Dermatol Apteo Med
How to use Dermatol Apteo Med
INFORMATION PLACED ON OUTER AND DIRECT PACKAGING
HEAT-SEALABLE PAPER SACHET COATED WITH POLYETHYLENE
(label-leaflet form)
1. NAME OF THE MEDICINAL PRODUCT
Dermatol APTEO MED, 100 g/100 g, medicinal powder
Bismuthi subgallas
2. CONTENT OF ACTIVE SUBSTANCE
1 g of medicinal powder contains 1g of basic bismuth gallate.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGING CONTENT
Medicinal powder
2 g
GTIN number: 5909991482497
5 g
GTIN number: 5909991482480
5. METHOD AND ROUTE OF ADMINISTRATION
Administration on the skin.
You should read the contents of this packaging before using the medicinal product.
6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT
IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN
The medicinal product should be stored in a place invisible and inaccessible to children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date
Do not use after the expiry date.
9. SPECIAL STORAGE CONDITIONS
No special storage recommendations.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE ARISING FROM IT, IF APPROPRIATE
Do not throw away in the sewage system or household waste containers.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing authorisation holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel.: 22 321 62 40
Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
12. MARKETING AUTHORISATION NUMBER
Marketing authorisation number 27059
13. BATCH NUMBER
Batch number
14. GENERAL CATEGORY OF AVAILABILITY
OTC - medicinal product available without a prescription.
15. INSTRUCTIONS FOR USE
Indications for use:
As a drying, haemostatic, and disinfecting agent in inflammatory skin conditions, weeping 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 a long time or on extensive skin changes, including extensive wounds and in the face area.
One should avoid inhaling the powder or getting it into the eyes due to the possibility of mild irritation of the respiratory tract or eyes.
One should exercise caution when using the medicinal product in patients with renal function impairment - there is a risk of kidney damage.
Dermatol APTEO MED and other medicinal products:
No data available.
Pregnancy and breastfeeding:
Do not use during pregnancy and breastfeeding.
Possible side effects:
Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.
There have been reports of mild irritation and redness of the skin.
After topical administration to the skin, allergic reactions may occur.
Kidney damage may occur, usually transient.
Reporting side effects:
If any side effects occur, including those not listed above, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warszawa,
tel.: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.
Dosage:
This medicinal product should always be used in accordance with the description on the packaging or the doctor's or pharmacist's recommendations.
Apply 2 to 3 times a day to the affected skin.
Method of administration:
For sprinkling wounds, ulcers, skin abrasions.
Do not use in children and adolescents.
Overdose:
In case of excessive use of the medicinal product, its excess should be washed off the skin with soap and water.
In case of eye irritation, they should be rinsed with a large amount of water for at least 15 minutes.
If the irritation persists, the patient should contact a doctor.
The medicinal product is in the form of a yellow powder.
The heat-sealable paper sachet coated with polyethylene contains 2 g of the medicinal product.
The heat-sealable paper sachet coated with polyethylene contains 5 g of the medicinal product.
Date of last text update:
16. INFORMATION PROVIDED IN BRAILLE SYSTEM
Dermatol apteo med
17. UNIQUE IDENTIFIER – 2D CODE
Not applicable.
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
Not applicable.
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- ImporterLaboratorium Galenowe Olsztyn Sp. z o.o.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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