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Genciana 0,5% roztvur vodni

Genciana 0,5% roztvur vodni

Ask a doctor about a prescription for Genciana 0,5% roztvur vodni

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use Genciana 0,5% roztvur vodni

INFORMATION PLACED ON OUTER PACKAGING

Bottle 20 g or 100 g

1. NAME OF THE MEDICINAL PRODUCT

GENCJANA 0.5% AQUEOUS SOLUTION

5 mg/g, solution for the skin

Methylrosanilinium chloride

2. CONTENT OF ACTIVE SUBSTANCE

Composition

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

3. LIST OF EXCIPIENTS

excipients:purified water.

4. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING

20 g
EAN Code: 5909990668212
100 g
EAN Code: 5909990668229

5. METHOD AND ROUTE OF ADMINISTRATION

Method and route of administration

Application to the skin.

6. WARNINGS REGARDING STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicine 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. STORAGE CONDITIONS

Storage conditions

Store at a temperature below 25°C, in the original packaging.
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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE ARISING FROM IT, IF APPROPRIATE

PRECAUTIONS

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

Marketing authorisation number 6682

13. BATCH NUMBER

Batch number

14. GENERAL CATEGORY OF ACCESSIBILITY

OTC - Medicine available without a prescription.

15. INSTRUCTIONS FOR USE

Indications for use

For the treatment of superficial skin and mucous membrane damage, and for use in purulent skin and mucous membrane infections, some fungal and yeast infections.

When not to use the medicine GENCJANA 0.5%

Do not use in case of hypersensitivity to methylrosanilinium chloride. Do not use in patients with porphyria.

Warnings and precautions

Do not use in the eyes, on granulating or ulcerating lesions on the face. Methylrosanilinium chloride stains tissues, stains fabrics and clothing. Stains on fabrics can be removed with a mixture of ethanol and acetic acid.

Medicine GENCJANA 0.5% and other medicines

Acidification or colloidal hydrated aluminium silicate (bentonite) weakens the effect of the medicine.

Pregnancy or breastfeeding

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Effect on ability to drive and use machines

The medicine has no effect or a negligible effect on the ability to drive and use machines.

How to use the medicine GENCJANA 0.5%

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The medicine should be used externally - locally, as a disinfectant.
In case of doubt, consult a doctor or pharmacist.

Use of a higher dose of the medicine GENCJANA 0.5% than recommended

In case of accidental ingestion of the medicine, consult a doctor.

Undesirable effects

Prolonged and frequent use, especially in children, may cause irritation or ulceration of the skin or mucous membranes in direct contact with the medicine. After application of methylrosanilinium chloride in children in cases of oral mucous membrane thrush, cases of respiratory distress associated with severe irritation of the upper respiratory tract mucous membranes have been reported.
If any undesirable effects occur, including any undesirable effects not listed on the label, consult a doctor or pharmacist. Undesirable effects 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. Undesirable effects can also be reported to the marketing authorisation holder.

16. INFORMATION PROVIDED IN BRAILLE

gencjana 0.5% aqueous solution

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.
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