Octenisept solution for skin 50ml

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

Octenisept
®
, 1mg/g + 20 mg/g, skin solution
octenidine, phenoxyethanol
Read this instruction carefully before you start using this medicine, because it contains
information that is important to you..
Always use this medicine exactly as stated in these instructions or as explained to you
Your doctor or pharmacist or nurse.
- Save the instructions. You may need to read it again.
- If you have additional questions or need advice, contact your pharmacist.
- If you experience any side effects, contact your doctor or pharmacist or
nurse. This includes any side effects not listed in this guide.
See section 4.
- If you do not feel better or feel worse after 14 days, you must contact your doctor.
In this guide you will read:
1. What is the drug Octenisept and what is it intended for
2. What you need to know before using the medicine Octenisept
3. How to administer the drug Octenisept
4. Possible side effects
5. How to store the medicine Octenisept
6. Contents of the package and other information
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1. What is the drug Octenisept and what is it intended for
The drug Octenisept contains two active substances: octenidine dihydrochloride and phenoxyethanol. It belongs to the group of antiseptics
and disinfectants. They act by preventing the growth and destruction of microorganisms, i.e. they have antiseptic properties
effect.
The drug Octenisept is intended for repeated, short-term antiseptic therapy of mucous membranes and surrounding skin
diagnostic or surgical procedures:
– in the ano-genital region (vagina, vulva, glans penis), as well as before bladder catheterization
– in the oral cavity
The drug Octenisept is also used for the time-limited supportive therapy of fungal infections on the skin between the fingers
feet and for supportive antiseptic therapy of wounds.
2. What you need to know before using the medicine Octenisept
You must not use Octenisept:
 if you know that you are hypersensitive to octenidine dihydrochloride and phenoxyethanol or to any of the
auxiliary substances of the drug, listed in section 6.
The drug Octenisept should not be used to wash the abdominal cavity (eg during surgery) or the bladder, as well as for
ear washing.
Warning and precautions
Talk to your doctor or pharmacist before using Octenisept.
The drug Octenisept must not be administered into the bloodstream, e.g. by injection (accidental injection), nor se
recommends its ingestion.
It should be used with caution in premature children with low body weight. The drug Octenisept,
can lead to serious damage to the skin. Remove the excess drug and make sure that the solution does not remain on the skin for a long time
than prescribed (including materials that are soaked in the solution and that are in direct contact with
patient).
Application of the drug Octenisept in the eye should be avoided. In case of contact with the drug in the eyes, immediately rinse the eyes with plenty of water
water.
After rinsing deep wounds with a syringe, persistent edema (swelling), erythema (redness) and necrosis may occur.
tissue (tissue death), and in some cases surgical treatment is required (see section 4).
To prevent possible tissue damage, the drug must not be injected or applied under pressure into the tissue. Medicine
is intended for external use only and is applied with a dab or spray pump.
Other medicines and the medicine Octenisept
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines.
The medicine Octenisept should not be applied near the skin treated with other antiseptics based on PVP iodine, because on
a dark brown to purple color of the skin may appear where the two solutions come into contact.
Children
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor or pharmacist for
advice before using this medicine.
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Data on the use of Octenisept during pregnancy are limited. Current data do not indicate a risk to the fetus.
Administration of the drug Octenisept during pregnancy can be considered, if necessary.
There are no adequate data on the use of Octenisept during breastfeeding.
Octenidine dihydrochloride is resorbed in very small amounts or not at all, so it can
assume that it is not excreted in breast milk
Phenoxyethanol is resorbed quickly and almost completely and as an oxidized metabolite it is almost completely excreted
through the kidneys. Therefore, accumulation in breast milk is unlikely.
Driving vehicles and operating machines
The drug Octenisept has no influence on the ability to drive vehicles and operate machines.
3. How to apply the drug Octenisept
Always use this medicine exactly as stated in these instructions or as explained to you by your doctor
doctor or pharmacist. If you are not sure, check with your doctor or pharmacist.
The solution is intended for local use only and must not be applied directly to tissue, e.g. using a syringe.
The medicine Octenisept is applied once a day to the mucous membrane and the surrounding skin with a swab completely soaked in the medicine or
by spraying on hard-to-reach surfaces. Application with a tupfer is recommended.
Unless otherwise prescribed, carefully apply the solution to the surface to be treated with at least two
soaked cotton swab, one after the other, so that it is completely wet. The drug can also be sprayed on hard-to-reach areas
surface. In all cases, a contact time of at least one to two must be ensured after application
minutes before performing further procedures, e.g. applying a surgical bandage.
