In this manual :
1. WHAT IS LOMEXIN 600 mg, vaginal softgel and WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING LOMEXIN 600 mg, vaginal softgels?
3. HOW DO I USE LOMEXIN 600 mg, vaginal softgel?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE LOMEXIN 600 mg, vaginal softgel?
6. ADDITIONAL INFORMATION
1. WHAT IS LOMEXIN 600 mg, vaginal softgel and WHAT IS IT USED FOR?
Pharmacotherapeutic class
Synthetic antifungal agent belonging to the imidazole class.
This medicine is recommended for the local treatment of genital candidiasis (disorders caused by microscopic fungi) whether or not superinfected by Gram-positive bacteria.
2. WHAT DO YOU NEED TO KNOW BEFORE USING LOMEXIN 600 mg, vaginal softgels?
List of information needed before taking the medicine
Not applicable.
Never use LOMEXIN 600 mg, vaginal softgel in the following cases:
- Hypersensitivity to any of the components (or cross-sensitivity to other members of the imidazole group),
- If used with male condoms or latex diaphragms.
- If you are allergic (hypersensitive) to peanuts or soya, due to the presence of soya lecithin.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with LOMEXIN 600 mg, vaginal softgel:
Special warnings
Local treatment of the fungus is only one part of the treatment. To avoid relapses, it is essential that your doctor check for contributing factors.
This medicine contains parahydroxybenzoate and may cause allergic reactions.
Precautions for use
- Do not use acidic soap for local hygiene (acidity promotes the growth of fungi) (See practical advice in the section: How to use this medicine).
- This treatment may cause local burning and increased itching. Generally, these phenomena cease spontaneously with continued treatment. If the symptoms persist beyond 24 to 48 hours, consult your doctor.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines:
Do not use with male condoms or latex diaphragms (risk of rupture).
Do not use with spermicidal products (risk of inactivation).
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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 judge whether it is necessary to continue the treatment.
In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notorious effect : sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217), soya lecithin.
3. HOW TO USE LOMEXIN 600 mg, vaginal softgel?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
One 600 mg capsule at bedtime, as a single administration.
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.
- To treat vulvar or perianal extensions of the mycosis, it is recommended to combine gynaecological ova with a locally applied antifungal milk or cream.
Method and route of administration
The capsule should be inserted deep into the vagina, preferably in a lying position.
Treatment of the partner (prepuce and glans) should be discussed on a case-by-case basis.
Frequency and timing of administration
In the evening, at bedtime, a capsule should be inserted, placed deep in the vagina, preferably in a lying position.
In case of recurrent or resistant mycosis, the administration can be renewed after three days.
IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR'S PRESCRIPTION.
Duration of treatment
The treatment consists of a single administration.
IN ALL CASES STRICTLY ADHERE TO 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 600 mg, vaginal softgel is likely to have undesirable effects, although not everyone is subject to them:
- possible occurrence of local burning, itching and possible allergy.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE LOMEXIN 600 mg, vaginal softgels?
Keep out of the reach and sight of children.
Do not use LOMEXIN 600 mg, vaginal softgel after the expiry date stated on the outer packaging.
No special storage conditions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the 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 600 mg, vaginal softgel contain?
The active substance is:
Fenticonazole nitrate .................................................................................................................. 600.0 mg
Amount corresponding to fenticonazole base ................................................................................... 527.1 mg
For one vaginal softgel.
The other components are:
Liquid paraffin, light liquid paraffin, soya lecithin, gelatine, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217).
Pharmaceutical form and content
What is LOMEXIN 600 mg, vaginal softgel and what does it contain?
This medicine is presented as a vaginal softgel. Box of 1 or 2 vaginal softgels.
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
Operator
EFFIK
LE NEWTON" BUILDING
9-11, RUE JEANNE BRACONNIER
92366 MEUDON LA FORET
Manufacturer
EFFIK
LE NEWTON" BUILDING
9-11, RUE JEANNE BRACONNIER
92366 MEUDON LA FORET
Names of the medicinal product in the member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
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