Directions for use Lomexin 600 mg softgel vaginal capsule Box 1 unit
One 600 mg capsule, at bedtime, as a single administration. The capsule should be inserted deep into the vagina, preferably in a lying position. In case of recurrent or resistant mycosis, the administration can be renewed after three days. The treatment of the partner (foreskin and glans) will be discussed according to each case. Practical advice: - wash with a neutral or alkaline pH soap, - the treatment will be accompanied by hygiene advice (wear cotton underwear, avoid vaginal showers...) and as far as possible, the elimination of favouring factors, - to treat vulvar or perianal extensions of the mycosis, it is recommended to associate with gynecological ovules a locally applied antifungal milk or cream, - do not interrupt the treatment during menstruation.
Directions for use Lomexin 600 mg softgel vaginal capsule Box 1 unit
Contraindications:
- Hypersensitivity to any of the components (or cross-sensitivity to other members of the imidazole group).
- Use of latex condoms or diaphragms.
- Due to the presence of soy lecithin, this medication is contraindicated in cases of peanut or soy allergy.
Warnings
- In the absence of suggestive clinical symptoms, the mere presence of candida on the skin or mucous membranes does not in itself constitute an indication.
- Once candidiasis has been confirmed, a careful search must be made for ecological factors that allow and encourage the development of the fungus. In order to avoid relapses, eradication and management of the favouring factors is essential.
- It is desirable to treat simultaneously any associated candida focus, recognized pathogenic.
- This medicine contains parahydroxybenzoate and may cause allergic reactions (possibly delayed).
- This medicine contains soy lecithin and may cause hypersensitivity reactions (urticaria, anaphylactic shock).
Precautions for use
- In case of local intolerance or allergic reaction, the treatment should be stopped.
- It is not recommended to use a soap with an acid pH (pH favoring the multiplication of candidiasis) (see section Dosage and administration: Practical advice).
Pregnancy and lactation :
Pregnancy Oral studies in animals have not demonstrated a teratogenic effect but have shown fetotoxicity (see section Preclinical safety data). In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals in well-conducted studies in two species. In clinical studies, no particular malformative or fetotoxic effect has been observed to date. However, the follow-up of pregnancies exposed to fenticonazole is insufficient to exclude any risk. Therefore, as a precautionary measure, it is preferable not to use fenticonazole nitrate during pregnancy.
Breastfeeding In women, the absorption of fenticonazole nitrate through the vaginal mucosa is very low. The passage of fenticonazole nitrate from this topical form into breast milk is expected to be negligible.
Effects on ability to drive and use machines: No effect on the ability to drive and use machines has been observed.
Composition Lomexin 600 mg softgel vaginal capsule Box 1 unit
vaginal soft capsule: Fenticonazole nitrate 600 mg, i.e. Fenticonazole base 527.1 mg.
Excipients : Liquid kerosene, Light liquid kerosene, Soy lecithin, Gelatin, Glycerol, Titanium dioxide (E 171), Sodium ethyl parahydroxybenzoate, Sodium propyl parahydroxybenzoate (E 217), qsp 1 vaginal soft capsule.
Excipients with notorious effect: sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217), soya lecithin.
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