Biguanelle

Biguanelle is available in two forms that allow precise adaptation to the type of condition:

• Biguanelle gel, 30 ml – intended for application to the skin or mucous membranes, this gel is ideal for the treatment of vulvitis and balanitis, even in cases with skin lesions. The gel has a pH stabilised at 4.0 and is fragrance-free, which reduces the risk of hypersensitivity reactions.
• Biguanelle isotonic gynaecological solution, 100 ml – ready-to-use solution, packaged in single-dose vials with a vaginal cannula. This format is intended for vaginal administration and supports the restoration of the physiological vaginal balance, and is also indicated after minimally invasive gynaecological procedures.

Biguanelle is indicated for the treatment of:

• Vulvovaginitis and cervicovaginitis of various aetiologies (bacterial, fungal or non-specific)
• Vulvitis and balanitis, including in the presence of skin or mucosal lesions
• During the post-operative re-epithelialisation process (laser, cryotherapy)
• As an adjunctive measure in maintaining intimate hygiene during periods of increased risk of infection

Biguanelle should be administered according to the doctor's recommendations, following the instructions on the package:

• For Biguanelle gel, apply a sufficient amount locally to the affected area, which should be cleaned and dried beforehand. It can be reapplied 1–2 times a day, depending on the severity of the symptoms.
• For Biguanelle solution, a single dose is recommended, with the possibility of repeating after 4 days, depending on clinical assessment. It is inserted intravaginally using the cannula, preferably in the evening, in a lying position.

Biguanelle is contraindicated in people with known hypersensitivity to any of the product's excipients or to polyhexamethylene biguanide hydrochloride.

Oral or ocular use should also be strictly avoided.

The product should be kept out of the reach of children and is not intended for paediatric use without medical advice.

It is essential that the product is used exclusively for its intended purpose – topical or vaginal application, depending on the pharmaceutical form.

It is important to note that the gynaecological solution is a single-use product – after application, the bottle must be discarded, even if there is unused liquid remaining.

Biguanelle is very well tolerated thanks to its non-irritating composition, which is free from fragrances and other common allergens. However, in rare cases, local hypersensitivity reactions may occur, such as itching, erythema or a slight burning or stinging sensation at the application site.

These reactions are usually transient and resolve spontaneously. If symptoms persist or worsen, treatment should be discontinued and a doctor consulted.

To date, no significant interactions of Biguanelle with other topical or systemic medications have been reported.

However, caution is recommended when using other vaginal or skin products (creams, ovules, gels) at the same time, as changes in local pH or interactions between excipients may occur.

As Biguanelle acts locally and is not absorbed systemically in relevant amounts, the risk of overdose is minimal. However, excessive application may cause local discomfort or imbalance of the local flora. Accidental ingestion of the solution or gel requires emergency medical attention.

Biguanelle should be stored at temperatures between 5 and 25°C, away from direct light and heat sources. Once opened, the product should be used immediately and the bottle should be discarded, in the case of the single-dose format. Do not use after the expiry date stated on the packaging.

• PubMed, Lactic acid products for bacterial vaginosis and their impact on the vaginal microbiota: A systematic review
• PubMed, Treatment of bacterial vaginosis with polyhexamethylene biguanide hydrochloride (Biguanelle)
• Sage Journals, Polyhexamethylene biguanide hydrochloride (PHMB) - properties and application as an antiseptic agent. A narrative review
• MDPI, Evaluation of the in vitro and in vivo efficacy of an antiseptic solution based on polyhexamethylene biguanide and cross-linked hyaluronic acid