Gyno-Canesten combination pack 3 vaginal tablets and 20 g cream

What is Gyno-Canesten Kombipack and when is it used?

Gyno-Canesten Kombipack contains the active ingredient clotrimazole and is used to treat fungal diseases in the genital area.

When should you see a doctor?

Should the symptoms of a genital fungal disease (e.g. itching, redness, increased but odorless vaginal discharge, possibly . swelling of the external genitals) occur together or individually for the first time, please see your doctor. He or she will make the correct diagnosis of your illness and also help you with the appropriate medicines.Please see your doctor if the symptoms persist for more than 7 days despite treatment, if you have had more than 2 such fungal infections in the past 6 months, if you are pregnant or if you think you may be pregnant.If you are under 18 years old or have ever had an intolerance to medicines for fungal diseases, also seek medical advice or the doctor.

In all other cases, treatment is possible on the basis of specialist advice from your pharmacist or druggist.

What should be considered?

Fungi are usually found in the vagina (vagina) together with bacteria, but they do not have to develop pathogenic properties. The most common fungus is called Candida albicans and under certain circumstances it can spread and lead to a troublesome infection. This infection is mostly related to the vagina and surrounding tissues, such as the labia.The antifungal in Gyno-Canesten Combo Pack is not effective against all microorganisms that cause fungal infections. Using an incorrectly chosen or incorrectly dosed antifungal drug can cause complications. Therefore, never use it on your own to treat other diseases or other people.While using the product, no tampons, intravaginal douches or other vaginal products should be used.While using Gyno-Canesten Kombipack it is recommended to refrain from sexual intercourse, as the infection can be transmitted to the sexual partner.

When must Gyno-Canesten Kombipack not be taken/used?

Gyno-Canesten Kombipack should not be used in the case of hypersensitivity to certain antifungal medicines, antifungals of the imidazole type or to a component of the preparation.Hypersensitivity manifests itself, for example, in asthma, shortness of breath, circulatory problems, swelling of the skin (e.g. nettle rash) and mucous membranes or skin rashes.

When is caution required when using Gyno-Canesten Kombipack?

Cetylstearyl alcohol and benzyl alcohol (additives in the enclosed Canesten cream) can cause local skin irritation (e.g. contact dermatitis).In the event of a local irritation or allergic reaction, treatment with Gyno-Canesten Kombipack should be discontinued.If you suffer from fever, abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or accompanying shoulder pain, you should consult a doctor.Contact with the eyes should be avoided.If you are using Tacrolim us, an immunosuppressant, you should tell your doctor about it; he/she may monitor the drug levels in your blood.The use of Gyno-Canesten Kombipack may reduce the protective effect of latex products such as vaginal diaphragms or condoms. Simultaneous use should be avoided.In addition, the healing effect of Gyno-Canesten Kombipack may be impaired.Inform your doctor, pharmacist or druggist if you

• suffer from other diseases,have allergies orother medicines (also self-madeair!) or use it externally.

Can Gyno-Canesten Kombipack be used during pregnancy or breastfeeding?

Gyno-Canesten Kombipack should not be used during pregnancy unless your doctor decides that this is clearly necessary.Your doctor will decide whether to administer it during pregnancy, especially in the 1st trimester.During pregnancy treatment with Gyno-Canesten vaginal tablets should be carried out without an applicator.Your doctor will decide whether to use Gyno-Canesten combi-pack while breastfeeding.

How do you use Gyno-Canesten combi-pack?

Unless otherwise prescribed by your doctor:During 3 consecutive days, one Gyno-Canesten vaginal tablet every evening after going to bed, if possible insert deep into the vagina. This is best done lying on your back with your legs slightly bent

Application of the vaginal tablet with applicator

1. Pull rod A out as far as it will go. Then insert the vaginal tablet into the applicator B.2. Carefully insert the applicator with the tablet as deep as possible into the vagina (preferably lying on your back).3. Gently push rod A all the way in, placing the tablet in the sheath.4. Clean the applicator carefully with warm (not boiling) water after use.

