KADEFEMIN Mycostop Combo Pack 3 Vag Tabl+20g Cream

What is Kadefemin Mycostop and when is it used?

Kadefemin Mycostop contains vaginal tablets and cream with the active ingredient clotrimazole and is a medicine against fungal infections (mycoses). Kadefemin Mycostop is used for infections of the vagina and the external genital area caused by fungi (usually Candida). Candida is a fungus that can be found on the skin and in many women also in the vagina. A fungal disease (mycosis) only develops when it multiplies excessively, which is usually noticeable through reddening, burning, itching, discharge and painful inflammation. A reliable diagnosis can only be made by your doctor.

What should be considered?

During treatment, you should only use deodorants or personal hygiene products after consulting your doctor, as they can reduce their effectiveness of Kadefemin Mycostop cannot be excluded. If Kadefemin Mycostop is used together with latex products such as condoms or diaphragms, the additives contained in the latex products may reduce tear strength and thus impair the safety of these products. This effect is transient and limited to the period of treatment. While using Kadefemin Mycostop it is recommended to avoid sexual intercourse as the infection can be transmitted to the sexual partner. To avoid possible reinfection, the partner should also be examined by a doctor. In the case of a medically diagnosed inflammation of the glans and foreskin of the partner due to a fungal infection, an additional local treatment with the application forms intended for this should be carried out.

When should Kadefemin Mycostop not be used?

Kadefemin Mycostop should not be used if you are hypersensitive to clotrimazole or any of the excipients (see «What is in Kadefemin Contain Mycostop?»).

When should you be careful when using Kadefemin Mycostop?

Some of the ingredients in the vaginal tablets and cream may cause localized skin irritation (e.g. contact dermatitis). In case of local irritation or allergic reaction, treatment with Kadefemin Mycostop should be discontinued. Contact with eyes should be avoided. Kadefemin Mycostop should only be used with particular caution during pregnancy (see «Pregnancy, breast-feeding»). If you are taking tacrolimus at the same time, you should consult your doctor before using Kadefemin Mycostop, as any tacrolimus overdose should be carefully monitored. Under laboratory conditions (experimental and microbiological), the active substance of Kadefemin Mycostop can reduce the effectiveness of other substances that act locally against yeast fungi (such as amphotericin B, nystatin or natamycin). If Kadefemin Mycostop is taken in large quantities, e.g. by children, no serious symptoms of poisoning are to be expected. However, symptoms such as abdominal pain and nausea can occur. To be on the safe side, the doctor should be informed. This medicinal product contains 10 mg benzyl alcohol or 100 mg cetostearyl alcohol per 1 g cream. Benzyl alcohol can cause allergic reactions and mild local irritation. Cetylstearyl alcohol may cause localized skin irritation (e.g. contact dermatitis). Itell your doctor, pharmacist or druggist if you

• suffer from other illnesses,have allergies ortake other medicines (including those you bought yourself!) or use them externally!

Can Kadefemin Mycostop be used during pregnancy or breastfeeding?Pregnancy

As a precaution, you may Use Kadefemin Mycostop during pregnancy only after a risk/benefit assessment by your doctor. During pregnancy, treatment with the vaginal tablets should be carried out without an applicator.

Breastfeeding

If you are breastfeeding, you can only use Kadefemin Mycostop after consulting your doctor.

How do you use Kadefemin Mycostop?Recommended dosage

Usually, 1 vaginal tablet (200 mg clotrimazole) is used. The cream is usually applied 3 times a day. The amount depends on the size of the skin area to be treated.

How to use

The vaginal tablets are inserted in the evening before going to bed using the enclosed applicator. This is best done lying on your back with your legs slightly bent. The cream is applied thinly with the finger to the external genitals up to the anus.

Application of the applicator:

The treatment should not be carried out during menstruation or should be completed before it begins. The applicator should not be used during pregnancy (see «Can Kadefemin Mycostop be used during pregnancy or breast-feeding?»).

Duration of application

A sufficiently long application is important for success. In general, an application for 3 consecutive days is sufficient. However, if necessary, a second treatment over a further 3 days can be added on medical advice. The doctor decides on the duration of the application depending on the extent and localization of the disease.

If you use more Kadefemin Mycostop than you should

If used as directed, no overdose or poisoning is to be expected. If you have accidentally inserted more than 1 vaginal tablet when using Kadefemin Mycostop or applied the cream more frequently, no serious side effects are to be expected (see also «What side effects can Kadefemin Mycostop have?»). In this case, in consultation with your doctor, reduce the application to the intended dose and otherwise stick to the treatment plan.

If you forget to use Kadefemin Mycostop

Do not apply a double dose if you have forgotten the previous application. If you have forgotten several applications, please speak to your doctor to what extent you need to extend the treatment duration.

If you stop using Kadefemin Mycostop

Please discuss how to proceed with your doctor, as the success of the treatment is at risk in this case. This medicine is not intended for use in children and adolescents. Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Kadefemin Mycostop have?

• Local skin irritation with temporary redness, itching, burning or stinging.Hypersensitivity, allergic reactions with symptoms such as itching, reddening of the skin, hives, shortness of breath, drop in blood pressure that requires treatment and even disturbances of consciousness. Contact your doctor and discuss the continuation of the treatment with him or her.Abdominal pain, nausea, diarrhoea.Abdominal pain, vaginal bleeding.

If you notice any side effects, talk to 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 considered?Shelf life

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

Use by after opening

Once opened, Kadefemin Mycostop Cream should not be used for more than 6 months.

Storage Instructions

Store at room temperature (15 - 25 °C). Keep out of the reach of children.

Further information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Kadefemin Mycostop contain?Active ingredients

1 vaginal tablet contains 200 mg clotrimazole. 1 g cream contains 20 mg clotrimazole.

Excipients

Vaginal tablet: lactose monohydrate, pregelatinized corn starch, adipic acid, sodium hydrogen carbonate, stearic acid, magnesium stearate, colloidal silicon dioxide, polysorbate 80. p>Cream: Purified Water, Octyldodecanol, Cetylstearyl Alcohol, Cetyl Palmitate, Sorbitan Monostearate, Polysorbate 60, Benzyl Alcohol.

Approval number

67736 (Swissmedic)

Where can you get Kadefemin Mycostop? What packs are available?

In pharmacies and drugstores, without a doctor's prescription. Combo pack with 20 g cream and 3 vaginal tablets with applicator.

Authorization holder

Max Zeller Söhne AG, Seeblickstrasse 4, 8590 Romanshorn This package leaflet was last checked by the medicines authority (Swissmedic) in December 2020.