ZALAIN OVULI

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ZALAIN OVULO (ZALAIN OVULO)

Composition:

Active substance: sertaconazole nitrate;

1 suppository contains sertaconazole nitrate 0.3 g;

Excipients: solid semisynthetic glycerides (Witepsol H19, Suppocire NAI 50), colloidal anhydrous silicon dioxide.

Pharmaceutical form. Suppositories.

Main physicochemical properties: oval, waxy suppository of white or almost white color.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATC code G01AF.

Pharmacological properties.

Pharmacodynamics.

Sertaconazole is an antifungal agent, an imidazole derivative, with high fungicidal activity, intended for topical use in gynecology. Its mechanism of action involves inhibition of ergosterol synthesis and increased cell membrane permeability, leading to destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp., and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton, and Microsporum spp.), and pathogens causing skin and mucous membrane infections, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics.

Systemic absorption is absent. After vaginal administration, the concentration of the active substance in plasma does not reach the limit of detection. After vaginal administration of radiolabeled sertaconazole, radioactivity was not detected in plasma.

Clinical characteristics.

Indications.

Local treatment of vaginal candidiasis.

Contraindications.

• Hypersensitivity to antifungal agents, imidazole derivatives, or to any excipients of the drug.
• Concomitant use of the drug with latex condoms or diaphragms is contraindicated.

Interaction with other medicinal products and other forms of interaction.

When diaphragms are used concomitantly with local contraceptives, a reduction in their spermicidal effect may occur.

Concomitant use with latex condoms or diaphragms is contraindicated due to the risk of damaging them.

Special precautions for use

If the diagnosis of candidiasis has been confirmed, it is necessary to identify and eliminate contributing factors (hygienic or lifestyle-related) that promote the development and manifestation of fungal infection.

During treatment, to prevent recurrences, the use of acidic pH soaps and douching is not recommended. It is advisable to wear predominantly cotton underwear.

It is also advisable to apply the antifungal cream Zalain to the vulvar and perineal areas.

Sexual intercourse should be avoided during treatment. Simultaneous treatment of the sexual partner should be considered.

Treatment may be carried out during menstruation.

It is also recommended to treat other pathogenic microorganisms that may be associated with candidiasis.

Treatment should be discontinued if local allergic reactions occur.

In the absence of characteristic clinical signs of vaginal candidiasis, a positive microbiological test result alone is not an indication for treatment.

Use during pregnancy or breastfeeding

There are no data on the embryotoxic or teratogenic effects of sertaconazole. Due to the route of administration (single treatment dose) and the absence of systemic absorption of the drug, sertaconazole may be used during pregnancy, but only when the expected benefit to the woman outweighs the potential risk to the fetus.

There are also no data on the passage of sertaconazole into breast milk. Therefore, during breastfeeding, the drug should not be used, except when, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the infant.

Ability to affect reaction speed while driving or operating machinery

No effect.

Method of administration and dosage.

For adult women: 1 suppository should be inserted deeply into the vagina, preferably while lying on the back, in the evening before bedtime, as a single dose. If clinical signs of the disease do not disappear, the treatment may be repeated after 7 days.

Children.

Zalain ovuli are not used in children.

Overdose.

Overdose has practically not been observed after vaginal administration.

Adverse Reactions

Immune system disorders

Occasionally, a transient local irritant reaction (burning sensation and itching) may occur. This may result from cellular fragments released during pathogen destruction; therefore, such a reaction could be a sign of successful therapy.

Reporting suspected adverse reactions

Allergic reactions are not uncommon. Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product.

Shelf life

5 years.

Storage conditions

Store at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging

1 suppository per blister, in a cardboard box.

Prescription status

Prescription only.

Manufacturer

Egis Pharmaceuticals Ltd., Hungary.

Stada Arzneimittel AG, Germany.

Manufacturer's address and place of business

1165 Budapest, Bekéscsaba Street 118-120, Hungary.

Thrommsdorffstraße 2-6, 52477 Alsdorf, Germany.