To do this, pull rod A completely out of the applicator B beyond the stop.

Using the vaginal tablet without the applicator

Gyno-Canesten vaginal tablets require a wet vagina, to be able to dissolve completely. Otherwise, broken pieces of the tablet may leak out of the vagina. To prevent this, the vaginal tablet must be inserted as far as possible into the vagina. If the vaginal tablet does not completely dissolve during the night, the use of Gyno-Canesten vaginal cream should be considered.The use of Gyno-Canesten combination pack should not be carried out during menstruation or should be completed before the start of menstruation.

For external treatment:

If there is accompanying vulvitis (infection of the vaginal lips), an additional external treatment with the 1% clot Canesten cream containing rimazole (in the Gyno-Canesten combination pack). The cream is applied thinly to the affected area 1-3 times a day for 1-2 weeks.The partner should also be treated with a clotrimazole cream if he has balanitis (infection of the glans and foreskin) and itching and/or inflammation occurs.The symptoms of the disease often disappear before the infection has completely healed. Insufficient duration of use or stopping treatment too early can result in the disease flaring up again.In general, a 3-day treatment is sufficient for genital fungal disease. If necessary, a second treatment can be carried out over 3 days.Therefore, if there is no significant improvement or if the symptoms have worsened, consult your doctor immediately.For adolescents, the same dosage as for adults is recommended, if indicated. Dose adjustments based on age are not required.Stick to the dosage provided in the package insert or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.The vaginal tablets contained in Gyno-Canesten combi pack are odorless and white.

What side effects can Gyno-Canesten combination pack?

Temporary local skin irritations (e.g. reddening of the skin, blistering, swelling, itching, burning, stinging) may occur. Discontinuation of treatment is therefore generally not necessary.Generalized hypersensitivity reactions of varying degrees of severity may occur. These can affect the skin (e.g. itching, reddening, nettle rash), breathing (e.g. shortness of breath), the circulatory system (e.g. drop in blood pressure that requires treatment and even disturbances of consciousness) and the gastrointestinal tract (e.g. nausea, abdominal pain, diarrhea) as well as abdominal pain or vaginal bleeding.If you notice side effects, contact your doctor, pharmacist or druggist or your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be taken into account?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage instructions:

Store at room temperature (15 - 25 °C). Store in the original packaging. Keep the container tightly closed.Keep out of the reach of children.

Additional information:

The vaginal tablets contained in the Gyno-Canesten combination pack are white tablets for use in the vagina. The vaginal tablets must not be taken or swallowed.

To avoid re-infection, the laundry used (washcloths, towels, underwear, if possible made of cotton) should be changed and boiled daily.

A fungal infection of the vagina is also transmitted through sexual intercourse, among other things. Most of the time, the partner does not have any symptoms of the disease, but he can still be infected in the limb. Therefore, ask your doctor, pharmacist or druggist whether it is advisable to treat your partner at the same time.Your doctor, pharmacist or druggist can give you further information. These people have the detailed technical information.

What does Gyno-Canesten combination pack contain?Active ingredients

1 vaginal tablet contains 0.2 g clotrimazole. 1 g Canesten cream contains 10 mg clotrimazole.

Excipients

1 vaginal tablet contains: calcium lactate pentahydrate, micro cristalline cellulose (E 460a), crospovidone (E1202), hypromellose, lactic acid (E 270), lactose monohydrate, corn starch, magnesium stearate (E 470b), colloidal anhydrous silicon dioxide.

1 g Canesten Cream contains: benzyl alcohol (E 1519), cetostearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60 (E 435), purified water, sorbitan monostearate (E 491).

Authorization number

60954 (Swissmedic).

Where can you get the Gyno-Canesten combi pack? Which packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Packs of 3 vaginal tablets with applicator and 20 g Canesten cream.

Authorization holder

Bayer (Schweiz) AG, Zurich

This package leaflet was last checked by the medicines authority (Swissmedic) in June 2020.