TANNOLACT

TANNOLACT Lotion

Important notes (mandatory information)

Tannolact Lotio 1% Suspension. Active ingredient: Phenol-methanal-urea-polycondensate-sodium salt, sulfonated (synthetic tannin). Areas of application: for skin diseases associated with inflammation, weeping and itching, such as skin diseases in intertriginous areas (i.e. areas where skin areas rub against each other: in the armpits, in the genital-anal area, under the breast or on the thighs) and skin inflammation in the diaper area (diaper dermatitis) in infants and toddlers and other inflammatory skin diseases such as chickenpox.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tannolact Lotio 1% Suspension for application to the skin, for use in infants from one month of age, toddlers, children, adolescents and adults
Active ingredient: Phenol-methanal-urea-polycondensate-sodium salt, sulfonated (synthetic tannin)

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 need to read it again later.
• Ask your pharmacist if you need more information or advice.
• 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.
• If you do not feel better or even worse, contact your doctor. If there is no improvement in the treatment of diaper dermatitis after 3 days, contact your doctor.

What this package leaflet contains

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

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

Tannolact Lotion is a medicine for application to the skin (dermatic). Tannolact Lotion is used for skin diseases associated with inflammation, weeping and itching, such as skin diseases in intertriginous areas (i.e. areas where skin areas rub against each other: in the armpits, in the genital-anal area, under the breast or on the thighs) and skin inflammation in the diaper area (diaper dermatitis) in infants and toddlers and other inflammatory skin diseases such as chickenpox.

2. WHAT SHOULD YOU CONSIDER BEFORE USING TANNOLACPLOTION?

Tannolact Lotion 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 Lotion must not be used on the eye.

Warnings and precautions

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

Use of Tannolact Lotion 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 Lotion can be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Tannolact Lotion contains propylene glycol (E1520)

Propylene glycol (E1520) can cause skin irritation.

3. HOW TO USE TANNOLACT LOTION?

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

Tannolact Lotion is applied thinly to the affected skin areas 1 to 2 times a day after shaking the bottle vigorously. When treating diaper dermatitis, it can be used after each diaper change. Tannolact Lotion is for external use only. The treatment can be continued until the inflammatory skin symptoms such as itching, weeping and redness have subsided. As a rule, 4 weeks are sufficient. The duration of treatment is determined by the attending physician.

If you have used more Tannolact Lotion than you should

No cases of overdose have been reported.

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.

Very common (may affect more than 7 in 10 patients)

Burning.

Common (may affect up to 1 in 10 patients)

Contact dermatitis, skin irritation, skin pain, itching, skin redness.

Uncommon (may affect up to 1 in 100 patients)

Skin discoloration.

Tannolact Lotion 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 TANNOLACTLOTION?

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

The active ingredient is: Phenol-methanal-urea-polycondensate-sodium salt, sulfonated (synthetic tannin). 1 g suspension for application to the skin contains 10 mg phenol-methanal-urea-polycondensate-sodium salt, sulfonated (synthetic tannin). The other ingredients are glycerol 85%, zinc oxide, talcum, propylene glycol (E1520), calcium lactate pentahydrate, highly dispersed silicon dioxide, cetylstearyl isononanoate (Ph.Eur.), macrogol lauryl ether (Ph.Eur.) (23), purified water.

What Tannolact Lotion looks like and contents of the pack

Tannolact Lotion is a white suspension. Tannolact Lotion is available in bottles containing 75 g suspension for application to the skin.

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 tannin). Areas of application: for skin diseases associated with inflammation, weeping and itching, such as skin diseases in intertriginous areas (i.e. areas where skin areas rub against each other: in the armpits, in the genital-anal area, under the breast or on the thighs) and skin inflammation in the diaper area (diaper dermatitis) in infants and toddlers and other inflammatory skin diseases such as chickenpox.