GARGARIN Powder

Contents of the leaflet

1. INFORMATION PLACED ON OUTER PACKAGING
2. Carton Box
3. NAME OF THE MEDICINAL PRODUCT
4. CONTENT OF ACTIVE SUBSTANCES
5. LIST OF EXCIPIENTS
6. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING
7. METHOD AND ROUTE OF ADMINISTRATION
8. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT
   1. IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN
9. OTHER SPECIAL WARNINGS, IF NECESSARY
10. EXPIRY DATE
11. STORAGE CONDITIONS
12. SPECIAL PRECAUTIONS FOR DISPOSAL
    1. OF UNUSED MEDICINAL PRODUCT OR WASTE ARISING FROM IT, IF APPROPRIATE
13. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER
14. MARKETING AUTHORIZATION NUMBER
    1. MARKETING AUTHORIZATION NUMBERS
15. BATCH NUMBER
16. GENERAL CATEGORY OF AVAILABILITY
17. INSTRUCTIONS FOR USE
18. INFORMATION PROVIDED IN BRAILLE
    1. MINIMUM INFORMATION TO BE INCLUDED ON BLISTERS OR
    2. FOIL PACKAGING {Sachet}
19. NAME OF THE MEDICINAL PRODUCT
20. NAME OF THE MARKETING AUTHORIZATION HOLDER
21. EXPIRY DATE
22. BATCH NUMBER
23. OTHER
    1. INFORMATION TO BE INCLUDED ON IMMEDIATE PACKAGING
    2. Container
24. NAME OF THE MEDICINAL PRODUCT
25. CONTENT OF ACTIVE SUBSTANCES
26. LIST OF EXCIPIENTS
27. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING
28. METHOD AND ROUTE OF ADMINISTRATION
29. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT
    1. IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN
30. OTHER SPECIAL WARNINGS, IF NECESSARY
31. EXPIRY DATE
32. STORAGE CONDITIONS
33. SPECIAL PRECAUTIONS FOR DISPOSAL
    1. OF UNUSED MEDICINAL PRODUCT OR WASTE ARISING FROM IT, IF APPROPRIATE
34. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER
35. MARKETING AUTHORIZATION NUMBER
    1. MARKETING AUTHORIZATION NUMBERS
36. BATCH NUMBER
37. GENERAL CATEGORY OF AVAILABILITY
38. INSTRUCTIONS FOR USE
39. INFORMATION PROVIDED IN BRAILLE

INFORMATION PLACED ON OUTER PACKAGING

Carton Box

1. NAME OF THE MEDICINAL PRODUCT

Gargarin
Powder for solution for gargling

2. CONTENT OF ACTIVE SUBSTANCES

Composition: 5 g of powder for solution for gargling contains 1.74 g of borax,
1.74 g of sodium bicarbonate, 0.75 g of sodium chloride, 0.75 g of sodium benzoate, 0.02 g
of levomenthol.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING

6 sachets of 5 g each
EAN Code: 5909990269938

5. METHOD AND ROUTE OF ADMINISTRATION

Administration on the mucous membrane of the mouth and throat.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use after the expiry date.

8. EXPIRY DATE

Expiry date:

9. STORAGE CONDITIONS

Store at a temperature below 25°C. Store the medicinal product in a place invisible
and inaccessible to children.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE ARISING FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków

12. MARKETING AUTHORIZATION NUMBER

MARKETING AUTHORIZATION NUMBERS

Marketing Authorization No. R/2699

13. BATCH NUMBER

Batch No.:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product available without a prescription - OTC

