TYROSUR

TYROSUR wound healing powder

Important notes (mandatory information)

Tyrosur Wound Healing Powder. Active ingredient: Tyrothricin. Areas of application: for the treatment of small-scale, superficial, slightly weeping wounds with bacterial superinfection with Tyrothricin-sensitive pathogens such as e.g. cuts, scratches, abrasions.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tyrosur Wound Healing Powder, powder for application to the skin
Active ingredient: Tyrothricin 1 mg/g

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

• 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 after 7 days, you must see a doctor in any case.
• If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

The package leaflet contains

1. WHAT IS TYROSUR WOUND HEALING POWDER AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING TYROSUR WOUND HEALING POWDER?
3. HOW SHOULD TYROSUR WOUND HEALING POWDER BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD TYROSUR WOUND HEALING POWDER BE STORED?
6. FURTHER INFORMATION

1. WHAT IS TYROSUR WOUND HEALING POWDER AND WHAT IS IT USED FOR?

Tyrosur Wound Healing Powder is a wound treatment. Tyrosur Wound Healing Powder is used to treat small-scale, superficial, slightly weeping wounds with bacterial superinfection with Tyrothricin-sensitive pathogens such as e.g. cuts, scratches, abrasions.

2. WHAT SHOULD YOU CONSIDER BEFORE USING TYROSUR WOUND HEALING POWDER?

Tyrosur Wound Healing Powder must not be used if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of Tyrosur Wound Healing Powder.

Special care should be taken when using Tyrosur Wound Healing Powder

When using Tyrosur Wound Healing Powder with other medicines

No medicines are known that influence the effect of Tyrosur Wound Healing Powder or are influenced by Tyrosur Wound Healing Powder. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

Pregnancy

There is no data on the safety of using Tyrosur Wound Healing Powder in pregnant women. Since it is not known to what extent Tyrothricin, the active ingredient of Tyrosur Wound Healing Powder, is absorbed into the bloodstream through the skin, you should only use Tyrosur Wound Healing Powder for a short period of time and on a small area and only on the express instructions of your doctor if you are pregnant.

Breastfeeding

It is not known whether Tyrothricin, the active ingredient of Tyrosur Wound Healing Powder, passes into breast milk. If you are breastfeeding, you must not use Tyrosur Wound Healing Powder in the breast area. If you are breastfeeding, you must only use Tyrosur Wound Healing Powder for a short period of time and on a small area and only on the express instructions of your doctor. Contact between the infant and the treated areas of skin must be avoided.

Driving and operating machinery

No special precautions are required.

3. HOW SHOULD TYROSUR WOUND HEALING POWDER BE USED?

Always use Tyrosur Wound Healing Powder exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Tyrosur Wound Healing Powder is sprinkled thinly onto the affected areas of skin 1 to 2 times a day.

Type of application

Powder for application to the skin. The powder is sprinkled in a thin layer onto the areas of skin to be treated in the morning (and evening) and, if necessary, covered with a dressing.

Duration of application

The duration of treatment depends on the severity and course of the clinical picture. After the symptoms have subsided, Tyrosur Wound Healing Powder should be used for about another week to prevent the infection from breaking out again.

Please talk to your doctor or pharmacist if you have the impression that the effect of Tyrosur Wound Healing Powder is too strong or too weak.

If you have used more Tyrosur Wound Healing Powder than you should

No consequences are to be expected. Then continue treatment as described above. However, if you notice any unusual symptoms, please contact your doctor.

If you forget to use Tyrosur Wound Healing Powder

Continue treatment as specified in the dosage instructions.

Effects if treatment with Tyrosur Wound Healing Powder is discontinued

The duration of treatment depends on the severity and course of the clinical picture. If you discontinue treatment with Tyrosur Wound Healing Powder prematurely, the desired effect may not occur.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Tyrosur Wound Healing Powder can have side effects, although not everybody gets them.

The following frequency information is used to assess 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

Skin and subcutaneous tissue disorders

Hypersensitivity reactions can occur very rarely.

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, Department 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 SHOULD TYROSUR WOUND HEALING POWDER BE STORED?

Keep medicines out of the reach of children! Do not use the medicine after the expiry date stated on the shaker and folding box! The expiry date refers to the last day of the month. Please close the shaker carefully after use! Do not store above 25°C.

6. FURTHER INFORMATION

What does Tyrosur Wound Healing Powder contain?
The active ingredient is Tyrothricin. 100 g of powder for application to the skin contain 0.1 g of Tyrothricin. The other ingredients are: Lactose monohydrate, macrogol 6000, highly dispersed silicon dioxide.

What Tyrosur Wound Healing Powder looks like and contents of the pack

Tyrosur Wound Healing Powder is available in packs of 5 g (N 1) and 20 g (N 2) of powder for application to the skin.

Pharmaceutical entrepreneur and manufacturer

Engelhard Arzneimittel GmbH Er Co. KG
Herzbergstraße 3
61138 Niederdorfelden
Tel.: 06101 539-300
Fax: 06101 539-315
Internet: www.engelhard-am.de
E-mail: ¡nfo@engelhard-am.de

This package leaflet was last revised in April 2016.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Tyrothricin. Areas of application: for the treatment of small-scale, superficial, slightly weeping wounds with bacterial superinfection with Tyrothricin-sensitive pathogens such as e.g. cuts, scratches, abrasions.