PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcium Gluconate

Generic medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What CALCIO GLUCONATO MONICO is and what it is used for
What you need to know before using CALCIO GLUCONATO MONICO
How to use CALCIO GLUCONATO MONICO
Possible side effects
How to store CALCIO GLUCONATO MONICO
Contents of the pack and other information

1. What CALCIO GLUCONATO MONICO is and what it is used for

CALCIO GLUCONATO MONICO is an infusion solution administered directly into a vein (intravenous infusion) containing the active substance calcium gluconate.
Calcium is an essential element for the proper functioning of the nervous system, muscles, heart, and blood vessels; it is also a fundamental component of bones.
This medicinal product is indicated for the treatment of calcium deficiency states (hypocalcemia) and, in combination with other medicinal products, for the treatment of severe allergic reactions (anaphylactic treatment). It is also indicated for controlling increased permeability of small blood vessels in allergic conditions and in cases of a skin disease characterized by redness and bruising (non-thrombocytopenic purpura).

2. What you need to know before using CALCIO GLUCONATO MONICO

Do not use CALCIO GLUCONATO MONICO

if you are allergic to calcium gluconate or to any of the other ingredients of this medicine (listed in section 6);
if you have diseases or conditions causing high levels of calcium in the blood (hypercalcemia), such as overactivity of the parathyroid glands (hyperparathyroidism), high levels of vitamin D (hypervitaminosis D), tumour disease with bone calcium loss (neoplastic disease with bone decalcification);
if you have high levels of calcium in the urine (severe hypercalciuria);
if you have severe kidney problems (severe renal failure);
if you have a heart rhythm disorder called ventricular fibrillation;
if you are taking cardiac glycosides, medicines for heart conditions (see section “Other medicines and CALCIO GLUCONATO MONICO”);
if the patient is a neonate (up to 28 days of age), CALCIO GLUCONATO MONICO (or other calcium solutions) must not be administered simultaneously with ceftriaxone (an antibiotic), even when using separate infusion lines. There is a risk of fatal formation of particles in the neonate's bloodstream.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using CALCIO GLUCONATO MONICO.
Calcium gluconate solution must not be administered by intramuscular or subcutaneous injection because it is irritating and may cause local inflammation with pus accumulation (abscesses) and tissue death (necrosis).
This medicine should be administered with caution in the following cases:

if you have kidney problems (impaired renal function or nephrocalcinosis);
if you have heart problems (cardiac patients).

During treatment, your doctor will regularly check the infusion site to prevent leakage of the medicine from the vein (local extravasation). Furthermore, blood and urine calcium levels should be monitored, especially in children, patients with severe kidney problems (chronic renal failure), or those with urinary tract stones. If calcium levels rise too much, treatment must be stopped immediately, as heart rhythm disturbances (cardiac arrhythmias) may occur.
This medicine must not be mixed in the same infusion set with incompatible drugs (e.g. ceftriaxone) or total parenteral nutrition solutions containing calcium and phosphate, nor administered sequentially through the same line, as serious, even fatal, complications may occur due to precipitation of insoluble calcium salts in the body.

Laboratory Tests
This medicine may cause false negative results in blood and urine magnesium level tests.

Children
As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (up to 28 days of age), even when separate infusion lines are used, due to the risk of fatal precipitation of calcium-ceftriaxone salt in the neonate's bloodstream (see section “Possible side effects”).

Other medicines and CALCIO GLUCONATO MONICO
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
This medicine should be administered with caution if you are taking:

thiazide diuretics, used to treat high blood pressure, as they increase the risk of elevated calcium levels in the blood (hypercalcemia);
medicines for heart conditions (cardiac glycosides, digitalis), as they may have their effects enhanced;
verapamil (and other calcium channel blockers), used to treat high blood pressure, because it may reverse the hypotensive effect;
ceftriaxone (an antibiotic), due to the risk of forming dangerous insoluble crystals.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered to you.
This medicine should not be administered during pregnancy or breastfeeding unless clearly necessary and under medical supervision.
Calcium is excreted in breast milk. This should be taken into account when prescribing calcium to women who are breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use CALCIO GLUCONATO MONICO

