NOTICE
ANSM - Updated on: 29/07/2016
Name of the medicinal product
LOMEXIN 600 mg, soft vaginal capsule
Fenticonazole Nitrate
framed
Read all of this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS LOMEXIN 600 mg, soft vaginal capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU USE LOMEXIN 600 mg, soft vaginal capsule?
3. HOW TO USE LOMEXIN 600 mg vaginal soft capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LOMEXIN 600 mg vaginal soft capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS LOMEXIN 600 mg, soft vaginal capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
A synthetic antifungal belonging to the class of imidazoles.
Therapeutic indications
This medication is recommended in the local treatment of genital candidiasis (diseases due to microscopic fungi) superinfected or not by Gram + bacteria.
2. BEFORE YOU USE LOMEXIN 600 mg, soft vaginal capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use LOMEXIN 600 mg vaginal soft capsule in the following cases:
· Hypersensitivity to one component (or cross-sensitivity to other members of the imidazole group),
· For use with male condoms or latex diaphragms.
· If you are allergic (hypersensitive) to peanut or soybean, due to the presence of soy lecithin.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with LOMEXIN 600 mg, soft vaginal capsule:
Special warnings
Local treatment of mycosis is only one element of treatment. To avoid relapses, the search for factors favoring your doctor is essential.
This medicine contains parahydroxybenzoate and may cause allergic reactions.
Precautions for use
· Do not use acid soap for local hygiene (acidity promoting fungal growth) ( See practical tips in the section: How to use this medicine ).
· This treatment can cause local burning sensations and increased itching. Generally, these phenomena yield spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, consult your doctor.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
Do not use when using male condoms or latex diaphragms (risk of rupture).
Do not use with spermicidal products (risk of inactivation).
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
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.
In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect : Sodium parahydroxybenzoate, Sodium propyl parahydroxybenzoate (E 217), Soy lecithin.
3. HOW TO USE LOMEXIN 600 mg vaginal soft capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
A capsule at 600 mg at bedtime, in single administration.
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.
· To treat vulvar or perianal extensions of mycosis, it is recommended to associate with the gynecological ovules a milk or antifungal cream applied locally.
Method and route of administration
The capsule should be inserted deep into the vagina, preferably in the extended position.
The treatment of the partner (foreskin and glans) will be discussed according to each case.
Frequency and timing of administration of the drug
In the evening, at bedtime, a capsule will be inserted, placed deep in the vagina, preferably in the lying position.
In the case of recurrent or rebellious mycosis, administration may be repeated after three days.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Duration of treatment
The treatment consists of a single administration.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, LOMEXIN 600 mg, soft vaginal capsule is likely to have side effects, although not everyone is subject to it:
· possible local burning sensation, itching and possible allergy.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE LOMEXIN 600 mg vaginal soft capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use LOMEXIN 600 mg vaginal soft capsule after the expiry date which is stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does LOMEXIN 600 mg contain, soft vaginal capsule?
The active substance is :
Fenticonazole Nitrate ............................................... .................................................. 600.0 mg
Quantity corresponding to fenticonazole base ............................................. ...................................... 527.1 mg
For a soft vaginal capsule.
The other components are :
Liquid paraffin, light liquid paraffin, soy lecithin, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, soda propyl parahydroxybenzoate (E 217).
Pharmaceutical form and content
What is LOMEXIN 600 mg, soft vaginal capsule and contents of the pack?
This medication is in the form of a soft vaginal capsule. Box of 1 or 2 soft vaginal capsules.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
EFFIK
9/11, RUE JEANNE BRACONNIER
BUILDING "THE NEWTON"
92366 MEUDON LA FORET
exploiting
EFFIK
BUILDING "LE NEWTON"
9-11, RUE JEANNE BRACONNIER
92366 MEUDON LA FORET
Maker
EFFIK
BUILDING "LE NEWTON"
9-11, RUE JEANNE BRACONNIER
92366 MEUDON LA FORET
LA FRANCE
or
CATALENT ITALY SPA
VIA NETTUNENSE, KM 20, 100
04011 APRILIA (LT)
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.