Iodi Gel 10%

Leaflet attached to the packaging: patient information

JODI GEL 10%, 100 mg/g, gel
Povidone iodine

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after a few days or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet:

• 1. What is 10% and what is it used for
• 2. Important information before using the 10% medicine
• 3. How to use 10%
• 4. Possible side effects
• 5. How to store 10%
• 6. Package contents and other information

1. What is 10% and what is it used for

10% contains povidone iodine as the active substance, which is a complex combination of iodine and povidone. When in contact with the skin or mucous membrane, the medicine undergoes slow decomposition, releasing free iodine. It exhibits a broad spectrum of antiseptic action, fighting and preventing infections of wounds, skin, and body cavities, including cuts. The gel effectively prevents inflammatory conditions of the vagina and oral infections. It acts on bacteria (especially staphylococci and Staphylococcus aureus) and fungi without causing resistance. The gel form provides prolonged action compared to liquid and prevents the medicine from flowing out of the application site.
Indications for use:
10% is intended for use as an antiseptic:

• for disinfecting wounds and skin before surgical procedures;
• for disinfecting infected wounds;
• in primary or secondary local skin infections;
• in infected surgical incisions;
• in vaginal inflammation;
• in oral infections. Povidone iodine can also be used for skin disinfection before inserting needles and catheters. The medicine is used in both hospital and outpatient settings, as well as at home.

2. Important information before using the 10% medicine

When not to use the 10% medicine

• if the patient has been diagnosed with hypersensitivity (allergy) to the active substance or any of the other ingredients of the medicine (listed in section 6);
• if the patient has thyroid disease;
• if the patient has Cushing's disease;
• on deep wounds or severe burns without consulting a doctor.

Warnings and precautions

Before starting to use this gel, it should be discussed with a doctor or pharmacist.
An increase in iodine levels in the blood may cause thyroid function disorders and other side effects (see section 4).

Children and adolescents

Use in children under 11 years of age only on the doctor's prescription.

10% and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.
The absorption of iodine from the medicine may have an adverse effect on thyroid function tests: thyroid scintigraphy, diagnosis using a radioactive iodine isotope, evaluation of PBI (protein-bound iodine).
Medicines containing mercury, silver, or hydrogen peroxide should not be used together with povidone iodine.
Povidone iodine may affect some tests for detecting blood or glucose in stool or urine, giving false-positive results.

Pregnancy and breastfeeding

Before using any medicine, a doctor or pharmacist should be consulted.
Do not use during pregnancy and breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive or operate machinery.

3. How to use 10%

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
The gel is for use on the skin and mucous membranes. The use of the medicine should be limited to small wound surfaces. For external use only. Apply to diseased areas, minor cuts, or small wound surfaces.

Children and adolescents

Use in children under 11 years of age only on the doctor's prescription.

Using a higher dose of the 10% medicine than recommended

No cases of overdose of this medicine have been reported.
In case of using a higher dose of the medicine than recommended, the excess gel should be removed.

Missing a dose of the 10% medicine

The next dose of the medicine should be taken. A double dose should not be used to make up for a missed dose.

Stopping the use of the 10% medicine

In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions may occur. Increased absorption of iodine through the skin as a result of prolonged use of the medicine on large skin surfaces may cause the development of goiter with symptoms of hyperthyroidism or hypothyroidism, as well as generalized symptoms such as metallic taste in the mouth, salivation, burning or tingling in the mouth, irritation or swelling of the lungs, diarrhea, metabolic acidosis, hypernatremia (increased sodium levels in the blood), kidney function disorders, skin swelling, acne-like rashes.
In newborns and infants, due to iodine absorption through the skin, metabolic acidosis, neutropenia, or hypothyroidism may occur.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store 10%

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
The medicine has thermoreversible properties. At a temperature of 20-45°C, it is in the form of a gel; below 20°C and above 45°C, it is a liquid.
Shelf life after first opening the packaging - 1 year.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Package contents and other information

What 10% contains

• The active substance of the medicine is povidone iodine. 100 g of gel contains 10 g of povidone iodine.
• Other ingredients are: poloxamer 407, sodium chloride, purified water.

What 10% looks like and what the packaging contains

10% is a dark brown gel with a characteristic odor.
1 aluminum tube of 10 ml gel in a cardboard box;
1 glass bottle with a dispenser of 1000 ml gel.

Responsible entity and manufacturer

GEMIPHARMA sp. z o.o.
ul. Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 w. 70
e-mail: [email protected]
Date of last update of the leaflet:03/2025