Colpofix Vaginal Spray Gel

INDICATION

Prevention and treatment of cervical lesions caused by human papillomavirus (HPV) through a mechanism that regulates the physiological conditions of the so-called transformation zone, located in the vaginal part of the cervix.

DESCRIPTION

Colpofix® is an innovative product, both in terms of its composition and its method of use. It is a gel with thixotropic properties, which turns into a liquid under mechanical pressure during application, but returns to a gel form after application. The unique, ergonomic design of the applicator allows for an even and effective distribution of the mucus-adherent preparation on the surface and deep into the cervical-vaginal mucosa, thus avoiding reflux.
Colpofix® spray achieves its effectiveness in the indicated cases through several mechanisms:

• It forms a bioadhesive film that adheres to living tissues and protects the cervical-vaginal epithelial surface from the damaging effects of microbes from the external environment.
• By regulating the physiological conditions of the transformation zone located in the vaginal part of the cervix, it ensures proper tissue hydration, thereby promoting epithelial formation and the healing of lesions on the cervix.
• Thanks to its pH-regulating and prebiotic effects, it restores and maintains the health of the vaginal flora.

INGREDIENTS

Water, sorbitol, carboxymethyl beta-glucan, cross-linked acrylic polymer (polycarbophil), imidazolidinyl urea, sodium dehydroacetate

WARNING

The colour of the gel may change due to the presence of natural ingredients, however this change does not affect the quality of the product. The product is for vaginal use. Do not swallow. In case of suspected or confirmed pregnancy or concomitant topical medication, use the product only on the advice of your doctor or pharmacist. The product is not intended for pediatric use. Keep the product out of reach of children. As with any other topical product, this product may cause local sensitivity or irritation with long-term use. If this occurs, discontinue use and consult your doctor or pharmacist. Do not use the product if the packaging or applicator is damaged or not completely intact when first opened. Do not use the product after the expiry date. Use the product according to the instructions for use. The applicator should be discarded after a single use and should not be reused.

STORAGE

Store in a dry place, away from light and heat sources. The indicated expiration date applies to the unopened and properly stored product.

USER GUIDE

Do not shake the product before use.
Remove the vaginal applicator from its protective cover. Remove the cap from the spray bottle. Insert the applicator into the spray dispenser opening. To start the application, press the dispenser button until the product appears. Lying on your back with your knees drawn up, insert the applicator deep into the vagina. Do 5 puffs at a time. Discard the applicator after use. Close the spray bottle with its cap.

POSSIBLE SIDE EFFECTS

Do not use the product if you are hypersensitive to any of its ingredients or if you know of any incompatibility with them. Studies conducted with the product so far have not revealed any signs of hypersensitivity or other side effects. If you experience persistent discomfort during use, consult a doctor.

WHAT DOES COLPOFIX LOOK LIKE AND WHAT DOES THE PACKAGE CONTAINS?

Colpofix is available in the following 2 packages:

• Box containing one 20 ml bottle and 10 individually wrapped disposable applicators

Each applicator is for single use only.
Fragrance-free.
Colpofix® is a Class IIa medical device and complies with the requirements of Directive 93/42/EEC and subsequent amendments.
Do not dispose of the product via wastewater or household waste. Ask your pharmacist what to do with your unused medical products. These measures help protect the environment.

Last reviewed: September 2020

Manufacturer:  Uriach Italy, Srl A SOCIO UNICO
Assago Milanofiori, Sir. 1, Pal. F6 – 20057 Assago (Ml)