SCHWARZE SALBE

BLACK OINTMENT 50% Lichtenstein N

Important notes (mandatory information)

Black Ointment 50% Lichtenstein N. Active ingredient: Ammonium bituminosulfonate. Areas of application: for boils and suppurating melting processes.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Black Ointment 50% Lichtenstein N
Active ingredient: Ammonium bituminosulfonate

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.
• If you do not feel better or even worse, talk to your doctor.

What is in this package leaflet

1. WHAT IS BLACK OINTMENT 50% LICHTENSTEIN N AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BLACK OINTMENT 50% LICHTENSTEIN N?
3. HOW TO USE BLACK OINTMENT 50% LICHTENSTEIN N?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BLACK OINTMENT 50% LICHTENSTEIN N?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BLACK OINTMENT 50% LICHTENSTEIN N AND WHAT IS IT USED FOR?

Black Ointment 50% Lichtenstein N contains the active ingredient ammonium bituminosulfonate, an active ingredient from the group of sulfonated shale oils. It is a remedy for the treatment of inflammatory skin diseases. Black Ointment 50% Lichtenstein N is used for boils and suppurating melting processes.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BLACK OINTMENT 50% LICHTENSTEIN N?

Black Ointment 50% Lichtenstein N must not be used:

• if you are allergic to ammonium bituminosulfonate and other sulfonated shale oil products or any of the other ingredients of this medicine listed in section 6,
• if you are pregnant or breastfeeding.

Warnings and precautions

Avoid contact with eyes. Note: If Black Ointment 50% Lichtenstein N is used in the genital or anal area and condoms at the same time, the tear resistance may be reduced due to the auxiliary substances contained and thus the safety of condoms may be impaired.

Use of Black Ointment 50%

Lichtenstein N together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Ammonium bituminosulfonate can improve the solubility of other active ingredients and thus increase their absorption into the skin. Precipitation may occur if acids and salts are added in higher concentrations. The simultaneous, additional use of other ointments or creams may impair the effect of Black Ointment 50% Lichtenstein N.

Pregnancy and breastfeeding

Since there is insufficient scientific evidence on absorption with external use in humans, Black Ointment 50% Lichtenstein N must not be used during pregnancy and breastfeeding.

Ability to drive and operate machinery

No interactions known.

Black Ointment 50%

Lichtenstein N contains wool wax and cetyl stearyl alcohol

Wool wax and cetyl stearyl alcohol can cause localized skin irritation (e.g. contact dermatitis).

3. HOW TO USE BLACK OINTMENT 50% LICHTENSTEIN N?

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. Black Ointment 50% Lichtenstein N is applied to the skin in a thick layer. The treated area is covered with a bandage. The bandage is changed daily or every other day. The duration of use should be a maximum of 3 - 5 days.

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

Rare (1 to 10 in 10,000 treated):

• Skin irritation with severe itching, burning and redness. With higher concentrated preparations, slight irritations are common, but only in rare cases so severe that the treatment has to be discontinued.
• Contact allergy.

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 BLACK OINTMENT 50% LICHTENSTEIN N?

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 after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Protect from strong temperature fluctuations.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Black Ointment 50%

Lichtenstein N contains

The active ingredient is ammonium bituminosulfonate. 100 g of ointment contain 50 g of ammonium bituminosulfonate. The other ingredients are: white petrolatum, wool wax alcohols, cetyl stearyl alcohol (Ph. Eur.) [vegetable], purified water.

What Black Ointment 50%

Lichtenstein N looks like and contents of the pack

Ointment that looks black in a thick layer and brown in a thin layer. Tube with 40 g, can with 500 g.

Stain removal

The greasy ointment base can be removed with petrol, the rest can then be cleaned with soap or a detergent.

Pharmaceutical entrepreneur and manufacturer

Winthrop Arzneimittel GmbH
65927 Frankfurt am Main
Telephone: (01 80) 2 02 00 10*
Telefax: (01 80) 2 02 00 11*
*0.06 EUR/call (German landline); max. 0.42 EUR/min (mobile)

Co-distribution

Zentiva Pharma GmbH
65927 Frankfurt am Main

or

Manufacturer

C.P.M. ContractPharma GmbH & Co. KG,
Frühlingsstraße 7,
83650 Feldkirchen-Westerham

This leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Ammonium bituminosulfonate. Areas of application: for boils and suppurating melting processes.