MYKUNDEX

MYKUNDEX healing ointment

Important notes (mandatory information)

Mykundex Healing Ointment. Areas of application: for skin infections caused by nystatin-sensitive yeasts (e.g. Candida albicans).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mykundex Healing Ointment
Active ingredients: Nystatin (100,000 IU/g), zinc oxide (200 mg/g)

Read the entire package leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, to achieve the best possible treatment results, Mykundex Healing Ointment must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

This package leaflet contains

1. WHAT IS MYKUNDEX HEALING OINTMENT AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING MYKUNDEX HEALING OINTMENT?
3. HOW TO USE MYKUNDEX HEALING OINTMENT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MYKUNDEX HEALING OINTMENT?
6. FURTHER INFORMATION

1. WHAT IS MYKUNDEX HEALING OINTMENT AND WHAT IS IT USED FOR?

Mykundex Healing Ointment is a remedy for yeast infections of the skin. Mykundex Healing Ointment is used for skin infections caused by nystatin-sensitive yeasts (e.g. Candida albicans).

2. WHAT DO YOU NEED TO KNOW BEFORE USING MYKUNDEX HEALING OINTMENT?

Mykundex Healing Ointment must not be used if you are hypersensitive (allergic) to nystatin, zinc oxide or any of the other ingredients of Mykundex Healing Ointment.

Special care must be taken when using Mykundex Healing Ointment

Use of condoms: When treating with Mykundex Healing Ointment in the genital or anal area, the use of latex condoms may result in a reduction in tear resistance and thus impair the safety of condoms due to the excipient paraffin.

Children

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

When using Mykundex Healing Ointment with other medicines

Interactions with other medicines have not been reported to date. Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

When using Mykundex Healing Ointment with food and drink

Not applicable.

Pregnancy and breast-feeding

There is insufficient data on the use of Mykundex Healing Ointment during pregnancy. Mykundex Healing Ointment should only be used during pregnancy and breast-feeding after careful consideration of the benefits and risks. Large-scale use of Mykundex Healing Ointment and use on the nursing breast should be avoided.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Mykundex Healing Ointment

Wool alcohol ointment can cause localised skin reactions (e.g. contact dermatitis).

3. HOW TO USE MYKUNDEX HEALING OINTMENT?

Always use Mykundex Healing Ointment exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Apply the healing ointment to the affected skin areas once or several times a day. Cover the affected skin areas completely with healing ointment. Treatment should be continued for a few days after complete healing.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Mykundex Healing Ointment can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

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

In rare cases, allergic reactions to one of the ingredients of the healing ointment are possible.

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, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE MYKUNDEX HEALING OINTMENT?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the folding box and the tube.

Storage conditions

Do not store above 25°C.

Note on shelf life after opening

The shelf life after opening the tube is 9 months.

6. FURTHER INFORMATION

What Mykundex Healing Ointment contains

The active ingredients are: Nystatin and zinc oxide. 1 g of healing ointment contains 100,000 IU (International Units) of nystatin and 200 mg of zinc oxide. The other ingredients are: wool alcohol ointment, liquid paraffin.

What Mykundex Healing Ointment looks like and contents of the pack

White to slightly yellowish homogeneous ointment. Original pack of 25 g healing ointment, original pack of 50 g healing ointment, original pack of 100 g healing ointment, original pack of 100 g (2 x 50 g) healing ointment.

Pharmaceutical entrepreneur

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems
phone: +4930338427-0
fax: + 49 38351 308
e-mail: info@RIEMSER.com

Manufacturer

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems

L-A-W Services GmbH
Leipziger Arzneimittelwerk
Elisabeth-Schumacher-Straße 54/56
04328 Leipzig

This package leaflet was last revised in April 2014.

Source: Information from the package leaflet
Status: 02/2016
Areas of application: for skin infections caused by nystatin-sensitive yeasts (e.g. Candida albicans).