Hyalosan 2265 Vaginal Suppositories Instructions

Hyalosan 2265 Vaginal Suppositories Instructions

Sodium hyaluronate 5 mg in one suppository

Intended purpose:

HYALOSAN vaginal suppositories are intended to maintain naturally moist environment of the vaginal mucosa.
It is used to support regeneration and restoration of the natural state of the vaginal mucosa in the case of problems caused by:

• vaginal dryness associated with hormonal changes in all stages of a woman‘s life, especially during menopause, after labour, during breast-feeding, after chemotherapy and radiotherapy or gynaecological operations,
• vaginal atrophy manifested by itching, burning, redness.

The device is intended to be used by a lay person – adult women.

Clinical benefits:

• moisturization of vaginal mucosa
• removing the itching of vaginal mucosa during sex
• removing the erythema of vaginal mucosa during sex
• removing the unpleasant feelings during sex
• improving the overall life quality.

Mode of action:

The main intended function of HYALOSAN vaginal suppositories on the vaginal mucosa is not obtained by pharmacological, immunological or metabolic means, but thanks to its physical properties, especially hygroscopicity of hyaluronic acid, assuring tissue hydration and elasticity. Character and its mechanism of action is purely physical, does not act by pharmacological, immunological or metabolic means.

Indications:

• Vaginal dryness.
• Vaginal atrophy manifested by itching, burning, redness.

How to use:
Wash your hands thoroughly before use. Remove the suppository from the aluminium foil by tearing over the tip of the suppository and insert it into the vagina as deep as possible. Apply while lying on your back. Stay lying on your back a few minutes after application, after insertion into vagina, vaginal suppository softens due to body temperature and evenly covers the entire surface of the vaginal mucosa. Pollution of underwear occurs during application, use a panty liner for protection if needed.
Apply preferable before the bedtime.

1 package contains 10 vaginal suppositories with content of hyaluronic acid.

Dosage:
One suppository daily for first ten days or as recommended by your doctor.
For the treatment of vaginal dryness caused by menopause, apply one suppository for first 10–20 days, followed by a long term treatment with one vaginal suppository 2 times per week.

Ingredients:
Sodium Hyaluronate (min. 0.25 %), Tocopherol, Centella Asiatica, Malva Sylvestris, Chamomilla Recutita, Melaleuca Alternifolia, Silica, Hydrogenated C12-18 Trigly- cerides.

Contraindications:
Do not use during menstruation or in case of increased vaginal secretion.
Known hypersensitivity to any ingredient of the product.

Side-effects:
Allergic reaction.

Warnings:
HYALOSAN vaginal suppositories are intended for vaginal use only.
Consult your doctor during pregnancy and when concomitantly using other vaginal preparations (including vaginal contraception).
Do not use if the packaging is damaged.
Do not use after the expiry date listed on the package.

Precautions:
Any serious adverse event that has occurred in relation to the use of device should be reported to the manufacturer and the national competent authority, and product should not be used again.

Storage:
Keep out of reach of children.
Store at temperatures from +5 °C to +25 °C.

Disposal of the device:
Dispose of aluminum foil into mixed waste container and dispose of other parts of the packaging in the appropriate container for sorted waste (paper).

Date of issue of the latest revision of the instructions for use: 11.10.2023

SI 8810_001_03

Dr. Müller Pharma s.r.o.
U Mostku 182, 503 41 Hradec Králové, Česko
info@muller-pharma.cz, tel.: +420 495 809 111
www.muller-pharma.cz • www.muller- pharma.com

Distribútor pre Slovensko:
Dr. Müller Pharma Slovakia s.r.o.
Továrenská 5668, 901 01 Malacky
www.muller-pharma.sk

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