TANNOLACT

TANNOLACT Cream

Important notes (mandatory information)

Tannolact Cream 1%. Active ingredient: Phenol-methanal-urea-polycondensate sodium salt, sulfonated (synthetic tanning agent). Areas of application: for inflammatory skin diseases associated with redness, weeping and itching.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tannolact Cream 1%
Active ingredient: Phenol-methanal-urea-polycondensate sodium salt, sulfonated (synthetic tanning agent)

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.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience 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, contact your doctor.

What this package leaflet contains

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

1. WHAT IS TANNOLACT CREAM AND WHAT IS IT USED FOR?

Tannolact Cream is a medicine for use on the skin (dermatic). Tannolact Cream is used for inflammatory skin diseases associated with redness, weeping and itching.

2. WHAT SHOULD YOU CONSIDER BEFORE USING TANNOLACT CREAM?

Tannolact Cream must not be used if you are allergic to the active ingredient or any of the other ingredients of this medicine listed in section 6. Tannolact Cream must not be used on the eyes.

Warnings and precautions

Please talk to your doctor or pharmacist before using Tannolact Cream. Tannolact Cream has an eye-irritating effect. Make sure that the cream does not get into your eyes when using Tannolact Cream on your face. If Tannolact Cream accidentally comes into contact with your eyes, rinse your eyes immediately for about 10 minutes under running water and then consult an ophthalmologist.

When used together with latex products (e.g. condoms, diaphragms)

Due to the auxiliary substances contained (paraffin, stearate), the functionality of these products may be reduced and thus their safety impaired.

Use of Tannolact Cream together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines.

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. Tannolact Cream can be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Tannolact Cream contains propylene glycol (E1520), sorbic acid, cetyl stearyl alcohol and butylhydroxyanisole

Propylene glycol (E 1520) can cause skin irritation. Sorbic acid and cetyl stearyl alcohol can cause localised skin reactions (e.g. contact dermatitis). Butylhydroxyanisole can cause localised skin reactions (e.g. contact dermatitis), irritation of the eyes and mucous membranes

3. HOW TO USE TANNOLACT CREAM?

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.

The recommended dose is

You should apply Tannolact Cream thinly to the affected areas of skin 3 times a day. For external use only. The treatment is continued until the inflammatory skin symptoms have subsided. There is experience with the tolerability of the cream for up to three weeks. The duration of use is determined by the treating physician.

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.

Unknown frequency of occurrence (frequency cannot be estimated from the available data)

Mild skin irritation, contact dermatitis, itching, skin redness, blisters, dry skin.

Tannolact Cream has an eye-irritating effect, so appropriate precautions are recommended.

Reporting of side effects

If you experience 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 TANNOLACT CREAM?

Keep this medicine out of the reach of children. This medicine does not require any special storage conditions. The shelf life after opening the container is 6 months. Do not use the medicine after the expiry date which is stated on the carton and container after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tannolact Cream contains

The active ingredient is: Phenol-methanal-urea-polycondensate sodium salt, sulfonated (synthetic tanning agent). 1 g Tannolact Cream contains 10 mg phenol-methanal-urea-polycondensate sodium salt, sulfonated (synthetic tanning agent). The other ingredients are sorbic acid (Ph.Eur.), butylhydroxyanisole (Ph.Eur.), propylene glycol (E1520), liquid paraffin, cetyl stearyl alcohol (Ph.Eur.), polysorbate 60, sorbitan stearate, dimethicone 350, purified water.

What Tannolact Cream looks like and contents of the pack

Tannolact Cream is a white to off-white cream. Tannolact Cream is available in tubes containing 20 g and 50 g of cream. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Düsseldorf
Telephone: +49 (0)800 - 5888850
Telefax: +49 (0)211 - 6355-8270
E-mail: patientenservice@galderma.com

This package leaflet was last revised in June 2018.

Source: Information from the package leaflet
Status: 10/2020
Active ingredient: Phenol-methanal-urea-polycondensate sodium salt, sulfonated (synthetic tanning agent). Areas of application: for inflammatory skin diseases associated with redness, weeping and itching.