This medicine will be prepared by a doctor, pharmacist or nurse and will not be mixed or administered simultaneously with injections containing ceftriaxone or other incompatible medicines.
This medicine must be administered by trained medical personnel through a slow intravenous infusion (recommended infusion rate not exceeding 1.5 ml per minute). It must not be injected via other routes of administration (intramuscular or subcutaneous routes) (see section “Warnings and precautions”).
The recommended dose in adults is 500–2000 mg of calcium gluconate (equivalent to 5–20 ml of solution).
Treatment with calcium gluconate aims to restore or maintain blood calcium levels between 2.25–2.75 mmol/l (or 4.5–5.5 mEq/l). Therefore, during treatment, blood calcium levels must be closely monitored.

Use in children
In children, the recommended dose is 200–500 mg of calcium gluconate (equivalent to 2–5 ml of solution).
In infants, the recommended dose must not exceed 200 mg of calcium gluconate (no more than 2 ml of solution).

Use in elderly patients
In elderly patients, the dosage of the medicine should be reduced according to tolerance, which may be influenced by advanced age and pre-existing clinical conditions and factors.

Preparation of the medicine: Calcium gluconate for intravenous use may be diluted with 5% glucose or 0.9% sodium chloride solutions. Dilution in solutions containing bicarbonates, phosphates or sulfates must be avoided. Do not use the medicine if the solution is not clear; any precipitate may be redissolved by gentle warming in warm water.

If you use more CALCIO GLUCONATO MONICO than you should
Since this medicine will be administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think you have been given an excessive dose of CALCIO GLUCONATO MONICO, inform your doctor or another healthcare professional immediately.
Following administration of an excessive dose of this medicine, an increase in blood calcium levels (hypercalcemia) may occur, resulting in loss of appetite (anorexia), nausea, vomiting, constipation, abdominal pain, muscle weakness, intense thirst (polydipsia), increased urine production (polyuria), mental disturbances, bone pain, kidney damage due to deposition of calcium salts (nephrocalcinosis, kidney stones), heart rhythm irregularities (cardiac arrhythmias) and coma.

If you have any doubts about the use of CALCIO GLUCONATO MONICO, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur.
Not known (frequency cannot be estimated from the available data)

effects due to too rapid administration of the medicine such as sweating, hot flushes, nausea, vomiting, low blood pressure (hypotension), reduced heart rate (bradycardia), irregular heartbeat (arrhythmias), loss of consciousness (syncope), and vasomotor collapse, even fatal;
effects due to local leakage of the solution such as calcium deposits in tissues (soft tissue calcification), inflammation due to pus accumulation (abscesses), and tissue damage and death (necrosis);
effects due to administration of high doses of the medicine (overdose) such as formation of kidney stones (nephrolithiasis due to hypercalcaemia) and abnormal presence of calcium in the urine (hypercalciuria);
kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or the amount of urine produced may decrease.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CALCIO GLUCONATO MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Store in the original packaging. Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CALCIO GLUCONATO MONICO 500 mg/5 ml solution for infusion contains

The active substance is calcium gluconate. Each vial contains 500 mg of calcium gluconate (equivalent to 475 mg of monohydrate calcium gluconate and 18 mg of tetrahydrate calcium saccharate). Each litre of solution contains 446 mEq of calcium.
The other components (excipients) are water for injections and tetrahydrate calcium saccharate.

What CALCIO GLUCONATO MONICO 1000 mg/10 ml solution for
infusion contains

The active substance is calcium gluconate. Each vial contains 1000 mg of calcium gluconate (equivalent to 950 mg of monohydrate calcium gluconate and 36 mg of tetrahydrate calcium saccharate). Each litre of solution contains 446 mEq of calcium.
The other components (excipients) are water for injections and tetrahydrate calcium saccharate.

Description of the appearance of CALCIO GLUCONATO MONICO and contents of the
pack

CALCIO GLUCONATO MONICO 500 mg/5 ml solution for infusion: carton containing 5 glass vials of 5 ml.
CALCIO GLUCONATO MONICO 1000 mg/10 ml solution for infusion: carton containing 5 or 10 glass vials of 10 ml.

Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy.