MIRFULAN

MIRFULAN N ointment spray

Important notes (mandatory information)

Mirfulan Spray N, ointment. Areas of application: mild-acting medicinal product to support wound healing.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirfulan Spray N, ointment
Active ingredients: zinc oxide 13 g, (+/-)-alpha-bisabolol 0.026 g, cod liver oil 5.2 g, vitamin A 0.0245 g, colecalciferol 0.0104 g
Traditional medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicinal product is available without a prescription. However, Mirfulan Spray N must be used as directed in order to be as effective as possible.

• 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.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

This package leaflet includes

1. WHAT IS MIRFULAN SPRAY N AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING MIRFULAN SPRAY N?
3. HOW SHOULD MIRFULAN SPRAY N BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MIRFULAN SPRAY N BE STORED?
6. FURTHER INFORMATION

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

Traditional medicinal product. Mirfulan Spray N is a traditionally used mild-acting medicinal product to support wound healing.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING MIRFULAN SPRAY N?

Mirfulan Spray N must not be used in case of hypersensitivity to wool wax alcohols and/or other components of the ointment and on infected skin.

Special care must be taken when using Mirfulan Spray N

Butylhydroxyanisole and butylhydroxytoluene can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes. Wool wax and cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis). Before using Mirfulan Spray N, make sure that the wound is not infected. If there is no improvement despite treatment with Mirfulan Spray N, 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. The spray can is filled with a neutral safety propellant and is under pressure. It must therefore be protected from heating above 50°C (e.g. sunlight). The spray can must not be opened or burned by force. Do not spray towards flames or onto glowing objects. Shake Mirfulan? Spray N well before use! If no or too little ointment is released, the spray head may be clogged. The white spray head can be easily removed and, if necessary, cleaned with hot soapy water and pierced with a needle. Do not spray into the eyes!

When using Mirfulan Spray N with other medicinal products

Please inform your doctor or pharmacist if you are using or have recently used other medicinal products, even if they are non-prescription medicinal products. Mirfulan Spray N must not be used at the same time as other external products (products for external use, e.g. ointments, solutions, etc.) as Mirfulan Spray N can reduce or weaken the effect of these external products.

Pregnancy and breast-feeding
So far, there have been no indications of risks from the use of Mirfulan Spray N in pregnant women, nursing mothers and children under 12 years of age, but no product-specific studies have been conducted. Mirfulan Spray N should not be used on the lactating (milk-producing) breast. There are no sufficient studies on the use and dosage of Mirfulan Spray N in infants and toddlers.

3. HOW SHOULD MIRFULAN SPRAY N BE USED?

Always use Mirfulan Spray N 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: Hold the can upright, press the spray valve and spray an adequate amount of ointment (the wound surface should be covered with a fine white ointment coating) evenly onto the wound surface from a distance of approx. 20 cm. Note: 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 Spray N is too strong or too weak.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicinal products, Mirfulan Spray N can cause side effects, although not everybody gets them.

Possible side effects

After applying Mirfulan Spray N, irritation, allergic reactions and contact allergies with e.g. itching, weeping and redness may occur. In this case, Mirfulan Spray N should be discontinued and a doctor should be consulted if necessary. The medicinal product should only be used for a longer period of time after consulting a doctor. When sprayed onto fresh wounds, the propellant (propane/butane) may cause temporary burning. If you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Countermeasures

If side effects occur, you should stop using Mirfulan Spray N 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 medicinal product.

5. HOW SHOULD MIRFULAN SPRAY N BE STORED?

Keep medicinal products out of the reach of children. The expiry date of this pack is printed on the outer carton and on the spray can. Do not use the medicinal product after the expiry date which is stated on the outer carton and the spray can. The expiry date refers to the last day of the month. Shelf life after first opening: 12 months. Storage conditions: Do not store above 25°C.

6. FURTHER INFORMATION

What Mirfulan Spray N contains
The active ingredients are: 125 ml (equivalent to 99 g) of ointment spray contain: Active pharmaceutical ingredients: zinc oxide 13.00 g, (+/-)-alpha-bisabolol 0.026 g used as Dragosantol preparation, cod liver oil (type A) 5.2 g, oily solution of vitamin A 0.0245g corresponding to 41,600 IU retinol palmitate (contains butylhydroxyanisole, butylhydroxytoluene), oily solution of colecalciferol 0.0104g corresponding to 10,400 IU colecalciferol in medium-chain triglycerides (contains all-rac-alpha-tocopherol). The other ingredients are: 2,6-di-tert-butyl-4-methylphenol - L-(+)-6-O-palmitoylascorbic acid - citric acid. 1 H2O - glycerol monostearate - propylene glycol (10:5:2.5:5:27.5)(G/G), wool wax alcohol ointment (contains, among other things, cetyl stearyl alcohol), white petrolatum, liquid paraffin, perfume oil Dermasafe Dolcenta. Propellant: butane, propane/2-methylpropane mixture.

What Mirfulan?

Spray N looks like and contents of the pack

Spray can with white ointment spray. 1 spray can with 125 ml (equivalent to 99 g) of ointment spray contains 52 g of ointment and 47 g of propellant [(propane/2-methylpropane)]. Original pack with 125 ml ointment spray, non-saleable sample with 125 ml ointment spray.

Pharmaceutical entrepreneur

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 March 2015.

Source: Information from the package leaflet
Status: 04/2018
Areas of application: mild-acting medicinal product to support wound healing.