EXODERIL SOL 10ML

ATC code: D01AE22 

Active substances: Naftifini Hydrochloridum

Vendor, principal: Biochemie Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

EXODERIL 1%ML 10ML

Package leaflet: Information for the user

Exoderil 1 % cutaneous solution

Naftifine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-   Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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

The active ingredient of Exoderil cutaneous solution is the anti-fungal agent naftifine that acts to eliminate fungi or inhibit their growth and reproduction, depending on the type of the pathogen (fungus).
Exoderil easily penetrates the skin and the therapeutic concentrations of the agent will persist in different layers of skin for an extended period of time.
Exoderil cutaneous solution is used for the topical treatment of a fungal foot infection (tinea pedis).

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

- if you are allergic to the active substance or any of the other ingredients of this medicine. Exoderil cutaneous solution should not be applied onto open wounds and skin fissures.

Warnings and precautions

Talk to your doctor or pharmacist before using Exoderil.
Only use Exoderil externally.
When using Exoderil cutaneous solution, make sure that the medicine does not get into the eye. Exoderil cutaneous solution is for topical (cutaneous) use only. It must not be applied on open wounds. In this case, you should use Exoderil cream, the ingredients of which do not contain ethanol.

Other medicines and Exoderil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interaction studies have been carried out

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 taking this medicine.
Fertility
No studies have been carried out on the effect of Exoderil on fertility.
Pregnancy and breast-feeding
There is no or very limited experience in using naftifine in pregnant patients. Animal tests show no direct or indirect harmful effect related to reproductive toxicity.
As a precaution, the use of Exoderil should be avoided during pregnancy and breast-feeding.

Driving and using machines

Exoderil is not known to have any influence on the ability to drive or use machines.

Exoderil cutaneous solution contains propylene glycol

Exoderil cutaneous solution contains propylene glycol that can cause local skin irritation.

3. How to use Exoderil

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Exoderil cutaneous solution is for topical cutaneous use only.
Exoderil is applied 1 time per day.
Carefully clean and dry the treated area and surrounding areas of skin before the application of the medicine.
Apply a thin layer of Exoderil solution on and around the affected area.
After using Exoderil solution, wash your hands, as otherwise, you may transmit the infection to other areas of your body or to other people.
In order to prevent the recurrence of the disease, treatment should be continued for two weeks after clinical healing.
Symptoms of the disease can start receding after several days. Complete healing of the affected area can take up to 4 weeks.
Keep the affected area clean in order to facilitate healing by occasionally washing the affected area and drying carefully, without rubbing the skin. Even though the treated area can become itchy, try to avoid scratching, as this can cause new damage to the skin or propagate the infection.
If you feel that the effect of Exoderil cutaneous solution is too strong or too weak, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following incidence categories are used for evaluating side effects:
very common ≥ 1/10); common ≥ 1/100 to < 1/10); uncommon ≥ 1/1,010 to < 1/100); rare
^ 1/10,000 to < 1/1,000); very rare (< 1/10,000); unknown (cannot be estimated from available data)
General disorders and application site reactions
Unknown: dryness, redness and burning sensation

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Exoderil

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C.
After the initial opening, the cream can be stored for up to 4 weeks at 25 °C.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
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 Exoderil cutaneous solution contains

-   The active ingredient is naftifine hydrochloride. 1 mL of cutaneous solution contains 10 mg of naftifine hydrochloride.
-   The excipients are propylene glycol, ethanol and purified water.

What Exoderil cutaneous solution looks like and contents of the pack

Clear cutaneous solution in a dark glass bottle.
The bottle contains 10 mL of solution.

Marketing Authorisation Holder and Manufacturer

Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz d.d. Estonian branch Pärnu mnt 105 11312 Tallinn Phone: 6652400

This leaflet was last revised in August 2016.