Gentiana 0.5% aqueous solution

INFORMATION PRINTED ON THE OUTER PACKAGING
Bottle 20 g or 100 g

1. NAME OF THE MEDICINAL PRODUCT

GENCIANA 0.5% AQUEOUS SOLUTION
5 mg/g, topical solution
Methylrosanilinii chloridum

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition
1 g of solution contains
active substance: methylrosaniline chloride 5 mg,

3. LIST OF EXCIPIENTS

excipients: purified water.

4. PHARMACEUTICAL FORM AND CONTENTS OF THE CONTAINER

20 g EAN code: 5909990668212
100 g EAN code: 5909990668229

5. METHOD AND ROUTE OF ADMINISTRATION

Method and route of administration
Topical application to the skin.

6. KEEPING THE MEDICINAL PRODUCT OUT OF REACH OF CHILDREN

KEEP IN A PLACE NOT VISIBLE AND NOT ACCESSIBLE TO CHILDREN
Keep the medicine in a place not visible and inaccessible to children.
7. OTHER SPECIAL PRECAUTIONS, IF NECESSARY
8. EXPIRY DATE
Expiry date
Do not use after the expiry date.

9. STORAGE INSTRUCTIONS

Storage conditions
Store below 25°C, in the original packaging.
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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING FROM SUCH MEDICINAL PRODUCT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder and Manufacturer
PPF HASCO-LEK S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
(Logo of the marketing authorisation holder)

12. MARKETING AUTHORISATION NUMBER

Authorisation number 6682

13. BATCH NUMBER

Batch number

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Indications for use
For disinfection of superficial skin injuries, mucous membranes and skin; for use in purulent skin and mucous membrane infections, certain fungal infections and candidiasis.

When not to use GENCJANA 0.5%
Do not use in case of hypersensitivity to methylrosaniline chloride. Do not use in patients with porphyria.

Warnings and precautions
Do not apply to eyes, granulating wounds or ulcerating lesions on the face.
Methylrosaniline chloride stains tissues and may stain fabrics and clothing. Stains on fabrics can be removed using a mixture of ethanol and acetic acid.

Interaction of GENCJANA 0.5% with other medicines
Acidification or colloidal hydrated aluminium silicate (bentonite) reduces the effectiveness of the medicinal product.

Pregnancy or breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.

Effect on ability to drive and operate machinery
The medicinal product has no effect or has negligible effect on the ability to drive and operate machinery.

How to use GENCJANA 0.5%
The medicinal product is intended for external, local use as a disinfectant.
In case of doubt, consult a doctor or pharmacist.

Use of a higher than recommended dose of GENCJANA 0.5%
In case of accidental oral ingestion of this medicinal product, seek medical advice immediately.

Adverse reactions
Prolonged and frequent use, especially in children, may cause irritation or ulceration of the skin or mucous membranes that are in direct contact with the medicinal product.
Following application of methylrosaniline chloride in children with oral mucosal candidiasis, cases of respiratory disturbances associated with severe irritation of the upper respiratory tract mucosa have been reported.

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: e-mail: [email protected], tel.: (22) 49 21 301. Adverse reactions can also be reported to the responsible entity.

16. INFORMATION PROVIDED IN BRAILLE

Gencjana 0,5% roztwór wodny

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE INFORMATION

Not applicable.
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