Therapeutic indications
This medicine is recommended for the treatment or supplementary treatment of certain skin or mucous membrane disorders (mycoses) caused by microscopic fungi (candidiasis, dermatophytes, pityriasis versicolor).
2. WHAT YOU SHOULD KNOW BEFORE USING LOMEXIN 2 PER CENT, cream
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use LOMEXIN 2 PER CENT cream in the following cases:
Allergyto any of the components (or cross-sensitivity to other members of the imidazole group).
IF IN DOUBT, SEEK THE ADVICE OF YOUR PHYSICIAN OR PHARMACIST.
Precautions for use; special warnings
Use caution with LOMEXIN 2 PER CENT, cream:
Special Warnings
Prolonged use may cause sensitization reactions or irritation. If such reactions occur, the product should be discontinued.
Precautions for use
Avoid contact with the eye.
Tell your doctor if you have a history of allergy to imidazoles.
This medicine contains lanolin and may cause local skin reactions (e.g. eczema).
This medicine contains cetyl alcohol and may cause local skin reactions (e.g. eczema).
This medicine contains propylene glycol and may cause skin irritation.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medications:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue the treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: propylene glycol, lanolin, cetyl alcohol.
3. HOW TO USE LOMEXIN 2 PER CENT, cream
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Apply the cream regularly to the lesions to be treated, once a day for the duration recommended by the doctor depending on the mycosis.
Practical advice:
In the case of Candidiasis, washing should be done with a neutral or alkaline pH soap.
In gynaecology, the treatment should be accompanied by hygiene advice (wear cotton underwear, avoid vaginal showers, etc.) and, as far as possible, the elimination of favourable factors. Do not interrupt the treatment during menstruation.
Method of administration
This is a topical drug.
Duration of treatment
IN ALL CASES, FOLLOW YOUR DOCTOR'S PRESCRIPTION.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LOMEXIN 2 PER CENT cream may have adverse reactions, although not everyone is susceptible:
-local manifestations ofintolerance, itching and irritation, burning, redness,
Theactive ingredient of this medicine may pass into the bloodstream, especially when applied to injured skin, large areas or infants.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW DO I USE LOMEXIN 2 PER CENT CREAM?
Keep out of the reach and sight of children.
Expiry date
Do not use LOMEXIN 2 PER CENT cream after the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does LOMEXIN 2 PER CENT cream contain?
The active substance is:
Fenticonazole nitrate .................................................................................................................... 2,000 g
Quantity corresponding to fenticonazole base ...................................................................................... 1.757 g
For 100 g of cream.
The other components are:
Propylene glycol, hydrogenated lanolin, almond oil, polyglycol esters of fatty acids, cetyl alcohol, glycerol monostearate, sodium edetate (E 385), purified water.
Pharmaceutical form and content
What is LOMEXIN 2 PER CENT cream and what does it contain?
This medicinal product is presented in the form of a cream; tube of 15 g or 30 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
EFFIK
9/11, RUE JEANNE BRACONNIER
LE NEWTON" BUILDING
92366 MEUDON-LA-FORET