iladiamed

Package Leaflet: Information for the Patient

iladiamed, (1 mg + 10 mg)/g, gel
Octenidine dihydrochloride + Phenoxyethanol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse within 7 days of starting to use the medicine, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is iladiamed and what is it used for
• 2. Important information before using iladiamed
• 3. How to use iladiamed
• 4. Possible side effects
• 5. How to store iladiamed
• 6. Contents of the pack and other information

1. What is iladiamed and what is it used for

iladiamed contains the active substances: octenidine dihydrochloride and phenoxyethanol. Octenidine dihydrochloride acts on the skin surface. Phenoxyethanol complements the action of octenidine dihydrochloride, penetrating deeper into the skin and mucous membranes.
The iladiamed medicine has disinfecting and anesthetizing effects. It acts bactericidally, fungicidally, and virucidally.
It is effective against bacteria (including Chlamydiaand Mycoplasma), fungi, yeasts (e.g., Candida albicans), protozoa (e.g., Trichomonas sp.), lipophilic viruses (e.g., Herpes simplexvirus), and also inactivates hepatitis B virus (HBV) and HIV.
The effectiveness of the medicine in destroying microorganisms or inactivating viruses occurs after just 1 minute of application. The action of the medicine lasts for 1 hour, thus ensuring safety during diagnostic, therapeutic, or surgical procedures.
iladiamed is indicated for use:

• in the genital area, e.g., in cases of vaginal inflammation, as well as in cases of inflammation of the glans penis in men;
• for multiple, short-term antiseptic treatment of mucous membranes and adjacent tissues before and after diagnostic procedures in the genital and anal areas, including the vagina, vulva, and glans penis, as well as before catheterization of the urinary bladder.

The medicine is intended for use in adults and adolescents.

2. Important information before using iladiamed

When not to use iladiamed:

• the medicine must not be introduced into the abdominal cavity or the interior of the ear (onto the eardrum).

Warnings and precautions

Before starting to use iladiamed, the patient should discuss it with their doctor or pharmacist.

Warning! To avoid tissue damage and local swelling, iladiamed must not be administered using a syringe into deep tissues. The medicine is intended for external use on the skin and mucous membranes only.

• Any excess medicine should be removed and it should be ensured that the gel does not remain on the skin longer than necessary (this also applies to materials soaked in the solution that come into direct contact with the patient).
• The medicine must not be used in the eye. If the medicine comes into contact with the eyes, they should be rinsed immediately with a large amount of water.

The use of iladiamed after an episiotomy (perineal incision) should be consulted with a gynecologist.

iladiamed and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• The medicine must not come into contact with soap and detergents (e.g., washing, cleaning, or washing agents), as insoluble residues may form. This may lead to a weakening or loss of the medicine's effect.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effect of iladiamed on the ability to drive and use machines.

iladiamed contains ethanol

This medicine contains 47.6 mg of alcohol (ethanol) per gram of gel.

3. How to use iladiamed

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Mucous membrane antiseptics of the vagina

The medicine should be applied to the surface of the vaginal mucous membrane using the enclosed applicator/cannula, preferably in a lying position with slightly bent legs.

Applicator usage instructions

Only a clean applicator should be used. The applicator should be washed after each use.

Cannula usage instructions

Only a clean cannula should be used. The cannula should be washed after each use.

Antiseptics of the glans penis in men

The medicine should be applied to the surface of the glans penis mucous membrane, ensuring the medicine comes into contact with the mucous membrane for at least 1 minute. The medicine can also be applied using a sterile swab or dressing. On the first day of treatment, apply the medicine in the morning and evening. Then, for the next 6 days, apply once a day.

Disinfection of skin and mucous membranes

Areas of skin and mucous membranes to be disinfected should be thoroughly and evenly covered with a small amount of the medicine. The medicine can also be applied using a sterile swab or dressing. After applying the medicine, wait for at least 1 minute; it is recommended to extend the exposure time to 5 minutes.

Using a larger than recommended dose of iladiamed

Overdose of iladiamed after local application is very unlikely.

4. Possible side effects

Like all medicines, iladiamed can cause side effects, although not everybody gets them.
Rarely(may affect up to 1 in 1000 people):

• after vaginal disinfection, a feeling of heat or burning may occur;
• a burning sensation, redness, itching, feeling of heat.

Very rarely(may affect up to 1 in 10,000 people):

• contact allergic reactions, e.g., transient redness at the application site.

Frequency not known(cannot be estimated from the available data):

• after flushing deep wounds with a syringe, cases of persistent swelling, redness, and tissue necrosis have been reported, sometimes requiring surgical intervention (see section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store iladiamed

Store in a temperature below 25°C. Do not store in a refrigerator or freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the month stated.
Shelf life after first opening the tube: 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What iladiamed contains

• The active substances of the medicine are octenidine dihydrochloride and phenoxyethanol.
• 1 g of gel contains 1 mg of octenidine dihydrochloride and 10 mg of phenoxyethanol.
• The other ingredients are: poloxamer 407, glycerol 85%, ethanol 96%, purified water.

What iladiamed looks like and contents of the pack

iladiamed is a colorless gel.
The packaging of the medicine is: an aluminum tube with a polyethylene (HDPE) cap and a polyethylene (LDPE) cannula with a polyethylene (LDPE) plug, in a cardboard box.
The packaging contains 30 g of gel.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. +48 (42) 22-53-100

Date of last revision of the leaflet: