Aknederm

AKNEDERM Ointment New

Important notes (mandatory information)

Aknederm Salbe Neu 1 g ointment with 0.02 g ammonium bituminosulfonate and 0.1 g zinc oxide. Areas of application: as a mild acting medicine for skin impurities.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Aknederm Salbe Neu 1 g ointment with 0.02 g ammonium bituminosulfonate and 0.1 g zinc oxide, for use in adults and children aged 12 and over
Active ingredients: Ammonium bituminosulfonate, 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 directed by your doctor or pharmacist.

• 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 if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS AKNEDERM SALBE NEU AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING AKNEDERM SALBE NEU?
3. HOW IS AKNEDERM SALBE NEU USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD AKNEDERM SALBE NEU BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS AKNEDERM SALBE NEU AND WHAT IS IT USED FOR?

Aknederm Salbe Neu is a traditional medicine. Aknederm Salbe Neu is used as a mild acting medicine for skin impurities. If the skin impurities do not improve or if inflammation occurs in the area of application, you should consult your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING AKNEDERM SALBE NEU?

Aknederm Salbe Neu must not be used:

• if you are allergic to ammonium bituminosulfonate, zinc oxide, methyl-4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.
• on the nursing breast.

Warnings and precautions

Please wash your hands after use. Do not bring Aknederm Salbe Neu into contact with eyes and mucous membranes. Do not apply it to open wounds or acute eczema.

Children

Aknederm Salbe Neu should not be used in children under 12 years of age.

Use of Aknederm Salbe Neu together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines, even if they are non-prescription medicines. Aknederm Salbe Neu can reduce the effectiveness of other medicines (externals) used on the skin at the same time and should therefore be removed before using other externals.

Pregnancy and breast-feeding

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. Aknederm Salbe Neu must not be used on the nursing breast.

Driving and using machines

No special precautions are required.

Aknederm Salbe Neu contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW IS AKNEDERM SALBE NEU USED?

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. Apply Aknederm Salbe Neu thinly and evenly to the affected skin areas in the morning and evening. Do not apply it to large areas of skin covering more than 20% of the body surface.

If you have used more Aknederm Salbe Neu than you should

Overdoses are not known. You can easily remove excess ointment with water.

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.

Occasional side effects (may affect up to 1 in 100 people)

Skin redness, dryness, rough skin, itching, burning and skin changes (acanthotic) with discoloration and coarsening of the skin.

Methyl-4-hydroxybenzoate can cause hypersensitivity reactions, even with a time delay.

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 AKNEDERM SALBE NEU BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the tube and carton after "use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Aknederm Salbe Neu can be stored for 6 months after opening the tube. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aknederm Salbe Neu contains

The active ingredients are: Ammonium bituminosulfonate and zinc oxide. 1 g of ointment contains 0.02 g of ammonium bituminosulfonate and 0.1 g of zinc oxide. The other ingredients are: Methyl-4-hydroxybenzoate (Ph.Eur.), purified water, talc, medium-chain triglycerides, white petrolatum, emulsifying cetyl stearyl alcohol type A (Ph.Eur.), glycerol monostearate, iron oxides and hydroxides (E 172).

What Aknederm Salbe Neu looks like and contents of the pack

Aknederm Salbe Neu is a reddish-light brown, homogeneous, ointment-like mass. Aknederm Salbe Neu is available in packs of 30 g and 60 g and as a bundle pack of 60 g (2 x 30 g). Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

gepepharm GmbH
Josef-Dietzgen-Straße 3
53773 Hennef
Telephone: 02242 8740-200
Telefax: 02242 8740-299
E-mail: gepe@gepepharm.de

Manufacturer

biomo pharma GmbH
Josef-Dietzgen-Straße 3
53773 Hennef

This leaflet was last revised in June 2020.

Source: Information from the package leaflet
Status: 02/2022
Areas of application: as a mild acting medicine for skin impurities.