Description

Hyalotim is intended for topical use in the vagina. It is used for moisturizing of vaginal mucous membrane in conditions accompanied in dryness of vaginal mucous membrane. The product is especially intended for:

• prevention of vaginal dryness due to ageing, low estrogens, hormonal therapy and use of contraceptives;
• lowering and preventing problems with vulva and vagina accompanied by dryness of the mucosa, itch, redness, inflammation or discharge;
• helping in healing processes of damaged mucosa after child delivery, gynecological or surgical procedures and also after loss of mucosa due to chemotherapy or radiotherapy;
• lowering discomfort of painful sexual intercourse;
• maintaining appropriate vaginal pH

Instructions for use

1. Description of the product

Hyalotim is a medical device designed for women for topical application in the vagina. The vaginal globules are packaged in

the slots of the plastic film. Each slot is separated by perforations to allow the removal of one slot with the vaginal globule

from the rest of the blister. The vaginal globule is removed from the slot by separating the sheets of film. After the vaginal

globule is applied into the vagina it is molten to form a moisturizing and barrier gel.

2. Composition

1 vaginal globule contains 10 mg hyaluronic acid as sodium salt, 5 mg lactic acid and neutral fat as an excipient.

3. Mode of action

After application the vaginal globule melts and dissolves in vaginal discharge. Released hyaluronic acid mixed with moisture

multiplies its volume and produces gel layer on the surface of vaginal mucous membrane. This creates a protective barrier

and makes appropriate conditions for natural regenerative and protective mechanisms to activate. Protective film made by

hyaluronic acid returns natural moisture, lowers inflammations and speeds up healing processes of damaged mucosa.

Lactic acid lowers pH of vaginal environment. Low pH (3.8 -4.2) is characteristic for healthy mucous membrane since it

unfavorable for development of pathogen microflora and helps maintain natural balance of vaginal microflora.

4. Indications

Hyalotim is intended for topical use in the vagina. It is used for moisturizing of vaginal mucous membrane in conditions

accompanied in dryness of vaginal mucous membrane.

The product is especially intended for:

– prevention of vaginal dryness due to ageing, low estrogens, hormonal therapy and use of contraceptives;

– lowering and preventing problems with vulva and vagina accompanied by dryness of the mucosa, itch, redness, inflammation

or discharge;

– helping in healing processes of damaged mucosa after child delivery, gynecological or surgical procedures and also after

loss of mucosa due to chemotherapy or radiotherapy;

– lowering discomfort of painful sexual intercourse;

– maintaining appropriate vaginal pH.

5. Usage

The vaginal globules are intended solely for vaginal use. Prior to application of vaginal globule wash your hands thoroughly.

If vaginal globule is too soft, before removing from the blister it should be placed for a few minutes in the refrigerator.

Separate one slot with vaginal globule from the blister. Grab each layer of foil (between the thumb and index finger) and

slowly separate them from each other. Carefully remove the vaginal globule from the slot. Gently push the vaginal globule

deep into the vagina with your finger. Application of the vaginal globule is best done in the recumbent position, with slightly

raised thighs. Unless your doctor tells you otherwise, apply one vaginal globule before sleep. Vaginal globules should be

used continuously for 14 – 20 consecutive days. As a single treatment do not use for more than 20 days. Applying vaginal

globules should be planned so that it is not interrupted by menstruation.

6. Warnings

The vaginal globules are suitable for vaginal administration – cannot be used in another way.

Do not swallow!

Do not use vaginal globules during menstruation.

Pregnant or lacting women may use the product only with the consent of the doctor.

Do not exceed the recommended treatment time.

Do not use if allergic to any of the ingredients.

Stop using the product and seek medical advice in case of any intensified changes, eczema, swelling of any other non-pre-

-existing problems in the vulva region.

Ask you doctor if after 14 consecutive days of use of the product there is no relief of symptoms. In case symptoms

previously alleviated by the product recur do not use the product again and seek medical advice.

Do not use with other products administered vaginally.

The preparation may cause difficult to remove soiling of the underwear, while using advised to use panty liners.

Interaction between product components and latex condom is possible. Therefore, do not use latex condom while treatment

with the globules.

Do not use the medical device after the expiry date.

Do not use if the immediate packaging is damaged.

7. Storage

Store at room temperature (15-25°C) in dry place. Do not expose the product to the sun or other heat sources. Medical

device should be stored out of the reach and sight of children.

8. Packaging

Package contains: 5 vaginal globules or 10 vaginal globules (2 blisters of 5vaginal globules).

Weight per vaginal globule – 1,6 g.