TYROSUR

TYROSUR wound healing gel

Important notes (mandatory information)

Tyrosur Wound Healing Gel. Active ingredient: Tyrothricin. Areas of application: for the soothing 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 Gel
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 Gel 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 severely or if you notice side effects not listed in this package leaflet, please inform your doctor or pharmacist.

The package leaflet contains

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

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

Tyrosur Wound Healing Gel is a wound treatment. Tyrosur Wound Healing Gel is used for the soothing treatment of 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 GEL?

Tyrosur Wound Healing Gel must not be used:

• if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of Tyrosur Wound Healing Gel.
• on the nasal mucosa.

Special care must be taken when using Tyrosur Wound Healing Gel

When used near the eyes

The gel must not get into the eyes, as this can cause burning.

When using Tyrosur Wound Healing Gel with other medicines

No medicines are known that affect the effect of Tyrosur Wound Healing Gel or are affected by Tyrosur Wound Healing Gel. 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 Gel in pregnant women. The potential risk to humans is unknown due to the lack of animal studies. Therefore, you should not use Tyrosur Wound Healing Gel during pregnancy.

Breastfeeding

Since it is not known whether Tyrothricin or Cetylpyridinium chloride passes into breast milk, you should not use Tyrosur Wound Healing Gel during breastfeeding.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Tyrosur Wound Healing Gel

Tyrosur Wound Healing Gel contains propylene glycol and can therefore cause skin irritation.

3. HOW IS TYROSUR WOUND HEALING GEL USED?

Always use Tyrosur Wound Healing Gel 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: The gel is applied 2 to 3 times a day in sufficient quantity.

Type of application

For application to the skin. Apply the gel in the morning, (noon) and evening so that the affected skin areas are covered with gel. A dressing is usually not necessary for minor injuries or skin inflammations on uncovered parts of the body. In the case of weeping wounds, it is advisable to apply a protective dressing, which should be changed every 1 - 2 days or as directed by your doctor.

Duration of use

The duration of treatment depends on the clinical picture. If the symptoms worsen or if there is no improvement within one week, you should definitely consult your doctor for advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Tyrosur Wound Healing Gel is too strong or too weak.

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

No consequences are to be expected. Continue treatment as directed in the dosage instructions. However, if you notice any unusual symptoms, please contact your doctor.

If you forget to use Tyrosur Wound Healing Gel

Continue treatment as directed in the dosage instructions.

Effects if treatment with Tyrosur Wound Healing Gel is discontinued

If you discontinue treatment with Tyrosur Wound Healing Gel prematurely, the desired effect may not occur.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate 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 Very rarely, hypersensitivity reactions, such as burning on the skin, may occur.

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 SHOULD TYROSUR WOUND HEALING GEL BE STORED?

Keep out of reach of children! Do not use the medicine after the expiry date which is stated on the tube and folding box! The expiry date refers to the last day of the month. Do not store above 25°C. Shelf life after opening: 3 months.

6. FURTHER INFORMATION

What does Tyrosur Wound Healing Gel contain?
The active ingredient is Tyrothricin. 100 g gel contains 0.1 g Tyrothricin. The other ingredients are: Cetylpyridinium chloride 1 H20, propylene glycol, ethanol 96%, carbomer (40,000-60,000 mPa s), trometamol, purified water.

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

Tyrosur Wound Healing Gel is available in packs of 5 g (N 1), 15 g and 25 g (N 3) gel.

Pharmaceutical entrepreneur and manufacturer

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

This package leaflet was last revised in October 2016.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Tyrothricin. Areas of application: for the soothing treatment of small-scale, superficial, slightly weeping wounds with bacterial superinfection with Tyrothricin-sensitive pathogens such as e.g. cuts, scratches, abrasions.