VAGISAN

VAGISAN Moist Cream with applicator

Product features

Vagisan Moisturising Cream
For vaginal dryness - cream for use in the vagina and on the skin of the external intimate area

Dear user, please read the following instructions for use carefully, as they contain important information on what to consider when using this medical device. Keep these instructions for use, you may want to read them again later. If you have any questions, please contact your doctor or pharmacist.

Ingredients

Aqua, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Palmitate, Lactic Acid, Octyldodecanol, Polysorbate 60, Sodium Lactate, Sorbitan Stearate. Vagisan Moisturising Cream is free from fragrances.

Area of application

For use in case of discomfort caused by dryness in the vagina and in the external intimate area (feeling of dryness, burning, itching, minor injuries and pain during sexual intercourse, e.g. in case of oestrogen deficiency during menopause). Vagisan Moisturising Cream can also be used to facilitate sexual intercourse.

Product information

Vagisan Moisturising Cream is a white, smooth cream that has been developed for use in case of vaginal dryness. Vagisan Moisturising Cream is free from hormones (oestrogens) and can therefore also be used together with hormone replacement therapy or alternately with hormone (oestrogen)-containing vaginal creams or vaginal suppositories. Due to the addition of lactic acid, the cream has a pH value of 4.5 - thus Vagisan Moisturising Cream supports the maintenance of a natural pH value in the vagina. Two effects contribute to the fact that Vagisan Moisturising Cream relieves discomfort in case of vaginal dryness:

• The cream has a high water content, which moisturises the skin in the area of the vagina and the external intimate area.
• Nourishing lipids (fats) keep the skin supple.

Regular use of Vagisan Moisturising Cream can help to prevent irritation and inflammation in the vagina and in the external intimate area. The cream can be used in case of vaginal dryness before sexual intercourse. If pregnancy is desired, there are no objections to the use of Vagisan Moisturising Cream in case of vaginal dryness, as the mobility of the sperm (male semen) is not impaired.

What you should know about the symptoms of "vaginal dryness"

The symptoms of vaginal dryness can significantly impair the quality of life of the women affected. The feeling of dryness is often accompanied by other symptoms, such as itching, burning, minor injuries and pain in the area of the vagina, the vaginal opening and in the external intimate area. In many cases, these symptoms also make sexual intercourse painful. Women are particularly affected during menopause (sometimes starting from the age of 40) and in the years thereafter. In these cases, the dryness in the intimate area is caused by a decreasing production of sex hormones (including oestrogen). Less vaginal fluid is produced in the vagina, the skin becomes thinner and more vulnerable. These are completely normal processes, which can nevertheless cause considerable discomfort. Hormone deficiency, hormonal fluctuations or shifts can also lead to the symptoms of vaginal dryness after operations on the uterus or on the ovaries, during pregnancy and breastfeeding as well as when taking the "pill". In addition, some metabolic diseases (such as diabetes), medication, radiation treatment for tumours and also stress can be associated with dryness in the internal and external intimate area.

Application of Vagisan Moisturising Cream

Vagisan Moisturising Cream is intended for use in the vagina and on the skin of the external intimate area. Vagisan Moisturising Cream can be used with and without an applicator. The 50 g pack size contains an applicator. In case of discomfort in the vaginal opening and in the external intimate area, the cream is applied and distributed with a clean finger as needed, even several times a day; a cream strand of approx. 0.5 cm in length is sufficient for this purpose. A small amount of cream can also be applied in the area of the vaginal opening to facilitate the insertion of the applicator. Vagisan Moisturising Cream can be inserted into the vagina with the help of the applicator. To do this, fill the applicator up to half (approx. 2.5 g of cream, see also "Instructions for use"). The application should be carried out daily - preferably in the evening before going to bed (if necessary, use a panty liner). Once the symptoms have improved, the frequency of application can be reduced as needed. The cream can also be used before sexual intercourse or during menstruation. Vagisan Moisturising Cream can also be used for a longer period of time if it is well tolerated, also during pregnancy (without applicator; see instructions for use during pregnancy) and during breastfeeding.

Instructions for use with applicator

The 50 g pack size contains an applicator.

• Loosen the applicator plunger so that it can move in the applicator tube
• Hold the tube opening upwards, attach the applicator to the tube opening
• Fill the applicator tube with cream up to half by applying light, even pressure to the tube (approx. 2.5 g of cream)
• Remove the applicator from the tube
• The applicator can be inserted into the vagina in a lying position (on your back) or in a standing position (as when inserting a tampon). The applicator is carefully inserted into the vagina as deeply as possible; the applicator is emptied by pressing the plunger and the cream is inserted into the vagina.
• After use, clean the applicator as follows: Press the spherical end of the applicator plunger firmly onto a solid surface. This separates the plunger from the applicator tube. Then clean the plunger and the applicator tube separately with warm water.

Instructions for use during pregnancy

For safety reasons, the applicator should not be used to insert the cream into the vagina during pregnancy. Instead, a cream strand of approx. 2 cm can be inserted into the vagina with a clean finger.

Instructions for use together with condoms

The cream can be used in case of vaginal dryness before sexual intercourse. According to recent studies, the tear resistance of condoms or pessaries (made of latex, polyurethane, polyisoprene) may be impaired when Vagisan Moisturising Cream is used at the same time; therefore, the cream should not be used at the same time as condoms or pessaries as a precaution.

Possible side effects

After application, mild local reactions (such as itching, burning) are possible for a short time. In rare cases, severe skin irritation or hypersensitivity reactions (e.g. redness, itching, burning) may occur, which may also last for a little longer. If these symptoms persist and do not improve, you should stop using Vagisan Moisturising Cream and consult a doctor. If you notice any other unpleasant effects, please talk to your doctor or pharmacist.

Restrictions on use

In case of more pronounced symptoms of dryness, medical advice should be sought first. Vagisan Moisturising Cream must not be used in case of known hypersensitivity or allergy to any of the ingredients. The cream should not be used immediately after childbirth. Vagisan Moisturising Cream should also not be used in case of a vaginal infection (e.g. vaginal fungus); in this case, you should talk to your doctor. In case of damage to the tube, the applicator or a change in the consistency of the cream, do not use the product and inform the manufacturer.

Storage and shelf life

Vagisan Moisturising Cream must be stored out of the reach of children. The tube must be closed and stored at no more than 25°C. The expiry date is printed on the flap of the packaging or on the tube fold. Do not use Vagisan Moisturising Cream after this date. The cream can be stored for a period of 6 months after opening.

Note

For women who do not want to use an applicator (or should not use one during pregnancy, see section "Use during pregnancy") and prefer a vaginal suppository, Vagisan Moisturising Cream Combi is recommended. The combination pack contains Vagisan Moisturising Cream Cremolum (vaginal suppositories) for use in the vagina - without applicator - and a tube of Vagisan Moisturising Cream (for use in the vaginal opening and in the external intimate area).

Pack sizes

Trial size with 10 g of cream, original sizes with 25 g of cream or 50 g of cream (with applicator). Not all pack sizes may be available in stores. The applicator (CE-certified) is used to insert the cream into the vagina.

Manufacturer and distributor

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Telephone: 0521 8808-05
Fax: 0521 8808-334
E-mail: info@wolff-arzneimittel.de

This information for use was last revised in April 2015.

Source: Information from the package leaflet
Status: 10/2017