TANNOLACT

TANNOLACT bath additive

Important notes (mandatory information)

Tannolact 40% bath additive. Active ingredient: Phenol-methanal-urea polycondensate sodium salt, sulfonated (synthetic tanning agent). Areas of application: for the treatment of nail fungus with an infestation of the nail of up to 80% (especially in the front area).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tannolact 40% bath additive
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 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 TANNOLACT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING TANNOLACT?
3. HOW TO USE TANNOLACT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE TANNOLACT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Tannolact is intended for use on the skin (dermatic). Tannolact is used for skin diseases that are associated with inflammation, oozing and itching. Due to its dosage form, Tannolact is particularly suitable for the symptomatic treatment of acute, inflammatory, oozing and itchy skin diseases on hard-to-reach skin areas (e.g. in the body folds and in the anal and genital area) and for supportive treatment of diaper dermatitis and excessive sweating (hyperhidrosis).

2. WHAT SHOULD YOU CONSIDER BEFORE USING TANNOLACT?

Tannolact must not be used if you are allergic to the active ingredient or any of the other ingredients listed in section 6 of this medicine. Tannolact must not be used as a full bath, in case of severe cardiovascular disease, high blood pressure, feverish diseases and tuberculosis. Due to the strain on the circulation, you must not take a full bath. Tannolact must not be used on the eyes.

Warnings and precautions

Please talk to your doctor or pharmacist before using Tannolact. Talk to your doctor before using Tannolact if you have major skin injuries and acute skin diseases. Tannolact has an eye-irritating effect. Make sure that Tannolact does not get into your eyes. If Tannolact, especially undiluted, accidentally comes into contact with the eyes, rinse the eyes immediately for about 10 minutes under running water and then consult an ophthalmologist.

Use of Tannolact together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take 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 can be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

3. HOW TO USE TANNOLACT?

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.

Tannolact is available in two different dosage forms

1. Tannolact in portion bags, each containing 10 grams, which allow for easy application.
2. Tannolact in the can (with spoon), which facilitates individual dosing with the enclosed spoon. The spoon holds approx. 10 grams and is particularly suitable for dosing in partial baths, moist compresses, washes and cold compresses.

For use, the required amount of Tannolact is dissolved in cold or warm water (32°C - 35°C). To dissolve the medicine more quickly, it is advisable to add the required amount of Tannolact to the jet of incoming water and then distribute it with your hand. The effectiveness of Tannolact is impaired in the presence of alkaline soaps, therefore soap should not be used at the same time during the bath. The usual plastic buckets used in the household, which usually hold approx. 10 litres, are suitable as a guide for measuring the amount of water. Suitable bowl inserts for the toilet are available in any good medical supply store for carrying out sitz baths.

The recommended dose is:

• Full baths (for adults): 30 g Tannolact in approx. 150 l water (= 3 portion bags or 3 spoons).
• Full baths (for children): 5 g Tannolact in approx. 25 l water (= 1/2 portion bag or 1/2 spoon).
• Sitz baths: 10 g Tannolact in approx. 25 l water (= 1 portion bag or 1 spoon).
• Partial baths (hand, arm, leg or foot baths): 5 g Tannolact in approx. 10 l water (= 1/2 portion bag or 1/2 spoon)
• Moist compresses, washes and cold compresses: 5 g Tannolact in approx. 5 l water (= 1/2 portion bag or 1/2 spoon) In case of highly acute inflamed skin, which already reacts with pain and burning even with light touch, a reduction of the Tannolact concentration is recommended: 2.5 g Tannolact in approx. 5 l water (= 1/4 portion bag, corresponds to a level teaspoon or 1/4 spoon).

The duration of treatment depends on the clinical picture of the skin disease and is generally between 3 and 14 days. In the case of longer-lasting diseases, Tannolact can also be used for long-term application. The duration of use is decided by the attending physician.

Full baths for adults:

• Dosage: for approx. 150 litres of water 3 portion bags or 3 spoons.
• Temperature: 32°C – 35°C.
• Bath duration: 10 – 15 minutes.
• Frequency of use: 2 – 3 times a week to 1 time a day.

Full baths for children:

• Dosage: for approx. 25 litres of water 1/2 portion bag or 1/2 spoon.
• Temperature: 32°C – 35°C.
• Bath duration: 10 – 15 minutes.
• Frequency of use: 2 – 3 times a week to 1 time a day.

Sitz baths:

• Shower and bathtubs as well as bowls suitable in size can be used for sitz baths. Suitable bowl inserts are available in any good medical supply store. They can be inserted directly into the toilet.
• Dosage: for approx. 25 litres of water 1 portion bag or 1 spoon.
• Temperature: 32°C – 35°C.
• Bath duration: 10 – 15 minutes.
• Frequency of use: 2 – 3 times a week to 1 time a day.

Partial baths (hand, arm, leg, or foot baths):

• Wash basins, shower trays and sufficiently large bowls are suitable for partial baths. Special arm and foot baths are available in specialist shops.
• Dosage: for approx. 10 litres of water 1/2 portion bag or 1/2 spoon.
• Temperature: 32°C – 35°C.
• Bath duration: 10 – 15 minutes.
• Frequency of use: 2 – 3 times a week to 1 time a day.

Moist compresses, cold compresses, washes:

• Moist compresses are applied loosely. They are intended to cool by evaporation. Therefore, they must not be covered with waterproof material. Re-moistening with Tannolact (dissolved in water) once or twice is possible. Cold compresses are best applied dripping wet.
• Dosage: for approx. 5 litres of water 1/2 portion bag or 1/2 spoon.
• Duration of use: 10 – 15 minutes.
• Frequency of use: 2 – 3 times a day.

If you have used more Tannolact than you should

After accidental ingestion, water should be drunk first. Then a doctor should be consulted, who will decide on further therapeutic measures.

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)

Skin irritation, itching, burning, skin redness, hypersensitivity reaction of the skin (contact dermatitis).

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

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 TANNOLACT?

Keep this medicine out of the reach of children. Do not store above 25°C. 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 contains

The active ingredient is: Phenol-methanal-urea polycondensate sodium salt, sulfonated (synthetic tanning agent). 1 g Tannolact contains 400 mg phenol-methanal-urea polycondensate sodium salt, sulfonated (synthetic tanning agent). The other ingredients are: Calcium lactate pentahydrate, sodium sulfate.

What Tannolact looks like and contents of the pack

Tannolact is a slightly yellowish powder. Tannolact is available in the following pack sizes: Envelope with 2 portion bags of 10 g bath additive, packs with 10 or 40 portion bags of 10 g bath additive, can with 150 g bath additive (with spoon). 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 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 the treatment of nail fungus with an infestation of the nail of up to 80% (especially in the front area).