Package leaflet: Information for the user

iladiamed, (1 mg + 10 mg)/g, gel
Octenidini dihydrochloridum + Phenoxyethanolum
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if you feel worse during the first 7 days of using the medicine, you should consult your doctor.

Table of contents of the leaflet

What iladiamed is and what it is used for
Important information before using iladiamed
How to use iladiamed
Possible side effects
How to store iladiamed
Contents of the pack and other information

1. What iladiamed is and what it is used for

iladiamed contains the active substances: octenidine dihydrochloride and phenoxyethanol. Octenidine dihydrochloride acts on the surface of the skin. Phenoxyethanol complements the activity of octenidine dihydrochloride by penetrating into deeper layers of the skin and mucous membranes.
iladiamed has antiseptic and local anaesthetic effects. It is bactericidal, fungicidal and virucidal.
It is effective against bacteria (including Chlamydium and Mycoplasma), fungi, yeasts (e.g. Candida albicans), protozoa (e.g. Trichomonas sp.), lipophilic viruses (e.g. herpes simplex virus), and also inactivates hepatitis B virus (HBV) and HIV.
The efficacy of the medicine in destroying microorganisms or inactivating viruses occurs within 1 minute after application. The effect lasts for up to 1 hour, thereby ensuring safety during diagnostic, therapeutic or surgical procedures.

iladiamed is indicated for use:

in the genital area, e.g. in inflammatory conditions of the vagina or in inflammatory conditions of the glans penis in men;
for repeated, 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 prior to urinary bladder catheterization.

The medicine is intended for use in adults and adolescents.

2. Important information before using iladiamed

When not to use iladiamed:

if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6),
do not introduce iladiamed into the abdominal cavity or into the ear (onto the eardrum).

Warnings and precautions
Before starting to use iladiamed, discuss it with your doctor or pharmacist.
iladiamed must not be swallowed or allowed to enter the bloodstream, e.g.
as a result of accidental injection.
Caution! To avoid tissue damage and local swelling, iladiamed must not be
administered via syringe into deep tissues. The medicine is intended exclusively for
external use on skin and mucous membranes.

Excess product should be removed, and care should be taken to ensure that the gel does not remain on the skin longer than necessary (this also applies to materials impregnated with the solution that are in direct contact with the patient).
Do not use the medicine in the eye. If contact with the eyes occurs, rinse immediately with a large amount of water.

The use of iladiamed after episiotomy (perineal incision) should be discussed with a gynecologist.
iladiamed with other medicines
Tell your doctor or pharmacist if you are currently using, have recently used, or plan to use any other medicines.

iladiamed should not be used simultaneously with antiseptics based on PVP-iodine (iodine-povidone complex) on adjacent areas of the body, as this may lead to strong brown or violet skin discolorations.
Avoid contact between iladiamed and soap or detergents (e.g. washing, cleaning, or bathing agents), as insoluble residues may form. This could lead to reduced or neutralized effectiveness of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There are no clinical data on the safety of using iladiamed during pregnancy and breastfeeding.
Driving and using machines
No studies have been conducted on the effects of iladiamed on the ability to drive or operate machinery.
iladiamed contains ethanol
This medicine contains 47.6 mg of alcohol (ethanol) in each gram of gel.
iladiamed may cause a burning sensation on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use iladiamed

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be applied to the affected area at least once daily, ensuring even coverage of the entire treatment site.

Vaginal mucosa antiseptic
Apply the medicine to the vaginal mucosa surface using the provided applicator/cannula, preferably while lying down with knees slightly bent.

Instructions for using the applicator
Use only a clean applicator. After each use, the applicator should be washed.
After unscrewing the cap, screw the applicator onto the gel tube.
Gently squeeze the tube from the bottom to fill the applicator.
Remove the applicator from the tube, and tightly close the tube cap.
Empty the applicator completely at the application site by pressing the plunger.

Instructions for using the cannula
Use only a clean cannula. After each use, the cannula should be washed.
After unscrewing the cap, screw the cannula onto the gel tube.
Gently squeeze the tube from the bottom and apply at the application site.
Ensure contact between the medicine and the mucosa for at least 1 minute.
On the first day of treatment, apply the medicine in the morning and evening. Then, for the following 6 days, once daily in the evening before going to bed.
If there is no improvement after 7 days, or if the patient feels worse within 7 days of starting treatment, consult a gynecologist.

Antiseptic for male glans penis
Apply the medicine to the mucosal surface of the glans penis, ensuring contact with the mucosa for at least 1 minute. The medicine may also be applied using a sterile gauze or swab. On the first day of treatment, apply the medicine in the morning and evening. Then, for the following 6 days, once daily.
If there is no improvement after 7 days, or if the patient feels worse within 7 days of starting treatment, consult a doctor.

Skin and mucous membrane disinfection
Areas of skin and mucous membranes to be disinfected should be thoroughly and evenly covered with a small amount of the medicine. The medicine may also be applied using sterile gauze or a swab. After application, wait at least 1 minute; prolonging the contact time up to 5 minutes is recommended.

iladiamed is intended for external use on skin and mucous membranes.
iladiamed contains the excipient poloxamer 407, which has thermoreversible properties and determines the formulation of the medicine. Below 20°C, it becomes liquid, and upon application to the skin, it forms a gel.

Use of a higher than recommended dose of iladiamed
Overdose of iladiamed following topical application is highly unlikely.
If a larger than recommended dose of iladiamed is used or if the medicine is ingested, contact a doctor immediately.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Rarely (may occur in less than 1 in 1,000 people):

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

Very rarely (may occur in less than 1 in 10,000 people):

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

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

following irrigation of deep wounds using a syringe, cases of persistent swelling, erythema and tissue necrosis have been reported, in some cases requiring surgical intervention (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store iladiamed

Store below 25°C. Do not store in the refrigerator or freeze.
Keep the medicine 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 indicated.
Shelf life after first opening the tube: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What iladiamed contains

The active substances in this medicinal product 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 colourless gel.
The medicinal product is packaged in an aluminium tube with a cap made of polyethylene (HDPE) and a cannula made of polyethylene (LDPE) with a plug made of polyethylene (LDPE) or an applicator made of polyethylene (LDPE, HDPE), packed in a cardboard box.
The pack contains 30 g of gel.

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