NOTICE
ANSM - Last updated: 06/03/2017
Name of the medicinal product
LOMEXIN 2% cream
Fenticonazole Nitrate
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement.
Do not use this medication for children.
What is in this leaflet?
1. What is LOMEXIN 2%, cream and in which cases is it used?
2. What should I know before using LOMEXIN 2%, cream?
3. How to use LOMEXIN 2%, cream?
4. What are the possible side effects?
5. How to store LOMEXIN 2%, cream?
6. Package contents and other information.
1. WHAT LOMEXIN 2%, cream AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code: D01AC12
This medication is recommended in the treatment or adjunctive treatment of certain skin conditions or mucous membranes (mycoses), due to microscopic fungi (candidoses, dermatophyties, pityriasis versicolor)
2. WHAT TO DO ABOUT BEFORE USING LOMEXIN 2%, cream?
Never use LOMEXIN 2%, cream:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6 (or cross-sensitization with other imidazole group members).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before using LOMEXIN 2%, cream .
Prolonged use may cause sensitization reactions, or irritation. If such reactions occur, use of the product should be discontinued.
Avoid contact with the eye.
Tell your doctor if you have an allergy to imidazole.
This medicine contains lanolin and may cause local skin reactions (eg, eczema).
This medicine contains cetyl alcohol and may cause local skin reactions (eg, eczema).
This medicine contains propylene glycol and may cause skin irritation.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
Not applicable.
Other medicines and LOMEXIN 2%, cream
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
LOMEXIN 2%, cream with food and beverages
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Sport
Not applicable.
Driving and using machines
Not applicable.
LOMEXIN 2%, cream contains propylene glycol, lanolin and cetyl alcohol.
3. HOW TO USE LOMEXIN 2%, cream?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Apply the cream regularly to the lesions to be treated once a day for the duration recommended by the doctor according to the mycosis.
Practical advice
· In the case of candidiasis, the toilet is to be performed with a soap at neutral or alkaline pH.
· In gynecology, treatment will be accompanied by hygiene advice (wearing cotton underwear, avoiding vaginal showers ...) and, as far as possible, the removal of favorable factors.
Do not stop treatment during menstruation.
This is a drug for local use.
If you used more than 2% LOMEXIN, cream you should:
Not applicable.
If you forget to use LOMEXIN 2%, cream:
Not applicable.
If you stop using LOMEXIN 2%, cream:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
· local manifestations of intolerance, itching and irritation, burning sensation, redness,
· rarely, possibility of passage of the active principle of this drug into the blood circulation, in particular when applied to injured skin, an extended surface or in the infant.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE LOMEXIN 2%, cream?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What LOMEXIN contains 2%, cream
· The active substance is:
Fenticonazole Nitrate ............................................... .................................................. ... 2,000 g
Quantity corresponding to fenticonazole base: ............................................ ...................... 1.757 g
For 100 g of cream
· The other excipients are: propylene glycol, hydrogenated lanolin, almond oil, polyglycol esters of fatty acids, cetyl alcohol, glycerol monostearate, sodium edetate (E 385), purified water.
What is LOMEXIN 2%, cream and contents of the pack
This medication is in the form of a cream; 15 g or 30 g tube.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EFFIK
BUILDING "LE NEWTON"
9/11 RUE JEANNE BRACONNIER
92366 MEUDON-LA-FORET
LA FRANCE
Marketing Authorization Operator
EFFIK
BUILDING "LE NEWTON"
9/11 RUE JEANNE BRACONNIER
92366 MEUDON-LA-FORET
LA FRANCE
Maker
EFFIK
BUILDING "LE NEWTON"
9/11 RUE JEANNE BRACONNIER
92366 MEUDON-LA-FORET
LA FRANCE
Or
Schering-Plow
2, rue Louis Pasteur
14200 HEROUVILLE SAINT CLAIR
la France
Or
CHEMINEAU Laboratories
93, route de Monnaie
37210 VOUVRAY
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).