Gargarin

INFORMATION ON OUTER PACKAGING
Cardboard box

1. NAME OF THE MEDICINAL PRODUCT

Gargarin
Powder for solution for gargling

2. COMPOSITION OF ACTIVE SUBSTANCES

Composition: 5 g of powder for preparing a 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 PACKAGE CONTENTS
6 sachets of 5 g each EAN code: 5909990269938

5. METHOD AND ROUTE OF ADMINISTRATION

Administration to the oral and pharyngeal mucosa.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use after the expiry date.

8. EXPIRY DATE

Expiry date:

9. STORAGE INSTRUCTIONS

Store below 25°C. Keep the medicine in a place out of sight and reach of children.

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

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

12. MARKETING AUTHORISATION NUMBER(S)

MARKETING AUTHORISATION NUMBERS
Authorisation number R/2699

13. BATCH NUMBER

Batch number:

14. GENERAL AVAILABILITY CATEGORY

Medicinal product available without a doctor's prescription - OTC

15. INSTRUCTIONS FOR USE

An antiseptic and locally anesthetic medicinal product.
Indications: adjunctive treatment in inflammatory conditions of the throat and oral cavity.
Contraindications: hypersensitivity to the active substances. Do not use on damaged oral
mucosa.
Warnings: do not swallow. Prolonged use or application over extensive areas of damaged
mucosa may lead to boric acid accumulation in the body and cause poisoning.
Sodium benzoate, when applied topically, may cause mild irritation of the eyes, skin, and
mucous membranes.
Interactions: none known.
Pregnancy and breastfeeding: use only upon consultation with a physician or pharmacist.
Method of administration: dissolve 5 g of powder (1 sachet) in a glass of warm water and
gargle. Repeat the procedure 2 to 3 times daily.
If symptoms worsen or do not improve within a few days, consult a physician.
In case of doubt regarding the use of the medicine, seek advice from a physician or
pharmacist.
Adverse effects: irritation of the oral mucosa may occur.
If any adverse effects occur, discontinue use of the medicine. Adverse effects may 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, telephone and fax numbers, e-mail address].
Overdose: lack of appetite, gastrointestinal disturbances, weakness, headache, inflammatory
reactions of the skin and mucous membranes.
[Logo]

16. INFORMATION PROVIDED IN BRAILLE

Gargarin
MINIMUM INFORMATION ON BLISTER PACKS OR
ALUMINUM FOIL PACKAGING
{Sachet}

1. NAME OF THE MEDICINAL PRODUCT

GARGARIN

2. NAME OF THE RESPONSIBLE ENTITY

[Company logo]

3. EXPIRY DATE

[Batch number]

4. BATCH NUMBER

[Expiry date]

5. OTHER

5 g
Batch number and expiry date: < on the reverse > < on the seal >
Legend:
< > optional
INFORMATION APPEARING ON THE PRIMARY PACKAGING
Container

1. NAME OF THE MEDICINAL PRODUCT

Gargarin
Powder for preparing a solution for gargling

2. COMPOSITION OF ACTIVE SUBSTANCES

Composition: 5 g of powder for preparing a 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 levo-menthol.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
30 g EAN code: 5909990269921

5. METHOD AND ROUTE OF ADMINISTRATION

Administration to the oral and pharyngeal mucosa.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use after the expiry date.

8. EXPIRY DATE

Expiry date:

9. STORAGE INSTRUCTIONS

Store below 25ºC. Keep the medicine in a place out of sight and reach of children.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER(S)

MARKETING AUTHORISATION NUMBERS
Authorisation number R/2699

13. BATCH NUMBER

Batch number:

14. GENERAL AVAILABILITY CATEGORY

Medicinal product available without a prescription - OTC

15. INSTRUCTIONS FOR USE

An antiseptic and locally anesthetic medicinal product.
Indications: as an adjunct in inflammatory conditions of the throat and oral cavity.
Contraindications: hypersensitivity to the active substances. Do not use on damaged oral
mucosa.
Warnings: do not swallow. Prolonged and extensive use on damaged mucosa may lead to
borax accumulation in the body and cause poisoning.
Sodium benzoate, when administered topically, may cause mild irritation of the eyes, skin,
and mucous membranes.
Interactions: none known.
Pregnancy and breastfeeding: use only after consultation with a physician or pharmacist.
Method of administration: dissolve 5 g of powder (1 teaspoon) in a glass of warm water and
gargle. Repeat the procedure 2 to 3 times daily.
If symptoms worsen or do not improve after several days, consult a physician.
In case of doubts regarding the use of the medicinal product, seek advice from a physician
or pharmacist.
Adverse reactions: irritation of the oral mucosa may occur.
If any adverse reactions occur, discontinue use of the product. Adverse reactions may 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, telephone number, fax, e-mail address].
Overdose: lack of appetite, gastrointestinal disturbances, weakness, headache, inflammatory
reactions of the skin and mucous membranes.
[Logo]

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

Gargarin