RIGENYA

Description
Vaginal ovules.
The medical device Rigenya forms a protective barrier on the mucosal surface, hydrating and protecting the vaginal mucosa from epithelial damage caused by: vaginal dryness, sexual intercourse, gynecological examinations, or physical activity. Use of the medical device improves vaginal elasticity, maintains and restores the physiological vaginal pH, helps preserve the normal vaginal bacterial flora, and reduces unpleasant odors. Under normal conditions, the vaginal pH is around 3.8-4.5, favoring the growth of beneficial bacteria such as Lactobacillus, which inhibits the growth of pathogens such as:
Gardnerella vaginalis;
Streptococcus sp., Enterococcus sp., Escherichia coli, Enterobacter;
Trichomonas;
fungi of the genus Candida.
After application, the medical device creates a protective layer with an acidic pH and helps to restore the natural and physiological vaginal environment, which translates into maintaining the proper microbiome of the entire female reproductive system (the microbiome is the set of microorganisms, including bacteria, that live in the host and regulate numerous physiological functions); therefore, the medical device can be used in the treatment of bacterial vaginosis (BV) and as an adjunct to therapies used in the prevention and treatment of endometriosis.
The product is intended for general users.
The product is intended for women of childbearing age, in menopause, and post-menopause.
It acts at the site of application through a physical mechanism. After vaginal application, a moisturizing protective film is formed on the mucosa, which protects the vaginal epithelium from mechanical damage and reduces the discomfort associated with dryness, tension, itching, and burning of the vaginal mucosa. The protective layer formed has an acidic pH that contributes to the normalization of the vaginal pH and the microbiome of the entire female reproductive system. The acidic pH of the product at the site of application is due to lactic acid and glycogen.

Instructions for use
- Wash your hands thoroughly before applying the product.
- Remove 1 vaginal ovule from the blister by tearing the foil along the perforation and opening the foil sheets.
- Insert the vaginal ovule deep into the vagina.
Note: if the ovule is too soft, place it in the refrigerator for a few minutes before removing it from the foil until it hardens.
Unless otherwise prescribed by a doctor, use 1 vaginal ovule per night for 7 consecutive days. Subsequently, to maintain the effect, use 1 vaginal ovule every 2-3 days until symptoms disappear. Do not use the product for more than 30 days. If your doctor recommends a method of use other than that described above, follow the doctor's instructions. If you forget to use an ovule, do not double the dose.

Components
1 ovule contains: sodium hyaluronate (10 mg), glycogen, lactic acid, tocopheryl acetate, sodium lactate, Witepsol S58.
The product does not contain: hormones, PEG, parabens, detergents (including SLS and SLES).

Warnings
This product is for vaginal use only.
This product is for single use.
Do not attempt to put the unused product back into the packaging, as this is contrary to the instructions for use and storage of the product and could cause contamination at the site of application due to the loss of product stability caused by improper storage conditions.
Hypersensitivity to the product components/onset of adverse effects after using the product: do not use the product in case of hypersensitivity (allergy) to any of its components.
If the patient does not have hypersensitivity to the product components and, during use of the ovule, experiences burning, itching, or redness that does not disappear spontaneously, this may indicate hypersensitivity to the product components; in this case, stop using the product and consult a doctor or pharmacist.
In case of use of the product by people suffering from severe vaginal dryness, due to the lactic acid content in the product, mild reactions may occur at the site of application (mild burning or itching). These symptoms are transient and usually disappear spontaneously. If the symptoms do not disappear, this may indicate hypersensitivity to the product components; in this case, stop using the product and consult a doctor or pharmacist.
Do not use with topical anesthetics and other vaginal preparations, as the preparation may weaken or delay their action.
Do not use with latex condoms and contraceptive devices, as the product, due to its fat content, may reduce their effectiveness.
Do not have sexual intercourse immediately after applying the ovule.
During pregnancy and breastfeeding, use after consulting a doctor or pharmacist.
In case of acute vaginal infection, use only after consulting a doctor.
The product can be used with other vaginal products, if recommended by a doctor.
Do not use during menstruation.
Avoid accidental contact of the product with the mucosa of the eyes, nose, or mouth.
The product is intended exclusively for vaginal use.
Do not use after the expiration date.
Do not use the product if the packaging is damaged.
Do not reuse once the ovule has been applied.
If you do not use the entire dose of the product, the product must be disposed of. Do not attempt to reuse the opened product later. This is incompatible with the guidelines regarding the use and storage of the product and may lead to a risk of infection at the site of application due to the loss of product stability caused by non-compliant storage conditions.
Keep away from light and heat sources.
Keep out of the reach and sight of children.
Do not use after the expiration date indicated on the packaging.
Do not use if the packaging is damaged.

Storage
Store at a temperature between 15°C and 25°C, away from light.

Format
Pack containing 10 ovules.
Net weight: 1.6 g.

Code LRVGIN001