Hydrex s
Poland
Table of Contents
Package leaflet: Information for the user
HYDREX S, 4% skin solution
Chlorhexidini digluconatis solutio
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You must always use this medicine exactly as described in this patient information leaflet or as your doctor, pharmacist, or nurse has advised.
- Keep this leaflet. You may need to read it again.
- If you need advice or further information, please contact your pharmacist.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
- If your symptoms persist or worsen, consult your doctor.
Leaflet contents:
- What Hydrex S is and what it is used for
- Important information before using Hydrex S
- How to use Hydrex S
- Possible side effects
- How to store Hydrex S
- Contents of the pack and other information
1. What Hydrex S is and what it is used for
Hydrex S is intended for topical use on the skin only.
The medicine contains the active substance chlorhexidine digluconate, which acts against a wide range of Gram-positive and Gram-negative bacteria, as well as some viruses and fungi.
Indications
For use as an antiseptic agent for handwashing, for hand disinfection prior to surgery, and for skin disinfection prior to surgery.
2. Important information before using Hydrex S
When not to use Hydrex S
- if the patient is allergic (hypersensitive) to chlorhexidine or any of the other ingredients of this medicine (listed in section 6).
- for disinfection of body cavities.
Warnings and precautions
Before starting to use Hydrex S, discuss this with your doctor, pharmacist, or nurse.
This medicine is intended for external use on the skin only.
Hydrex S must not come into contact with brain tissue or meninges.
Protect the ears from the medicine. Contact with the middle ear may lead to hearing loss.
Exercise caution when washing the head with this medicine.
In case of contact with mucous membranes, rinse immediately with large amounts of water.
Use with caution in newborns, especially premature infants. Hydrex S may cause chemical skin burns.
Avoid contact of Hydrex S with the eyes due to the risk of vision damage. In case of contact with the eyes, immediately and thoroughly rinse with water. If irritation, redness, eye pain or visual disturbances occur, contact a doctor immediately.
After accidental contact with the eyes during surgical procedures, severe cases of permanent corneal damage (surface damage to the eye) have been reported in patients under general anaesthesia (in deep, painless sleep) following use of medicinal products containing chlorhexidine digluconate, which may necessitate corneal transplantation.
Hydrex S and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Do not use together with products containing anionic surfactants, which may cause deactivation of the active substance of the medicine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
The effect of Hydrex S on the ability to drive and operate machinery is unknown.
Important information about certain ingredients of Hydrex S
This medicine may cause allergic reactions due to hypersensitivity to chlorhexidine digluconate, dialkylamine oxide, or carmine red.
This medicine contains denatured ethyl alcohol (ethanol).
Each dose of this medicine contains between 0.15 mg and 0.75 mg of ethyl alcohol (ethanol), equivalent to 0.03 mg/mL. It may cause a burning sensation on damaged skin.
In newborns (premature and full-term infants), high concentrations of ethanol may cause severe local and systemic toxicity due to significant absorption through immature skin.
This medicine contains fragrance components including linalool, citral, cinnamaldehyde, coumarin, D-limonene, geraniol, amyl cinnamaldehyde, which may cause allergic reactions.
3. How to use Hydrex S
This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Instructions for use
For external use only – for topical application to the skin.
As an antiseptic hand wash:
Wet the 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 surgical hand disinfection:
Wet the hands and forearms with water, then apply 5 ml of the medicine and rub into the skin for 1 minute, cleaning under the nails with a hand brush. Rinse hands and forearms with water, then reapply 5 ml of the medicine and rub into the skin for 2 minutes. Thoroughly rinse hands and forearms with water and dry.
For skin disinfection prior to surgery:
After bathing on the day before the procedure, wash the entire body's slightly moistened skin with 25 ml of the medicine. Pay particular attention to the area around the navel, armpits, groin, and perineum. Then rinse the whole body thoroughly with water and dry with a clean towel.
Repeat this procedure on the day of surgery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Use of a higher than recommended dose of Hydrex S
Chlorhexidine poorly penetrates from the skin surface into the body.
In case of accidental ingestion, contact a doctor immediately. The doctor will perform gastric lavage and provide symptomatic treatment appropriate to the patient's clinical condition.
4. Possible adverse reactions
Like all medicines, Hydrex S can cause adverse reactions, although not everybody will experience them.
Frequency unknown (cannot be estimated from available data): chemical burns in newborns, corneal damage (damage to the surface of the eye), and permanent eye damage, including permanent visual impairment (following accidental eye exposure during surgical procedures on the head, face, and neck) in patients under general anaesthesia (deep, painless sleep) – after administration of medicinal products containing chlorhexidine digluconate.
The medicine may cause allergic reactions due to hypersensitivity to chlorhexidine digluconate, carmine, or alkylamine oxides, particularly after repeated use.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Hydrex S
Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Other information
What Hydrex S contains
Active substance:
3.876 g of chlorhexidine digluconate, solution ( Chlorhexidini digluconatis solutio) in 100 g of skin liquid
Excipients:
glycerol, dialkylamino oxide, denatured ethyl alcohol with methyl alcohol, hydroxyethylcellulose, Hibitone Fragrance Mod 257858 fragrance, carmine red (E 124), purified water.
What Hydrex S looks like and contents of the pack
Hydrex S is a skin liquid.
Packaging:
Bottles containing 250 ml or 500 ml of skin liquid, or a canister containing 5000 ml of skin liquid.
Marketing Authorisation Holder
Ecolab Sp. z o.o.
Opolska Street 114
31-323 Kraków
Poland
+48 12 2616100
Importer:
Ecolab Deutschland GmbH
Ecolab-Allee 1
40789 Monheim am Rhein
Germany