HyaloGyn – Vaginal hydrating gel containing HYDEAL-D® 0.2 % in prefilled applicators

Paraben-free formulation

Product information

The vaginal epithelium is soft and supple, thanks to a delicately balanced mechanism that maintains the correct degree of hydration and lubrication.

At certain times during a woman’s lifetime (e.g. after childbirth, during breastfeeding, in menopause), following particular pharmacological treatments or diseases or at times of increased stress, this delicate balance may be upset, causing considerable discomfort characterised by vaginal dryness and a burning or itching sensation.

Burning and irritation are often associated with tiny lesions to the epithelium, caused by the lack of lubrication.

In such cases, it is advisable to use a local product that favours hydration of the mucosa and helps restore natural suppleness and softness.

XXXXX is a colorless gel with strong hydrating properties that contains Hydeal-D®, a derivative of hyaluronic acid that allows a prolonged release at the application site.

Hyaluronic acid is a natural molecule responsible for maintaining a correct level of hydration in the tissues, besides playing a fundamental role in tissue repair processes.

The formulation based on Hydeal-D®  offers an optimal adhesion to the vaginal mucosa, has a prolonged hydrating action and favours the natural healing of microlesions.

Composition

Principal component: Hydeal-D 0.2% (prolonged-release hyaluronic acid derivative)

Other components: glycerol, propanediol, ethylhexylglycerin, phenethyl alcohol, carbomer, sodium hydroxide, purified water.

The formulation contains neither parabens nor other preservatives.

Indications

Gel complementary to treatment for vaginal dryness of various origin; aid in the natural healing process of friction-induced microlesions in the vaginal mucosa.

How to use

The use is recommended at bedtime following these instructions:

1. Wash your hands and the area around the vagina accurately;
2. Open the sealed wrapper from the indicated side in order to remove the single-use applicator (Fig. 1);
3. Twist-off and remove the closing cap of the applicator to allow its opening (Fig. 2);
4. Preferably in a supine position, gently insert the cannula of the applicator into the vagina (Fig. 3);
5. Firmly squeeze the body of the prefilled applicator along its entire length, to deposit the gel into the vagina (Fig. 4). A small amount of gel is foreseen to be left inside the applicator, since it is specifically overfilled;
6. Gently remove the applicator and discard

  Frequency of use

The frequency with which the product should be used depends on how dry the vaginal mucosa is. One application every three days for a period of thirty days is recommended, unless otherwise prescribed. The treatment does not require interruptions during menstruation.

Contra-indications

Proven individual hypersensitivity towards the product.

Warnings and Precautions

The product is for vaginal use only.

The applicators are for single-use, i.e. they must be used only once and by a single patient only and discard after use.

If the applicators are reused, Fidia Farmaceutici cannot guarantee performance, functionality and hygienic conditions of the product.

In the use of products for the treatment of vaginal dryness, small whitish and odourless discharges might occur and these are to be considered normal.

In patients with particular individual sensitivity to any component of the formulation and/or at the beginning of treatment, transient vaginal burning or heat sensation may occur. In case of persistent burning, it is advisable to discontinue the treatment and to consult your doctor.

In cases of vaginal infection, consult your doctor before using the product.

In case of pregnancy or breastfeeding consult your doctor before using the product. The safety and efficacy of TRADE NAME in children is unknown.

This  product  can  be  used  with  lubricated/non-lubricated  latex,  polyisoprene  and  polyurethane condoms.

Interactions of the product with contraceptive drugs for vaginal use are unknown.

Do not use concomitantly with vaginal products containing quaternary ammonium salts (for example benzalkonium chloride), because they can interact with the product.

Do not use the product if the packaging is damaged, as this may compromise the integrity of the applicator.

Do not discard the empty packaging in the environment and dispose according to national regulations. Do not use the product after the expiry date indicated on the packaging.

The expiry date refers to the product stored properly in its original package. Keep out of the sight and reach of children.

Storage

Store at a temperature between 2 – 25 °C.

Do not freeze.

Package

Box contains 10 single-use prefilled vaginal applicators each of 4 g. Each applicator is packed in a plastic sealed wrapper.

Manufacturer: Fidia farmaceutici. Italy