Canesten Clotrimazol Gyn Once - Combi

Canesten Clotrimazol Gyn Once - Combi vaginal tablet and cream belong to the group of antifungal medicines used to treat fungal infections of the vagina.

Application

What is Canesten Clotrimazole Gyn Once and what is it used for?

Canesten Clotrimazole Gyn Once - Combi vaginal tablet and cream is an antifungal medicine used to treat fungal infections of the vagina.

The cream can also be used to treat fungal infections of the glans and foreskin.

The vaginal tablet is inserted once into the vagina, the cream is used for external treatment of diseased skin areas.

The treatment is effective against pathogens that can cause fungal infections of the vagina and also against some bacteria. The active ingredient clotrimazole contained in Canesten Clotrimazol Gyn Once Combi inhibits the growth of fungi or kills them.

When is Canesten Clotrimazol Gyn Once used?
Canesten Clotrimazol Gyn Once - Combi is used to treat:
Discharge and inflammation of the vagina caused by fungi, mostly Candida species, and by Canesten-susceptible bacteria.
Fungal diseases of the labia (Candida vulvitis) and adjacent areas Inflammation of the glans and foreskin of the male, caused by yeast fungi (Candida balanitis).

How is it applied?

What is Canesten Clotrimazole Gyn Once and what is it used for?

Canesten Clotrimazole Gyn Once - Combi vaginal tablet and cream belongs to the group of antifungal medicines used to treat fungal infections of the vagina.

The cream can also be used to treat fungal infections of the glans and foreskin.

The vaginal tablet is inserted once into the vagina, the cream is used for external treatment of diseased skin areas.

The treatment is effective against pathogens that can cause fungal infections of the vagina and additionally against some bacteria. The active ingredient clotrimazole contained in Canesten Clotrimazole Gyn Once Combi inhibits the growth of fungi or kills them.

When is Canesten Clotrimazole Gyn Once used?
Canesten Clotrimazole Gyn Once - Combi is used to treat:

. .

	Discharge and inflammation of the vagina caused by fungi, mostly Candida species, and
by Canesten-susceptible bacteria.
	Fungal diseases of the labia (Candida vulvitis) and adjacent areas
	Inflammation of the glans and foreskin of the male, caused by yeast fungi (Candida-
Balanitis).

What should you pay attention to before taking it?

- -2. What should you be aware of before using Canesten Clotrimazole Gyn Once?

Canesten Clotrimazole Gyn Once must not be used,
if you are allergic to clotrimazole, or any of the other ingredients of the two preparations mentioned in section 6.

Warnings and precautions
Please talk to your doctor or pharmacist before using Canesten.
Consult a doctor if you have a fever (38°C or more), pain in the lower abdomen, pain in the back and/or shoulder, foul-smelling discharge, nausea, bleeding from the vagina (vaginal haemorrhage).

Please consult your doctor,
- if the condition occurs for the first time,
- if you have had more than four such fungal infections during the past 12 months.

If you are sexually active:

• You should not have vaginal intercourse during treatment with Canesten to avoid infecting your partner.
.
• You should not use the following products at the same time as Canesten, it may reduce the functionality and thus impair the safety of these products: Vaginal tablets and latex products (e.g. condoms, diaphragms) or topical chemical contraceptives (e.g. vaginal suppositories).

The treatment should not be carried out during menstruation or should be completed before it begins.

Please consult a doctor immediately if the symptoms have not improved significantly within 3 to 4 days after starting treatment or if the symptoms worsen during treatment.

Avoid contact with the eyes.

Do not swallow the preparations.

Use of Canesten Clotrimazole Gyn Once with other medicines.
Inform your doctor or pharmacist if you are taking other medicines /
use , recently taken / used or intend to take / use other medicines.

If you are taking Tacrolimus or Sirolimus (medicines for organ transplant rejection or certain skin diseases), you should inform your doctor immediately.

Canesten clotrimazole should not be used together with other medicines for fungal infections (e.g. amphotericin, nystatin).

Pregnancy, lactation and procreation/parturition.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
- -

Pregnancy
There is no evidence to suggest that, if used during pregnancy
harmful effects on mother and child are to be expected. For precautionary reasons, clotrimazole must not be used during the first 3 months of pregnancy.

During pregnancy, you should carry out the treatment with the vaginal tablets without the applicator.

Breastfeeding time
Do not breastfeed during treatment with Canesten.

Breeding ability.
No studies have been conducted on the effect of clotrimazole on fertility, but animal studies showed no harmful effects of the drug.

Driving ability and ability to operate machinery.
The ability to react while driving or operating tools or machines is not impaired.

Important information about certain other ingredients of Canesten clotrimazole. Gyn Once
Canesten cream contains cetylstearyl alcohol. This may cause local skin reactions (e.g. contact dermatitis).

How should the medicine be taken?

