Octenidine Dihydrochloride / Phenoxyethanol 1 Mg/Ml + 20 Mg/Ml Cutaneous Spray Solution
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.
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).
- 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 into the 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.
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.
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.
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:
Schulke & 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 - OKTeHngnH gHXHgpoxnopng + ^eHOKcneTaHon FGK 1 mg/ml + 20 mg/ml Cnpen 3a xo^a, pa3TBop
Cyprus - AmSpox^rapiKp oKxsvrSrvp + ®arvo2,nar0avo^n FGK 1 mg/ml + 20 mg/ml AsppariKo SKvs^ropa, Sra^npa
Estonia - Oktenidiin + Fenoksuetanool 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, Losung
Hungary - Oktenidin-dihidroklorid + Fenoxietanol FGK 1 mg/ml + 20 mg/ml Kulsoleges oldatos spray
Italy - Octenidina e fenossietanolo FGK
Latvia - Oktenidina dihidrohlondu + Fenoksietanolu FGK 1 mg/ml + 20 mg/ml Uz adas izsmidzinams aeroso skidums
Lithuania - Oktenidino dihidrochloridas + Fenoksietanolis FGK 1 mg/ml + 20 mg/ml Odos purskalas (tirpalas)
Netherlands - Octenidine dihydrochloride + fenoxyethanol FGK 1 mg/ml + 20 mg/ml Huidspray, oplossing
Slovakia - Oktenidin dihydrochlorid + fenoxyetanol FGK 1 mg/ml + 20 mg/ml Dermalna roztokova aerodisperzia
Slovenia - Oktenidinijev diklorid + Fenoksietanol FGK 1 mg/20 mg v 1 ml Dermalno prsilo Spain - Octenidina dihidrocloruro + fenoxietanol FGK 1 mg/ml + 20 mg/ml Solution para pulverization cutanea
Sweden - Oktenidin dihydroklorid + Fenoxietanol FGK 1 mg/ml + 20 mg/ml Kutan spray, losning
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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