DERMATOL LGO

PACKAGING LABELING
INFORMATION ON PRIMARY PACKAGING
SACHET MADE OF TWO-LAYER LAMINATE PAPER/POLYETHYLENE

1. NAME OF THE MEDICINAL PRODUCT

Dermatol LGO, 100g/100g, powder
Bismuthi subgallas

2. ACTIVE SUBSTANCE CONTENT

Composition: basic bismuth gallate
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
Powder
2 g code: 5909990036400
5 g code: 5909990036431
10 g code: 5909990036494

5. METHOD AND ROUTE OF ADMINISTRATION

Method and route of administration
For topical application.
For dusting wounds, ulcers, and abrasions.
Data on use in children and adolescents are not available.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Contraindications
Hypersensitivity to basic bismuth gallate.
Pregnancy and breastfeeding.

Warnings and precautions
Do not apply to extensive skin lesions, including large wounds.
Avoid inhaling the powder or allowing it to enter the eyes. The product should not be used on facial areas.
Inhalation of the powder may cause mild irritation of the respiratory tract.
Contact with eyes may cause mild eye irritation.

Pregnancy and breastfeeding
This medicinal product should not be used during pregnancy and breastfeeding.

Driving and operating machinery
No effect.

Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Skin and subcutaneous tissue disorders: mild irritation and redness.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

8. EXPIRY DATE

Expiry date

9. STORAGE INSTRUCTIONS

Store in a dark place to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

ANY UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM
IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A, 11-001 Dywity

12. MARKETING AUTHORISATION NUMBER

Authorisation number IL-2053/ChF

13. BATCH NUMBER

Batch number

14. GENERAL AVAILABILITY CATEGORY

Medicinal product available without a doctor's prescription – OTC.

15. INSTRUCTIONS FOR USE

Indications
As an astringent product, inhibiting minor bleeding, disinfecting in inflammatory conditions
of the skin, oozing wounds and ulcers.
Overdose
In case of application of an excessive amount of the medicinal product, the skin should be washed with soap and water.
In case of eye irritation, rinse eyes with large amounts of water for at least 15 minutes. If irritation persists, the patient should contact a physician.

16. INFORMATION PROVIDED IN BRAILLE

Dermatol LGO

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

HUMAN-READABLE
Not applicable.