The oral cavity can also be rinsed. The use of rinsing the oral cavity should be limited to cases of
for which it is necessary to treat the entire oral cavity. Then 20 mL of the solution is used, and rinsing for 20 seconds.
For additional therapy in cases of treating fungal infections between the toes, the medicine should be sprayed on the affected person
places in the morning and in the evening.
Instructions for use should be followed carefully to achieve the desired results.
Since so far there is only experience of continuous application for no longer than 14 days, the drug Octenisept must not be used
longer than two weeks without medical supervision.
If you have used more Octenisept than you should
There are no data on overdose. However, the probability of overdose with drugs for local application is very high
small. In cases of local overdose, the affected areas can be flushed with a larger volume of Ringer's
solution.
If you have used more medicine than you should or have accidentally swallowed it, talk to your doctor immediately
Your doctor or pharmacist!
If you forget to use Octenisept
Do not take a double dose to make up for a missed dose.
If you suddenly stop using Octenisept
You will not feel any changes if you suddenly stop using the drug, however, it should be followed carefully
instructions for use in order to achieve the desired results.
If you have any further questions about the use of this medicine, ask your doctor, ask your doctor or pharmacist.
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
patients taking this medicine.
Rare side effects (may occur in up to 1 in 1000 patients taking the medicine):
burning sensation, redness, itching and heat at the application site
Very rare side effects (may occur in up to 1 in 10,000 patients taking the drug):
allergic reaction at the application site, such as transient redness
Frequency not known (cannot be estimated from the available data):
after washing deep wounds with a syringe, the appearance of long-term (persistent) edema (swelling), erythema (redness) is possible
and tissue necrosis (tissue death), and in some cases surgical treatment is required. (see section 2).
When applied to rinse the oral cavity, the drug Octenisept causes a transient bitter taste.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist. This
includes any possible adverse reaction not listed in this instruction. By reporting spam
reactions can help you assess the safety of this medicine. You can suspect unwanted reactions
report to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store the medicine Octenisept
Keep the medicine out of the sight and reach of children!
Do not use the medicine Octenisept after the expiry date indicated on the bottle after "Expiry until:". Expiry date
the expiration date refers to the last day of the specified month.
Store at a temperature of up to 250C
Unusable medicines are handed over to the pharmacy where the notice that they are to be collected is displayed in that pharmacy
unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with
communal waste. These measures will help protect the environment.
6. Contents of the package and other information
What does Octenisept contain?
Active substances are: octenidine dihydrochloride and phenoxyethanol.
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100 g of solution contains:
0.1 g of octenidine dihydrochloride
2.0 g of phenoxyethanol
Auxiliary substances are: cocamidopropyl betaine, sodium gluconate; glycerol 85%; sodium chloride
sodium hydroxide, solution (10%), water, purified.
What the medicine Octenisept looks like and the contents of the package
Skin solution.
Clear to almost clear, colorless solution.
Octenisept, solution for skin, 50 mL
The package of the drug is a 50 mL closed molded high-density polyethylene (HDPE) white bottle
with a sprayer made of polyethylene and a screw made of polypropylene, white color. The sprayer has a transparent protective cap.
The instructions for the medicine are glued to the medicine package (bottle).
Octenisept, solution for skin, 250 mL
The package of the drug is a 250 mL closed molded high-density polyethylene (HDPE) white bottle
with a sprayer made of polyethylene and a screw made of polypropylene, white color. The sprayer has a transparent protective cap.
The instructions for the medicine are glued to the medicine package (bottle).
Octenisept, solution for skin, 1000 mL
The packaging of the medicine is a transparent high-density polyethylene (HDPE) bottle of white color of 1000 mL closed
with a safety closure made of white polypropylene. The instructions for the medicine are glued to the medicine package (bottle).
The instructions for the medicine are glued to the medicine package (bottle).
License holder and manufacturer
License holder
MIOFARM EXPORT IMPORT DOO NOVI SAD, Novi Sad
Manufacturer
SCHÜLKE & MAYR GMBH
Robert-Koch Strasse 2, Norderstedt, Germany
This instruction was last approved
December, 2019.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
Octenisept, solution for skin, 1x50mL, (1mg/g+20 mg/g): 515-01-00933-19-001 from 17.12.2019.
Octenisept, solution for skin, 1x250mL, (1mg/g+20 mg/g): 515-01-00934-19-001 from 17.12.2019.
Octenisept, solution for skin, 1x1000mL, (1mg/g+20 mg/g): 515-01-00935-19-001 from 17.12.2019.