SODIUM INDIGOTINDISULFONATE MONICO

Package leaflet: Information for the user

SODIUM INDIGOTINDISULFONATE MONICO 40 mg/10 ml solution for injection

Sodium indigotindisulfonate
Equivalent 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What SODIO INDIGOTINDISOLFONATO MONICO is and what it is used for

SODIO INDIGOTINDISOLFONATO MONICO contains the active substance sodium indigotindisulfonate, which
belongs to the pharmaceutical class of diagnostic agents.
This medicine is a blue dye used to assess kidney function. Under normal conditions, it appears rapidly in the urine; therefore, kidney function is evaluated by measuring the time taken for the dye to appear in the urine.

2. What you need to know before using SODIO INDIGOTINDISOLFONATO MONICO

Do not use SODIO INDIGOTINDISOLFONATO MONICO

• if you are allergic to indigo carmine sodium salt, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or nurse before being administered SODIO INDIGOTINDISOLFONATO MONICO.
This medicine can only be used in appropriate medical facilities (hospitals, clinics, and care homes) and must be administered by specialized healthcare personnel.
Use of this medicine may occasionally cause allergic reactions with a slight increase in blood pressure.
The solution must not be diluted prior to administration, nor injected through infusion devices already in use with other solutions, to avoid precipitation of indigo carmine sodium salt.

Children and elderly:
In children and elderly patients (over 65 years of age), this medicine should be administered only when strictly necessary.

Other medicines and SODIO INDIGOTINDISOLFONATO MONICO
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No interactions with other medicines are currently known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.
If you are pregnant, this medicine will be administered only if clearly necessary.

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

3. How to use SODIO INDIGOTINDISOLFONATO MONICO

This medicine will be administered to you by a doctor or other healthcare professional. If you have any doubts, consult your doctor or nurse.
The recommended dose in adults is 40–80 mg administered intravenously (into a vein). Intramuscular injection (into the muscle) is only rarely used, as it requires higher doses.
Use in children and elderly
The recommended dose will be adjusted according to body weight.
If you use more SODIO INDIGOTINDISOLFONATO MONICO than you should
This medicine will be administered by trained medical personnel; therefore, overdose is unlikely. No cases of overdose have been reported.

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)

• rash, itching;
• difficulty in breathing (bronchoconstriction);
• reduced heart rate (bradycardia);
• nausea, vomiting;
• skin discoloration;
• increased blood pressure (hypertension).

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

5. How to store SODIO INDIGOTINDISOLFONATO MONICO

Keep this medicine out of the sight and reach 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 to protect the medicine from light.
The medicine should be used immediately after opening the vial. The solution should be deep blue in colour and free from visible particles.
The contents of one vial are intended for a single, uninterrupted administration; any remaining residue must not be reused.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What SODIO INDIGOTINDISOLFONATO MONICO contains

• The active substance is sodium indigotindisulfonate. Each vial contains 40 mg of sodium indigotindisulfonate.
• The other components (excipients) are: sucrose 1 g, water for injections up to 10 ml.

Description of the appearance of SODIO INDIGOTINDISOLFONATO MONICO and contents of the pack
Pack containing 5 vials of 10 ml of injectable solution.
Marketing Authorization Holder and Manufacturer
MONICO SPA - Via Ponte di Pietra 7 - VENEZIA/MESTRE – Italy