Medical product

What is Gynaedron Regenerating Vaginal Cream and when is it used?

What is Gynaedron^® Regenerating Vaginal Cream?< /h4>

Gynaedron^® is a hormone-free, regenerating vaginal cream with 0.8% lactic acid and 2% dexpanthenol.

Gynaedron^® is available in a pack of 7 monodoses, each with 5 ml of regenerating vaginal cream, or as a 50 g tube with applicator.

How does Gynaedron^® regenerating vaginal cream work?

Hormonal changes, stress, taking antibiotics or contraceptives (such as the pill) can cause vaginal dryness cause and reduce the number of lactic acid bacteria in the vagina (vagina), leading to an increase in the natural pH level. This can lead to recurring bacterial vaginosis (mixed infections) or fungal infections with an unpleasant smell.

4 effects contribute to the effectiveness of Gynaedron^® regenerating vaginal cream:

• Lactic acid lowers and stabilizes the pH value, thereby bringing the lactobacilli flora into balance and thus forming a defense system against bacteria and fungi.
• Dexpanthenol supports the structure and the physiological function of the skin and mucous membrane. In addition, dexpanthenol treats vaginal dryness with its water-binding and thus moisturizing properties and has an anti-itching, wound-healing and regenerating effect.
• The hydro cream has a high water content. This restores moisture to the skin in the area of ​​the vagina and the outer genital area and protects it from drying out and painful cracks.
• Nourishing lipids (fats) keep the skin and the vaginal mucous membrane supple and elastic.

What are the areas of application of Gynaedron^® regenerating vaginal cream?

Prophylactic (preventive):

Gynaedron^® regenerates the vaginal mucosa and the vaginal flora, stabilizes and lowers the vaginal pH value and thus prevents bacterial vaginosis (mixed infections) and fungal infections. Gynaedron^® treats vaginal dryness and thus relieves burning, itching, soreness and pain. Thanks to its hydrating (moisturizing) properties, Gynaedron^® restores moisture to the vaginal mucosa and keeps it supple. Gynaedron^® can be used, for example, after or during antibiotic therapy, after swimming, after sexual intercourse, after menstruation, for dry or itchy intimate areas and anus or for skin care.

Additional to therapy:

Gynaedron^® supports the treatment of vaginal thrush infections and bacterial infections and can be used in alternation with other local therapies (such as intravaginal estriol -Hormone therapies, eczema therapies) are used. In addition, Gynaedron^® can be administered alongside vaginal tablets such as vagi-C^® (vitamin C). The regenerating vaginal cream should be applied externally to the intimate area before using vagi-C^®, especially if there is skin damage and painful cracks.

When should Gynaedron Regenerating Vaginal Cream not be used?

In the event of hypersensitivity to one or more ingredients.

When is caution required when using Gynaedron Regenerating Vaginal Cream?

An impairment of the safety of condoms (tearing strength) cannot be ruled out.

There are no known interactions with other medical devices or drugs.

Can Gynaedron Regenerating Vaginal Cream be used during pregnancy or breastfeeding?

Due to the composition and mode of action of Gynaedron^{®< /sup> – the regenerating vaginal cream is not absorbed by the body – there is no risk for the child. Use during pregnancy should be discussed with a doctor, as no scientific studies have been carried out.}

How do you use Gynaedron Regenerating Vaginal Cream?

Gynaedron ^® is suitable for long-term use and can be applied daily until symptoms disappear. The vaginal cream is free of hormones, fragrances and dyes.

How do you use Gynaedron^® regenerating vaginal cream?

Gynaedron^® is best applied directly into the vagina (vagina) in the evening in a lying position.

Monodose

The monodose corresponds to one application and is easy and hygienic to apply. The vaginal cream is applied directly from the monodose to the mucous membrane of the vagina, where it adheres.

	1. Shake the contents against the closure of the monodose.
	2. Open the mono socket by turning the cap.
	3. Inserting the monodose into the vagina.
	4. Complete expression of the contents into the vagina.

If used as directed, a small amount of the cream will remain in the monodose. Please dispose of the monodose after use.

Tube with applicator

< /td>	1. Before first use, unscrew the cap of the tube and press the tube opening upside down to open the membrane seal.
	2. Screw the applicator onto the tube with the opening applying slight pressure up to the lower end of the thread and, if necessary, release the plunger from the lock.
	3. Squeeze the regenerating vaginal cream into the applicator up to the desired mark.
	4. Unscrew the applicator from the tube and close the tube tightly again.
	5. In the supine position, insert the filled applicator as deep as possible into the vagina and push out the regenerating vaginal cream with the plunger.
	6. After use, carefully clean the individual parts of the applicator with lukewarm water. Avoid boiling water to avoid deforming the applicator.

With the enclosed and reusable applicator, between 3 and 5 ml of vaginal cream can be applied individually.

What side effects can Gynaedron Regenerating Vaginal Cream have?

In the event of pre-existing damage to the vaginal mucosa, skin irritation such as itching or slight burning may occur, especially at the beginning of the application. As the vaginal mucosa regenerates, these symptoms will subside. If they persist and do not improve, stop using Gynaedron^® and see a doctor.

What else needs to be considered?

Storage and shelf life

Gynaedron^® should be kept between 5 and 25 °C and out of the reach of children. After use, the tube must be closed carefully to prevent it from drying out. The screw thread must be kept clean. Once opened, the tube has a shelf life of 12 months.

What does Gynaedron Regenerating Vaginal Cream contain?

Aqua, Isopropyl myristate, Cetearyl alcohol, Glyceryl stearate, PEG-20 Glyceryl stearate, Dexpanthenol (20 mg/g), Propylene glycol, Lactic acid (8 mg/g), Carbomer, Benzoic acid, Sodium hydroxide.

Where can you get Gynaedron Regenerating Vaginal Cream? Which packs are available?

Gynaedron^® Monodose: Pack of 7 monodoses, each with 5 ml of regenerating vaginal cream.

Gynaedron^® Tube: Pack with 50 g regenerating vaginal cream including applicator.

Distribution company

Drossapharm AG, 4002 Basel.

Manufacturer

Hälsa Pharma GmbH, Maria-Goeppert-Strasse 5, D-23562 Lübeck.

Status of information

September 2018.