Help4skin Septi-sprai

Leaflet attached to the packaging: patient information

Help4Skin SEPTI-SPRAY, 1 mg/g + 20 mg/g, skin spray, solution

Octenidine dihydrochloride + Phenoxyethanol

Read the 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 patient leaflet or as advised by a doctor, pharmacist, or nurse.

• 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 inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Help4Skin SEPTI-SPRAY and what is it used for
• 2. Important information before using Help4Skin SEPTI-SPRAY
• 3. How to use Help4Skin SEPTI-SPRAY
• 4. Possible side effects
• 5. How to store Help4Skin SEPTI-SPRAY
• 6. Package contents and other information

1. What is Help4Skin SEPTI-SPRAY and what is it used for

Help4Skin SEPTI-SPRAY is an antiseptic solution (disinfectant) for topical use.
It is used for repeated, short-term antiseptic treatment to destroy bacteria and fungi in the area of mucous membranes and adjacent tissues before surgical procedures in the genital and anal areas, as well as before catheterization of the urinary bladder.
Help4Skin SEPTI-SPRAY is used for repeated, short-term antiseptic treatment of wounds.
Help4Skin SEPTI-SPRAY should not be used for more than 14 days.

Use without a doctor's recommendation

Help4Skin SEPTI-SPRAY can be used without prior consultation with a doctor for disinfecting superficial wounds in adults, adolescents, and children (such as abrasions, scratches, minor cuts, burns, and insect bites).

Use according to a doctor's recommendations

Repeated, short-term antiseptic treatment of burns and larger wounds, antiseptic rinsing of the vagina and cervix, disinfection of the glans penis.

Use by a doctor

Antiseptic treatment in the area of mucous membranes and adjacent skin areas before diagnostic or surgical procedures in the genital and anal areas, as well as before catheterization of the urinary bladder, and repeated, short-term antiseptic treatment of wounds.

2. Important information before using Help4Skin SEPTI-SPRAY

When not to use Help4Skin SEPTI-SPRAY:

• Help4Skin SEPTI-SPRAY should not be applied directly to the eyes.

Use by doctors:

• Help4Skin SEPTI-SPRAY should not be used during surgical procedures for rinsing the abdominal cavity or urinary bladder.
• Help4Skin SEPTI-SPRAY should not be applied to the eardrum.

Warnings and precautions

Before starting to use Help4Skin SEPTI-SPRAY, the patient should discuss it with their doctor or pharmacist.
The patient should avoid getting Help4Skin SEPTI-SPRAY into the bloodstream, e.g., as a result of accidental injection.
The patient should not inhale the medicine while it is being sprayed.
To avoid tissue damage, the medicine should not be applied to tissue under pressure. The patient should ensure proper drainage of the solution from the wound (e.g., using an appropriate elastic drainage). Help4Skin SEPTI-SPRAY is intended for topical use only.
The patient should not apply the medicine to the eye. If the medicine accidentally comes into contact with the eyes, they should be rinsed immediately with a large amount of water.
Help4Skin SEPTI-SPRAY can be used with an occlusive dressing.
Contact between the medicine and other cleansing and washing agents may negatively affect its effectiveness.

Children and adolescents

Help4Skin SEPTI-SPRAY can be used in children and adolescents.
Help4Skin SEPTI-SPRAY should be used with caution in newborns, especially premature babies. Help4Skin SEPTI-SPRAY may cause severe skin changes. The patient should remove any excess medicine and ensure that the solution does not remain on the skin longer than necessary (this also applies to materials soaked with the solution that come into direct contact with the patient's body).

Help4Skin SEPTI-SPRAY 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, including those available without a prescription.
Help4Skin SEPTI-SPRAY should not be used on adjacent skin areas simultaneously with antiseptic agents (disinfectants) based on a povidone-iodine complex, as intense brown to purple discoloration of the skin may occur in the border areas.

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.
Pregnancy
Current experience with the use of Help4Skin SEPTI-SPRAY in pregnant women does not indicate any harmful effects. As a precaution, Help4Skin SEPTI-SPRAY should not be used during the first three months of pregnancy. From the fourth month of pregnancy, the medicine can be used if necessary.
Breastfeeding
There is no data on the use of Help4Skin SEPTI-SPRAY during breastfeeding.
Help4Skin SEPTI-SPRAY should not be used on the breast in breastfeeding women.

Driving and using machines

Help4Skin SEPTI-SPRAY has no effect on the ability to drive and use machines.

3. How to use Help4Skin SEPTI-SPRAY

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
It is recommended to use Help4Skin SEPTI-SPRAY undiluted. The patient should use Help4Skin SEPTI-SPRAY immediately after injury or when the first signs of inflammation appear to achieve the best treatment result.
Unless otherwise advised by a doctor, for the treatment of wounds and injuries, Help4Skin SEPTI-SPRAY should be applied to the affected area once a day for a maximum of 14 days.
Help4Skin SEPTI-SPRAY should be applied by repeatedly pressing the mechanical spray head so that the entire treated area is thoroughly moistened.
Usually, in the case of minor injuries, it is not necessary to cover them with a dressing or plaster. However, to prevent further infection of the wound, it is recommended to secure the wound with a bandage.
The patient should remember that the full effect of the medicine will only be visible after 1-2 minutes of application, so they should wait this time before performing any other procedures.
The maximum effect of Help4Skin SEPTI-SPRAY occurs within 2 hours of its application.
If the wound does not heal properly, signs of inflammation (redness, burning, swelling at the application site) or other complications occur during healing, the patient should consult their doctor or pharmacist. The medicine should not be used for more than 14 days without consulting a doctor.
So far, there is only limited experience with the long-term use of the medicine for up to 14 days, so Help4Skin SEPTI-SPRAY should not be used for longer than this period.

Using a higher dose of Help4Skin SEPTI-SPRAY than recommended

There is no data on overdose. When using the medicine according to the instructions, overdose of Help4Skin SEPTI-SPRAY is unlikely.
If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After using a medicine containing octenidine dihydrochloride and phenoxyethanol, the following side effects have been observed:
Rare (may affect up to 1 in 1,000 people):
Burning, redness, itching, or a feeling of heat at the application site.
Very rare (may affect up to 1 in 10,000 people):
Contact allergic reactions.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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
Aleje Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Help4Skin SEPTI-SPRAY

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
After first opening, Help4Skin SEPTI-SPRAY should be used within 12 months, but no later than the expiry date.
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. Package contents and other information

What Help4Skin SEPTI-SPRAY contains

• The active substances are octenidine dihydrochloride and phenoxyethanol. 1 g of solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
• The other ingredients are: cocamidopropyl betaine, 38% solution, sodium gluconate, glycerol 85%, sodium hydroxide, 10% solution (for pH adjustment), purified water.

What Help4Skin SEPTI-SPRAY looks like and what the pack contains

A clear to slightly opalescent, almost colorless solution in a white HDPE bottle with a mechanical spray head made of POM/LDPE/PP/stainless steel containing 50 ml or 250 ml of the medicine, in a cardboard box.
The pack contains 50 ml or 250 ml.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer

PROFARMA-PRODUKT, s. r. o.
Liberecka 801/20
466 01 Jablonec nad Nysą
Czech Republic
ARDEAPHARMA a. s.
Třeboňská 229
373 63 Ševětín
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Octicide
Hungary
Octicide
Romania
Octicide
Estonia
Octicide
Slovakia
Octicide
Poland
Help4Skin SEPTI-SPRAY
Date of last revision of the leaflet:February 2025