EXODERIL anti-fungal solution for feet 10 ml

EXODERIL 1% cutaneous solution 10 ml Exoderil 1% cutaneous solution Exoderil 1% cutaneous solution Naftifine hydrochloride Read all of this leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, to get the best results from the treatment, you should carefully follow the instructions for use of the medicinal product.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
You should seek medical attention if your symptoms worsen or do not improve within four weeks of starting treatment.
If any of the side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

What this leaflet contains
1. What Exoderil is and what it is used for 2. What you need to know before you use Exoderil 3. How to use Exoderil 4. Possible side effects 5. How to store Exoderil 6. Contents of the pack and other information
1. What Exoderil is and what it is used for

Exoderil 1% solution is suitable for the treatment of fungal infections and contains naftifine. It is active against skin fungi, yeasts, molds, etc. It is also active against various bacterial infections that often occur with fungal infections in humans.
Exoderil is used to treat fungal infections of the feet, especially between the toes, the bottom of the foot (appearing as redness, peeling and swelling or itchy blisters) and the nails.

2. What you need to know before you use Exoderil Do not use Exoderil

if you are allergic to naftifine or any of the excipients listed in section 6.

Warnings and precautions:

At the first signs of side effects, please inform your doctor. Do not use Exoderil solution if you experience an allergy.

Duration of treatment:

Treatment with Exoderil should be continued at the same dose for at least two weeks after the infection has cleared to prevent recurrence.

If no clinical improvement is observed within 4 weeks, the treating physician should be consulted and the treatment reviewed.
Paediatric population:

The safety and efficacy of naftifine in children and adolescents under 18 years of age have not been established. There are insufficient data available.

Patients with impaired renal or hepatic function:

No dose adjustment is necessary.

Patients should be informed about the usual hygiene measures to avoid sources of infection and reinfection.
Other medicines and Exoderil:

There are no known interactions with other drugs.

Pregnancy, lactation and fertility:

No studies have been conducted to determine the effect of Exoderil 1% solution on fertility.
Experience with the use of naftifine in pregnant women is very limited. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
When used correctly, this medicinal product is not expected to affect the fetus or newborn. Teratogenicity studies have not shown any embryotoxic effect of naftifine.
When used correctly, the medicine has no harmful effects on the fetus or newborn.
As a precautionary measure, the use of Exoderil 1% solution during pregnancy and lactation should be avoided.

This medicinal product contains propylene glycol and ethanol:

1 ml of solution contains 50 mg propylene glycol and 400 mg ethanol. Propylene glycol may cause skin irritation.
Ethanol can cause burning on damaged skin.
Avoid contact with eyes or open wounds.

3. How to use Exoderil

Unless otherwise prescribed, follow the recommended dosage carefully. Exoderil 1% solution is applied to the affected areas once a day. These areas should be cleaned and dried carefully before applying the solution.
Despite the rapid improvement of symptoms (itching, redness, etc.), it is important for patients with fungal skin infections to continue their treatment for 2 weeks after the symptoms have completely resolved, to prevent their recurrence.
Before and after treatment for a fungal infection, nails should be kept as short as possible and their surface filed. Fungal nail infections should be treated for several months until a healthy nail grows back.

To cure a fungal infection (mycosis) as quickly as possible, please note the following:

The microorganisms that cause the fungal infection can attach to pieces of clothing that are in contact with the affected areas. Therefore, they should be changed daily.
A normal and especially dry skin surface is the best protection against fungal infections. Avoid wearing tight and poorly ventilated clothing (e.g. synthetic socks and tight shoes) on the affected areas. You should also dry the affected areas carefully after washing. Towels should be changed daily.
If you have a fungal infection on your feet, do not walk barefoot at home, in swimming pools or, for example, in a hotel. This will prevent the spread of the infection to other people and especially your own reinfection.
Do not visit a sauna or steam room until the fungal infection has completely cleared up.

Method of application:
The solution can be applied directly from the vial using a dropper or on a piece of cotton.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The reported adverse drug reactions are from the group of general disorders and administration site conditions.
Not known (frequency cannot be estimated from the available data):

feeling of dryness, redness and burning.

The side effects are reversible and usually do not require discontinuation of treatment. They subside after the end of treatment.
Reporting side effects:
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
The Bulgarian Medicines Agency, Damyan Gruev St., 81303 Sofia, Tel.: +35928903417, Website: www.bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Exoderil

Store below 30°C.
Keep out of the reach of children.
Do not use Exoderil after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.
Shelf life after first opening the package: 6 months at a temperature below 25°C.

6. Contents of the pack and other information What Exoderil contains:

The active substance is naftifine hydrochloride. 1 ml of solution contains 10 mg of naftifine hydrochloride.
The other ingredients are: propylene glycol, ethanol, distilled water

What Exoderil looks like and what the pack contains:

Original packaging containing 10 ml, 20 ml or 30 ml of skin solution.
Not all types of packaging can be released for sale.

Marketing Authorisation Holder:
Sandoz GmbH, Austria
Manufacturers:
Sandoz GmbH, AustriaLek Verovskova, Slovenia