In infants and children, weight-state growth arrest may occur.
  • Hypophosphatemia.

Report any other undesirable effect not described above to your doctor or pharmacist.

Expiry and Retention

DO NOT USE THE PRODUCT BEYOND THE EXPIRY DATE STATED ON THE PACKAGE

Keep away from moisture. Close bottle carefully after use.

Deadline "> Other information

COMPOSITION

1 effervescent tablet of 3,560 mg contains:

  • Active ingredient: Calico carbonate 1,250 mg (equivalent to 500 mg of calcium).
  • Excipients: Citric acid, Sodium cyclamate, sodium saccharin, Orange flavor (MK 500), Orange yellow S (E110).

PHARMACEUTICAL FORM

effervescent tablets 3,560 mg to be dissolved in water for oral administration.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Cacit can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

CACIT 500

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

CACIT 500

1 effervescent tablet of 3,560 mg contains:

Active principle

Calcium carbonate 1,250 mg (equivalent to 500 mg of calcium)

Excipients:

See section 6.1 - list of excipients

03.0 PHARMACEUTICAL FORM -

Effervescent tablets.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

- Treatment and prevention of calcium deficiency

- Pathological states in which an "increased calcium intake is required

04.2 Posology and method of administration -

Dissolve the effervescent tablet in a glass of water and drink immediately after the solution. Adults: osteoporosis and states of calcium deficiency in general: 1 g / day, ie one tablet a day of CACIT 1000. Children: states of calcium deficiency during the growth period: 500 mg - 1 g / day, ie 1-2 tablets of CACIT 500 per day, depending on the age.

FOLLOW THE MEDICAL REQUIREMENT STRICTLY.

04.3 Contraindications -

States of hypersensitivity to the components. Hypercalcemia and hypercalciuria. Calcic lithiasis (kidney stones).

Severe renal insufficiency. In case of prolonged immobilization accompanied by hypercalcemia and / or hypercalciuria, calcium treatment should only be started when mobilization is resumed.

04.4 Special warnings and appropriate precautions for use -

- Calcium salts administered in high doses and / or for prolonged periods can cause hypercalcemia especially in subjects with renal insufficiency. They must therefore be used with caution and only when indispensable in carriers of kidney and cardiovascular diseases. In case of prolonged treatments, it is necessary to periodically check the calcium, whose values ​​must be kept within values ​​of 9-10 mg%, and the calcium and depending on these, possibly reduce the dose. If the calcium level exceeds the indicated values ​​and if the calciumuria exceeds 7.5 mmol / 24 h (300 mg / 24 h) in the adult and 0.12-0.15 mmol / kg / 24 h (5-6 mg / kg / 24 h) in the child, treatment should be stopped.

- In case of treatment associated with digitatics, tetracycline, vitamin D, fluorides: see interactions chapter.

04.5 Interactions with other medicinal products and other forms of interaction -

- Unless specifically instructed by the doctor, do not combine products containing vitamin D; in case of association, it is necessary to regularly measure the calcium in the blood and urine.

- In case of concomitant treatment with digitalis: since for the synergism on the heart serious disturbances of cardiac function can occur, the administration of calcium (especially if associated with vitamin D) requires regular surveillance and it will be the same doctor who will impose a precise timetable controls.

- In case of concomitant treatment with oral tetracycline, the administration of the two drugs should be separated by at least 3 hours.

- In case of treatment with sodium fluoride products, it is advisable to take calcium away from sodium fluoride.

TO AVOID INTERACTIONS WITH OTHER DRUGS, PERIODICALLY REPORT ANY OTHER CONCOMITANT THERAPY TO YOUR DOCTOR.

04.6 Pregnancy and breastfeeding -

It is advisable.

04.7 Effects on ability to drive and use machines -

Nobody.

04.8 Undesirable effects -

a) Constipation, flatulence, nausea.

b) Hypercalcemia (in case of prolonged treatment) with nausea, vomiting, constipation, abdominal pain, thirst, polyuria, polydipsia, characteristic changes in the E.C.G.trace, arterial hypertension, vasomotor disorders. In the infant and the child, arrest of weight-bearing growth may occur.

c) Hypophosphatemia.

04.9 Overdose -

Symptoms: thirst, polyuria, polydipsia, nausea, vomiting, dehydration, arterial hypertension, vasomotor disorders, constipation. In infants and children The symptoms described above may be preceded by arrest of growth. Treatment: interruption of calcium administration, rehydration and, depending on the severity of intoxication, administration of diuretics and cortisone drugs. If necessary, perform peritoneal dialysis.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

The specialty is indicated for oral calcium therapy. The administration of calcium salts in a high dose is necessary in those physiological and pathological conditions in which the dietary intake is inadequate. The concentration of calcium present in each tablet of CACIT allows the absorption of a suitable quantity of calcium while reducing at the same time the number of daily administrations.

05.2 "Pharmacokinetic properties -

CACIT is absorbed in the form of a calcium citrate solution, in an amount corresponding to 30-40% of the ingested dose.

In the gastric environment, calcium citrate releases the calcium ion regardless of the pH value. Consequently, calcium is well absorbed on an empty stomach even in hypochlorhydria conditions. Calcium is eliminated through bile, pancreatic, intestinal secretions or sweat. Urinary elimination is a function of glomerular filtration and of the quantities reabsorbed at the tubular level.

05.3 Preclinical safety data -

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

CACIT 500

1 tablet of 3,560 mg contains:

Citric acid 2,162 mg

Sodium cyclamate 40 mg

Saccharin sodium 6 mg

Orange flavor (MK 500) 100 mg

Orange yellow S (E 110) 2 mg

06.2 Incompatibility "-

None known.

06.3 Period of validity "-

3 years.

06.4 Special precautions for storage -

- Keep away from humidity

- Close the bottle carefully after use.

06.5 Nature of the immediate packaging and contents of the package -

Propylene tube fitted with a polyethylene cap

CACIT 500

20 effervescent tablets of 500 mg of calcium

06.6 Instructions for use and handling -

No special instructions.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

WARNER CHILCOTT ITALY S.r.l., Via dei Pratoni, 16 - 50018 Scandicci (FI)

08.0 MARKETING AUTHORIZATION NUMBER -

CACIT 500 20 cpr A.I.C. 027476035 (suspended on company request)

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

CACIT 500 20 cpr 1 February 1992/1 February 2007

10.0 DATE OF REVISION OF THE TEXT -

July 2010

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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