NYSTADERM

NYSTADERM Paste

Important notes (mandatory information)

Nystaderm Paste 100,000 IU/g. Active ingredient: Nystatin. Areas of application: for skin infections with nystatin-sensitive yeasts such as diaper dermatitis.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nystaderm Paste 100,000 IU/g, paste for application to the skin
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, talk to 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 PASTE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NYSTADERM PASTE?
3. HOW TO USE NYSTADERM PASTE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NYSTADERM PASTE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

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

Nystaderm Paste is used for skin infections with nystatin-sensitive yeasts such as diaper dermatitis. If you do not feel better or even worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NYSTADERM PASTE?

Nystaderm Paste must not be used

if you are allergic to nystatin or any of the other ingredients of Nystaderm Paste.

Warnings and precautions

If hypersensitivity occurs (e.g. itching, burning), the medication should be discontinued and a doctor consulted. Please talk to your doctor or pharmacist before using Nystaderm Paste.

Children

Due to the high osmolarity of nystatin, use in very underweight and immature premature infants is not recommended.

Use of Nystaderm Paste with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan 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 Paste, is hardly absorbed in therapeutic doses after oral administration, via intact skin or via mucous membranes. Nystatin does not cross the placental barrier, and passage into breast milk is also not to be expected. Nystaderm Paste can be used during pregnancy and breast-feeding.

Driving and using machines

There is no experience regarding impairment of driving ability and ability to operate machines.

3. HOW TO USE NYSTADERM PASTE?

Always use this medicine exactly as described in the package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Apply Nystaderm Paste thinly to the affected skin areas 2 - 4 times daily.

Duration of use

The symptoms usually subside after a few days. However, to ensure full therapeutic success, treatment should be continued for a few days after complete healing. The duration of treatment should not exceed 3 weeks.

Please talk to your doctor or pharmacist if you have the impression that the effect of Nystaderm Paste is too strong or too weak.

If you have used more Nystaderm Paste than you should:
You can continue treatment with the dose prescribed for you. No adverse effects are to be expected in the event of a short-term overdose.

If you forget to use Nystaderm Paste

Do not use a double dose to make up for the missed dose.

If you stop using Nystaderm Paste

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

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people)

In rare cases, hypersensitivity reactions may occur with local application.

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 PASTE?

Keep this medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the tube and carton after "usable until". The expiry date refers to the last day of the month indicated. Do not store above 25°C.

Nystaderm Paste can be stored for 12 months after first opening the tube.

Never dispose of this medicine via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment. For more information, see: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Nystaderm Paste contains

The active ingredient is: Nystatin. 1 g of paste contains 100,000 IU of nystatin.

The other ingredients are

Zinc oxide, liquid paraffin, polyethylene, white petrolatum, all-rac-a-tocopherol.

What Nystaderm Paste looks like and contents of the pack

Nystaderm Paste is a light yellow paste and is available in tubes of 20 g, 50 g and 100 g.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089/641860
Fax: 089/64186130
E-mail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Phone: 034954/247-0
Fax: 034954/247-100
(a subsidiary of Dermapharm AG)

This leaflet was last revised in January 2020.

Source: Package leaflet information
Status: 12/2024
Active ingredient: Nystatin. Areas of application: for skin infections with nystatin-sensitive yeasts such as diaper dermatitis.