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OCTENIDINE DIHYDROCHLORIDE / PHENOXYETHANOL 1 MG/ML + 20 MG/ML CUTANEOUS SPRAY SOLUTION

Active substance(s): OCTENIDINE DIHYDROCHLORIDE / PHENOXYETHANOL

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Package Leaflet: Information for the User

Octenidine dihydrochloride / Phenoxyethanol FGK 1 mg/ml + 20 mg/ml cutaneous spray,
solution
Octenidine Dihydrochloride
Phenoxyethanol

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Octenidine dihydrochloride / Phenoxyethanol FGK is and what it is used for
2.
What you need to know before you use Octenidine dihydrochloride / Phenoxyethanol FGK
3.
How to use Octenidine dihydrochloride / Phenoxyethanol FGK
4.
Possible side effects
5.
How to store Octenidine dihydrochloride / Phenoxyethanol FGK
6.
Contents of the pack and further information
1.

What Octenidine dihydrochloride / Phenoxyethanol FGK is and what it is used for
Octenidine dihydrochloride / Phenoxyethanol FGK is a cutaneous solution that contains the
active substances octenidine dihydrochloride and phenoxyethanol which have antiseptic
properties.
Octenidine dihydrochloride / Phenoxyethanol FGK is used as repeated, temporary
preparatory antiseptic treatment for mucous membranes and adjoining skin before diagnostic
procedures on or near the genital and excretory organs, as well as before the insertion of a
urinary catheter.
It is also used for antiseptic treatment of small superficial wounds and skin disinfection prior
to non-surgical procedures.
Octenidine dihydrochloride / Phenoxyethanol FGK may be used in patients of all age groups.

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2.

What you need to know before you use Octenidine dihydrochloride / Phenoxyethanol
FGK
Do not use Octenidine dihydrochloride / Phenoxyethanol FGK
if you are allergic to octenidine dihydrochloride, phenoxyethanol or any of the other
ingredients of this medicine (listed in section 6).

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in the abdominal cavity (e.g. during surgery) or the urinary bladder. Do not apply to the
ear drum.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Octenidine dihydrochloride /
Phenoxyethanol FGK.
To prevent possible tissue injury, the product must not be injected or applied to
tissues with pressure.


Avoid introducing Octenidine dihydrochloride / Phenoxyethanol FGK
bloodstream, e.g. by accidental injection.



If Octenidine dihydrochloride / Phenoxyethanol FGK is brought into contact with
anionic surfactants (soap, detergent), its active substance octenidine dihydrochloride
can be rendered ineffective.

into the

Other medicines and Octenidine dihydrochloride / Phenoxyethanol FGK
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
Do not apply Octenidine dihydrochloride / Phenoxyethanol FGK near skin areas treated with
antiseptics (disinfectants) which are based on povidone-iodine, as the bordering areas may
exhibit strong brown or violet discolorations.
Do not apply Octenidine dihydrochloride / Phenoxyethanol FGK together with anionic
surfactants (soap, detergent) since they can reduce or nullify its activity.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before using this medicine.
Present experiences with humans using Octenidine dihydrochloride / Phenoxyethanol FGK
during pregnancy do not indicate any harmful effects.
There are no data available on the application of Octenidine dihydrochloride / Phenoxyethanol
FGK during the nursing period. As a precaution, Octenidine dihydrochloride / Phenoxyethanol
FGK should not be applied in the area of the breast during the nursing period.
Driving and using machines
Octenidine dihydrochloride / Phenoxyethanol FGK does not affect the capability to drive a
vehicle or operate machinery.

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3.

How to use Octenidine dihydrochloride / Phenoxyethanol FGK
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or
nurse has told you. Check with your doctor or pharmacist if you are not sure.
• Method of administration
The solution is intended for cutaneous use.
Apply the medicine thoroughly to the area to be treated until it is completely moist. Following
use, you must wait for at least two minutes before applying other measures to the treated area
(such as applying a wound dressing). This is because this medicine requires a minimum of 2
minutes of exposure time to achieve the desired full effect.
• Use in children and adolescents
The recommended dose is identical in adults and children.
• Duration of treatment
Do not use this medicine for longer than 2 weeks without consulting your doctor.
• If you use more Octenidine dihydrochloride / Phenoxyethanol FGK than you should
There are no findings concerning overdosing. An overdose is highly unlikely if the medicine is
used as instructed.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4.

Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects:
Rare (may affect up to 1 in 1,000 people):
Burning sensations, reddening, itching and heat sensations in the treated areas.
Very rare (may affect up to 1 in 10,000 people):
Allergic contact reaction, e.g. temporary redness at the application site
Paediatric population
Frequency, type and severity of adverse reactions in children are the same as in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme.
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How to store Octenidine dihydrochloride / Phenoxyethanol FGK
Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date which is stated on the packaging. The expiry
date refers to the last day of the month.
This medicine does not require any special storage conditions.

After first opening of this medicine, use within one year.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information
What Octenidine dihydrochloride / Phenoxyethanol FGK contains
The active substances are octenidine dihydrochloride and phenoxyethanol. One ml of the
solution contains 1 mg octenidine dihydrochloride and 20 mg of phenoxyethanol.
The other ingredients are: cocamidopropylbetaine, sodium gluconate, glycerol 85 %, sodium
chloride, sodium hydroxide solution (10%), purified water.
What Octenidine dihydrochloride / Phenoxyethanol FGK looks like and contents of the
pack
Octenidine dihydrochloride / Phenoxyethanol FGK is a clear, colourless, almost odourless
cutaneous spray, solution available in white plastic bottles equipped with a spray pump.
The package sizes are 50 and 250 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
FGK Representative Service GmbH
Heimeranstr. 35
D-80339 Munich
Germany

Manufacturer:
Schülke & Mayr GmbH
Robert-Koch-Str. 2
D- 22851 Norderstedt
Germany

This medicinal product is authorised in the Member States of the EEA under the
following names:
Bulgaria - Октенидин дихидрохлорид + феноксиетанол FGK 1 mg/ml + 20 mg/ml
Спрей за кожа, разтвор
Cyprus - Διυδροχλωρική οκτενιδίνη + Φαινοξυαιθανόλη FGK 1 mg/ml + 20 mg/ml
Δερματικό εκνέφωμα, διάλυμα
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Estonia – Oktenidiin + Fenoksüetanool FGK
Finland – Oktenidiinidihydrokloridi + fenoksietanoli FGK 1 mg/ml + 20 mg/ml Sumute iholle,
liuos
Germany – Octenidindihydrochlorid + Phenoxyethanol FGK 1 mg/ml + 20 mg/ml Spray zur
Anwendung auf der Haut, Lösung
Hungary – Oktenidin-dihidroklorid + Fenoxietanol FGK 1 mg/ml + 20 mg/ml Külsőleges
oldatos spray
Italy – Octenidina e fenossietanolo FGK
Latvia - Oktenidīna dihidrohlorīdu + Fenoksietanolu FGK 1 mg/ml + 20 mg/ml Uz ādas
izsmidzināms aeroso šķīdums
Lithuania - Oktenidino dihidrochloridas + Fenoksietanolis FGK 1 mg/ml + 20 mg/ml Odos
purškalas (tirpalas)
Netherlands – Octenidine dihydrochloride + fenoxyethanol FGK 1 mg/ml + 20 mg/ml
Huidspray, oplossing
Slovakia - Oktenidín dihydrochlorid + fenoxyetanol FGK 1 mg/ml + 20 mg/ml Dermálna
roztoková aerodisperzia
Slovenia - Oktenidinijev diklorid + Fenoksietanol FGK 1 mg/20 mg v 1 ml Dermalno pršilo
Spain - Octenidina dihidrocloruro + fenoxietanol FGK 1 mg/ml + 20 mg/ml Solución para
pulverización cutánea
Sweden – Oktenidin dihydroklorid + Fenoxietanol FGK 1 mg/ml + 20 mg/ml Kutan spray,
lösning
United Kingdom - Octenidine dihydrochloride / Phenoxyethanol FGK 1 mg/ml + 20 mg/ml
cutaneous spray, solution
This leaflet was last revised in 08/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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