Help4skin septi-spray

Package leaflet: Information for the user

Help4Skin SEPTI-SPRAY, 1 mg/g + 20 mg/g, cutaneous aerosol, solution
Octenidini dihydrochloridum + Phenoxyethanolum
Please read all of this leaflet carefully before using this medicine, because 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, pharmacist, or nurse.

• 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 adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.

Table of contents

1. What Help4Skin SEPTI-SPRAY is and what it is 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. Contents of the pack and other information

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

Help4Skin SEPTI-SPRAY is an antiseptic (disinfectant) solution intended for topical use.
It is used for multiple, short-term antiseptic treatment to destroy bacteria and fungi on mucous membranes and adjacent tissues prior to surgical procedures involving the genital organs and anus, as well as prior to urinary bladder catheterization.
Help4Skin SEPTI-SPRAY is also indicated for multiple, short-term antiseptic treatment of wounds.
Help4Skin SEPTI-SPRAY should not be used for longer than 14 days.

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

Use as directed by a doctor
Multiple, short-term antiseptic treatment of burns and larger wounds, antiseptic irrigation of the vagina and cervix, disinfection of the glans penis.

Use by a healthcare professional
Antiseptic treatment of mucous membranes and adjacent skin areas prior to diagnostic or surgical procedures involving the genital organs and anus, as well as prior to urinary bladder catheterization, and multiple, short-term antiseptic treatment of wounds.

2. Important information before using Help4Skin SEPTI-SPRAY

When not to use Help4Skin SEPTI-SPRAY:

• if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicinal product (listed in section 6);
• Help4Skin SEPTI-SPRAY must not be used directly in the eyes.

Use by healthcare professionals:

• Help4Skin SEPTI-SPRAY must not be used during surgical procedures for irrigation of the abdominal cavity or urinary bladder.
• Help4Skin SEPTI-SPRAY must not be applied to the tympanic membrane of the ear.

Warnings and precautions
Before starting treatment with Help4Skin SEPTI-SPRAY, consult your doctor or pharmacist.
Avoid entry of Help4Skin SEPTI-SPRAY into the bloodstream, e.g. due to accidental injection.
Do not inhale the medicinal product during spraying.
To avoid tissue damage, do not apply Help4Skin SEPTI-SPRAY under pressure to tissues. Ensure adequate drainage of the solution from wound cavities (e.g. using an appropriate flexible drainage system). Help4Skin SEPTI-SPRAY is intended for topical use only.
Do not use Help4Skin SEPTI-SPRAY in the eye. In case of accidental contact with eyes, rinse immediately with large amounts of water.
Help4Skin SEPTI-SPRAY may be used with occlusive dressings.
Contact of Help4Skin SEPTI-SPRAY with other cleansing or cleaning agents may negatively affect its efficacy.

Children and adolescents
Help4Skin SEPTI-SPRAY may be used in children and adolescents.
Help4Skin SEPTI-SPRAY should be used with caution in newborns, especially in premature infants. Help4Skin SEPTI-SPRAY may cause severe skin reactions. Excess product should be removed, and care must be taken to ensure that the solution does not remain on the skin longer than necessary (this also applies to materials soaked with the solution that are in direct contact with the patient's body).

Help4Skin SEPTI-SPRAY and other medicinal products
Inform your doctor or pharmacist about all medicinal products you are currently using or have recently used, as well as any you plan to use, including those available without a prescription.
Help4Skin SEPTI-SPRAY should not be applied simultaneously to adjacent skin areas together with antiseptic agents based on iodine-povidone complex, as intense skin discolouration ranging from brown to violet may occur at the interface areas.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicinal product.

Pregnancy
Current experience with the use of Help4Skin SEPTI-SPRAY during pregnancy in women does not indicate any harmful effects. As a precautionary measure, Help4Skin SEPTI-SPRAY should not be used during the first three months of pregnancy. From the fourth month of pregnancy, the medicinal product may be used if necessary.

Breastfeeding
There are no data available on the use of Help4Skin SEPTI-SPRAY during breastfeeding. Help4Skin SEPTI-SPRAY should not be applied to the breast area in breastfeeding women.

Driving and operating machinery
Help4Skin SEPTI-SPRAY has no influence on the ability to drive or operate machinery.

3. How to use Help4Skin SEPTI-SPRAY

This medicine should always be used exactly as described in this patient leaflet, or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
It is recommended to use Help4Skin SEPTI-SPRAY in its undiluted form. Apply Help4Skin SEPTI-SPRAY immediately after injury or at the first signs of inflammation to achieve optimal treatment results.
Unless otherwise directed by a physician, for the treatment of wounds and injuries, apply Help4Skin SEPTI-SPRAY to the affected area once daily for up to 14 days.
Help4Skin SEPTI-SPRAY should be applied by repeatedly pressing the mechanical pump dispenser to thoroughly moisten the entire area to be treated.
In minor injuries, covering the wound with a dressing or plaster is usually not necessary.
However, to prevent further wound contamination, it is recommended to protect the wound with a bandage.
Please note that the full effect of the medicine will become apparent only after 1–2 minutes following application; therefore, this time should be observed before performing any other procedures.
The maximum effect of Help4Skin SEPTI-SPRAY occurs within 2 hours after application.
If the wound does not heal properly, signs of inflammation occur (redness, burning, swelling at the site of application), or other complications arise during healing, consult your doctor or pharmacist. Do not use this medicine for longer than 14 days without consulting a doctor.
Currently, there is only limited experience with long-term use of this medicine for up to 14 days; therefore, Help4Skin SEPTI-SPRAY should not be used for longer than this period.
Use of a higher than recommended dose of Help4Skin SEPTI-SPRAY
There are no data available regarding overdose. When used according to instructions, overdose of Help4Skin SEPTI-SPRAY is unlikely.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been observed after using a medicinal product containing octenidine dihydrochloride and phenoxyethanol:
Rare (may occur in fewer than 1 in 1,000 people):
Burning, redness, itching or sensation of warmth at the site of application.
Very rare (may occur in fewer than 1 in 10,000 people):
Allergic contact reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 to provide more information on the safety of this medicine.

5. How to store Help4Skin SEPTI-SPRAY

Keep the medicine 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 stated month.
Do not store above 30°C.
After first opening, Help4Skin SEPTI-SPRAY should be used within 12 months, but not beyond the expiry date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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.
• Other components: cocamidopropyl betaine, 38% solution, sodium gluconate, glycerol 85%, sodium hydroxide, 10% solution (for pH adjustment), purified water.

What Help4Skin SEPTI-SPRAY looks like and contents of the pack
A clear to slightly opalescent, almost colourless solution in a white HDPE bottle with a pump spray dispenser made of POM/LDPE/PP/stainless steel, containing 50 ml or 250 ml of solution, packed in a cardboard box.
The pack contains 50 ml or 250 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. 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 medicinal product is authorised in the following names in the European Economic Area countries:
Czech Republic Octicide
Hungary Octicide
Romania Octicide
Estonia Octicide
Slovakia Octicide
Poland Help4Skin SEPTI-SPRAY