NYSTADERM

NYSTADERM Cream

Important notes (mandatory information)

Nystaderm Cream 100,000 IU/g. Active ingredient: Nystatin. Areas of application: for proven Nystatin-sensitive yeast infections of the skin, if neither a greasy nor a drying component is desired, especially with the involvement of Candida spp., such as diaper candidiasis.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nystaderm Cream 100,000 IU/g
Active ingredient: Nystatin

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS NYSTADERM CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NYSTADERM CREAM?
3. HOW TO USE NYSTADERM CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NYSTADERM CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NYSTADERM CREAM AND WHAT IS IT USED FOR?

Nystaderm Cream is an antifungal agent (antimycotic). Nystaderm Cream is used for proven Nystatin-sensitive yeast infections of the skin, if neither a greasy nor a drying component is desired, especially with the involvement of Candida spp., such as diaper candidiasis. Nystaderm Cream is specifically effective against saprophytic and parasitic yeasts, especially against Candida species. The active ingredient Nystatin inhibits the spread of pathogens at low and medium doses. High doses of Nystatin kill them. The effect of Nystatin depends on the germ density, therefore, in case of unknown germ density, the maximum dose should always be used. Depending on the dose and germ density, this achieves a corresponding reduction and elimination of the yeasts. The therapeutic applicability and biological availability of Nystatin depend not only on the active ingredient, but also essentially on the choice of dosage form and the other suitable components used for this purpose. If you do not feel better or even worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NYSTADERM CREAM?

Nystaderm Cream must not be used if you are allergic to Nystatin, Methyl-4-hydroxybenzoate or any of the other ingredients of Nystaderm Cream.

Warnings and precautions

Please talk to your doctor or pharmacist before using Nystaderm Cream.

Use of Nystaderm Cream together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Pregnancy and breast-feeding

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. Nystatin, the active ingredient in Nystaderm Cream, is hardly absorbed after oral administration, via intact skin or via mucous membranes in therapeutic doses. Nystatin does not cross the placental barrier, and passage into breast milk is also not to be expected. Nystaderm Cream can be used during pregnancy and breast-feeding.

Driving and using machines

There is no experience regarding impairment of driving and using machines.

Cetyl alcohol

Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation. When used in the genital or anal area, the oils and fats contained as excipients can reduce the tear resistance and thus impair the safety of latex condoms.

3. HOW TO USE NYSTADERM CREAM?

Always use Nystaderm Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The usual dose is: Apply Nystaderm Cream thinly to the affected skin areas 2 - 4 times a day and rub in gently. In severe cases, hourly application may be useful.

Duration of use

Nystaderm Cream should be applied for about 6 days until the condition subsides. To ensure full therapeutic success, treatment should be continued for another 8-10 days. Please talk to your doctor or pharmacist if you have the impression that the effect of Nystaderm Cream is too strong or too weak.

If you have used more Nystaderm Cream than you should

You can continue treatment with the dose prescribed for you. No adverse effects are to be expected in the event of short-term overdose.

If you forget to use Nystaderm Cream

Do not use a double dose to make up for a forgotten application.

If you stop using Nystaderm Cream

You could jeopardize the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment with Nystaderm Cream.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Nystaderm Cream can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

In rare cases, hypersensitivity reactions may occur with local application. Methyl-4-hydroxybenzoate can cause hypersensitivity reactions, including late reactions. Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NYSTADERM CREAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the tube and carton after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25ºC. Nystaderm Cream can be stored for 6 months after first opening the tube.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nystaderm Cream contains

The active ingredient is: 1 g cream contains 100,000 IU Nystatin. The other ingredients are: Macrogol stearate 2000, Macrogol stearate 5000, Cetyl alcohol (Ph.Eur.), Methyl-4-hydroxybenzoate (Ph.Eur.) (E218), Sorbitan sesquioleate, Glycerol monostearate, Liquid paraffin, Propylene glycol, Purified water.

What Nystaderm Cream looks like and contents of the pack

Nystaderm Cream is a light yellow cream and is available in tubes of 20 g and 50 g.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Tel. 089 / 641 86-0
Fax 089 / 641 86-130
eMail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
(a subsidiary of Dermapharm AG)

This leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 07/2017
Active ingredient: Nystatin. Areas of application: for proven Nystatin-sensitive yeast infections of the skin, if neither a greasy nor a drying component is desired, especially with the involvement of Candida spp., such as diaper candidiasis.