Peroxygel 3.0
Poland
Table of Contents
Package leaflet: Information for the patient
Peroxygel 3,0
30 mg/g, gel
Hydrogenii peroxidum
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.
- Keep this leaflet, so that you can read it again if necessary.
- If you need advice or further information, please consult a pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
- If there is no improvement or if you feel worse after using the medicine, consult your physician.
Table of contents of the leaflet:
- What Peroxygel 3,0 is and what it is used for
- Important information before using Peroxygel 3,0
- How to use Peroxygel 3,0
- Possible side effects
- How to store Peroxygel 3,0
- Contents of the pack and other information
1. What Peroxygel 3,0 is and what it is used for
Peroxygel 3,0 is hydrogen peroxide in gel form.
This formulation prevents the medicine from running off the application site by forming a gentle protective film on the surface, shielding the damaged skin.
The medicine contains hydrogen peroxide as the active substance at a concentration of 3%.
Hydrogen peroxide, under the influence of enzymes present in tissues and many bacteria, rapidly decomposes into water and reactive atomic oxygen. This reaction occurs quickly in the presence of blood, pus, and necrotic tissue. The released oxygen forms foam and removes microorganisms from the disinfected area, destroys blood cells flowing from the wound, and mechanically cleans the exposed skin cells from debris of damaged tissue. Oxygen also exerts antiseptic, bleaching, and bactericidal effects. Studies have confirmed that the gel exerts bactericidal action within 1 minute against Gram-positive bacteria (Staphylococcus aureus) and Gram-negative bacteria (Pseudomonas aeruginosa). Peroxygel 3,0 also has fungicidal activity against pathogenic yeasts, particularly Candida albicans, and other fungi, such as Cladosporium niger.
Peroxygel 3,0 is indicated for disinfection of wounds, abrasions, and scratches of the skin.
2. Important information before using the medicine Peroxygel 3.0
When not to use the medicine Peroxygel 3.0
- if the patient is allergic to the active substance (hydrogen peroxide) or any of the other ingredients of the medicine (listed in section 6);
- do not apply the gel on mucous membranes or around the eyes.
Warnings and precautions
Before starting to use this gel, consult your doctor or pharmacist.
The gel should be used on the skin only. If the gel comes into contact with mucous membranes or the eye area, rinse immediately with plenty of water.
Do not use the gel in case of deep and extensive skin injuries requiring immediate surgical treatment.
Children and adolescents
There are no available data on the use of this medicine in children and adolescents.
Peroxygel 3.0 and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
No interaction studies have been conducted. Do not apply this medicine on the same area of skin as other medicinal products.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
The medicine does not affect the ability to drive or operate machinery.
3. How to use Peroxygel 3.0
This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For topical application.
Apply 0.5–1 cm of gel directly to the wound, abrasion, or scratch. After drying, a delicate protective film forms over the damaged skin.
The medicine has thermoreversible properties. It is liquid at temperatures below 20°C and above 45°C. When applied to the skin (temperature ~36.6°C), it becomes a gel.
If the effect of the medicine seems too strong or too weak, consult a doctor.
Use in children and adolescents
Before using Peroxygel 3.0, consult a doctor or pharmacist.
Use of a larger than recommended dose of Peroxygel 3.0
There have been no reported cases of overdose with Peroxygel 3.0.
If more medicine is used than recommended, remove the excess gel.
Missed application of Peroxygel 3.0
Apply the next dose as scheduled. Do not apply a double dose to make up for a missed application.
Discontinuation of Peroxygel 3.0
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, Peroxygel 3.0 may cause adverse reactions, although not everyone experiences them.
A brief, transient burning sensation at the application site may occur. Allergic reactions may also occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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.: + 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 to provide more information on the safety of the medicine.
5. How to store Peroxygel 3.0
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Usable period after first opening of the tube – 1 year.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the packaging and other information
What Peroxygel 3.0 contains
- The active substance is hydrogen peroxide. 1 g of gel contains 30 mg of hydrogen peroxide.
- The other ingredients are: disodium edetate, poloxamer 407, ethanol 96%, concentrated phosphoric acid, purified water.
What Peroxygel 3.0 looks like and contents of the pack
Peroxygel 3.0 is a gel. The medicinal product is packed in an aluminium tube containing 10 g, 15 g or 20 g of gel, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
GEMIPHARMA sp. z o.o.
Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 ext. 70
e-mail: [email protected]