Ginetantum 0.1% 5×140 ml vaginal solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Vulvovaginitis of any origin and nature, characterized by small vaginal discharge, itching, irritation, burning and vulvar pain. Intimate hygiene during the puerperium.

ACTIVE INGREDIENTS

100 ml contain: Active ingredient: benzydamine hydrochloride 100 mg (equal to 89.46 mg of benzydamine). Excipient with known effect: benzalkonium chloride, rose perfume base (Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Citral, Citronellol, Eugenol, Farnesol, Geraniol, Limonene, Linanool). For the full list of excipients, see section 6.1.

EXCIPIENTS

Benzalkonium chloride, disodium edetate, basic rose perfume, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1 or to closely related substances from a chemical point of view.

DOSAGE

Dosage 1-2 vaginal irrigations per day for seven consecutive days. The solution can be used at room temperature. If you want to warm it up, just expose the closed bottle to a jet of hot water for a few minutes.

CONSERVATION

This medicinal product does not require any special storage conditions. Store the bottle in an upright position.

WARNINGS

The use, especially if prolonged, of topical products could give rise to sensitization phenomena, in which case it is necessary to suspend treatment and adopt suitable therapeutic measures. Invite the patient to contact the doctor before use in case of vaginal bleeding and/or leukorrhea.

INTERACTIONS

No negative interactions have been observed with other drugs commonly used in the relevant therapy.

SIDE EFFECTS

Occasionally, especially with prolonged use of the product, skin irritation may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Intoxication is expected only in case of accidental ingestion of large quantities of benzydamine (>300 mg). The symptoms associated with overdose from ingestion of benzydamine are mainly gastrointestinal in nature and affect the central nervous system. The most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and esophageal irritation. Central nervous system symptoms include dizziness, hallucinations, agitation, anxiety, and irritability. In case of acute overdose, only symptomatic treatment can be carried out. Patients should be kept under close observation, and should receive supportive treatment. Adequate hydration must be maintained.

PREGNANCY AND BREASTFEEDING

There are no contraindications to the topical use of benzydamine during pregnancy or during breastfeeding.

EFFECTS ON DRIVING ABILITY

Ginetantum does not affect the ability to drive or use machines.