How should Canesten Clotrimazole Gyn Once be used?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

How and when should you use Canesten Clotrimazole Gyn Once?

Vaginal tablet
Insert one vaginal tablet once in the evening before going to bed, as deeply as possible into the vagina. This is best done lying on your back with your legs slightly pulled up.
Note: The vaginal tablet needs moisture to dissolve completely. If the vagina is dry, the vaginal tablet may dissolve incompletely. This can be recognised by the fact that friable parts of the tablet are excreted. To prevent this, it is important to insert the tablet as deeply as possible, preferably before going to bed.
If necessary, the treatment can be repeated. However, if symptoms reoccur within 2 months, you should consult your doctor.
Use of the vaginal tablet with applicator:
Pull out the applicator stick (A) as far as it will go.
Press the front of the applicator slightly
with your fingers and insert the tablet with the flat
side into the applicator (B). The
round side of the tablet should protrude approx. halfway.

Carefully insert the applicator with tablet as deeply as possible into

the tablet with the flat side in the applicator (B)
. The round side of the tablet should protrude about
halfway.
- -

Insert the vagina (preferably in the supine position).

Push the applicator rod (A) carefully
through to the stop, placing the tablet in the
vagina.
Remove the applicator.
Clean the applicator thoroughly after use with warm (not
boiling) water. For this purpose, remove the applicator rod (A) completely from the applicator (B).

During pregnancy, the treatment with the vaginal tablets should be carried out without the applicator.

Use without applicator:

Insert the tablet as deeply as possible into the vagina - preferably in the supine position with
slightly drawn legs.

Children and adolescents
The vaginal tablet is intended for use by adults. In persons under 18 years of age, treatment with the vaginal tablet may only be carried out on medical prescription.
Data on the safety and efficacy of Canesten Clotrimazol Gyn Once Kombi in children and adolescents are not available.

Cream:
The cream is applied thinly to the diseased skin areas 1 - 3 times a day and rubbed in. Usually, an ointment strand about 1/2 cm long is sufficient to treat an area about the size of a palm.

In case of infections of the labia (Candida vulvitis) and adjacent areas of the woman, apply the cream 1 - 3 times a day to the corresponding skin areas (external genitals up to the anus).

In case of simultaneous inflammation of the external female genitals and inflammation of the glans and foreskin of the man (candida balanitis), additional local treatment with Canesten clotrimazole - cream should also be carried out on the partner to prevent a relapse.

You should not use tampons, vaginal douches, sperm-killing products or other vaginal products during treatment with this medicine.
- -

How long should you use Canesten Clotrimazole Gyn Once?
Vaginal tablet: One vaginal tablet once in the evening is usually enough to get rid of a fungal infection. However, if necessary, the treatment can be repeated.You should not take the treatment during menstruation, as the medicine may not work sufficiently at this time. The treatment should therefore be completed before the onset of menstruation.
Cream: The general duration of treatment is 1 - 2 weeks.

In general, the signs of vaginitis caused by fungi (such as itching, discharge, burning sensation) decrease significantly within the first four days after treatment, i.e. the symptoms may persist for a few days after application of the 1-day
therapy. If there is no significant improvement in symptoms after 4 days, please contact your doctor.

If you forget to use Canesten Clotrimazole Gyn Once?Vaginal tablet: If you forget to use it in the evening, you can make up for it the next evening.
Cream: Do not apply a larger amount of cream next time, but continue the treatment as recommended.

If you stop taking Canesten Clotrimazole Gyn Once
In order to achieve complete healing of the infection and to prevent a relapse, you should not interrupt or stop treatment without consulting your doctor. If you do, your symptoms are likely to return, as your fungal infection is probably not yet cured.

What are the possible side effects?

How to store Canesten Clotrimazole Gyn Once?

Keep this medicine out of the reach of children.

No special storage conditions are required for this medicinal product.

Cream: Do not use for longer than 3 months after first use.

Do not use this medicine after the expiry date which is stated on the carton after "Use by". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How should Canesten Clotrimazole Gyn Once be stored?

Keep this medicine out of the reach of children.

No special storage conditions are required for this medicine.

Cream: Do not use for longer than 3 months after first use.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Canesten Clotrimazole Gyn Once contains

- The active substance is clotrimazole.
- Vaginal tablet: 1 vaginal tablet contains 0.5 g clotrimazole.
The other ingredients are: Calcium lactate pentahydrate, microcrystalline cellulose, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, maize starch, highly dispersed silicon dioxide, lactic acid.
- Cream: 1 g cream contains 0.01 g clotrimazole.
The other ingredients are: Benzyl alcohol, 0.1 g cetyl stearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate.

What Canesten Clotrimazole Gyn Once looks like and contents of the pack
Canesten Clotrimazole Gyn Once - Combi consists of a white and odourless vaginal tablet and a white cream. It is available in a combination pack with 1 vaginal tablet, 1 x 20 g cream and 1 applicator.