Dermovit f
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCES
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 9. STORAGE CONDITIONS
- 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
- 17. OTHERS
INFORMATION ON OUTER PACKAGING
{Cardboard box containing a PE tube 30 g}
1. NAME OF THE MEDICINAL PRODUCT
DERMOVIT F 25 mg/g, ointment
(Vitaminum F)
2. COMPOSITION OF ACTIVE SUBSTANCES
1 g of ointment contains: active substance - 25 mg of vitamin F
3. LIST OF EXCIPIENTS
Excipients: anhydrous eucerin, purified water, lavender oil.
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
ointment
30 g - EAN UCC Code: 5909990667598
5. METHOD AND ROUTE OF ADMINISTRATION
Apply to the skin.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date:
Do not use the medicine after the expiry date stated on the packaging.
9. STORAGE CONDITIONS
Store below 25°C. Store in the original, tightly closed
container, protected from light.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF
APPLICABLE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing Authorisation Holder:
WYTWÓRNIA EUCERYNY LABORATORIUM FARMACEUTYCZNE „COEL” S.J.
EZM KONSTANTY
ul. Wl. Zeleńskiego 45, 31-353 Kraków.
12. MARKETING AUTHORISATION NUMBER
Authorisation No R\2039
13. BATCH NUMBER
Batch number:
14. GENERAL AVAILABILITY CATEGORY
OTC - Medicinal product available without a prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE SYSTEM
dermovit F coel
17. OTHERS
Indications for use:
Topical ointment for use on the skin in children and adults for trophic skin disorders,
psoriasis, eczematous dermatitis, pressure ulcers, and burns.
Dosage and method of administration:
Apply a thin layer of ointment to the cleaned skin area once or twice daily. In acute
conditions, the skin may be treated several times a day.
Contraindications:
The product should not be used:
- in case of hypersensitivity to vitamin F or to any of the excipients;
- in the eyes or on mucous membranes.
Pregnancy and breastfeeding:
Consult a physician before use.
There is no data available regarding the use of the product in pregnant or breastfeeding women.
Adverse reactions:
Hypersensitivity reactions and contact dermatitis may occur.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a physician, 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.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.