Dermatol apteo med
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCE
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 9. SPECIAL STORAGE INSTRUCTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 15. INSTRUCTIONS FOR USE
- 16. INFORMATION PROVIDED IN BRAILLE SYSTEM
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
INFORMATION ON OUTER AND IMMEDIATE PACKAGING
AND ON THE DIRECT CONTAINER
SACHET MADE OF THERMOSEALABLE PAPER COATED WITH POLYETHYLENE
(form of label-leaflet)
1. NAME OF THE MEDICINAL PRODUCT
Dermatol APTEO MED, 100 g/100 g, medicinal powder
Bismuthi subgallas
2. COMPOSITION OF ACTIVE SUBSTANCE
1 g of medicinal powder contains 1 g of basic bismuth gallate.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGE
Medicinal powder
2 g GTIN number: 5909991482497
5 g GTIN number: 5909991482480
5. METHOD AND ROUTE OF ADMINISTRATION
For topical use only.
Read the information contained on this packaging before using the medicine.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP 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
8. EXPIRY DATE
Expiry date
Do not use after the expiry date.
9. SPECIAL STORAGE INSTRUCTIONS
No special storage requirements.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVING FROM IT, IF
APPLICABLE
Do not dispose of down the drain or in household waste containers.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków 65
02-255 Warsaw
Tel.: 22 321 62 40
Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
12. MARKETING AUTHORISATION NUMBER
Authorisation number: 27059
13. BATCH NUMBER
Batch number
14. GENERAL AVAILABILITY CATEGORY
OTC - a medicine supplied without a prescription.
15. INSTRUCTIONS FOR USE
Indications for use:
As an astringent, haemostatic agent for minor bleeding, antiseptic in inflammatory conditions of the skin, oozing wounds and ulcers.
When not to use Dermatol APTEO MED:
- if the patient is allergic to basic bismuth gallate;
- in patients with renal insufficiency.
Warnings and precautions:
Do not use for prolonged periods or on extensive skin lesions, including large wounds, or in the facial area.
Avoid inhaling the powder or allowing it to enter the eyes, due to the possibility of mild irritation of the respiratory tract or eyes.
Exercise caution when using this medicine in patients with impaired kidney function – there is a risk of kidney damage.
Dermatol APTEO MED and other medicines:
No data available.
Pregnancy and breastfeeding:
Do not use during pregnancy and breastfeeding.
Possible adverse effects:
Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
Cases of mild skin irritation and redness have been reported.
Allergic reactions may occur following topical application to the skin.
Kidney damage may occur, usually transient.
Reporting of adverse reactions:
If any adverse symptoms occur, including any not listed above, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Dosage:
This medicine should always be used according to the instructions on the packaging or as directed by a doctor or pharmacist.
Apply 2 to 3 times daily to affected skin areas.
Method of administration:
For sprinkling onto wounds, ulcers and abrasions.
Do not use in children and adolescents.
Overdose:
In case of excessive application, wash the excess product off the skin with soap and water.
If eye irritation occurs, rinse eyes thoroughly with plenty of water for at least 15 minutes.
If irritation persists, the patient should contact a doctor.
The medicine is a yellow powder.
A sachet made of heat-sealable paper coated with polyethylene contains 2 g of the medicine.
A sachet made of heat-sealable paper coated with polyethylene contains 5 g of the medicine.
Date of last text revision:
16. INFORMATION PROVIDED IN BRAILLE SYSTEM
Dermatol APTEO MED
17. UNIQUE IDENTIFIER – 2D CODE
Not applicable.
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
Not applicable.