Octenidine dihydrochloride + phenoxyethanol lavipharm

Package leaflet: Information for the user

Octenidine dihydrochloride + Phenoxyethanol Lavipharm, 1 mg/mL + 20 mg/mL,
cutaneous aerosol, solution
octenidine dihydrochloride + phenoxyethanol
Please read the entire leaflet carefully before use, as 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
doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or additional information is needed, please consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days, or if the patient feels worse, a doctor should be consulted.

Leaflet contents:

1. What Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm is and what it is used for
2. Important information before using Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm
3. How to use Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm
4. Possible side effects
5. How to store Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm
6. Contents of the pack and other information

1. What Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm is and what it is used for

Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm is a solution for topical use containing the active substances: octenidine dihydrochloride and phenoxyethanol, which have antiseptic properties.
Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm is used for repeated, short-term external antiseptic treatment of mucous membranes and adjacent tissues prior to diagnostic procedures involving genital organs and the anus, as well as prior to bladder catheterization.
It is also used for antiseptic treatment of minor, superficial wounds and for skin disinfection before non-surgical procedures.
The in vitro spectrum of activity of Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm includes Gram-positive and Gram-negative bacteria, enveloped viruses, and yeasts.
Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm may be used in patients of all age groups.

2. Important information before using Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm

When not to use Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm

• if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6).
• do not use intraperitoneally (e.g. during surgery), do not administer into the urinary bladder or into the ear.

Warnings and precautions
Before starting to use Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm, discuss this with your doctor, pharmacist, or nurse.
To prevent possible tissue damage, the product must not be injected or introduced into tissues under pressure.
Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm is intended for topical use only and must not be introduced into tissues, for example with a syringe. After wound irrigation with a syringe, persistent swelling, erythema, and tissue necrosis have been reported, which in some cases required surgical treatment (see section 4).
Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm must not be swallowed or introduced into the bloodstream, for example due to accidental injection.
Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm must not be used in the eyes.
In case of contact with eyes, immediately rinse thoroughly with large amounts of water.
This medicine is intended exclusively for external use on skin and mucous membranes.

Children
Use with caution in newborns, especially premature infants. Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm 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).

Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm should not be used simultaneously with antiseptics based on iodine-povidone complexes on adjacent body areas, as intense brown or violet discoloration may occur at the site of contact.
Do not use Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm together with anionic surfactants (e.g. soap, detergents), as this may lead to reduced or lost efficacy.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Current experience with use of this medicine in pregnant women does not indicate any risk.
There are no data available on the use of this medicine during breastfeeding. However, accumulation in breast milk is unlikely. As a precautionary measure, Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm should not be applied to the breast area during breastfeeding.

Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to use Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm

This medicine should always be used exactly as described in this patient leaflet or as advised by your
doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
The solution is intended for application to the skin and for external use only.
For supportive antiseptic treatment of minor, superficial wounds and for external antiseptic treatment of mucous membranes and skin in the genital area in both men and women, apply the product and leave it in place for 1 minute before performing any other procedure.
For skin antisepsis prior to non-surgical procedures, apply the product and leave it for 2 minutes.
The solution is intended for use on the skin and mucous membranes of the urogenital system; it should not be used in the mouth. It is intended exclusively for topical use (application as an aerosol).
The mucous membranes and skin in the urogenital area to be disinfected should be evenly and thoroughly moistened with the undiluted antiseptic medicine.
The medicine Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm should be sprayed directly onto accessible areas of skin and mucous membranes. Ensure even wetting of the area. Leave in place for 60 to 120 seconds (1 spray corresponds to 0.15–0.19 mL).
Use in children and adolescents
The recommended dose is the same for adults and children.
Duration of treatment
Do not use this medicine for longer than 2 weeks without consulting a doctor.
Use of more than the recommended dose of Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm
There is no data regarding overdose. However, overdose with a topically applied medicine is highly unlikely. In case of accidental ingestion of Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm, consult a doctor or pharmacist.
If you have any further questions regarding 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 everyone will experience them.
The following adverse reactions may occur:
Rare (may occur in not more than 1 in 1,000 people)
Burning sensation, redness, itching, feeling of warmth.
Very rare (may occur in not more than 1 in 10,000 people)
Contact allergic reactions, e.g. transient redness.
Frequency unknown (cannot be estimated from available data)
Persistent swelling, erythema, and tissue necrosis have been reported after wound irrigation using a syringe.
Children and adolescents
The frequency, type, and severity of adverse reactions in children and adolescents are the same as in adults.
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 also 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 provide more information on the safety of this medicine.

5. How to store Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the outer cardboard
carton after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze.
After first opening the bottle: 3 years, but not beyond the expiry date stated on the outer
packaging and bottle.
Do not use this medicine if the bottle is damaged or if there are signs of tampering.
Do not open the bottle or unscrew the pump.
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 package and other information

What Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm contains

• The active substances are oktenidyny dichlorowodorku and fenoksyetanol. One mL of colourless solution contains 1 mg of oktenidyny dichlorowodorku and 20 mg of fenoksyetanol.
• The other components are: sodu glukonian, kokamidopropylobetaina, 30% solution (containing kokamidopropylobetaina, water, sodu chlorek), glicerol, sodu wodorotlenek or kwas solny 1N solution (for pH adjustment), purified water.

What Dichlorowodorek oktenidyny + Fenoksyetanol Lavipharm looks like and contents of the pack
Packaging
Round white HDPE bottle containing a skin aerosol solution, closed with a screw-on adjustable HDPE spray pump and a polypropylene cap, packed in a cardboard box with a tamper-evident seal.
Pack sizes: 50 mL and 250 mL of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Taw Pharma (Ireland) Limited
104 Lower Baggot Street
Dublin 2
D02 Y940
Ireland
Manufacturer
Lavipharm S.A.
Agias Marinas str.
190 02 Peania, Attica
Greece
This medicinal product is authorised in the European Economic Area member states under the following names: