Colpofix – composition, action, indications, contraindications, side effects

Colpofix® is a medical device used in gynecology to prevent and treat cervical lesions caused by HPV, which is responsible for almost all cases of cervical cancer. It is in the form of a vaginal spray gel, applied with a cannula, which guarantees even distribution of the preparation.

Its operation has been proven in four clinical trials involving over two thousand women. Colpofix is ​​indicated for use in the case of low grade cervical lesions and after cervical procedures.

Colpofix – characteristics

Colpofix® is a medical device whose formula and method of use were developed in Italy, from where it found its way to many European pharmaceutical markets. Colpofix® is a spray gel with thixotropic properties. This means that under standard conditions, the preparation in the bottle is in the form of a gel. When the dosing pump is pressed, due to mechanical compression, the gel turns into a liquid and is applied with a cannula to the target place, where it decompresses and the preparation takes the form of a gel again. This feature allows for deep and even distribution of the gel in the place of its operation, but also prevents the preparation from flowing out.

Colpofix – composition

The active substances of the preparation are: carboxymethyl-beta-glucan, a synthetic high-molecular polymer of acrylic acid and polycarbophil, i.e. a cross-linked polymer of acrylic acid. The product also contains water, sorbitol, imidazolidine urea, and sodium dehydroacetate.

Colpofix – action

Colpofix® is a vaginal spray gel, the action of which is based on two components: carboxymethyl-beta-glucan and polycarbophil.

Carboxysmethyl beta-glucan stimulates the immune system, thus reducing the risk of recurrence of infections. It directly binds and activates TLR receptors (Toll like receptors) present on the surface of cells of the immune system, which, when activated, secrete cytokines (proteins involved in the immune response) and also activate NK (natural killer) lymphocytes and T lymphocytes. healing and reconstruction of damaged epithelium, which is related to the movement of macrophages, the effect of which is stimulation of tissue granulation, collagen deposition and reconstruction of existing epithelial defects.

It is also responsible for restoring and maintaining the correct vaginal microbiota, being a source of energy for Lactobacillus sp. Bacteria, thanks to which it supports the growth of lactobacilli, providing them with a quantitative advantage over other bacteria inhabiting the vaginal microbiota.

Polycarbophil is responsible for the consistency of the gel and its bioadhesiveness. It forms a tightly adhering protective film on the surface of the epithelium, which helps to maintain the integrity of the epithelium and thus prevent the penetration of the HPV virus into its basal layer. In addition, it supports the maintenance of normal vaginal microbiota – after the gel adheres to the mucosa, hydrogen ions (H +) are released from polycarbophil particles. Their acidic nature contributes to lowering the pH, i.e. acidifying the vaginal environment, which ensures optimal conditions for the microbiota.

Colpofix – indications

Colpofix® is indicated for the prevention and treatment of cervical lesions caused by the human papillomavirus – HPV.

Colpofix® can be used for:

1. HPV infection – promotes faster resolution of the infection;
2. small-scale changes ASC-US / LSIL / CIN1 – is an alternative to the “wait and watch” strategy, it promotes faster reversal of changes;
3. high-grade lesions ASC-H / H-SIL / CIN2 / CIN3 – supports the reconstruction and regeneration of damaged epithelium as a result of the procedures performed, stimulates the immune system, which reduces the risk of re-infection.

Colpofix – contraindications

Colpofix® should not be used if you are allergic to any of the ingredients. Being pregnant or breast-feeding, the decision to start treatment with Colpofix® or to use other vaginal medications at the same time should be consulted with the attending physician.

Colpofix – dosage

Colpofix®, according to the manufacturer’s instructions, should be used once a day, at night, for 20 days a month. During 1 application, 5 actuations of the dispenser are made. It is worth taking a 10-day break in using the preparation during menstruation to ensure comfortable therapy.

Unless the doctor has indicated a different duration of use, the recommended period of use of Colpofix® is from 3 to 6 months. After 6 months from the start of treatment, a regression of CIN1 changes was observed in 95,7% of the studied patients.

Colpofix – directions for use

Do not shake the product before use. During application, follow the steps below:

1. pull the vaginal applicator out of the protective film;
2. unscrew the bottle cap;
3. place the applicator in the dispensing nozzle;
4. press the applicator several times until the product appears;
5. lie on your back with your knees bent and insert the applicator deep into the vagina;
6. perform 5 presses of the dispenser – one product application;
7. the applicator is disposable, throw it away after use;
8. close the bottle with the cap.

Colpofix – precautions

The color of the gel may change when using Colpofix®. This is due to the use of natural ingredients that can change the color of the preparation without affecting its quality and operation.

The preparation is intended for vaginal use only and should not be spread on the skin or swallowed. If a woman is undergoing therapy with other topical medications, a decision to start and use Colpofix® at the same time should be consulted with a doctor or pharmacist. The product is not intended for use in children.

Store the product in a dry place, away from light and heat sources, and out of the reach and sight of children. Do not use the preparation if the packaging is damaged or there are signs of use of the product when first opened. The attached cannula is disposable and must be discarded after application.

The expiry date stated on the packaging refers to the unused and properly stored product, in accordance with the recommendations provided in the leaflet. After use, the product must not be disposed of via wastewater or household waste. The empty bottle (without cardboard packaging) should be taken to a pharmacy with a container for medicines for disposal.

Colpofix – side effects

Colpofix® gel should not be used if you are hypersensitive to any of the ingredients of the product. The studies conducted so far have not shown any allergies or other side effects. If discomfort persists during therapy with the preparation, local allergic reactions or irritation resulting from long-term use of the product occur, consult a doctor or pharmacist.

Colpofix – interactions with other drugs

The studies conducted so far have shown no interactions with other drugs.

Colpofix and pregnancy and breastfeeding

In the case of a pregnant or breast-feeding woman, the decision to start therapy with Colpofix® should be consulted with the attending physician.

Colpofix – cena

Colpofix® – vaginal spray gel – is available over the counter in pharmacies. One package of the product contains a 20 ml bottle and 10 disposable vaginal applicators, which is enough for 10 days of treatment. A monthly treatment requires 2 packages of the product.

The price of one Colpofix® product is approximately PLN 56-60.