Zalain ovuli vaginal suppositories 0.3 g No. 1

Instructions Zalain ovuli vaginal suppositories 0.3 g No. 1

Composition

active ingredient: sertaconazole nitrate;

1 pessary contains sertaconazole nitrate 0.3 g;

excipients: solid semi-synthetic glycerides (Witepsol H19, Suppocire NAI 50), colloidal anhydrous silicon dioxide.

Dosage form

Pessaries.

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

Pharmacotherapeutic group

Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATX code G01 AF.

Pharmacological properties

Pharmacodynamics

Sertaconazole is an antifungal drug, an imidazole derivative, with high fungicidal activity, intended for topical use in gynecology. The mechanism of action is to inhibit the synthesis of ergosterol and increase the permeability of the cell membrane, which leads to the destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp. and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton and Microsporium spp.) and pathogens that cause infectious diseases of the skin and mucous membranes, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics

There is no systemic absorption. With vaginal application, the concentration of the active substance in the blood plasma did not reach the detection limit. After vaginal application of radiolabeled sertaconazole, no radioactivity was detected in the plasma.

Indication

Topical treatment of vaginal candidiasis.

Contraindication

• Hypersensitivity to antifungal agents, imidazole derivatives or to any of the excipients of the drug.
• The simultaneous use of the drug with latex condoms or a pessary (diaphragm) is contraindicated.

Interaction with other medicinal products and other types of interactions

When pessaries are used simultaneously with local contraceptives, their spermicidal effect may be reduced.

Concomitant use with latex condoms or pessaries is contraindicated due to the risk of damage to them.

Application features

If the diagnosis of candidiasis is confirmed, factors (hygienic or lifestyle) that contribute to the development and manifestations of the fungal infection should be identified and eliminated.

During treatment, to avoid relapses, it is not recommended to use soap with an acidic pH and douching. You should use mainly cotton underwear.

It is also advisable to apply the antifungal cream Zalain to the vulva and perineum.

It is recommended to abstain from sexual intercourse while using the drug. It is recommended to consider the possibility of simultaneous treatment of the sexual partner.

Treatment can 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 a local allergic reaction occurs.

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 presence of embryotoxicity and teratogenic effects of sertaconazole. Given the method of administration (single dose of treatment) and the lack of systemic absorption of the drug, the use of sertaconazole in pregnant women is possible, but only in cases where the expected benefit to the woman outweighs the potential risk to the fetus.

There is also no data on the penetration of sertaconazole into breast milk. Therefore, the drug should not be used during breastfeeding, except in cases where, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the child.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Method of administration and doses

Adult women should insert 1 pessary deeply into the vagina, preferably in the supine position, once in the evening before going to bed. If the clinical signs of the disease do not disappear, the drug can be repeated after 7 days.

Children

Zalain ovuli is not used in children.

Overdose

After vaginal use, overdose was practically not observed.

Side effects

Immune system disorders

Sometimes a transient local irritant reaction (burning sensation and itching) is possible. This may be a consequence of the action of cell fragments during the death of pathogens, so such a reaction may be a sign of successful therapy.

Reporting a suspected adverse reaction

Allergic reactions are common. Reporting suspected adverse reactions after a medicinal product has been authorised is important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product.

Expiration date

5 years.

Storage conditions

Store at a temperature not exceeding 30 °C out of the reach of children.

Packaging

1 pessary in a blister and in a cardboard box.

Vacation category

According to the recipe.

Producer

CJSC Pharmaceutical Plant EGIS, Hungary.

Trommsdorff GmbH & Co. KG, Germany.

Manufacturer's location and business address

1165, Budapest, Bekenfeldi Street, 118-120, Hungary.

Trommsdorffstrasse 2-6, 52477 Alsdorf, Germany.