Local treatment of vaginitis due to sensitive germs and treatment of non-specific vaginitis.
The official recommendations concerning appropriate use of antibacterial products must be taken into
consideration.
 

Posology
FOR ADULTS ONLY
One vaginal capsule in the evening for 12 days.
Method of administration
Introduce one capsule deep in the vagina, preferably in lying down position.
Practical advice:
 The treatment should be associated with hygiene advice (wearing cotton underwear, avoiding vaginal
douches, avoiding the use of an internal tampon during treatment…) and, as far as possible, elimination of
contributing factors.
 Treating the partner must be discussed on a case by case basis.
 Do not discontinue the treatment during menstruation periods.
 

Warnings
In the event of local intolerance or allergic reaction, the treatment must be interrupted.
The sensitisation to antibiotics by local route may compromise the later use of the same antibiotic or related
antibiotics when administered by the systemic route.

Precautions for use
The duration of treatment should be limited because of the risk of selecting resistant germs and the risk of
superinfection by these germs.
In the absence of data on the importance of neomycin and polymyxin B fractions resorbed by the mucosa, the
risk of systemic effects, especially increased in case of renal insufficiency, cannot be excluded.
This medicinal product contains soybean oil and may cause hypersensitivity reactions (urticaria, anaphylactic
shock).
 

Contraindicated combinations
+ Condoms and Diaphragms (latex)
Risk of rupture.
Combinations not recommended:
+ Spermicide
Any local vaginal treatment is likely to inactivate a local spermicidal contraception.
 

Pregnancy
Due to the presence of an aminoside, neomycin, which can cause an ototoxic risk, and the possibility of its
systemic absorption, the use of this medicinal product is not recommended during pregnancy.
Lactation
Due to the digestive immaturity of the newborn and the pharmacokinetic properties of this medicinal product, its
prescription is not recommended during lactation.

Not relevant.
 

Possibility of contact allergic eczema, this occurs more frequently with long-term use. These lesions may spread
far from the treated areas.
The risk of occurrence of toxic systemic effects (renal, auditory) is limited, due to the short duration of treatment
recommended.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to
report any suspected adverse reactions via relevant competent national authority.
- To report any side effect(s):

An excessive and prolonged administration may produce systemic effects (auditory and renal), in particular in
patients with renal insufficiency. A prolonged use also entails an increased risk of allergic eczema.
 

Pharmacotherapeutic group: ANTIINFECTIVES and ANTISEPTICS IN GYNECOLOGICAL USE (G.genitourinary system and sex hormones), ATC code: G01AA51.
Combination of neomycin, polymyxin B and nystatin.
Neomycin is an aminoside antibiotic.
Polymyxin B is a polypeptide antibiotic.
Nystatin is an antifungal with anticandida activity.
ANTIBACTERIAL ACTIVITY SPECTRUM OF POLYMYXIN B AND NEOMYCIN
POLYMYXIN B
Critical concentrations separate sensitive strains from strains with intermediate sensitivity and the latter from
resistant strains:
S≤ 2 mg/l and R > 2 mg/l
The prevalence of acquired resistance may vary with geographical location and time for certain species. It is
therefore useful to have information on the prevalence of local resistance, in particular when treating severe
infections. These data can only be used as an orientation for the probabilities of sensitivity of a bacterial strain to
this antibiotic.
When the variability of the prevalence of resistance is known in France for a bacterial species, it is provided in
the following table:

NEOMYCIN
The prevalence of acquired resistance may vary with geographical location and time for certain species. It is
therefore useful to have information on the prevalence of local resistance, in particular when treating severe
infections. These data can only be used as an orientation for the probabilities of sensitivity of a bacterial strain to
this antibiotic.
When the variability of the prevalence of resistance is known in France for a bacterial species, it is provided in
the following table:

*The frequency of resistance to methicillin is approximately 30 to 50% of all staphylococci and is mainly
encountered in hospitals.
Remark: these spectra correspond to those of the systemic forms of these antibiotics. With local pharmaceutical
presentations, concentrations obtained in situ are much higher than plasma concentrations. There is some
remaining uncertainty concerning kinetics of in situ concentrations, local physicochemical conditions which can
alter the antibiotic activity and product stability in situ.

Not provided.
 

Not provided
 

PEG-6 stearate and glycol stearate and PEG-32 stearate (Tefose 63), hydrogenated soybean oil, dimeticone
1000.
Composition of the shell soft capsule: gelatine, glycerol, dimeticone 1000.
 

Not applicable.
 

Capsule under blister PVC/PE/PVDC/aluminium: Do not store above 30°C.
 

12 capsules under blister (PVC/PE/PVDC/aluminium).
Not all pack sizes may be marketed.
 

No special requirements.