Exoderil skin solution 1% 10ml

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.

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 by your doctor
doctor or pharmacist.
 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. This
includes any side effects not listed in this guide. See section 4.
 If you do not feel better or feel worse for 4 weeks, you must contact your doctor or
pharmacist.
In this guide you will read:
1. What is Exoderil and what is it for?
2. What you need to know before using Exoderil
3. How to administer Exoderil
4. Possible side effects
5. How to store Exoderil
6. Contents of the package and other information

1. What is Exoderil and what is it for?
The drug Exoderil, 10 mg/mL, solution for the skin is intended for external use in adults, contains active
the substance naftifine hydrochloride and is used to treat fungal infections of the skin of the feet. The drug Exoderil is
effective in the treatment of skin fungi, yeast, mold and other fungi. It is also effective in treating infections
caused by a large number of bacteria that often occur together with a fungal infection in humans.
The drug Exoderil, 10 mg/mL, solution for the skin is used in the treatment of fungal infections of the skin of the feet, especially
between the toes and on the soles of the feet (recognized by redness, peeling, swelling of the skin and formation of blisters which are
accompanied by itching).
2. What you need to know before using Exoderil

Exoderil should not be used:
- if you are allergic (hypersensitive) to naftifine hydrochloride, propylene glycol or any of the excipients
substances of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Exoderil.
The drug Exoderil, 10 mg/mL, solution for the skin is intended for external use only and must not come into contact with
with eyes.
The solution should not be applied to open skin wounds, as it contains alcohol, which can cause pain
burning sensation
If the symptoms do not pass or the therapy is not effective as expected after 4 weeks of treatment, it is necessary to
consult a doctor as soon as possible.
Other drugs and the drug Exoderil
Inform your doctor and pharmacist if you are using it, have used it recently or may be using it
apply any other medicines.
Pregnancy and breastfeeding
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.
As a precautionary measure, it is advised to avoid using this medicine during pregnancy and breastfeeding.
Driving vehicles and operating machines
The drug Exoderil has no effect on the ability to drive a vehicle or use machines.
The drug Exoderil, 10 mg/mL, solution for the skin contains ethanol and propylene glycol
This medicine contains ethanol and therefore must not come into contact with the eyes and must not be applied to open wounds
the skin.
This medicine contains propylene glycol which may cause skin irritation.

3. How to use the drug Exoderil
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.
Unless otherwise prescribed, apply the dosage of the medicine as indicated.
The drug Exoderil, 10g/mL, solution for the skin should be applied once a day on clean and well-dried skin.
affected by changes.
Children and adolescents: the safety and efficacy of naftifine in children and adolescents under 18 years of age are not yet established
always fixed. No data available.
Patients with impaired liver or kidney function: no dose adjustment is required.
Elderly patients: no dose adjustment is required.
Length of therapy
Regardless of the rapid improvement of the symptoms (itching, burning, etc.), it is important to continue the treatment of the fungus
skin infections and during the following two weeks after the resolution of all symptoms of the disease, in order to ensure
permanent cure.
If symptoms do not improve within 4 weeks of starting treatment with Exoderil 10 mg/mL
skin solution, consult your doctor.
Method of application
The drug Exoderil, 10 mg/mL, solution for the skin should be applied exclusively to the skin.
A sufficient amount of solution should be applied directly from the bottle or with a cotton ball. Apply so that it is affected
place, as well as the area around the diseased skin, moisten well with the solution.
The drug Exoderil 10 mg/mL solution for the skin must not come into contact with the eyes and must not be applied to the mucous membrane.
In order to achieve a faster cure, please pay attention to the following recommendations for the treatment of fungal infections
infection (mycosis):
1. Microorganisms that are responsible for the appearance of fungal infections can adhere to clothing that comes in
contact with infected skin. Therefore, it is necessary to change clothes every day.
2. An undamaged and, above all, dry skin surface provides the best protection against fungal infections. Because of
it is necessary to avoid tight clothing or clothing that hinders air circulation (e.g. synthetic socks
material in tight footwear). It is also necessary to dry the affected parts of the skin well after washing. You use
only your own clothes and towels and do not share them with others to prevent the spread of infection. Face towels and
towels should be changed daily..
3. If you have a fungal infection of the feet, do not walk barefoot around the house, in the bathroom or, for example, in the hotel room
room. This will prevent the further spread of microorganisms and, above all, prevent re-infection.
4. Do not go to the sauna or Turkish bath until you have cured the yeast infection.
If you have used more Exoderil than you should
If you have used more Exoderil than you should, life-threatening situations are not expected to occur.
If you accidentally swallow part of the solution, inform your doctor who will advise you on what to do.
Appropriate symptomatic therapy is recommended.

If you forget to take Exoderil
If you forget to apply the solution, apply it as soon as possible and continue with your usual application. if you remember
only at the time of the next application, apply the usual amount and continue with the application.
Try to apply the solution as prescribed. This is important because missing a dose carries a risk
reoccurrence of infection.
If you suddenly stop taking Exoderil
In order to prevent the recurrence of the infection, it is very important to continue the treatment with Exoderil for two years
weeks after the symptoms of the infection have subsided.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
patients taking this medicine.
There may be a reaction at the site of application of the drug, such as a feeling of dryness, redness and burning. This
it usually does not require discontinuation of therapy, except in rare cases. Adverse effects disappear after discontinuation
therapy.
Reporting adverse reactions
If you experience any unwanted reaction, you need to inform your doctor or pharmacist or
nurse. This includes any possible side effects that are not listed in this guide.
By reporting side effects, you can help evaluate the safety of this medicine. Doubt on
You can report adverse reactions 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 Exoderil
Keep the medicine out of the sight and reach of children.
Expiration date
You must not use the medicine Exoderil after the expiration date indicated on the outer package after
"Valid until". The expiration date refers to the last day of the specified month.
Store unopened medicine at a temperature of up to 30ºC.
After first opening, store the medicine for 6 months at a temperature of up to 25ºC.
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. Package contents and other information
What Exoderil contains
 The active substance is naftifine hydrochloride.
1 mL of solution contains 10 mg of naftifine hydrochloride
 Auxiliary substances are: ethanol; propylene glycol; water, purified.
What Exoderil looks like and the contents of the package
The drug Exoderil, solution for the skin is a clear, colorless to light yellow solution with an ethanol odor.
The inner packaging is a dark glass bottle (type III) with a polyethylene dropper and polyethylene
cap with safety ring containing 10 mL of skin solution.
The outer packaging is a collapsible cardboard box containing 1 vial of 10 mL skin solution (1 x
10 mL) and Instructions for the drug.
License holder and manufacturers
License holder:
REPRESENTATIVE OFFICE OF SANDOZ PHARMACEUTICALS DD BELGRADE
Kneginje Zorke 2, Belgrade
Manufacturers:
SANDOZ GMBH
Biochemiestrasse 10, Kundl, Austria
LEK PHARMACEUTICAL COMPANY DD
Verovškova 57, Ljubljana, Slovenia
Note:
The printed instructions for the drug in the specific packaging of the drug must clearly indicate the manufacturer
responsible for putting into circulation exactly that batch of the drug in question, i.e. to specify only that manufacturer, a
leave the others out.
This instruction was last approved
September, 2020
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-04456-19-001 from 16.09.2020

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