15. INSTRUCTIONS FOR USE

Medicinal product with antiseptic and local anesthetic action
Indications: as an auxiliary in inflammatory conditions of the throat and mouth.
Contraindications: hypersensitivity to active substances. Do not use on damaged mucous membrane
of the mouth.
Warnings: do not swallow. Prolonged use and on extensive damage to the mucous membrane
may cause accumulation of borax in the body and lead to poisoning.
Sodium benzoate may cause mild irritation of the eyes, skin, and mucous membranes after local administration.
Interactions: none
Pregnancy and breastfeeding: use only in consultation with a doctor or pharmacist.
Method of administration: 5 g of powder (1 sachet) dissolved in a glass of warm water and gargle.
Repeat the procedure 2 to 3 times a day.
If symptoms worsen or do not improve after a few days, consult a doctor.
In case of doubts about the use of the medicinal product, consult a doctor or pharmacist.
Undesirable effects: may cause irritation of the mucous membrane of the mouth.
In case of any undesirable effects, discontinue use of the medicinal product. Undesirable effects can be reported to a healthcare professional,
the marketing authorization holder or the President of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products [current address, phone and fax number, e-mail address].
Overdose: lack of appetite, gastrointestinal disorders, weakness, headaches,
inflammatory reactions of the skin and mucous membranes.
[Logo]

16. INFORMATION PROVIDED IN BRAILLE

Gargarin

MINIMUM INFORMATION TO BE INCLUDED ON BLISTERS OR

FOIL PACKAGING {Sachet}

1. NAME OF THE MEDICINAL PRODUCT

GARGARIN

2. NAME OF THE MARKETING AUTHORIZATION HOLDER

[Company Logo]

3. EXPIRY DATE

[Batch Number]

4. BATCH NUMBER

[Expiry Date]

5. OTHER

5 g
Batch number and expiry date:
Legend:
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INFORMATION TO BE INCLUDED ON IMMEDIATE PACKAGING

Container

1. NAME OF THE MEDICINAL PRODUCT

Gargarin
Powder for solution for gargling

2. CONTENT OF ACTIVE SUBSTANCES

Composition: 5 g of powder for solution for gargling contains 1.74 g of borax,
1.74 g of sodium bicarbonate, 0.75 g of sodium chloride, 0.75 g of sodium benzoate, 0.02 g
of levomenthol.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING

30 g EAN Code: 5909990269921

5. METHOD AND ROUTE OF ADMINISTRATION

Administration on the mucous membrane of the mouth and throat.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use after the expiry date.

8. EXPIRY DATE

Expiry date:

9. STORAGE CONDITIONS

Store at a temperature below 25°C. Store the medicinal product in a place invisible
and inaccessible to children.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE ARISING FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków

12. MARKETING AUTHORIZATION NUMBER

MARKETING AUTHORIZATION NUMBERS

Marketing Authorization No. R/2699

13. BATCH NUMBER

Batch No.:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product available without a prescription - OTC

15. INSTRUCTIONS FOR USE

Medicinal product with antiseptic and local anesthetic action
Indications: as an auxiliary in inflammatory conditions of the throat and mouth.
Contraindications: hypersensitivity to active substances. Do not use on damaged mucous membrane
of the mouth.
Warnings: do not swallow. Prolonged use and on extensive damage to the mucous membrane
may cause accumulation of borax in the body and lead to poisoning.
Sodium benzoate may cause mild irritation of the eyes, skin, and mucous membranes after local administration.
Interactions: none
Pregnancy and breastfeeding: use only in consultation with a doctor or pharmacist.
Method of administration: 5 g of powder (1 teaspoon) dissolved in a glass of warm water and gargle.
Repeat the procedure 2 to 3 times a day.
If symptoms worsen or do not improve after a few days, consult a doctor.
In case of doubts about the use of the medicinal product, consult a doctor or pharmacist.
Undesirable effects: may cause irritation of the mucous membrane of the mouth.
In case of any undesirable effects, discontinue use of the medicinal product. Undesirable effects can be reported to a healthcare professional,
the marketing authorization holder or the President of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products [current address, phone and fax number, e-mail address].
Overdose: lack of appetite, gastrointestinal disorders, weakness, headaches,
inflammatory reactions of the skin and mucous membranes.
[Logo]

16. INFORMATION PROVIDED IN BRAILLE

Gargarin