Papilocare

Papilocare

Manufacturer:

Procare Health

Distributor:

Metro Drug
Full Prescribing Info
Contents
Hyaluronic acid niosomes, β-glucan niosomes, Centella asiatica phytosomes, Coriolus versicolor extract, neem extract, BioEcolia-alpha-oligoglucan, aloe vera extract.
Description
The main ingredients of the formulation are: Components that allow the formation of a mucoadhesive gel on the cervical-vaginal mucosa, creating a protective film on it that promotes the product's barrier action.
Hyaluronic acid niosomes, with hydrating action, to help maintain tissue elasticity.
β-glucan niosomes, whose antioxidant properties maintain the structure and natural functionality of the skin and mucous membranes.
Centella asiatica phytosomes (Centella asiatica extract, complex form with phospholipids) which act to repair mucosal lesions.
Coriolus versicolor extract, (extracts from the medicinal components of Yunzhi mushrooms) with re-epithelialising and restorative action for cervical-vaginal lesions and microlesions.
Neem extract, with emollient properties that promote the natural healing process.
BioEcolia-alpha-oligoglucan, a prebiotic that stimulates the growth of beneficial bacterial flora and rebalances the microbiota in the cervical-vaginal zone.
Aloe vera extract, with hydrating, re-epithelialising, and restorative action for the cervical-vaginal zone.
Action
Papilocare is a gel that acts by forming a film on the cervical mucosa, creating a defensive barrier to prevent the risk of HPV integration. In this way, it disrupts HPV integration (risk factor of pre-cancerous lesions progress to invasive cervical cancer), preventing the formation of new lesions, and also acts as to aid in re-epithelialising pre-existing lesions.
It also stimulates the regeneration of the vaginal microbiota.
Clinical Evidence: Several studies have been carried out with Papilocare that support its clinical efficacy and safety. In several studies performed by the manufacturer, improvement in cervical-vaginal mucosal re-epithelialisation was observed with the use of Papilocare. In a study comparing mucosal repair in untreated women and women treated with Papilocare, it was observed that in women using Papilocare, the percentage of women whose HPV-induced lesions were repaired was higher than for untreated women.
Other studies performed by independent investigators in university hospitals also confirmed the efficacy and safety of use of Papilocare.
Indications/Uses
Gel for the prevention and adjuvant treatment of HPV-induced lesions.
Papilocare is indicated for: Controlling and helping re-epithelialise the cervical transformation zone to prevent the risk of HPV-induced lesions (LSIL).
Adjuvant treatment of HPV-induced intra-epithelial lesions.
Repairing and helping re-epithelialise lesions of the cervical-vaginal mucosa.
Treating cervical-vaginal mucosal dryness.
Rebalancing vaginal microbiota.
Improving vaginal health.
Creating the conditions for rapid healing of lesions caused by scratching due to burning or itching.
Forming a protective film that rapidly reduces irritation, creating suitable conditions to promote the natural healing process.
Dosage/Direction for Use
Who Can Use Papilocare: The use of Papilocare is recommended in women (over 18 years of age) infected by the human papillomavirus (HPV), independently of whether they have virus-induced lesions (ASCUS Atypical Squamous Cells of Undetermined Significance or LSIL-Low-grade squamous intraepithelial lesion).
Mode of Use: The treatment duration is 6 months, which can be extended for longer based on the medical prescription. It is important to complete the full length of treatment in order to obtain the desired results.
It is recommended to start treatment after menstruation.
First month: One cannula should be applied per day, for 21 consecutive days, then taking the next 7 days off.
Following months (month 2 to 6): One cannula should be applied every other day for 21 days. The recommendation to pause treatment with Papilocare during menstruation has to do with patient comfort, and not because there is any clinical incompatibility.
Papilocare should ideally be used just before bedtime. Papilocare is compatible with the use of condoms.
How to Apply Papilocare: Papilocare is supplied in single-use vaginal cannulas. Any cannula that appears open or broken should be discarded. The cannula is designed to aid in the product's application. For application, patient should lie on her back. The cannula should be inserted into the vagina, then press to release its contents. Then, remove it from the vagina, while continuing to press the cannula, in order to not suction out the product already applied.
It is possible that a small amount of gel remains in the cannula. This does not mean that a dose less than that recommended has been administered, as the cannula releases a sufficient amount to cover the cervical-vaginal mucosa (3 mL). Once the cannula is used, it should be discarded. A cannula should not be reused nor shared between two patients.
Warnings
Papilocare should not be used in people who have known hypersensitivity to any of its ingredients. If after the application, the patient feels any discomfort, discontinue the use of the product and consult a doctor. There is no available data on the use of Papilocare in patients using vaginal contraceptives (for example, vaginal ring, female condom). Therefore, Papilocare is not recommended for use in women using these types of contraceptives. In case of pregnancy, a doctor should be consulted prior to using Papilocare, and its use must only be considered under strict medical supervision.
Adverse Reactions
The safety profile of Papilocare is good and no serious adverse reactions have been observed in the clinical studies performed with the product or since its marketing.
The only adverse reaction reported since the product has been marketed is irritation following application, with a frequency not exceeding one case per 10,000. This reaction is more common in women with a very sensitive or significantly damaged genital area or in post-menopausal patients with a high vaginal pH (pH 7). If this occurs, space out the doses (every 3 days) and consult the doctor.
Storage
Papilocare should be kept between 2°C and 25°C.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
D03AX14 - Centella asiatica herba, incl. combinations ; Belongs to the class of other cicatrizants. Used in the treatment of wounds and ulcers.
Presentation/Packing
Form
Papilocare vag gel
Packing/Price
((single dose) 5 mL) 7 × 1's