Hidrex S

Patient Information Leaflet: User Information

HYDREX S, 4%, skin solution

Chlorhexidine digluconate solution
Read this leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription. However, to achieve the best treatment result, the medicine Hydrex S should be used carefully.

• This leaflet should be kept in case it needs to be read again.
• The pharmacist should be consulted if advice or additional information is needed.
• If symptoms worsen or do not improve, a doctor should be contacted. If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor or pharmacist should be informed.

Table of Contents of the Leaflet:

• 1. What is Hydrex S and what is it used for
• 2. Important information before using Hydrex S
• 3. How to use Hydrex S
• 4. Possible side effects
• 5. How to store Hydrex S
• 6. Other information

1. What is Hydrex S and what is it used for

Hydrex S is intended for use on the skin only.
The medicine contains the active substance chlorhexidine digluconate, which acts on many Gram-positive and Gram-negative bacteria and some viruses and fungi.
Indications
For use as an antiseptic hand wash, for skin disinfection of hands before surgery, and for skin disinfection before surgery.

2. Important information before using Hydrex S

When not to use Hydrex S

• for disinfecting body cavities.

When to exercise special caution when using Hydrex S

The medicine is intended for use on the skin only.
Hydrex S must not come into contact with brain tissue and meninges.
Ears should be protected from the medicine. Contact of the medicine with the middle ear can cause hearing loss.
Caution should be exercised when rinsing the head with the medicine.
If the medicine comes into contact with mucous membranes, they should be rinsed immediately with a large amount of water.
Hydrex S should not come into contact with the eyes due to the risk of eye damage. If contact with the eyes occurs, they should be rinsed immediately and thoroughly with water. If irritation, redness, or eye pain occurs or vision is impaired, a doctor should be contacted immediately.
After using medicines containing chlorhexidine digluconate, severe cases of permanent corneal damage (eye surface damage) have been reported in patients under general anesthesia (deep, painless sleep) due to accidental contact with the eyes during surgical procedures, which may require corneal transplantation.

Using other medicines

The doctor or pharmacist should be informed about all medicines currently being used or recently used, including those available without a prescription.
There is no data on interactions with other medicines.

Pregnancy and breastfeeding

A doctor or pharmacist should be consulted before using any medicine.

Driving and operating machinery

The effect of Hydrex S on the ability to drive and operate machinery is not known.

Important information about some ingredients of Hydrex S

The medicine may cause allergic reactions due to hypersensitivity to chlorhexidine digluconate, dialkylamine oxide, or koschenillo red.
The medicine contains ethanol denatured with methanol.

3. How to use Hydrex S

The medicine should be used as directed by the doctor. In case of doubts, a doctor should be consulted.

Method of use

For external use only - for local application on the skin.

As an antiseptic for hand washing:

Wet hands and forearms with water, then apply 5 ml of the medicine and rub into the skin for 1 minute. Rinse hands and forearms thoroughly with water, then dry.
For skin disinfection of hands before surgery:
Wet hands and forearms with water, then apply 5 ml of the medicine and rub into the skin for 1 minute, and clean the nails with a nail brush. Then rinse hands and forearms with water, reapply 5 ml of the medicine, and rub into the skin for 2 minutes. Rinse hands and forearms thoroughly with water and dry.
For skin disinfection before surgery:
After bathing on the day before the procedure, lightly moisten the skin of the entire body and rinse with 25 ml of the medicine.
Particular attention should be paid to the areas around the navel, armpits, groin, and perineum. Then rinse the entire body thoroughly with water and dry with a clean towel.
The procedure should be repeated on the day of surgery.
In case of doubts about using the medicine, a doctor or pharmacist should be consulted.

Using a higher dose of Hydrex S than recommended

Chlorhexidine is poorly absorbed from the skin surface into the body.
If the medicine is swallowed, a doctor should be contacted immediately. The doctor will perform gastric lavage and symptomatic treatment, as appropriate for the patient's condition.

4. Possible side effects

Like all medicines, Hydrex S can cause side effects, although they may not occur in everyone.
Frequency not known (cannot be determined from available data): corneal damage (eye surface damage) and permanent eye damage, including permanent vision impairment (after accidental exposure of the eye during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep) - after using medicines containing chlorhexidine digluconate.
The medicine may cause allergic reactions due to hypersensitivity to chlorhexidine digluconate, koschenillo red, or dialkylamine oxide, especially after repeated use.

Reporting side effects

If any side effects occur, including any side effects not mentioned in this leaflet, the doctor, pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hydrex S

Store in a place out of sight and reach of children.
Store at a temperature below 25°C.
Shelf life: 3 years.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Other information

What Hydrex S contains

Active substance:
100 g of skin solution contains 3.876 g of chlorhexidine digluconate, solution, (Chlorhexidini digluconatis solutio)
Excipients:
glycerol, dialkylamine oxide, denatured ethanol, hydroxyethyl cellulose, fragrance, koschenillo red (E 124), purified water.

What Hydrex S looks like and what the pack contains

Hydrex S is a skin solution.
Packaging:
Bottles containing 250 ml or 500 ml of skin solution, or a canister containing 5000 ml of skin solution.

Marketing authorization holder

Ecolab Sp. z o.o. ul. Opolska 114

31-323 Kraków

Poland +48 12 2616100

Importer:

Ecolab Deutschland GmbH

Ecolab-Allee 1

40789 Monheim am Rhein

Germany

Date of approval of the leaflet: