Sodium edetate monico

Patient Information Leaflet

monic edetate sodium

500 mg/5 ml concentrate for solution for infusion
2 g/10 ml concentrate for solution for infusion
edetate sodium
Generic medicine
Please read all of this leaflet carefully before you start 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 or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What monic edetate sodium is and what it is used for
2. What you need to know before you use monic edetate sodium
3. How to use monic edetate sodium
4. Possible side effects
5. How to store monic edetate sodium
6. Contents of the pack and other information

1. What is monobasic sodium edetate and what is it used for

Monobasic sodium edetate is a medicine that works by binding metals and facilitating their elimination through urine. This medicine is used for the emergency treatment of elevated calcium levels in the blood (hypercalcaemia).

2. What you need to know before using monosodium edetate

Do not use monosodium edetate:

• if you are allergic to edetate sodium or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to substances chemically similar to edetate sodium;
• if your kidneys do not function properly (renal insufficiency);
• if you are pregnant (first trimester) or during breastfeeding;
• if you are elderly and have thickened arteries with loss of elasticity (generalized atherosclerosis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using monosodium edetate.
This medicine should be administered to you with caution if you have any of the following conditions:

• if you suffer from low potassium levels in the blood (hypokalaemia);
• if you have tuberculosis;
• if your heart function is impaired (reduced cardiac function);
• if you have diabetes mellitus;
• if you have previously experienced seizures;
• if you are diabetic, because edetate sodium lowers blood glucose and reduces insulin requirements;
• if you have muscle cramps, tremors, and involuntary muscle contractions (tetany);
• if you are taking digitalis-containing medicines, as the effects of digitalis may be reduced.

During treatment, your heart and kidney function, as well as blood electrolyte levels (plasma electrolyte concentrations), particularly calcium, will be closely monitored. In addition, you will need to have a daily urine analysis.
If treatment is prolonged, monitor your blood magnesium levels, as they may decrease (hypomagnesaemia).
Do not confuse edetate sodium with calcium disodium edetate. Avoid using the abbreviations “EDTA” or “edetate” when prescribing or dispensing the medicine to prevent confusion.

Other medicines and monosodium edetate
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Monosodium edetate must not be administered during the first trimester of pregnancy.
This medicine should be administered with caution during the second and third trimesters of pregnancy, and only under direct medical supervision, with careful assessment of the risk-benefit ratio.
This medicine must not be administered during breastfeeding.

Driving and using machines
No data are available to determine the effect of this medicine on the ability to drive vehicles or operate machinery.

Monosodium edetate contains sodium
This medicine contains 3.94 mmol (or 90.50 mg) of sodium per 500 mg/5 ml dose; it contains 15.75 mmol (or 362.02 mg) of sodium per 2 g/10 ml dose. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How to use monosodium edetate

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or nurse.
This medicine will be administered to you in a hospital or other specialized center by a doctor or nurse. This medicine must be diluted before administration and injected slowly and carefully into a vein, as it may irritate tissues. The solution must not leak outside the vein.
Your doctor will adjust the dose based on body weight.
The recommended dose for the treatment of hypercalcemia is 50 mg/kg per day, up to a maximum of 3 g per day.
This dose should be administered for five consecutive days, followed by two days without treatment. The cycle should be repeated two more times.

Use in children
The recommended dose for the treatment of hypercalcemia is 40 mg/kg per day.
This dose should be administered for five consecutive days, followed by two days without treatment. The cycle should be repeated two more times.

If you use more monosodium edetate than you should
This medicine will be administered by trained medical personnel, so overdose is unlikely.
However, if you are given an excessive amount of this medicine (overdose), symptoms may include involuntary muscle contractions (tetany), seizures, and absence of heartbeat (cardiac arrest), as well as kidney toxicity (nephrotoxicity).
If you are concerned that you may have accidentally received a higher-than-recommended dose of monosodium edetate, inform your doctor or nurse immediately or go to the nearest hospital.
If you have any doubts about how to use monosodium edetate, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Not known (frequency of side effects cannot be determined from the available data)

• cardiac arrest;
• increased uric acid in the blood (hyperuricemia);
• severe headache;
• slight drop in blood pressure (hypotension) during administration and for a few hours afterwards;
• nausea, vomiting and diarrhoea, abdominal pain;
• skin inflammation (dermatitis) localized around the nose and corners of the mouth, on the chin, forehead, oral mucosa and testicles, skin rashes;
• kidney damage following prolonged treatment;
• fever.

Too rapid intravenous administration or use of overly concentrated solutions may cause a burning sensation at the injection site, reduced calcium levels in the blood (hypocalcemia), muscle cramps, tremors and involuntary muscle contractions (tetany), seizures, respiratory blockage (respiratory arrest), and changes in heart rhythm (cardiac arrhythmias).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store monosodium edetate

Keep this medicine out of the sight and reach of children.
Warning: 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.
The expiry date applies to the product in its original, undamaged packaging,
correctly stored.
Storage conditions: store in the original packaging to protect the
medicine from light.
Do not dispose of any medicine 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 sodium edetate monic 500 mg/5 ml concentrate for solution for infusion contains

• The active substance is disodium edetate. Each vial contains 0.5 g of disodium edetate.
• The other components are sodium hydroxide and water for injections.

What sodium edetate monic 2 g/10 ml concentrate for solution for infusion contains

• The active substance is disodium edetate. Each vial contains 2 g of disodium edetate.
• The other components are sodium hydroxide and water for injections.

Description of the appearance of sodium edetate monic and contents of the pack
Sodium edetate monic 500 mg/5 ml concentrate for solution for infusion: pack containing 5 glass vials of 5 ml each.
Sodium edetate monic 2 g/10 ml concentrate for solution for infusion: pack containing 5 glass vials of 10 ml each.
Marketing Authorisation Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended for healthcare professionals only

Posology and method of administration
In the treatment of hypercalcaemia, the usual dose in adults is 50 mg/kg/day up to a maximum of 3 g/day; the usual dose in children is 40 mg/kg/day.
This dose is administered for 5 consecutive days followed by 2 days without administration. The cycle is repeated two more times.
Administration is performed after dilution (1 g in 100 ml of 5% glucose solution or in physiological saline). The dose calculated according to body weight must be diluted in 500 ml of physiological saline or 5% glucose solution and administered by slow intravenous infusion (2–4 hours). The infusion rate should be reduced if signs of muscular reactivity occur; the infusion must be stopped in case of tetany and may be resumed only after contractions have ceased and if plasma calcium concentrations indicate the need for further treatment.
The solution must be clear, colourless and free from visible particles. The vial must be used for a single, uninterrupted administration and any residual solution must not be used.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Special precautions for disposal and handling
Edetate sodium must be stored in warehouses or storage areas separate from calcium disodium edetate to reduce the risk of confusion between the two medicinal products.
Unused medicine and waste materials resulting from this medicinal product must be disposed of in accordance with local regulations.