MIRFULAN

MIRFULAN wound and healing ointment

Important notes (mandatory information)

Mirfulan 10 g/100 g ointment. Active ingredient: Zinc oxide. Areas of application: Occlusive-protective and secretion-binding treatment of non-infected acute and subacute skin damage accompanied by redness, itching and pain (e.g. nappy rash).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirfulan 10 g/100 g ointment
Active ingredient: Zinc oxide

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 your doctor or pharmacist has told you. This medicine is available without prescription. However, to achieve the best possible treatment results, Mirfulan must be used as prescribed.

• 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, talk to your doctor.

What this package leaflet contains

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

1. WHAT IS MIRFULAN AND WHAT IS IT USED FOR?

Mirfulan is a wound and healing ointment. Areas of application: Occlusive-protective and secretion-binding treatment of non-infected acute and subacute skin damage accompanied by redness, itching and pain (e.g. nappy rash). Zinc oxide has an occlusive-protective and secretion-binding effect.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MIRFULAN?

Mirfulan must not be used if you are allergic to wool wax alcohols, the active ingredient or any of the other ingredients of the ointment listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Mirfulan. Before using Mirfulan, make sure that the wound is not infected. If there is no improvement despite treatment with Mirfulan, it must be checked whether an infection has occurred in the wound area in the meantime and whether appropriate treatment of this infection is necessary.

Use of Mirfulan together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines, even if they are non-prescription medicines. Mirfulan must not be used at the same time as other external medicines (e.g. ointments, solutions, etc.), as Mirfulan can reduce or weaken the effect of these external medicines.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

Mirfulan can be used during pregnancy if used as intended and the dosage instructions are followed. However, large-scale use should be avoided (no more than 8 g of ointment per day, which corresponds to an ointment strand length of approx. 10 cm).

Breast-feeding

Mirfulan can be used during breast-feeding if used as intended and the dosage instructions are followed. However, large-scale use on the breast should be avoided in breast-feeding women.

Fertility

There is no data on the effect of Mirfulan on fertility.

Driving and using machines

There is no experience with regard to impairment of driving ability and the ability to operate machines.

Mirfulan contains butylhydroxyanisole, butylhydroxytoluene, cetyl stearyl alcohol and wool wax

Butylhydroxyanisole and butylhydroxytoluene can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes. Cetyl stearyl alcohol and wool wax contained in wool wax alcohol ointment can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE MIRFULAN?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Please follow the instructions for use, otherwise Mirfulan will not work properly! Unless otherwise prescribed by your doctor, the usual dose is: Apply Mirfulan to the affected skin areas once to several times a day, about ½ - 1 millimetre thick, as needed. Ointment residues can be carefully removed with warm soapy water, as far as the condition of the wound permits. Please talk to your doctor or pharmacist if you have the impression that the effect of Mirfulan is too strong or too weak.

If you forget to use Mirfulan

Do not use twice the amount if you have forgotten the previous application.

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

Possible side effects

In individual cases, local intolerance and/or hypersensitivity reactions such as itching, weeping, redness, drying out, allergic contact reactions may occur. A slight burning sensation may occur after applying Mirfulan to severely inflamed skin areas.

Special notes

If side effects occur, you should stop using Mirfulan and consult your doctor or pharmacist.

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 MIRFULAN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Storage conditions: Do not store above 25°C. Note on shelf life after opening or preparation: Mirfulan has a shelf life of 12 months after opening the tube.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mirfulan contains

The active ingredient is: Zinc oxide. 100 g ointment contains: 10 g zinc oxide. The other ingredients are: Urea; cod liver oil (standardised to 10,000 IU Vit. A and 2,000 IU Vit. D3 per g cod liver oil); witch hazel bark, distillate with ethanol/ethanol-water (% indications); white petroleum jelly, wool wax alcohol ointment; liquid paraffin; glycerol monostearate 40-55; 2,6-di-tert-butyl-4-methylphenol-L(+)-6-0-palmitoylascorbic acid-citric acid-1H20-glycerol-monostearate-propylene glycol (10:5:2.5:5:27.5) (G/G); purified water.

What Mirfulan looks like and contents of the pack

Tube with white ointment. Tube with 20, 50 and 100 g ointment. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Recordati Pharma GmbH
Eberhard-Finckh-Str. 55
89075 Ulm
Telephone: (0731) 7047-0
Fax: (0731) 7047-297

Manufacturer

C.P.M. ContractPharma GmbH & Co. KG
Frühlingstraße 7
83620 Feldkirchen-Westerham

This package leaflet was last revised in December 2015.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Zinc oxide. Areas of application: Occlusive-protective and secretion-binding treatment of non-infected acute and subacute skin damage accompanied by redness, itching and pain (e.g. nappy rash).