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Sertagyn 300 mg Vaginal Ovule

  • Ferrer Internacional S.A.
  • 033928019
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Sertagyn vaginal ovule is a concentrated treatment indicated for the treatment of vaginitis and candida. Only treatment that can be repeated after 7 days.



















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SERTAGYN 300 mg ovule

Therapeutic indications

Local treatment of clinically proven vaginal candidiasis.

Dosage and method of use

Introduce the egg deeply into the vagina, preferably in a supine position, in the evening at bedtime. The treatment involves a single administration. If symptoms persist, a second egg can be introduced 7 days later.

Contraindications

Hypersensitivity towards the components or other substances closely related from a chemical point of view. In particular towards antifungals of the imidazole group. Generally contraindicated during pregnancy and breastfeeding (see "Pregnancy and breastfeeding" paragraph).

Side effects

Rarely, manifestations of local intolerance have been reported, such as a burning or itching sensation, which generally resolved spontaneously. Allergy phenomena are possible. Rarely, an increase in liver enzymes has been reported.

Special warnings

In the case of candidiasis also involving the vulvar and/or perianal areas, it is advisable to combine therapy with sertaconazole in ovules for vaginal use with local treatment with another antifungal. In order to prevent reinfections with the so-called ping-pong mechanism, treating the partner with antifungals is also essential. For local hygiene we recommend the use of soaps with a neutral or alkaline pH, as soaps with an acidic pH can encourage the proliferation of Candida. In case of local intolerance or allergic reaction, the treatment must be interrupted and the residual product can be removed by vaginal irrigation. The use of the product may interfere with the effectiveness of latex contraceptive devices (condoms and diaphragms), as it may cause them to break. The product can also be used during the menstrual period.

Pregnancy and breastfeeding

Imidazole antifungals, despite their minimal systemic absorption, are generally not recommended during pregnancy as undesirable effects on the fetus have been reported in animal studies. However, studies carried out with sertaconazole on various animal species have not shown embryotoxic and/or teratogenic effects. There are no adequate and well-controlled studies on the use of the medicine during pregnancy or breastfeeding. Therefore the medicine must be used only if necessary, under the direct supervision of the doctor, after having evaluated the expected benefit for the mother in relation to the possible risk for the fetus or infant.

Expiration and conservation

Do not store above 30°C.

Interactions with other drugs

The concomitant use of spermicides is not recommended, as the product can reduce or inactivate their contraceptive activity.

Overdose

Phenomena related to overdose of the drug are not foreseeable.

Active principles

One egg contains: Active ingredient: sertaconazole nitrate 300 mg.

Excipients

Solid semi-synthetic glycerides (WITEPSOL H19), solid semi-synthetic glycerides (SUPPOCIRE NAI-50), anhydrous colloidal silica.

033928019

Data sheet

Packaging
1 vaginal suppository 300 mg
Product Type
HUMAN DRUG
ATC code
G01AF19
ATC description
Sertaconazole
Therapeutic Group
Antifungals
Active principle
sertaconazole nitrate (FU)
Class
C.
Pharmaceutical form
ovum
Type of Administration
vaginal
Container
alveolus
Quantity
1 ova
Quantity of the Active Ingredient
300MG
Recipe required
SOP - non-prescription medicine
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