SUMMARY OF PRODUCT CHARACTERISTICS

French National Agency for the Safety of Medicines and Health Products - Updated: 06/06/2016

1. NAME OF THE MEDICINAL PRODUCT

MONAZOL, vaginal suppository

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sertaconazole nitrate 0.300 g

Per suppository.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Vaginal suppository.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Topical treatment of Candida infections of the vaginal mucosa.

In the absence of an suggestive clinical symptoms, the sole finding of yeast (Candida ...) on the vaginal
mucosa cannot constitute an indication in itself.

4.2. Dosage and method of administration

One suppository at bedtime, in a single administration inserted deep into the vagina, preferably while
laying on your back.

In case of persistence of clinical signs, a second suppository should be inserted applied after a 7-day
interval.

Practical advice:

 External genital wash with neutral or alkaline pH soap,

 The treatment, will be accompanied by hygiene tips (wearing cotton underwear, avoiding vaginal
douching ...) and if possible, the removal of the contributing factors,

 To treat vulvar or perianal spread of mycosis, it is recommended to combine a topically applied

antifungal cream with gynecological suppositories,

 Treatment of your partner will be discussed according to each case,

  Treatment will not be interrupted during menstruation.

4.3. Contraindications

 Hypersensitivity to an antimycotic agent of the imidazole group or to any of the excipients.

 Use of latex condoms or diaphragms.

4.4. Special warnings and precautions to use

 Confirmed candidiasis, it is necessary to look carefully for the ecological factors allowing and favoring
the development of the mushroom.

 To avoid relapses, eradication and consideration of putting contributing factors into consideration, is
essential.

 It is desirable to simultaneously treat any associated pathogenic Candida outbreak.

Precautions for use

 In case of local intolerance or allergic reaction, the treatment will be interrupted.

 It is not recommended to use an acidic pH soap (pH promoting the multiplication growth of
candidiasis) (see section 4.2).

4.5. Interaction with other medicinal products and other forms of interaction

Contraindicated combinations

+latex condoms and diaphragms:

Risk of rupture of the condom or diaphragm.

Combinations not recommended

+ Spermicides:

Any topical vaginal treatment may inactivate local spermicidal contraception.

4.6. Pregnancy and breast-feeding Pregnancy

Animal studies have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a
malformative effect is not expected in humans. Indeed, to date, the substances responsible for
malformations in humans have proved to be teratogenic in animals in well-conducted studies on two
species.
 Clinically, there is currently no relevant data on the possible malformative or fetotoxic effects of
sertaconazole when administered during pregnancy.

Accordingly, considering its method of administration (single dose) and the absence of systemic passage,
the use of sertaconazole should be considered during pregnancy only if necessary.

Breast-feeding

There is no data on the passage of sertaconazole in breast milk. Due to an extremely weak systemic passage,
breast-feeding is possible.

4.7. Effects on ability to drive and use machines

No effect on the ability to drive and use machines has been reported.

4.8. Undesirable effects

Rare:

 Manifestation of local intolerance: sensations of burning or pruritus exacerbation usually disappearing

with continued treatment.

 Possibility of allergy.

4.9. Overdose

No case of overdose has been reported. However, excessive use may result in an exacerbation of adverse
effects.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: TOPICAL ANTIFUNGAL.

(G: Genito-urinary system and sex hormones).

Sertaconazole is an antifungal of the imidazole group.

Its in-vitro activity has been demonstrated on yeasts of the genus Candida.

The mechanisms of action are is identical to those of other derivatives of the group; they essentially pass work
through the inhibition of ergosterol synthesis. Antimycotic activity has been observed in vivo in classical
animal models. Sertaconazole has an antibiotic effect against Gram + organisms.

5.2. Pharmacokinetic properties

 Plasma concentrations measured after application to the vaginal mucosa are always below the limit of
quantification by using high performance liquid chromatography.

No radioactivity has been detected in the plasma after the administration of labeled product on the vaginal
mucosa.

5.3. Preclinical safety data

Long-term toxicity studies show that sertaconazole has a very low toxicity in animals and qualitatively
identical to that of other antifungal imidazoles.

The comparison between the plasma levels observed during these studies and the limit of quantification
ever reached in humans makes it possible to conclude that there is a very wide margin of safety.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Solid semi-synthetic glycerides (WITEPSOL H19), solid semi-synthetic glycerides (SUPPOCIRE

NA150), colloidal anhydrous silica.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years

6.4. Special precautions for storage

No special precautions for storage.

6.5. Nature and contents of container

1 Suppository in a thermoformed blister pack (PVC/PE)

2 Suppositories in a thermoformed blister pack (PVC/PE)

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

 FERRER INTERNACIONAL, S.A
GRAN VIA CARLOS III, 94
08028 BARCELONA
SPAIN

8. MARKETING AUTHORIZATION NUMBER(S)

 341 952-1 or 34009 341 952 1 1 :1 suppository in a thermoformed blister pack (PVC/PE).

 419 995-5 or 34009 419 995 5 0: 2 suppositories in a thermoformed blister pack (PVC/PE).

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[to be completed by the holder]

10. DATE OF REVISION OF THE TEXT

[to be completed by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.
 PRESCRIPTION AND DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.